Date/Time of Define-XML document generation: 2021-02-25T16:18:22Z
Define-XML version: 2.0.0
Stylesheet version: 2018-11-21
Datasets
| Dataset | Description | Class | Structure | Purpose | Keys | Documentation | Location |
|---|---|---|---|---|---|---|---|
| TA | Trial Arms | TRIAL DESIGN | One record per planned element per arm | Tabulation | STUDYID, ARMCD, TAETORD | ta.xpt | |
| TE | Trial Elements | TRIAL DESIGN | One record per planned element | Tabulation | STUDYID, ETCD | te.xpt | |
| TI | Trial Inclusion/Exclusion Criteria | TRIAL DESIGN | One record per I/E criterion per protocol criteria versions | Tabulation | STUDYID, IETESTCD, TIVERS | ti.xpt | |
| TS | Trial Summary | TRIAL DESIGN | One record per trial summary parameter value | Tabulation | STUDYID, TSPARMCD, TSSEQ | ts.xpt | |
| TV | Trial Visits | TRIAL DESIGN | One record per planned visit per arm | Tabulation | STUDYID, VISITNUM, ARMCD | tv.xpt | |
| CO | Comments | SPECIAL PURPOSE | One record per related domain per comment reference per identifying variable per identifying variable value per evaluator per time point per subject | Tabulation | STUDYID, USUBJID, RDOMAIN, COREF, IDVAR, IDVARVAL, COEVAL, CODTC | co.xpt | |
| DM | Demographics | SPECIAL PURPOSE | One record per subject | Tabulation | STUDYID, USUBJID | dm.xpt | |
| SE | Subject Elements | SPECIAL PURPOSE | One record per actual element per subject | Tabulation | STUDYID, USUBJID, TAETORD | se.xpt | |
| SV | Subject Visits | SPECIAL PURPOSE | One record per actual visit per subject | Tabulation | STUDYID, USUBJID, VISITNUM | sv.xpt | |
| CM | Concomitant/Prior Medications | INTERVENTIONS | One record per recorded medication occurrence or constant-dosing interval per subject | Tabulation | STUDYID, USUBJID, CMTRT, CMSTDTC | cm.xpt | |
| EC | Exposure as Collected | INTERVENTIONS | One record per protocol-specified study treatment, collected-dosing interval, per subject | Tabulation | STUDYID, USUBJID, ECTRT, ECSTDTC | ec.xpt | |
| EX | Exposure | INTERVENTIONS | One record per constant dosing interval per subject | Tabulation | STUDYID, USUBJID, EXTRT, EXSTDTC | ex.xpt | |
| AE | Adverse Events | EVENTS | One record per adverse event per subject | Tabulation | STUDYID, USUBJID, AEDECOD, AESTDTC, AELLT | ae.xpt | |
| CE | Clinical Events | EVENTS | One record per reaction per observation period per subject | Tabulation | STUDYID, USUBJID, CETERM, CERFTDTC, CESTDTC | ce.xpt | |
| DS | Disposition | EVENTS | One record per disposition status or protocol milestone per subject | Tabulation | STUDYID, USUBJID, DSSTDTC, DSCAT, DSSCAT, DSDECOD | ds.xpt | |
| DV | Protocol Deviations | EVENTS | One record per protocol deviation per subject | Tabulation | STUDYID, USUBJID, DVSEQ | dv.xpt | |
| MH | Medical History | EVENTS | One record per medical history event per subject | Tabulation | STUDYID, USUBJID, MHTERM, MHDECOD | mh.xpt | |
| EG | ECG Test Results | FINDINGS | One record per ECG observation per time point per visit per subject | Tabulation | STUDYID, USUBJID, EGTESTCD, VISITNUM | eg.xpt | |
| FACE | Findings About Clinical Events (FA) | FINDINGS | One record per finding per object per reference time point per time point per evaluator per subject | Tabulation | STUDYID, USUBJID, FASCAT, FATESTCD, FAOBJ, FARFTDTC, FADTC, FATPTNUM, FAEVAL, QNAM.STUDYDAY | face.xpt | |
| IS | Immunogenicity Specimen Assessments | FINDINGS | One record per test per visit per subject | Tabulation | STUDYID, USUBJID, ISTESTCD, VISITNUM, ISDTC | is.xpt | |
| LB | Laboratory Test Results | FINDINGS | One record per analyte per specimen type per LOINC code per time point per visit number per subject | Tabulation | STUDYID, USUBJID, LBCAT, LBSCAT, LBTESTCD, LBSPEC, LBLOINC, LBDTC, VISITNUM | lb.xpt | |
| MB | Microbiology Specimen | FINDINGS | One record per microbiology specimen finding per time point per subject | Tabulation | STUDYID, USUBJID, MBTESTCD, MBDTC | mb.xpt | |
| PE | Physical Examination | FINDINGS | One record per body system or abnormality per visit per subject | Tabulation | STUDYID, USUBJID, PETESTCD, VISITNUM | pe.xpt | |
| RP | Reproductive System Findings | FINDINGS | One record per Reproductive System Finding per time point per visit per subject | Tabulation | STUDYID, USUBJID, RPTESTCD, VISITNUM, RPDTC | rp.xpt | |
| VS | Vital Signs | FINDINGS | One record per vital sign measurement per time point per subject | Tabulation | STUDYID, USUBJID, VSTESTCD, VSDTC, VSTPTNUM, VSCAT | vs.xpt | |
| XA | Ancillary Analysis and Visit Details | FINDINGS | One record per finding per time point per visit per subject | Tabulation | STUDYID, USUBJID, XACAT, XATESTCD, XADTC, VISITNUM | xa.xpt | |
| XB | HLA Typing | FINDINGS | One record per finding per time point per subject | Tabulation | STUDYID, USUBJID, XBCAT, XBTESTCD, XBDTC | xb.xpt | |
| RELREC | Related Records | RELATIONSHIP | One record per related record, group of records or datasets | Tabulation | STUDYID, RELID, RDOMAIN, IDVAR | relrec.xpt | |
| SUPPAE | Supplemental Qualifiers for AE (Adverse Events) | RELATIONSHIP | One record per IDVAR, IDVARVAL and QNAM value per subject | Tabulation | STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM | suppae.xpt | |
| SUPPCM | Supplemental Qualifiers for CM (Concomitant/Prior Medications) | RELATIONSHIP | One record per IDVAR, IDVARVAL and QNAM value per subject | Tabulation | STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM | suppcm.xpt | |
| SUPPDM | Supplemental Qualifiers for DM (Demographics) | RELATIONSHIP | One record per IDVAR, IDVARVAL and QNAM value per subject | Tabulation | STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM | suppdm.xpt | |
| SUPPDS | Supplemental Qualifiers for DS (Disposition) | RELATIONSHIP | One record per IDVAR, IDVARVAL and QNAM value per subject | Tabulation | STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM | suppds.xpt | |
| SUPPDV | Supplemental Qualifiers for DV (Protocol Deviations) | RELATIONSHIP | One record per IDVAR, IDVARVAL and QNAM value per subject | Tabulation | STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM | suppdv.xpt | |
| SUPPEC | Supplemental Qualifiers for EC (Exposure as Collected) | RELATIONSHIP | One record per IDVAR, IDVARVAL and QNAM value per subject | Tabulation | STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM | suppec.xpt | |
| SUPPEG | Supplemental Qualifiers for EG (ECG Test Results) | RELATIONSHIP | One record per IDVAR, IDVARVAL and QNAM value per subject | Tabulation | STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM | suppeg.xpt | |
| SUPPEX | Supplemental Qualifiers for EX (Exposure) | RELATIONSHIP | One record per IDVAR, IDVARVAL and QNAM value per subject | Tabulation | STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM | suppex.xpt | |
| SUPPFACE | Supplemental Qualifiers for FACE (SUPPFA) | RELATIONSHIP | One record per IDVAR, IDVARVAL and QNAM value per subject | Tabulation | STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM | suppface.xpt | |
| SUPPLB | Supplemental Qualifiers for LB (Laboratory Test Results) | RELATIONSHIP | One record per IDVAR, IDVARVAL and QNAM value per subject | Tabulation | STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM | supplb.xpt | |
| SUPPPE | Supplemental Qualifiers for PE (Physical Examination) | RELATIONSHIP | One record per IDVAR, IDVARVAL and QNAM value per subject | Tabulation | STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM | supppe.xpt | |
| SUPPRP | Supplemental Qualifiers for RP (Reproductive System Findings) | RELATIONSHIP | One record per IDVAR, IDVARVAL and QNAM value per subject | Tabulation | STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM | supprp.xpt | |
| SUPPVS | Supplemental Qualifiers for VS (Vital Signs) | RELATIONSHIP | One record per IDVAR, IDVARVAL and QNAM value per subject | Tabulation | STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM | suppvs.xpt | |
| SUPPXA | Supplemental Qualifiers for XA (Ancillary Analysis and Visit Details) | RELATIONSHIP | One record per IDVAR, IDVARVAL and QNAM value per subject | Tabulation | STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM | suppxa.xpt |
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Trial Arms (TA)
| Variable | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | |
| DOMAIN | Domain Abbreviation | text | Identifier | 2 | Assigned Domain abbreviation of dataset. | |
| ARMCD | Planned Arm Code | text | Topic | 14 | Planned Arm Code [18 Terms] | Assigned |
| ARM | Description of Planned Arm | text | Synonym Qualifier | 24 | Description of Planned Arm [18 Terms] | Protocol |
| TAETORD | Planned Order of Element within Arm | integer | Timing | 8 | Protocol | |
| ETCD | Element Code | text | Record Qualifier | 8 | Element Code [39 Terms] | Assigned |
| ELEMENT | Description of Element | text | Synonym Qualifier | 32 | Description of Element [39 Terms] | Protocol |
| TABRANCH | Branch | text | Rule | 27 | Protocol | |
| TATRANS | Transition Rule | text | Rule | 50 | Protocol | |
| EPOCH | Epoch | text | Timing | 9 | Epoch
| Protocol |
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Trial Elements (TE)
| Variable | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | |
| DOMAIN | Domain Abbreviation | text | Identifier | 2 | Assigned Domain abbreviation of dataset. | |
| ETCD | Element Code | text | Topic | 8 | Element Code [39 Terms] | Assigned |
| ELEMENT | Description of Element | text | Synonym Qualifier | 32 | Description of Element [39 Terms] | Protocol |
| TESTRL | Rule for Start of Element | text | Rule | 28 | Protocol | |
| TEENRL | Rule for End of Element | text | Rule | 45 | Protocol | |
| TEDUR | Planned Duration of Element | durationDatetime | Timing | ISO 8601 | Protocol |
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Trial Inclusion/Exclusion Criteria (TI)
| Variable | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | |
| DOMAIN | Domain Abbreviation | text | Identifier | 2 | Assigned Domain abbreviation of dataset. | |
| IETESTCD | Inclusion/Exclusion Criterion Short Name | text | Topic | 6 | Inclusion/Exclusion Test Code [68 Terms] | Assigned |
| IETEST | Inclusion/Exclusion Criterion | text | Synonym Qualifier | 200 | Inclusion/Exclusion Test Code [68 Terms] | Assigned |
| IECAT | Inclusion/Exclusion Category | text | Grouping Qualifier | 9 | Category for Inclusion/Exclusion
| Assigned |
| TIVERS | Protocol Criteria Versions | text | Record Qualifier | 3 | Protocol |
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Trial Summary (TS)
| Variable | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | |
| DOMAIN | Domain Abbreviation | text | Identifier | 2 | Assigned Domain abbreviation of dataset. | |
| TSSEQ | Sequence Number | integer | Identifier | 8 | Derived Sequential number uniquely identifying the records within the domain by TSPARMCD. | |
| TSGRPID | Group ID | text | Identifier | 7 | Assigned | |
| TSPARMCD | Trial Summary Parameter Short Name | text | Topic | 8 | Trial Summary Parameter Test Code [50 Terms] | Assigned |
| TSPARM | Trial Summary Parameter | text | Synonym Qualifier | 40 | Trial Summary Parameter Test Name [50 Terms] | Assigned |
| TSVAL | Parameter Value | text | Result Qualifier | 198 | Assigned | |
| TSVAL1 | Parameter Value 1 | text | Result Qualifier | 191 | Assigned | |
| TSVAL2 | Parameter Value 2 | text | Result Qualifier | 59 | Assigned | |
| TSVALNF | Parameter Null Flavor | text | Result Qualifier | 3 | Assigned | |
| TSVALCD | Parameter Value Code | text | Result Qualifier | 14 | Assigned | |
| TSVCDREF | Name of the Reference Terminology | text | Result Qualifier | 18 | Assigned | |
| TSVCDVER | Version of the Reference Terminology | date | Result Qualifier | ISO 8601 | Assigned |
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Trial Visits (TV)
| Variable | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | |
| DOMAIN | Domain Abbreviation | text | Identifier | 2 | Assigned Domain abbreviation of dataset. | |
| VISITNUM | Visit Number | float | Topic | 4 | Assigned Numeric value assigned to VISIT variable | |
| VISIT | Visit Name | text | Synonym Qualifier | 30 | Protocol | |
| VISITDY | Planned Study Day of Visit | integer | Timing | 8 | Protocol | |
| ARMCD | Planned Arm Code | text | Record Qualifier | 1 | Planned Arm Code [18 Terms] | Assigned |
| TVSTRL | Visit Start Rule | text | Rule | 72 | Protocol | |
| TVENRL | Visit End Rule | text | Rule | 33 | Protocol |
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Comments (CO)
| Variable | Where Condition | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | ||
| DOMAIN | Domain Abbreviation | text | Identifier | 2 | Assigned Domain abbreviation of dataset. | ||
| RDOMAIN | Related Domain Abbreviation | text | Record Qualifier | 2 | SDTM Domain Abbreviation (CO)
| Assigned Abbreviation for the domain of the parent record(s). | |
| USUBJID | Unique Subject Identifier | text | Identifier | 21 | Derived Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) | ||
| COSEQ | Sequence Number | integer | Identifier | 8 | Derived Unique sequence number within a subject when dataset is sorted by the key variables. | ||
| IDVAR | Identifying Variable | text | Record Qualifier | 5 | Identifying Variable in Comments
| Assigned Identifying variable in the related dataset that identifies the related record(s). | |
| IDVARVAL | Identifying Variable Value | text | Record Qualifier | 3 | Assigned Value of variable specified by IDVAR on the parent record(s). | ||
| COREF | Comment Reference | text | Record Qualifier | 81 | CRF Annotated Case Report Form [37 ] | ||
| COVALVLM | Comment | text | Topic | 200 | |||
| RDOMAIN = "LB" (Laboratory Test Results) | Related Domain Abbreviation (CO) | text | 97 | eDT | |||
| RDOMAIN ≠"LB" (Laboratory Test Results) | Related Domain Abbreviation (CO) | text | 200 | CRF Annotated Case Report Form [37 ] | |||
| COVAL1 | Comment 1 | text | Topic | 133 | CRF Annotated Case Report Form [37 ] | ||
| COEVAL | Evaluator | text | Record Qualifier | 12 | Evaluator for CO
| eDT | |
| CODTC | Date/Time of Comment | date | Timing | ISO 8601 | CRF Annotated Case Report Form [37 ] | ||
| CODY | Study Day of Visit/Collection/Exam | integer | Timing | 8 | Derived Study day of observation relative to the Subject Reference Start Date/Time (DM.RFSTDTC).
--DY = (date portion of --DTC) - (date portion of DM.RFSTDTC) + 1 where date portion of --DTC is on or after date portion of DM.RFSTDTC; Otherwise --DY = (date portion of --DTC) - (date portion of DM.RFSTDTC). |
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Demographics (DM)
| Related Supplemental Qualifiers Dataset: SUPPDM (Supplemental Qualifiers for DM) | |||||||
| Variable | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment | |
|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | ||
| DOMAIN | Domain Abbreviation | text | Identifier | 2 | Assigned Domain abbreviation of dataset. | ||
| USUBJID | Unique Subject Identifier | text | Identifier | 21 | Derived Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) | ||
| SUBJID | Subject Identifier for the Study | text | Topic | 5 | CRF Annotated Case Report Form [1 ] | ||
| RFSTDTC | Subject Reference Start Date/Time | partialDatetime | Record Qualifier | ISO 8601 | Derived Date of First Dose in ISO8601 format. | ||
| RFENDTC | Subject Reference End Date/Time | date | Record Qualifier | ISO 8601 | Derived Date of last dose equal to DS.DSSTDTC when DSSCAT='END OF TRIAL' and dsdecod='COMPLETED' else if DS.DSCAT='DISPOSITION EVENT' and DSDECOD ne 'COMPLETED' then RFENDTC =SUPPDS.LASTCONT. | ||
| RFXSTDTC | Date/Time of First Study Treatment | partialDatetime | Record Qualifier | ISO 8601 | Derived Date of First Dose in ISO8601 format. | ||
| RFXENDTC | Date/Time of Last Study Treatment | partialDatetime | Record Qualifier | ISO 8601 | Derived Date of last dose equal to last non-missing value of EX.EXENDTC in ISO8601 format. | ||
| RFICDTC | Date/Time of Informed Consent | partialDatetime | Record Qualifier | ISO 8601 | CRF Annotated Case Report Form [1 ] | ||
| RFPENDTC | Date/Time of End of Participation | date | Record Qualifier | ISO 8601 | Derived if DS.DSCAT='DISPOSITION EVENT' and DSDECOD ne 'COMPLETED' then RFPENDTC =SUPPDS.LASTCONT. | ||
| DTHDTC | Date/Time of Death | date | Record Qualifier | ISO 8601 | CRF Annotated Case Report Form [25 ] | ||
| DTHFL | Subject Death Flag | text | Record Qualifier | 1 | No Yes Response (Yes only)
| Derived DTHFL='Y' when disposition reason is 'Death' | |
| SITEID | Study Site Identifier | text | Record Qualifier | 12 | Study Site Identifier
| Assigned | |
| INVID | Investigator Identifier | text | Record Qualifier | 2 | Investigator Identifier
| Assigned | |
| INVNAM | Investigator Name | text | Synonym Qualifier | 13 | Investigator Name
| Assigned | |
| AGE | Age | integer | Record Qualifier | 2 | CRF Annotated Case Report Form [2 ] | ||
| AGEU | Age Units | text | Variable Qualifier | 5 | Age Unit
| CRF Annotated Case Report Form [2 ] | |
| SEX | Sex | text | Record Qualifier | 1 | Sex
| CRF Annotated Case Report Form [2 ] | |
| RACE | Race | text | Record Qualifier | 25 | Race [9 Terms] | CRF Annotated Case Report Form [2 ] | |
| ETHNIC | Ethnicity | text | Record Qualifier | 22 | Ethnic Group
| CRF Annotated Case Report Form [2 ] | |
| ARMCD | Planned Arm Code | text | Record Qualifier | 14 | Planned Arm Code [18 Terms] | Assigned | |
| ARM | Description of Planned Arm | text | Synonym Qualifier | 24 | Description of Planned Arm [18 Terms] | Assigned | |
| ACTARMCD | Actual Arm Code | text | Record Qualifier | 14 | Actual Arm Code [18 Terms] | Assigned | |
| ACTARM | Description of Actual Arm | text | Synonym Qualifier | 24 | Description of Actual Arm [18 Terms] | Derived DM.ACTARM=DM.ARM | |
| COUNTRY | Country | text | Record Qualifier | ISO3166 | Country
| Assigned Assigned based on the site. | |
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Subject Elements (SE)
| Variable | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | |
| DOMAIN | Domain Abbreviation | text | Identifier | 2 | Assigned Domain abbreviation of dataset. | |
| USUBJID | Unique Subject Identifier | text | Identifier | 21 | Derived Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) | |
| SESEQ | Sequence Number | integer | Identifier | 8 | Derived Unique sequence number within a subject when dataset is sorted by the key variables. | |
| ETCD | Element Code | text | Topic | 8 | Element Code [39 Terms] | Derived Record created with ETCD = 'SCRN' when record exists in DS with DSDECOD = 'INFORMED CONSENT OBTAINED'. Record created with ETCD = 'PREDOSE' when record exists in SV with VISITNUM = 2 (Day 1 visit). Record created with ETCD = 'VAXB#C#P' when record exists in EX with VISITNUM = 2 (Day 1 visit). Record created with ETCD = 'VAXB#C#B' when record exists in EX with VISITNUM = 6 (Day 22 visit). Record created with ETCD = 'FUP' when record exists in SV with VISITNUM = 9 (EoT visit). Note: In the VAXB#C#P/VAXB#C#B elements, B# represents the name of the vaccine (B1 or B2) and C# represents the name of the cohort (C1-C5) to which the subject is allocated. This information is found in SUPPDS.GROUP and SUPPDS.COHORT. |
| ELEMENT | Description of Element | text | Synonym Qualifier | 32 | Description of Element [39 Terms] | Protocol |
| TAETORD | Planned Order of Element within Arm | integer | Timing | 8 | Protocol | |
| EPOCH | Epoch | text | Timing | 9 | Epoch
| Derived Set to EPOCH value from the record in SE for the given USUBJID meeting the following criteria: If the observation date or event start date (--DTC / --STDTC) is prior to the element start date (SESTDTC) for the record with ETCD='PREDOSE', set to 'SCREENING'. Otherwise, if the observation date / event start date is prior to element start date for the record with ETCD='VXxxxxxP', set to 'BASELINE'. Otherwise, if the observation date / event start date is prior to element start date for the record with ETCD='FUP' or if the 'FUP' record does not exist, set to 'TREATMENT'. Otherwise, set to 'FUP'. |
| SESTDTC | Start Date/Time of Element | partialDatetime | Timing | ISO 8601 | Derived Set to DS.DSSTDTC where DSDECOD = 'INFORMED CONSENT OBTAINED' when ETCD = 'SCRN'. Set to date part of SV.SVSTDTC where VISITNUM = 2 + 00:00 for time when ETCD = 'PREDOSE'. Set to EX.EXSTDTC where VISITNUM = 2 when ETCD = 'VAXB#C#P'. Set to EX.EXSTDTC where VISITNUM = 6 when ETCD = 'VAXB#C#B'. Set to SV.SVENDTC where VISITNUM = 9 when ETCD = 'FUP'. | |
| SEENDTC | End Date/Time of Element | partialDatetime | Timing | ISO 8601 | Derived Set to SESTDTC of the succeeding element for all values of ETCD except 'FUP'. When ETCD = 'FUP', set to DS.DSSTDTC where DSDECOD = 'END OF FOLLOW-UP COMPLETED'. | |
| SESTDY | Study Day of Start of Observation | integer | Timing | 8 | Derived Study day of start of event relative to the Subject Reference Start Date/Time (DM.RFSTDTC).
--STDY = (date portion of --STDTC) - (date portion of DM.RFSTDTC) + 1 when date portion of --STDTC is on or after date portion of DM.RFSTDTC; Otherwise --STDY = (date portion of --STDTC) - (date portion of DM.RFSTDTC). | |
| SEENDY | Study Day of End of Observation | integer | Timing | 8 | Derived Study day of end of event relative to the Subject Reference Start Date/Time (DM.RFSTDTC).
--ENDY = (date portion of --ENDTC) - (date portion of DM.RFSTDTC) + 1 when date portion of --ENDTC is on or after date portion of DM.RFSTDTC; Otherwise --ENDY = (date portion of --ENDTC) - (date portion of DM.RFSTDTC). |
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Subject Visits (SV)
| Variable | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | |
| DOMAIN | Domain Abbreviation | text | Identifier | 2 | Assigned Domain abbreviation of dataset. | |
| USUBJID | Unique Subject Identifier | text | Identifier | 21 | Derived Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) | |
| VISITNUM | Visit Number | float | Topic | 5 | Assigned Numeric value assigned to VISIT variable | |
| VISIT | Visit Name | text | Synonym Qualifier | 30 | Derived Populated with the complete list of visits that a subject attended, excluding any unscheduled visits. | |
| EPOCH | Epoch | text | Timing | 9 | Epoch
| Derived Set to EPOCH value from the record in SE for the given USUBJID meeting the following criteria: If the observation date or event start date (--DTC / --STDTC) is prior to the element start date (SESTDTC) for the record with ETCD='PREDOSE', set to 'SCREENING'. Otherwise, if the observation date / event start date is prior to element start date for the record with ETCD='VXxxxxxP', set to 'BASELINE'. Otherwise, if the observation date / event start date is prior to element start date for the record with ETCD='FUP' or if the 'FUP' record does not exist, set to 'TREATMENT'. Otherwise, set to 'FUP'. |
| SVSTDTC | Start Date/Time of Visit | date | Timing | ISO 8601 | Derived Populated with the most historic date/time combination found at a given visit using the following SDTM variables: xx.xxDTC, xx.xxSTDTC | |
| SVENDTC | End Date/Time of Visit | date | Timing | ISO 8601 | Derived Populated with the most recent date/time combination found at a given visit using the following SDTM variables: xx.xxDTC, xx.xxENDTC | |
| SVSTDY | Study Day of Start of Visit | integer | Timing | 8 | Derived Study day of start of event relative to the Subject Reference Start Date/Time (DM.RFSTDTC).
--STDY = (date portion of --STDTC) - (date portion of DM.RFSTDTC) + 1 when date portion of --STDTC is on or after date portion of DM.RFSTDTC; Otherwise --STDY = (date portion of --STDTC) - (date portion of DM.RFSTDTC). | |
| SVENDY | Study Day of End of Visit | integer | Timing | 8 | Derived Study day of end of event relative to the Subject Reference Start Date/Time (DM.RFSTDTC).
--ENDY = (date portion of --ENDTC) - (date portion of DM.RFSTDTC) + 1 when date portion of --ENDTC is on or after date portion of DM.RFSTDTC; Otherwise --ENDY = (date portion of --ENDTC) - (date portion of DM.RFSTDTC). | |
| SVUPDES | Description of Unplanned Visit | text | Synonym Qualifier | 148 | Assigned |
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Concomitant/Prior Medications (CM)
| Related Supplemental Qualifiers Dataset: SUPPCM (Supplemental Qualifiers for CM) | |||||||
| Variable | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment | |
|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | ||
| DOMAIN | Domain Abbreviation | text | Identifier | 2 | Assigned Domain abbreviation of dataset. | ||
| USUBJID | Unique Subject Identifier | text | Identifier | 21 | Derived Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) | ||
| CMSEQ | Sequence Number | integer | Identifier | 8 | Derived Unique sequence number within a subject when dataset is sorted by the key variables. | ||
| CMTRT | Reported Name of Drug, Med, or Therapy | text | Topic | 58 | CRF Annotated Case Report Form [36 ] | ||
| CMMODIFY | Modified Reported Name | text | Synonym Qualifier | 85 | Assigned | ||
| CMDECOD | Standardized Medication Name | text | Synonym Qualifier | 73 | Assigned | ||
| CMINDC | Indication | text | Record Qualifier | 155 | CRF Annotated Case Report Form [36 ] | ||
| CMDOSTXT | Dose Description | text | Record Qualifier | 22 | CRF Annotated Case Report Form [36 ] | ||
| CMDOSU | Dose Units | text | Variable Qualifier | 11 | Unit (CM) [20 Terms] | CRF Annotated Case Report Form [36 ] | |
| CMDOSFRQ | Dosing Frequency per Interval | text | Variable Qualifier | 16 | Frequency (CM) [86 Terms] | CRF Annotated Case Report Form [36 ] | |
| CMROUTE | Route of Administration | text | Variable Qualifier | 12 | Route of Administration Response (CM) [133 Terms] | CRF Annotated Case Report Form [36 ] | |
| EPOCH | Epoch | text | Timing | 9 | Epoch
| Derived Set to EPOCH value from the record in SE for the given USUBJID meeting the following criteria: If the observation date or event start date (--DTC / --STDTC) is prior to the element start date (SESTDTC) for the record with ETCD='PREDOSE', set to 'SCREENING'. Otherwise, if the observation date / event start date is prior to element start date for the record with ETCD='VXxxxxxP', set to 'BASELINE'. Otherwise, if the observation date / event start date is prior to element start date for the record with ETCD='FUP' or if the 'FUP' record does not exist, set to 'TREATMENT'. Otherwise, set to 'FUP'. | |
| CMSTDTC | Start Date/Time of Medication | partialDatetime | Timing | ISO 8601 | CRF Annotated Case Report Form [36 ] | ||
| CMENDTC | End Date/Time of Medication | partialDatetime | Timing | ISO 8601 | CRF Annotated Case Report Form [36 ] | ||
| CMSTDY | Study Day of Start of Medication | integer | Timing | 8 | Derived Study day of start of event relative to the Subject Reference Start Date/Time (DM.RFSTDTC).
--STDY = (date portion of --STDTC) - (date portion of DM.RFSTDTC) + 1 when date portion of --STDTC is on or after date portion of DM.RFSTDTC; Otherwise --STDY = (date portion of --STDTC) - (date portion of DM.RFSTDTC). | ||
| CMENDY | Study Day of End of Medication | integer | Timing | 8 | Derived Study day of end of event relative to the Subject Reference Start Date/Time (DM.RFSTDTC).
--ENDY = (date portion of --ENDTC) - (date portion of DM.RFSTDTC) + 1 when date portion of --ENDTC is on or after date portion of DM.RFSTDTC; Otherwise --ENDY = (date portion of --ENDTC) - (date portion of DM.RFSTDTC). | ||
| CMSTRTPT | Start Relative to Reference Time Point | text | Timing | 6 | Relation to Reference Period (CM Start)
| CRF Annotated Case Report Form [36 ] | |
| CMSTTPT | Start Reference Time Point | text | Timing | 11 | Start Reference Time Point
| CRF Annotated Case Report Form [36 ] | |
| CMENRTPT | End Relative to Reference Time Point | text | Timing | 1 | Relation to Reference Period (End)
| CRF Annotated Case Report Form [36 ] | |
| CMENTPT | End Reference Time Point | text | Timing | 1 | End Reference Time Point
| CRF Annotated Case Report Form [36 ] | |
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Exposure as Collected (EC)
| Related Supplemental Qualifiers Dataset: SUPPEC (Supplemental Qualifiers for EC) | |||||||
| Variable | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment | |
|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | ||
| DOMAIN | Domain Abbreviation | text | Identifier | 2 | Assigned Domain abbreviation of dataset. | ||
| USUBJID | Unique Subject Identifier | text | Identifier | 21 | Derived Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) | ||
| ECSEQ | Sequence Number | integer | Identifier | 8 | Derived Unique sequence number within a subject when dataset is sorted by the key variables. | ||
| ECTRT | Name of Treatment | text | Topic | 8 | Name of Treatment
| CRF Annotated Case Report Form [20 ] | |
| ECPRESP | Pre-Specified | text | Record Qualifier | 1 | No Yes Response (Yes only)
| Assigned | |
| ECOCCUR | Occurrence | text | Record Qualifier | 1 | No Yes Response
| CRF Annotated Case Report Form [20 ] | |
| ECDOSE | Dose | float | Record Qualifier | 4 | CRF Annotated Case Report Form [20 ] | ||
| ECDOSU | Dose Units | text | Variable Qualifier | 2 | Dose Units in EC
| CRF Annotated Case Report Form [20 ] | |
| ECDOSFRM | Dose Form | text | Variable Qualifier | 9 | Dose Form in EC
| CRF Annotated Case Report Form [20 ] | |
| ECROUTE | Route of Administration | text | Variable Qualifier | 13 | Route of Administration in EC
| CRF Annotated Case Report Form [20 ] | |
| ECLOC | Location of Dose Administration | text | Record Qualifier | 3 | Location of Dose Administration for EC
| CRF Annotated Case Report Form [20 ] | |
| ECLAT | Laterality | text | Record Qualifier | 5 | Laterality in EC
| CRF Annotated Case Report Form [20 ] | |
| ECDIR | Directionality | text | Variable Qualifier | 5 | Directionality in EC
| CRF Annotated Case Report Form [20 ] | |
| VISITNUM | Visit Number | float | Timing | 5 | Assigned Numeric value assigned to VISIT variable | ||
| VISIT | Visit Name | text | Timing | 25 | Assigned Assigned from raw data visit variable collected on CRF | ||
| EPOCH | Epoch | text | Timing | 9 | Epoch
| Derived Set to EPOCH value from the record in SE for the given USUBJID meeting the following criteria: If the observation date or event start date (--DTC / --STDTC) is prior to the element start date (SESTDTC) for the record with ETCD='PREDOSE', set to 'SCREENING'. Otherwise, if the observation date / event start date is prior to element start date for the record with ETCD='VXxxxxxP', set to 'BASELINE'. Otherwise, if the observation date / event start date is prior to element start date for the record with ETCD='FUP' or if the 'FUP' record does not exist, set to 'TREATMENT'. Otherwise, set to 'FUP'. | |
| ECSTDTC | Start Date/Time of Treatment | partialDatetime | Timing | ISO 8601 | CRF Annotated Case Report Form [20 ] | ||
| ECENDTC | End Date/Time of Treatment | partialDatetime | Timing | ISO 8601 | Derived EC.ECENDTC=EX.EXENDTC where EX.VISITNUM=EC.VISITNUM | ||
| ECSTDY | Study Day of Start of Treatment | integer | Timing | 8 | Derived Study day of start of event relative to the Subject Reference Start Date/Time (DM.RFSTDTC).
--STDY = (date portion of --STDTC) - (date portion of DM.RFSTDTC) + 1 when date portion of --STDTC is on or after date portion of DM.RFSTDTC; Otherwise --STDY = (date portion of --STDTC) - (date portion of DM.RFSTDTC). | ||
| ECENDY | Study Day of End of Treatment | integer | Timing | 8 | Derived Study day of end of event relative to the Subject Reference Start Date/Time (DM.RFSTDTC).
--ENDY = (date portion of --ENDTC) - (date portion of DM.RFSTDTC) + 1 when date portion of --ENDTC is on or after date portion of DM.RFSTDTC; Otherwise --ENDY = (date portion of --ENDTC) - (date portion of DM.RFSTDTC). | ||
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Exposure (EX)
| Related Supplemental Qualifiers Dataset: SUPPEX (Supplemental Qualifiers for EX) | |||||||
| Variable | Where Condition | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | ||
| DOMAIN | Domain Abbreviation | text | Identifier | 2 | Assigned Domain abbreviation of dataset. | ||
| USUBJID | Unique Subject Identifier | text | Identifier | 21 | Derived Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) | ||
| EXSEQ | Sequence Number | integer | Identifier | 8 | Derived Unique sequence number within a subject when dataset is sorted by the key variables. | ||
| EXTRT | Name of Treatment | text | Topic | 8 | Name of Treatment
| CRF Annotated Case Report Form [20 ] | |
| EXDOSEVLM | Dose | integer | Record Qualifier | 8 | |||
| QNAM = "TOTDOS" and QVAL = "No" | Total Dose is not given | integer | 4 | Derived When total dose is not given, computed as the total dose (EC.ECDOSE) - (rest of dose (SUPPEX.RESTVOL) * planned dose / total dose). | |||
| QNAM = "TOTDOS" and QVAL = "Yes" | Total Dose is given | integer | 4 | CRF Annotated Case Report Form [20 ] | |||
| EXDOSU | Dose Units | text | Variable Qualifier | 2 | Dose Units in EX
| CRF Annotated Case Report Form [20 ] | |
| EXDOSFRM | Dose Form | text | Variable Qualifier | 9 | Dose Form in EX
| CRF Annotated Case Report Form [20 ] | |
| EXROUTE | Route of Administration | text | Variable Qualifier | 13 | Route of Administration in EX
| CRF Annotated Case Report Form [20 ] | |
| EXLOC | Location of Dose Administration | text | Record Qualifier | 3 | Location of Dose Administration for EX
| CRF Annotated Case Report Form [20 ] | |
| EXLAT | Laterality | text | Variable Qualifier | 5 | Laterality in EX
| CRF Annotated Case Report Form [20 ] | |
| EXDIR | Directionality | text | Variable Qualifier | 5 | Directionality in EX
| CRF Annotated Case Report Form [20 ] | |
| VISITNUM | Visit Number | float | Timing | 5 | Assigned Numeric value assigned to VISIT variable | ||
| VISIT | Visit Name | text | Timing | 25 | Assigned Assigned from raw data visit variable collected on CRF | ||
| EPOCH | Epoch | text | Timing | 9 | Epoch
| Derived Set to EPOCH value from the record in SE for the given USUBJID meeting the following criteria: If the observation date or event start date (--DTC / --STDTC) is prior to the element start date (SESTDTC) for the record with ETCD='PREDOSE', set to 'SCREENING'. Otherwise, if the observation date / event start date is prior to element start date for the record with ETCD='VXxxxxxP', set to 'BASELINE'. Otherwise, if the observation date / event start date is prior to element start date for the record with ETCD='FUP' or if the 'FUP' record does not exist, set to 'TREATMENT'. Otherwise, set to 'FUP'. | |
| EXSTDTC | Start Date/Time of Treatment | partialDatetime | Timing | ISO 8601 | CRF Annotated Case Report Form [20 ] | ||
| EXENDTC | End Date/Time of Treatment | partialDatetime | Timing | ISO 8601 | Derived EX.EXENDTC=EX.EXSTDTC | ||
| EXSTDY | Study Day of Start of Treatment | integer | Timing | 8 | Derived Study day of start of event relative to the Subject Reference Start Date/Time (DM.RFSTDTC).
--STDY = (date portion of --STDTC) - (date portion of DM.RFSTDTC) + 1 when date portion of --STDTC is on or after date portion of DM.RFSTDTC; Otherwise --STDY = (date portion of --STDTC) - (date portion of DM.RFSTDTC). | ||
| EXENDY | Study Day of End of Treatment | integer | Timing | 8 | Derived Study day of end of event relative to the Subject Reference Start Date/Time (DM.RFSTDTC).
--ENDY = (date portion of --ENDTC) - (date portion of DM.RFSTDTC) + 1 when date portion of --ENDTC is on or after date portion of DM.RFSTDTC; Otherwise --ENDY = (date portion of --ENDTC) - (date portion of DM.RFSTDTC). | ||
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Adverse Events (AE)
| Related Supplemental Qualifiers Dataset: SUPPAE (Supplemental Qualifiers for AE) | |||||||
| Variable | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment | |
|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | ||
| DOMAIN | Domain Abbreviation | text | Identifier | 2 | Assigned Domain abbreviation of dataset. | ||
| USUBJID | Unique Subject Identifier | text | Identifier | 21 | Derived Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) | ||
| AESEQ | Sequence Number | integer | Identifier | 2 | Derived Unique sequence number within a subject when dataset is sorted by the key variables. | ||
| AEGRPID | Group ID | text | Identifier | 1 | CRF Annotated Case Report Form [34 ] | ||
| AESPID | Sponsor-Defined Identifier | text | Identifier | 2 | CRF Annotated Case Report Form [34 ] System generated unique identifier. | ||
| AETERM | Reported Term for the Adverse Event | text | Topic | 145 | CRF Annotated Case Report Form [34 ] | ||
| AEMODIFY | Modified Reported Term | text | Synonym Qualifier | 37 | Assigned | ||
| AELLT | Lowest Level Term | text | Variable Qualifier | 37 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Assigned MedDRA Version 23.0 | |
| AELLTCD | Lowest Level Term Code | integer | Variable Qualifier | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Assigned MedDRA Version 23.0 | |
| AEDECOD | Dictionary-Derived Term | text | Synonym Qualifier | 35 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Assigned MedDRA Version 23.0 | |
| AEPTCD | Preferred Term Code | integer | Variable Qualifier | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Assigned MedDRA Version 23.0 | |
| AEHLT | High Level Term | text | Variable Qualifier | 64 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Assigned MedDRA Version 23.0 | |
| AEHLTCD | High Level Term Code | integer | Variable Qualifier | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Assigned MedDRA Version 23.0 | |
| AEHLGT | High Level Group Term | text | Variable Qualifier | 58 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Assigned MedDRA Version 23.0 | |
| AEHLGTCD | High Level Group Term Code | integer | Variable Qualifier | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Assigned MedDRA Version 23.0 | |
| AECAT | Category for Adverse Event | text | Grouping Qualifier | 7 | Category for Adverse Event
| Assigned | |
| AEBODSYS | Body System or Organ Class | text | Record Qualifier | 52 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Assigned MedDRA Version 23.0 | |
| AEBDSYCD | Body System or Organ Class Code | integer | Variable Qualifier | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Assigned MedDRA Version 23.0 | |
| AESOC | Primary System Organ Class | text | Variable Qualifier | 52 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Assigned MedDRA Version 23.0 | |
| AESOCCD | Primary System Organ Class Code | integer | Variable Qualifier | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Assigned MedDRA Version 23.0 | |
| AESEV | Severity/Intensity | text | Record Qualifier | 8 | Severity/Intensity Scale for AE
| CRF Annotated Case Report Form [34 ] | |
| AESER | Serious Event | text | Record Qualifier | 1 | No Yes Response
| CRF Annotated Case Report Form [34 ] | |
| AEACN | Action Taken with Study Treatment | text | Record Qualifier | 16 | Action Taken with Study Treatment [6 Terms] | CRF Annotated Case Report Form [34 ] | |
| AEREL | Causality | text | Record Qualifier | 11 | Causality
| CRF Annotated Case Report Form [34 ] | |
| AEOUT | Outcome of Adverse Event | text | Record Qualifier | 20 | Outcome of Event in AE [6 Terms] | CRF Annotated Case Report Form [34 ] | |
| AESCONG | Congenital Anomaly or Birth Defect | text | Record Qualifier | 1 | No Yes Response (Yes only)
| CRF Annotated Case Report Form [34 ] | |
| AESDISAB | Persist or Signif Disability/Incapacity | text | Record Qualifier | 1 | No Yes Response (Yes only)
| CRF Annotated Case Report Form [34 ] | |
| AESDTH | Results in Death | text | Record Qualifier | 1 | No Yes Response (Yes only)
| CRF Annotated Case Report Form [34 ] | |
| AESHOSP | Requires or Prolongs Hospitalization | text | Record Qualifier | 1 | No Yes Response (Yes only)
| CRF Annotated Case Report Form [34 ] | |
| AESLIFE | Is Life Threatening | text | Record Qualifier | 1 | No Yes Response (Yes only)
| CRF Annotated Case Report Form [34 ] | |
| AESMIE | Other Medically Important Serious Event | text | Record Qualifier | 1 | No Yes Response (Yes only)
| CRF Annotated Case Report Form [34 ] | |
| AECONTRT | Concomitant or Additional Trtmnt Given | text | Record Qualifier | 1 | No Yes Response
| CRF Annotated Case Report Form [34 ] | |
| AETOXGR | Standard Toxicity Grade | text | Record Qualifier | 8 | Standard Toxicity Grade in Adverse Events
| CRF Annotated Case Report Form [34 ] | |
| EPOCH | Epoch | text | Timing | 9 | Epoch
| Derived Set to EPOCH value from the record in SE for the given USUBJID meeting the following criteria: If the observation date or event start date (--DTC / --STDTC) is prior to the element start date (SESTDTC) for the record with ETCD='PREDOSE', set to 'SCREENING'. Otherwise, if the observation date / event start date is prior to element start date for the record with ETCD='VXxxxxxP', set to 'BASELINE'. Otherwise, if the observation date / event start date is prior to element start date for the record with ETCD='FUP' or if the 'FUP' record does not exist, set to 'TREATMENT'. Otherwise, set to 'FUP'. | |
| AESTDTC | Start Date/Time of Adverse Event | partialDatetime | Timing | ISO 8601 | CRF Annotated Case Report Form [34 ] | ||
| AEENDTC | End Date/Time of Adverse Event | partialDatetime | Timing | ISO 8601 | CRF Annotated Case Report Form [34 ] | ||
| AESTDY | Study Day of Start of Adverse Event | integer | Timing | 2 | Derived Study day of start of event relative to the Subject Reference Start Date/Time (DM.RFSTDTC).
--STDY = (date portion of --STDTC) - (date portion of DM.RFSTDTC) + 1 when date portion of --STDTC is on or after date portion of DM.RFSTDTC; Otherwise --STDY = (date portion of --STDTC) - (date portion of DM.RFSTDTC). | ||
| AEENDY | Study Day of End of Adverse Event | integer | Timing | 2 | Derived Study day of end of event relative to the Subject Reference Start Date/Time (DM.RFSTDTC).
--ENDY = (date portion of --ENDTC) - (date portion of DM.RFSTDTC) + 1 when date portion of --ENDTC is on or after date portion of DM.RFSTDTC; Otherwise --ENDY = (date portion of --ENDTC) - (date portion of DM.RFSTDTC). | ||
| AEENRTPT | End Relative to Reference Time Point | text | Timing | 1 | Relation to Reference Period (End)
| CRF Annotated Case Report Form [34 ] | |
| AEENTPT | End Reference Time Point | text | Timing | 1 | End Reference Time Point
| CRF Annotated Case Report Form [34 ] | |
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Clinical Events (CE)
| Variable | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | |
| DOMAIN | Domain Abbreviation | text | Identifier | 2 | Assigned Domain abbreviation of dataset. | |
| USUBJID | Unique Subject Identifier | text | Identifier | 21 | Derived Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) | |
| CESEQ | Sequence Number | integer | Identifier | 2 | Derived Unique sequence number within a subject when dataset is sorted by the key variables. | |
| CEGRPID | Group ID | text | Identifier | 37 | Group ID (CE)
| Derived Concatenation of Time Point Reference (CETPTREF) and Subcategory for Clinical Event (CESCAT), separated by '-'. |
| CELNKGRP | Link Group ID | text | Identifier | 77 | Derived Set to VS.VSLNKGRP on records having CETERM = 'Fever', and set to FA.FALNKGRP on all other records. Used to link the records from the FACE and VS domains which are used to populate records in the "flat model" reactogenicity CE domain. | |
| CETERM | Reported Term for the Clinical Event | text | Topic | 45 | Reported Term for the Clinical Event [15 Terms] | CRF |
| CELLT | Lowest Level Term | text | Variable Qualifier | 25 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Assigned MedDRA Version 23.0 |
| CELLTCD | Lowest Level Term Code | integer | Variable Qualifier | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Assigned MedDRA Version 23.0 |
| CEDECOD | Dictionary-Derived Term | text | Synonym Qualifier | 23 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Assigned MedDRA Version 23.0 |
| CEPTCD | Preferred Term Code | integer | Variable Qualifier | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Assigned MedDRA Version 23.0 |
| CEHLT | High Level Term | text | Variable Qualifier | 32 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Assigned MedDRA Version 23.0 |
| CEHLTCD | High Level Term Code | integer | Variable Qualifier | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Assigned MedDRA Version 23.0 |
| CEHLGT | High Level Group Term | text | Variable Qualifier | 52 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Assigned MedDRA Version 23.0 |
| CEHLGTCD | High Level Group Term Code | integer | Variable Qualifier | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Assigned MedDRA Version 23.0 |
| CECAT | Category for Clinical Event | text | Grouping Qualifier | 14 | Category for Clinical Event
| Assigned |
| CESCAT | Subcategory for Clinical Event | text | Grouping Qualifier | 19 | Subcategory for Clinical Event
| Assigned |
| CEPRESP | Clinical Event Pre-Specified | text | Variable Qualifier | 1 | No Yes Response (Yes only)
| Assigned |
| CEOCCUR | Clinical Event Occurrence | text | Record Qualifier | 1 | No Yes Response
| CRF Annotated Case Report Form [29 31 ] If any of the diary entries in the Day 1 - Day 8 assessment period reflect an occurrence of a particular reactogenicity event, then CEOCCUR is 'Y'. Note that (1) a temperature of 38.0 degrees Celsius or higher is considered to be an occurrence of 'Fever', and (2) an event having a complete date/time that is prior to the associated reference date/time is not considered as an occurrence. Otherwise, 'N'. |
| CEBODSYS | Body System or Organ Class | text | Record Qualifier | 52 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Assigned MedDRA Version 23.0 |
| CEBDSYCD | Body System or Organ Class Code | integer | Variable Qualifier | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Assigned MedDRA Version 23.0 |
| CESOC | Primary System Organ Class | text | Variable Qualifier | 52 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Assigned MedDRA Version 23.0 |
| CESOCCD | Primary System Organ Class Code | integer | Variable Qualifier | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Assigned MedDRA Version 23.0 |
| CESEV | Severity/Intensity | text | Record Qualifier | 8 | Severity Response - CE
| Derived Populated when CEOCCUR = 'Y' as the maximum severity reported for the reactogenicity event during the assessment period. For records with a Reported Term (CETERM) of 'Fever', severity is derived from the VS.VSSTRESN as follows: 'MILD' when VSSTRESN <= 38.4; else 'MODERATE' when VSSTRESN <= 38.9; else 'SEVERE' when VSSTRESN <= 40.0; else 'POTENTIALLY LIFE THREATENING' when VSSTRESN. For all other records (CETERM is not 'Fever'), severity is obtained from FACE.FASTRESC. |
| EPOCH | Epoch | text | Timing | 9 | Epoch
| Derived Always 'TREATMENT' since reactogenicity events are captured only in the assessment period following a vaccine. |
| CESTDTC | Start Date/Time of Clinical Event | date | Timing | ISO 8601 | Derived Earliest reported date of the symptom [i.e. minimum FADTC or VSDTC for given subject, time point reference, and term]. Populated only when CEOCCUR = 'Y'. | |
| CEENDTC | End Date/Time of Clinical Event | date | Timing | ISO 8601 | Derived Latest reported date of the symptom [i.e. maximum FADTC or VSDTC for given subject, time point reference, and term]. Populated only when CEOCCUR = 'Y'. | |
| CESTDY | Study Day of Start of Observation | integer | Timing | 2 | Derived Study day of start of event relative to the Subject Reference Start Date/Time (DM.RFSTDTC).
--STDY = (date portion of --STDTC) - (date portion of DM.RFSTDTC) + 1 when date portion of --STDTC is on or after date portion of DM.RFSTDTC; Otherwise --STDY = (date portion of --STDTC) - (date portion of DM.RFSTDTC). | |
| CEENDY | Study Day of End of Observation | integer | Timing | 2 | Derived Study day of end of event relative to the Subject Reference Start Date/Time (DM.RFSTDTC).
--ENDY = (date portion of --ENDTC) - (date portion of DM.RFSTDTC) + 1 when date portion of --ENDTC is on or after date portion of DM.RFSTDTC; Otherwise --ENDY = (date portion of --ENDTC) - (date portion of DM.RFSTDTC). | |
| CEDUR | Duration | durationDatetime | Timing | ISO 8601 | Derived Difference between the date part of the End Date/Time of Clinical Event (CEENDTC) or the end of the assessment period (date part of CERFTDTC + 7 days), whichever is earlier, and the date part of the Start Date/Time of Clinical Event (CESTDTC) + 1 day. Populated only when CEOCCUR = 'Y'. | |
| CETPT | Planned Time Point Name | text | Timing | 5 | Planned Time Point Name
| Protocol |
| CETPTNUM | Planned Time Point Number | integer | Timing | 8 | Assigned Set to 8, since records from FACE and VS having FATPTNUM / VSTPTNUM <=8 are used to populate the "flat model" CE records. | |
| CETPTREF | Time Point Reference | text | Timing | 17 | Time Point Reference
| Derived Set to VS.VSTPTREF on records having CETERM = 'Fever', and set to FA.FATPTREF on all other records. |
| CERFTDTC | Date/Time of Reference Time Point | datetime | Timing | ISO 8601 | Derived Set to VS.VSRFTDTC on records having CETERM = 'Fever', and set to FA.FARFTDTC on all other records. | |
| CEEVINTX | Evaluation Interval Text | text | Timing | 17 | Evalutation Interval Text (CE)
| Protocol |
| CEENRTPT | End Relative to Reference Time Point | text | Timing | 7 | Relation to Reference Period (End)
| Derived ONGOING' when End Date/Time of Clinical Event (CEENDTC) is after the end of the assessment period [i.e. when date part of CEENDTC is greater than or equal to date part of CERFTDTC + 8 days]. |
| CEENTPT | End Reference Time Point | text | Timing | 5 | Planned Time Point Name
| Protocol |
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Disposition (DS)
| Related Supplemental Qualifiers Dataset: SUPPDS (Supplemental Qualifiers for DS) | |||||||
| Variable | Where Condition | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | ||
| DOMAIN | Domain Abbreviation | text | Identifier | 2 | Assigned Domain abbreviation of dataset. | ||
| USUBJID | Unique Subject Identifier | text | Identifier | 21 | Derived Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) | ||
| DSSEQ | Sequence Number | integer | Identifier | 8 | Derived Unique sequence number within a subject when dataset is sorted by the key variables. | ||
| DSTERMVLM | Reported Term for the Disposition Event | text | Topic | 31 | CRF | ||
| DSCAT = "DISPOSITION EVENT" (Protocol Disposition Event) | Disposition Event Reported Term | text | 26 | CRF | |||
| DSCAT = "PROTOCOL MILESTONE" (Protocol Milestone) | Protocol Milestone Reported Term | text | 31 | CRF | |||
| DSDECODVLM | Standardized Disposition Term | text | Synonym Qualifier | 31 | CRF | ||
| DSCAT = "DISPOSITION EVENT" (Protocol Disposition Event) | Disposition Event Standardized Term | text | 21 | Completion/Reason for Non-Completion [13 Terms] | CRF | ||
| DSCAT = "PROTOCOL MILESTONE" (Protocol Milestone) | Protocol Milestone Standardized Term | text | 31 | Protocol Milestone
| CRF | ||
| DSCAT | Category for Disposition Event | text | Grouping Qualifier | 18 | Category for Disposition Event
| Assigned | |
| DSSCAT | Subcategory for Disposition Event | text | Grouping Qualifier | 12 | Subcategory for Disposition Event
| Assigned | |
| EPOCH | Epoch | text | Timing | 9 | Epoch
| Derived Set to EPOCH value from the record in SE for the given USUBJID meeting the following criteria: If the observation date or event start date (--DTC / --STDTC) is prior to the element start date (SESTDTC) for the record with ETCD='PREDOSE', set to 'SCREENING'. Otherwise, if the observation date / event start date is prior to element start date for the record with ETCD='VXxxxxxP', set to 'BASELINE'. Otherwise, if the observation date / event start date is prior to element start date for the record with ETCD='FUP' or if the 'FUP' record does not exist, set to 'TREATMENT'. Otherwise, set to 'FUP'. | |
| DSSTDTC | Start Date/Time of Disposition Event | partialDatetime | Timing | ISO 8601 | CRF | ||
| DSSTDY | Study Day of Start of Disposition Event | integer | Timing | 8 | Derived Study day of start of event relative to the Subject Reference Start Date/Time (DM.RFSTDTC).
--STDY = (date portion of --STDTC) - (date portion of DM.RFSTDTC) + 1 when date portion of --STDTC is on or after date portion of DM.RFSTDTC; Otherwise --STDY = (date portion of --STDTC) - (date portion of DM.RFSTDTC). | ||
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Protocol Deviations (DV)
| Related Supplemental Qualifiers Dataset: SUPPDV (Supplemental Qualifiers for DV) | |||||||
| Variable | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment | |
|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | ||
| DOMAIN | Domain Abbreviation | text | Identifier | 2 | Assigned Domain abbreviation of dataset. | ||
| USUBJID | Unique Subject Identifier | text | Identifier | 21 | Derived Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) | ||
| DVSEQ | Sequence Number | integer | Identifier | 8 | Derived Unique sequence number within a subject when dataset is sorted by the key variables. | ||
| DVREFID | Reference ID | text | Identifier | 75 | CRF Annotated Case Report Form [38 ] | ||
| DVTERM | Protocol Deviation Term | text | Topic | 141 | CRF Annotated Case Report Form [38 ] | ||
| DVDECOD | Protocol Deviation Coded Term | text | Synonym Qualifier | 41 | Protocol Deviation Coded Term [8 Terms] | CRF Annotated Case Report Form [38 ] | |
| EPOCH | Epoch | text | Timing | 9 | Epoch
| Derived Set to EPOCH value from the record in SE for the given USUBJID meeting the following criteria: If the observation date or event start date (--DTC / --STDTC) is prior to the element start date (SESTDTC) for the record with ETCD='PREDOSE', set to 'SCREENING'. Otherwise, if the observation date / event start date is prior to element start date for the record with ETCD='VXxxxxxP', set to 'BASELINE'. Otherwise, if the observation date / event start date is prior to element start date for the record with ETCD='FUP' or if the 'FUP' record does not exist, set to 'TREATMENT'. Otherwise, set to 'FUP'. | |
| DVSTDTC | Start Date/Time of Deviation | date | Timing | ISO 8601 | CRF Annotated Case Report Form [38 ] | ||
| DVSTDY | Study Day of Start of Deviation | integer | Timing | 8 | Derived Study day of start of event relative to the Subject Reference Start Date/Time (DM.RFSTDTC).
--STDY = (date portion of --STDTC) - (date portion of DM.RFSTDTC) + 1 when date portion of --STDTC is on or after date portion of DM.RFSTDTC; Otherwise --STDY = (date portion of --STDTC) - (date portion of DM.RFSTDTC). | ||
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Medical History (MH)
| Variable | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | |
| DOMAIN | Domain Abbreviation | text | Identifier | 2 | Assigned Domain abbreviation of dataset. | |
| USUBJID | Unique Subject Identifier | text | Identifier | 21 | Derived Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) | |
| MHSEQ | Sequence Number | integer | Identifier | 8 | Derived Unique sequence number within a subject when dataset is sorted by the key variables. | |
| MHTERM | Reported Term for the Medical History | text | Topic | 63 | CRF Annotated Case Report Form [27 ] | |
| MHMODIFY | Modified Reported Term | text | Synonym Qualifier | 32 | Assigned | |
| MHLLT | Lowest Level Term | text | Variable Qualifier | 32 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Assigned MedDRA Version 23.0 |
| MHLLTCD | Lowest Level Term Code | integer | Variable Qualifier | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Assigned MedDRA Version 23.0 |
| MHDECOD | Dictionary-Derived Term | text | Synonym Qualifier | 30 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Assigned MedDRA Version 23.0 |
| MHPTCD | Preferred Term Code | integer | Variable Qualifier | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Assigned MedDRA Version 23.0 |
| MHHLT | High Level Term | text | Variable Qualifier | 80 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Assigned MedDRA Version 23.0 |
| MHHLTCD | High Level Term Code | integer | Variable Qualifier | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Assigned MedDRA Version 23.0 |
| MHHLGT | High Level Group Term | text | Variable Qualifier | 86 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Assigned MedDRA Version 23.0 |
| MHHLGTCD | High Level Group Term Code | integer | Variable Qualifier | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Assigned MedDRA Version 23.0 |
| MHBODSYS | Body System or Organ Class | text | Record Qualifier | 67 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Assigned MedDRA Version 23.0 |
| MHBDSYCD | Body System or Organ Class Code | integer | Variable Qualifier | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Assigned MedDRA Version 23.0 |
| MHSOC | Primary System Organ Class | text | Variable Qualifier | 67 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Assigned MedDRA Version 23.0 |
| MHSOCCD | Primary System Organ Class Code | integer | Variable Qualifier | 8 | Medical Dictionary for Regulatory Activities MedDRA 23.0 | Assigned MedDRA Version 23.0 |
| MHSTDTC | Start Date/Time of Medical History Event | date | Timing | ISO 8601 | CRF Annotated Case Report Form [27 ] | |
| MHENDTC | End Date/Time of Medical History Event | date | Timing | ISO 8601 | CRF Annotated Case Report Form [27 ] | |
| MHENRTPT | End Relative to Reference Time Point | text | Timing | 7 | Relation to Reference Period (MH End)
| CRF Annotated Case Report Form [27 ] |
| MHENTPT | End Reference Time Point | text | Timing | 9 | End Reference Time Point (MH)
| CRF Annotated Case Report Form [27 ] |
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ECG Test Results (EG)
| Related Supplemental Qualifiers Dataset: SUPPEG (Supplemental Qualifiers for EG) | |||||||
| Variable | Where Condition | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | ||
| DOMAIN | Domain Abbreviation | text | Identifier | 2 | Assigned Domain abbreviation of dataset. | ||
| USUBJID | Unique Subject Identifier | text | Identifier | 21 | Derived Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) | ||
| EGSEQ | Sequence Number | integer | Identifier | 8 | Derived Unique sequence number within a subject when dataset is sorted by the key variables. | ||
| EGTESTCD | ECG Test or Examination Short Name | text | Topic | 8 | ECG Test Code [11 Terms] | Assigned | |
| EGTESTVLM | ECG Test or Examination Name | text | Synonym Qualifier | 39 | ECG Test Name [11 Terms] | ||
| EGCAT = "FINDING" | ECG Finding Test Name | text | 39 | Derived 'Interpretation' when Normal/Abnormal result is obtained from CRF. Otherwise, derived from code entered on CRF (SUPPEG.CODE) to describe abnormal finding: 'Atrioventricular Conduction' when CODE is '1' or '12'; 'Axis and Voltage' when CODE is '24'; 'Intraventricular-Intraatrial Conduction' when CODE is '39'; 'Rhythm Not Otherwise Specified' when CODE is '100'; 'Sinus Node Rhythms and Arrhythmias' when CODE is '109' or '110'; ST Segment, T wave, and U wave' when CODE is '120', '122', '123', or '135'; 'Supraventricular Arrhythmias' when CODE is '149'; 'Technical Quality' when CODE is '187'; 'Ventricular Arrhythmias' when CODE is '204', '211'. | |||
| EGCAT = "MEASUREMENT" | ECG Measurement Test Name | text | 19 | CRF Annotated Case Report Form [9 ] | |||
| EGCAT | Category for ECG | text | Grouping Qualifier | 11 | Category for ECG
| Assigned | |
| EGPOS | ECG Position of Subject | text | Record Qualifier | 6 | ECG Position of Subject
| CRF Annotated Case Report Form [9 ] | |
| EGORRESVLM | Result or Finding in Original Units | text | Result Qualifier | 50 | |||
| EGTESTCD = "INTP" (Interpretation) | Interpretation (EG) | text | 8 | Normal Abnormal Response
| CRF Annotated Case Report Form [9 ] | ||
| EGTESTCD = "EGHRMN" (ECG Mean Heart Rate) | ECG Mean Heart Rate | integer | 2 | CRF Annotated Case Report Form [9 ] | |||
| EGTESTCD NOT IN ( "EGHRMN" (ECG Mean Heart Rate), "INTP" (Interpretation) ) | Finding (EG) | text | 50 | ECG Result [17 Terms] | Derived Mapped from abnormality code entered on CRF (SUPPEG.CODE). See Codelist for SUPPEG.CODE for decode information. | ||
| EGORRESU | Original Units | text | Variable Qualifier | 9 | Original Units for EG
| CRF Annotated Case Report Form [9 ] | |
| EGSTRESC | Character Result/Finding in Std Format | text | Result Qualifier | 50 | Derived --STRESC = --ORRES | ||
| EGSTRESN | Numeric Result/Finding in Standard Units | integer | Result Qualifier | 8 | Derived The numeric equivalent of xxSTRESC. | ||
| EGSTRESU | Standard Units | text | Variable Qualifier | 9 | Standard Units for EG
| Derived --STRESU = --ORRESU | |
| EGSTAT | Completion Status | text | Record Qualifier | 1 | Not Done
| CRF Annotated Case Report Form [9 ] | |
| EGREASND | Reason ECG Not Performed | text | Record Qualifier | 1 | CRF Annotated Case Report Form [9 ] | ||
| EGMETHOD | Method of ECG Test | text | Record Qualifier | 16 | ECG Test Method
| CRF Annotated Case Report Form [9 ] | |
| EGBLFL | Baseline Flag | text | Record Qualifier | 1 | No Yes Response (Yes only)
| Derived EG.EGBLFL = 'Y' per unique USUBJID/EGTESTCD for the last non-null EGORRES where EG.EGDTC <= DM.RFSTDTC; else EG.EGBLFL = null. | |
| EGEVAL | Evaluator | text | Record Qualifier | 12 | Evaluator for EG
| Assigned | |
| VISITNUM | Visit Number | float | Timing | 5 | Assigned Numeric value assigned to VISIT variable | ||
| VISIT | Visit Name | text | Timing | 22 | Assigned Assigned from raw data visit variable collected on CRF | ||
| EPOCH | Epoch | text | Timing | 9 | Epoch
| Derived Set to EPOCH value from the record in SE for the given USUBJID meeting the following criteria: If the observation date or event start date (--DTC / --STDTC) is prior to the element start date (SESTDTC) for the record with ETCD='PREDOSE', set to 'SCREENING'. Otherwise, if the observation date / event start date is prior to element start date for the record with ETCD='VXxxxxxP', set to 'BASELINE'. Otherwise, if the observation date / event start date is prior to element start date for the record with ETCD='FUP' or if the 'FUP' record does not exist, set to 'TREATMENT'. Otherwise, set to 'FUP'. | |
| EGDTC | Date/Time of ECG | partialDatetime | Timing | ISO 8601 | CRF Annotated Case Report Form [9 ] | ||
| EGDY | Study Day of ECG | integer | Timing | 8 | Derived Study day of observation relative to the Subject Reference Start Date/Time (DM.RFSTDTC).
--DY = (date portion of --DTC) - (date portion of DM.RFSTDTC) + 1 where date portion of --DTC is on or after date portion of DM.RFSTDTC; Otherwise --DY = (date portion of --DTC) - (date portion of DM.RFSTDTC). | ||
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Findings About Clinical Events (FACE)
| Related Supplemental Qualifiers Dataset: SUPPFACE (Supplemental Qualifiers for FACE) | |||||||
| Variable | Where Condition | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | ||
| DOMAIN | Domain Abbreviation | text | Identifier | 2 | Assigned Domain abbreviation of dataset. | ||
| USUBJID | Unique Subject Identifier | text | Identifier | 21 | Derived Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) | ||
| FASEQ | Sequence Number | integer | Identifier | 8 | Derived Unique sequence number within a subject when dataset is sorted by the key variables. | ||
| FAGRPID | Group ID | text | Identifier | 37 | Derived Concatenation of Time Point Reference (FATPTREF) and Subcategory for Findings About (FASCAT), separated by '-'. Null when FATPTREF is null. | ||
| FALNKID | Link ID | text | Identifier | 83 | Derived Concatenation of Link Group ID (FALNKGRP) and Planned Time Point Name (FATPT), separated by '-' (Ex. PRIME VACCINATION-STUDY SUBJECT-Headache-DAY 1). Null when FALNKGRP is null. | ||
| FALNKGRP | Link Group ID | text | Identifier | 77 | Derived Populated only on records used to populate CEOCCUR values on the CE domain, which includes those obtained from diary data collected on Days 1 through 8 following each vaccination or those collected after Day 8 but representing an occurrence [i.e. where the Evaluator (FAEVAL) is 'STUDY SUBJECT' and either (a) the Planned Time Point Number (FATPTNUM) is less than or equal to 8 and the Completion Status (FASTAT) is null or (b) FATPTNUM > 8 and FAORRES has a value other than 'N' or 'None']. FALNKGRP is set to the concatenation of Time Point Reference (FATPTREF), Evaluator (FAEVAL), and Object of the Observation (FAOBJ), separated by '-' (Ex. PRIME VACCINATION-STUDY SUBJECT-Headache). Used to link the records from the FACE and VS domains which are used to populate records in the "flat model" reactogenicity CE domain. | ||
| FATESTCD | Findings About Test Short Name | text | Topic | 5 | Vaccines Findings About Test Code
| Assigned | |
| FATEST | Findings About Test Name | text | Synonym Qualifier | 20 | Vaccines Findings About Test Name
| CRF | |
| FAOBJ | Object of the Observation | text | Record Qualifier | 45 | Object of the Observation [16 Terms] | CRF | |
| FACAT | Category for Findings About | text | Grouping Qualifier | 14 | Category for FACE
| Assigned | |
| FASCAT | Subcategory for Findings About | text | Grouping Qualifier | 19 | Subcategory for FACE
| Assigned | |
| FAORRESVLM | Result or Finding in Original Units | text | Result Qualifier | 8 | |||
| FATESTCD = "OCCUR" (Occurrence Indicator) | Occurrence Indicator | text | 1 | No Yes Response
| CRF | ||
| FATESTCD = "SEV" (Severity/Intensity) | Severity/Intensity | text | 8 | Severity Response - FACE
| CRF | ||
| FASTRESC | Character Result/Finding in Std Format | text | Result Qualifier | 8 | Derived FAORRES in upper case. | ||
| FASTAT | Completion Status | text | Record Qualifier | 8 | Not Done
| CRF | |
| FAREASND | Reason Not Performed | text | Record Qualifier | 32 | CRF | ||
| FAEVAL | Evaluator | text | Record Qualifier | 13 | Evaluator for FACE
| CRF | |
| VISITNUM | Visit Number | float | Timing | 5 | Assigned Numeric value assigned to VISIT variable | ||
| VISIT | Visit Name | text | Timing | 28 | Assigned Assigned from raw data visit variable collected on CRF | ||
| EPOCH | Epoch | text | Timing | 9 | Epoch
| Derived Always 'TREATMENT' since reactogenicity events are captured only in the assessment period following a vaccine. | |
| FADTC | Date/Time of Collection | partialDatetime | Timing | ISO 8601 | CRF | ||
| FADY | Study Day of Collection | integer | Timing | 8 | Derived Study day of observation relative to the Subject Reference Start Date/Time (DM.RFSTDTC).
--DY = (date portion of --DTC) - (date portion of DM.RFSTDTC) + 1 where date portion of --DTC is on or after date portion of DM.RFSTDTC; Otherwise --DY = (date portion of --DTC) - (date portion of DM.RFSTDTC). | ||
| FATPTVLM | Planned Time Point Name | text | Timing | 7 | |||
| FATPT IN ( "PREDOSE", "1 HOUR", "3 HOURS", "6 HOURS" ) | Planned Time Point Name - Investigator Evaluated on Day 1 of Assessment Period | text | 7 | Planned Time Point Name - Day 1
| CRF | ||
| FATPT NOT IN ( "PREDOSE", "1 HOUR", "3 HOURS", "6 HOURS" ) | Planned Time Point Name - Subject Diary Records | text | 6 | Derived Concatenation of 'DAY ' with the number of days between the Date/Time of Collection and the Date/Time of Reference Time Point [date part of FADTC - date part of FARFTDTC + 1]. | |||
| FATPTNUM | Planned Time Point Number | float | Timing | 4 | Assigned Set to the integer following 'DAY ' in the value of FATPT when FATPT begins with 'DAY'. Otherwise, -1 when FATPT = 'PREDOSE', 0.1 when FATPT = '1 HOUR', 0.3 when FATPT = '3 HOURS', and 0.6 when FATPT = '6 HOURS'. | ||
| FATPTREFVLM | Time Point Reference | text | Timing | 17 | Time Point Reference
| ||
| FATPT IN ( "PREDOSE", "1 HOUR", "3 HOURS", "6 HOURS" ) | Time Point Reference - Investigator Evaluated on Day 1 of Assessment Period | text | 17 | Derived PRIME VACCINATION' when VISITNUM = 2 (Day 1 Visit). 'BOOST VACCINATION' when VISITNUM = 6 (Day 22 Visit). Null, otherwise. | |||
| FATPT NOT IN ( "PREDOSE", "1 HOUR", "3 HOURS", "6 HOURS" ) | Time Point Reference - Subject Diary Records | text | 17 | Derived PRIME VACCINATION' when (i) Date of Collection (date part of FADTC) is prior to the Start Date of Treatment at the Day 22 Visit (date part of EX.EXSTDTC where VISITNUM = 6), (ii) when the subject has not received a boost vaccination (record does not exist in EX with VISITNUM = 6 and non-missing EXSTDTC), or (iii) when the Date of Collection is missing and the Completion Status (FASTAT) is null (not flagged as 'NOT DONE'). 'BOOST VACCINATION' when Date of Collection is on or after the Start Date of Treatment at the Day 22 Visit. Null, otherwise. | |||
| FARFTDTC | Date/Time of Reference Time Point | datetime | Timing | ISO 8601 | Derived Start Date/Time of Treatment at the Day 1 Visit (EX.EXSTDTC where EX.VISITNUM = 2) when FATPTREF="PRIME VACCINATION". Start Date/Time of Treatment at the Day 22 Visit (EX.EXSTDTC where EX.VISITNUM = 6) when FATPTREF="BOOST VACCINATION". | ||
| FAEVLINT | Evaluation Interval | durationDatetime | Timing | ISO 8601 | Protocol '-PT1H' when FATPT is '1 HOUR'; '-PT2H' when FATPT is '3 HOURS'; '-PT3H' when FATPT is '6 HOURS'; '-P1D' when FATPT is 'DAY xx', except when FATPT is 'DAY 1'. | ||
| FAEVINTX | Evaluation Interval Text | text | Timing | 17 | Protocol 'AT PRESENT' when FATPT is 'PREDOSE'; 'SINCE VACCINATION' when FATPT is 'DAY 1'. | ||
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Immunogenicity Specimen Assessments (IS)
| Variable | Where Condition | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | ||
| DOMAIN | Domain Abbreviation | text | Identifier | 2 | Assigned Domain abbreviation of dataset. | ||
| USUBJID | Unique Subject Identifier | text | Identifier | 21 | Derived Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) | ||
| ISSEQ | Sequence Number | integer | Identifier | 8 | Derived Unique sequence number within a subject when dataset is sorted by the key variables. | ||
| ISREFID | Reference ID | text | Identifier | 10 | Assigned | ||
| ISTESTCD | Immunogenicity Test/Exam Short Name | text | Topic | 8 | Immunogenicity Test/Exam Short Name
| Assigned Assigned based on test provided in eDT records. | |
| ISTEST | Immunogenicity Test or Examination Name | text | Synonym Qualifier | 38 | Immunogenicity Test or Examination Name
| Assigned | |
| ISCAT | Category for Immunogenicity Test | text | Grouping Qualifier | 14 | Category for Immunogenicity Specimen Assessments
| Assigned | |
| ISORRESVLM | Results or Findings in Original Units | text | Result Qualifier | 11 | eDT | ||
| ISTESTCD = "C19RBDIG" (COVID-19 RBD IgG) | COVID-19 RBD IgG | text | 9 | eDT | |||
| ISTESTCD = "C19S1IGG" (COVID-19 S1 IgG) | COVID-19 S1 IgG | text | 10 | eDT | |||
| ISTESTCD = "C2NGNT50" (SARS-CoV-2 Serum Neutralizing Titer 50) | SARS-CoV-2 Serum Neutralizing Titer 50 | float | 13 | eDT | |||
| ISTESTCD = "C2NGNT90" (SARS-CoV-2 Serum Neutralizing Titer 90) | SARS-CoV-2 Serum Neutralizing Titer 90 | float | 13 | eDT | |||
| ISORRESUVLM | Original Units | text | Variable Qualifier | 4 | Original Units for Immunogenicity Specimen Assessments
| eDT | |
| ISTESTCD = "C19RBDIG" (COVID-19 RBD IgG) | COVID-19 RBD IgG | text | 4 | eDT | |||
| ISTESTCD = "C19S1IGG" (COVID-19 S1 IgG) | COVID-19 S1 IgG | text | 4 | eDT | |||
| ISTESTCD = "C2NGNT50" (SARS-CoV-2 Serum Neutralizing Titer 50) | SARS-CoV-2 Serum Neutralizing Titer 50 | text | 2 | eDT | |||
| ISTESTCD = "C2NGNT90" (SARS-CoV-2 Serum Neutralizing Titer 90) | SARS-CoV-2 Serum Neutralizing Titer 90 | text | 2 | eDT | |||
| ISSTRESC | Result or Finding in Standard Format | text | Result Qualifier | 11 | Derived --STRESC = --ORRES | ||
| ISSTRESN | Numeric Results/Findings in Std. Units | float | Result Qualifier | 11 | Derived The numeric equivalent of xxSTRESC. | ||
| ISSTRESU | Standard Units | text | Variable Qualifier | 4 | Standard Units for Immunogenicity Specimen Assessments
| Derived --STRESU = --ORRESU | |
| ISSTAT | Completion Status | text | Record Qualifier | 8 | Not Done
| CRF Annotated Case Report Form [18 ] | |
| ISREASND | Reason Not Done | text | Record Qualifier | 44 | CRF Annotated Case Report Form [18 ] | ||
| ISNAM | Vendor Name | text | Record Qualifier | 39 | Vendor Name for IS
| eDT | |
| ISSPEC | Specimen Type | text | Record Qualifier | 5 | Specimen Type in IS
| CRF Annotated Case Report Form [18 ] | |
| ISMETHOD | Method of Test or Examination | text | Record Qualifier | 1 | eDT | ||
| ISBLFL | Baseline Flag | text | Record Qualifier | 1 | No Yes Response (Yes only)
| Derived Y on the closest non-missing result before the reference start date (DM.RFSTDTC) for each test. | |
| ISLLOQ | Lower Limit of Quantitation | float | Variable Qualifier | 6 | eDT | ||
| VISITNUM | Visit Number | float | Timing | 5 | Assigned Numeric value assigned to VISIT variable | ||
| VISIT | Visit Name | text | Timing | 28 | Assigned Assigned from raw data visit variable collected on CRF | ||
| EPOCH | Epoch | text | Timing | 9 | Epoch
| Derived Set to EPOCH value from the record in SE for the given USUBJID meeting the following criteria: If the observation date or event start date (--DTC / --STDTC) is prior to the element start date (SESTDTC) for the record with ETCD='PREDOSE', set to 'SCREENING'. Otherwise, if the observation date / event start date is prior to element start date for the record with ETCD='VXxxxxxP', set to 'BASELINE'. Otherwise, if the observation date / event start date is prior to element start date for the record with ETCD='FUP' or if the 'FUP' record does not exist, set to 'TREATMENT'. Otherwise, set to 'FUP'. | |
| ISDTC | Date/Time of Collection | partialDatetime | Timing | ISO 8601 | CRF Annotated Case Report Form [18 ] | ||
| ISDY | Study Day of Visit/Collection/Exam | integer | Timing | 8 | Derived Study day of observation relative to the Subject Reference Start Date/Time (DM.RFSTDTC).
--DY = (date portion of --DTC) - (date portion of DM.RFSTDTC) + 1 where date portion of --DTC is on or after date portion of DM.RFSTDTC; Otherwise --DY = (date portion of --DTC) - (date portion of DM.RFSTDTC). |
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Laboratory Test Results (LB)
| Related Supplemental Qualifiers Dataset: SUPPLB (Supplemental Qualifiers for LB) | |||||||
| Variable | Where Condition | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | ||
| DOMAIN | Domain Abbreviation | text | Identifier | 2 | Assigned Domain abbreviation of dataset. | ||
| USUBJID | Unique Subject Identifier | text | Identifier | 21 | Derived Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) | ||
| LBSEQ | Sequence Number | integer | Identifier | 3 | Derived Unique sequence number within a subject when dataset is sorted by the key variables. | ||
| LBREFID | Specimen ID | text | Identifier | 10 | Assigned | ||
| LBTESTCD | Lab Test or Examination Short Name | text | Topic | 8 | Laboratory Test Code [68 Terms] | Assigned | |
| LBTESTVLM | Lab Test or Examination Name | text | Synonym Qualifier | 39 | |||
| LBCAT = "CHEMISTRY" and LBSCAT = "PREGNANCY" | Pregnancy Lab Test Name | text | 23 | Laboratory Test Name (Pregnancy)
| CRF Annotated Case Report Form [5 ] | ||
| LBCAT = "CHEMISTRY" and LBSCAT = "DRUG OF ABUSE" | Chemistry Drug of Abuse Lab Test Name | text | 7 | Laboratory Test Name (Chemistry - Drug of Abuse)
| CRF Annotated Case Report Form [11 ] | ||
| LBCAT = "CHEMISTRY" and LBSCAT NOT IN ( "PREGNANCY", "DRUG OF ABUSE" ) | Chemistry Lab Test Name | text | 28 | Laboratory Test Name (Chemistry) [18 Terms] | eDT | ||
| LBCAT = "URINALYSIS" and LBSCAT = "DRUG OF ABUSE" | Urinalysis Drug of Abuse Lab Test Name | text | 25 | Laboratory Test Name (Urinalysis - Drug of Abuse) [10 Terms] | CRF Annotated Case Report Form [10 ] | ||
| LBCAT = "URINALYSIS" and LBSCAT ≠"DRUG OF ABUSE" | Urinalysis Lab Test Name | text | 22 | Laboratory Test Name (Urinalysis) [17 Terms] | eDT | ||
| LBCAT = "HEMATOLOGY" | Hematology Lab Test Name | text | 39 | Laboratory Test Name (Hematology) [26 Terms] | eDT | ||
| LBCAT | Category for Lab Test | text | Grouping Qualifier | 10 | Category for Lab Test
| Assigned | |
| LBSCAT | Subcategory for Lab Test | text | Grouping Qualifier | 13 | Subcategory for Lab Test
| Assigned | |
| LBORRESVLM | Result or Finding in Original Units | text | Result Qualifier | 50 | |||
| LBTESTCD = "HCG" (Choriogonadotropin Beta) | Pregnancy Test Result | text | 8 | Negative/Positive Result
| CRF Annotated Case Report Form [5 ] | ||
| LBTESTCD = "METHAMPH" (Methamphetamine) | Methamphetamine Test Result | text | 8 | Negative/Positive Result
| CRF Annotated Case Report Form [10 ] | ||
| LBTESTCD = "OPIATE" (Opiate) | Opiate Test Result | text | 8 | Negative/Positive Result
| CRF Annotated Case Report Form [10 ] | ||
| LBTESTCD = "COCAINE" (Cocaine) | Cocaine Test Result | text | 8 | Negative/Positive Result
| CRF Annotated Case Report Form [10 ] | ||
| LBTESTCD = "CANNAB" (Cannabinoids) | Cannabinoids Test Result | text | 8 | Negative/Positive Result
| CRF Annotated Case Report Form [10 ] | ||
| LBTESTCD = "PCP" (Phencyclidine) | Phencyclidine Test Result | text | 8 | Negative/Positive Result
| CRF Annotated Case Report Form [10 ] | ||
| LBTESTCD = "BNZDZPN" (Benzodiazepine) | Benzodiazepine Test Result | text | 8 | Negative/Positive Result
| CRF Annotated Case Report Form [10 ] | ||
| LBTESTCD = "BARB" (Barbiturates) | Barbiturates Test Result | text | 8 | Negative/Positive Result
| CRF Annotated Case Report Form [10 ] | ||
| LBTESTCD = "METHDN" (Methadone) | Methadone Test Result | text | 8 | Negative/Positive Result
| CRF Annotated Case Report Form [10 ] | ||
| LBTESTCD = "TRCYANDP" (Tricyclic Antidepressants) | Tricyclic Antidepressants Test Result | text | 8 | Negative/Positive Result
| CRF Annotated Case Report Form [10 ] | ||
| LBTESTCD = "AMPHET" (Amphetamine) | Amphetamine Test Result | text | 8 | Negative/Positive Result
| CRF Annotated Case Report Form [10 ] | ||
| LBTESTCD = "BACT" (Bacteria) | Bacteria Test Result | text | 14 | eDT | |||
| LBTESTCD = "BILI" (Bilirubin) and LBCAT = "URINALYSIS" | Bilirubin Test Result (Urinalysis) | text | 8 | eDT | |||
| LBTESTCD = "CASTS" (Casts) | Casts Test Result | text | 14 | eDT | |||
| LBTESTCD = "CRYSTALS" (Crystals) | Crystals Test Result | text | 14 | eDT | |||
| LBTESTCD = "EPIC" (Epithelial Cells) | Epithelial Cells Test Result | text | 14 | eDT | |||
| LBTESTCD = "EPIROCE" (Round Epithelial Cells) | Round Epithelial Cells Test Result | text | 14 | eDT | |||
| LBTESTCD = "GLUC" (Glucose) and LBCAT = "URINALYSIS" | Glucose Test Result (Urinalysis) | text | 8 | eDT | |||
| LBTESTCD = "HGB" (Hemoglobin) and LBCAT = "URINALYSIS" | Hemoglobin Test Result (Urinalysis) | text | 8 | eDT | |||
| LBTESTCD = "KETONES" (Ketones) | Ketones Test Result | text | 8 | eDT | |||
| LBTESTCD = "NITRITE" (Nitrite) | Nitrite Test Result | text | 8 | eDT | |||
| LBTESTCD = "PH" (pH) | pH Test Result | float | 3 | eDT | |||
| LBTESTCD = "PROT" (Protein) and LBCAT = "URINALYSIS" | Protein Test Result (Urinalysis) | text | 8 | eDT | |||
| LBTESTCD = "RBC" (Erythrocytes) and LBCAT = "URINALYSIS" | Erythrocytes Test Result (Urinalysis) | text | 14 | eDT | |||
| LBTESTCD = "SPGRAV" (Specific Gravity) | Specific Gravity Test Result | float | 5 | eDT | |||
| LBTESTCD = "UROBIL" (Urobilinogen) | Urobilinogen Test Result | text | 6 | eDT | |||
| LBTESTCD = "WBC" (Leukocytes) and LBCAT = "URINALYSIS" | Leukocytes Test Result (Urinalysis) | text | 14 | eDT | |||
| LBTESTCD = "YEAST" (Yeast Cells) | Yeast Cells Test Result | text | 7 | eDT | |||
| LBTESTCD = "ETHANOL" (Ethanol) | Ethanol Test Result | text | 8 | Negative/Positive Result
| CRF Annotated Case Report Form [11 ] | ||
| LBTESTCD = "ALB" (Albumin) | Albumin Test Result | integer | 2 | eDT | |||
| LBTESTCD = "ALP" (Alkaline Phosphatase) | Alkaline Phosphatase Test Result | text | 3 | eDT | |||
| LBTESTCD = "ALT" (Alanine Aminotransferase) | Alanine Aminotransferase Test Result | text | 3 | eDT | |||
| LBTESTCD = "AMYLASE" (Amylase) | Amylase Test Result | integer | 3 | eDT | |||
| LBTESTCD = "AST" (Aspartate Aminotransferase) | Aspartate Aminotransferase Test Result | text | 2 | eDT | |||
| LBTESTCD = "BILI" (Bilirubin) and LBCAT = "CHEMISTRY" | Bilirubin Test Result (Chemistry) | text | 4 | eDT | |||
| LBTESTCD = "CA" (Calcium) | Calcium Test Result | text | 5 | eDT | |||
| LBTESTCD = "CK" (Creatine Kinase) | Creatine Kinase Test Result | integer | 3 | eDT | |||
| LBTESTCD = "CREAT" (Creatinine) | Creatinine Test Result | text | 5 | eDT | |||
| LBTESTCD = "CRP" (C Reactive Protein) | C Reactive Protein Test Result | text | 4 | eDT | |||
| LBTESTCD = "FERRITIN" (Ferritin) | Ferritin Test Result | float | 5 | eDT | |||
| LBTESTCD = "FSH" (Follicle Stimulating Hormone) | Follicle Stimulating Hormone Test Result | float | 5 | eDT | |||
| LBTESTCD = "GGT" (Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase Test Result | integer | 3 | eDT | |||
| LBTESTCD = "GLUC" (Glucose) and LBCAT = "CHEMISTRY" | Glucose Test Result (Chemistry) | float | 4 | eDT | |||
| LBTESTCD = "K" (Potassium) | Potassium Test Result | text | 50 | eDT | |||
| LBTESTCD = "LIPASET" (Lipase) | Lipase Test Result | integer | 3 | eDT | |||
| LBTESTCD = "SODIUM" (Sodium) | Sodium Test Result | integer | 3 | eDT | |||
| LBTESTCD = "UREAN" (Urea Nitrogen) | Urea Nitrogen Test Result | float | 5 | eDT | |||
| LBTESTCD = "ANISO" (Anisocytes) | Anisocytes Test Result | text | 2 | eDT | |||
| LBTESTCD = "BASO" (Basophils) | Basophils Test Result | text | 14 | eDT | |||
| LBTESTCD = "BASOLE" (Basophils/Leukocytes) | Basophils/Leukocytes Test Result | text | 22 | eDT | |||
| LBTESTCD = "EOS" (Eosinophils) | Eosinophils Test Result | text | 14 | eDT | |||
| LBTESTCD = "EOSLE" (Eosinophils/Leukocytes) | Eosinophils/Leukocytes Test Result | text | 22 | eDT | |||
| LBTESTCD = "HCT" (Hematocrit) | Hematocrit Test Result | text | 10 | eDT | |||
| LBTESTCD = "HGB" (Hemoglobin) and LBCAT = "HEMATOLOGY" | Hemoglobin Test Result (Hematology) | text | 10 | eDT | |||
| LBTESTCD = "LYM" (Lymphocytes) | Lymphocytes Test Result | text | 14 | eDT | |||
| LBTESTCD = "LYMATLE" (Lymphocytes Atypical/Leukocytes) | Lymphocytes Atypical/Leukocytes Test Result | integer | 2 | eDT | |||
| LBTESTCD = "LYMLE" (Lymphocytes/Leukocytes) | Lymphocytes/Leukocytes Test Result | text | 22 | eDT | |||
| LBTESTCD = "MCH" (Ery. Mean Corpuscular Hemoglobin) | Ery. Mean Corpuscular Hemoglobin Test Result | float | 4 | eDT | |||
| LBTESTCD = "MCHC" (Ery. Mean Corpuscular HGB Concentration) | Ery. Mean Corpuscular HGB Concentration Test Result | float | 4 | eDT | |||
| LBTESTCD = "MCV" (Ery. Mean Corpuscular Volume) | Ery. Mean Corpuscular Volume Test Result | float | 5 | eDT | |||
| LBTESTCD = "MACROCY" (Macrocytes) | Macrocytes Test Result | text | 1 | eDT | |||
| LBTESTCD = "MICROCY" (Microcytes) | Microcytes Test Result | text | 2 | eDT | |||
| LBTESTCD = "MONO" (Monocytes) | Monocytes Test Result | text | 14 | eDT | |||
| LBTESTCD = "MONOLE" (Monocytes/Leukocytes) | Monocytes/Leukocytes Test Result | text | 22 | eDT | |||
| LBTESTCD = "MYCY" (Myelocytes) | Myelocytes Test Result | integer | 1 | eDT | |||
| LBTESTCD = "NEUT" (Neutrophils) | Neutrophils Test Result | text | 14 | eDT | |||
| LBTESTCD = "NEUTLE" (Neutrophils/Leukocytes) | Neutrophils/Leukocytes Test Result | text | 22 | eDT | |||
| LBTESTCD = "PLAT" (Platelets) | Platelets Test Result | text | 10 | eDT | |||
| LBTESTCD = "POIKILO" (Poikilocytes) | Poikilocytes Test Results | text | 3 | eDT | |||
| LBTESTCD = "RBC" (Erythrocytes) and LBCAT = "HEMATOLOGY" | Erythrocytes Test Result (Hematology) | text | 10 | eDT | |||
| LBTESTCD = "SMDGCELE" (Smudge Cells/Leukocytes) | Smudge Cells/Leukocytes Test Results | integer | 2 | eDT | |||
| LBTESTCD = "WBC" (Leukocytes) and LBCAT = "HEMATOLOGY" | Leukocytes Test Result (Hematology) | text | 10 | eDT | |||
| LBORRESU | Original Units | text | Variable Qualifier | 7 | Original Units for LB [15 Terms] | eDT | |
| LBORNRLO | Reference Range Lower Limit in Orig Unit | text | Variable Qualifier | 4 | eDT | ||
| LBORNRHI | Reference Range Upper Limit in Orig Unit | text | Variable Qualifier | 5 | eDT | ||
| LBSTRESC | Character Result/Finding in Std Format | text | Result Qualifier | 22 | Derived Lab value converted to standard units. | ||
| LBSTRESN | Numeric Result/Finding in Standard Units | float | Result Qualifier | 8 | Derived The numeric equivalent of xxSTRESC. | ||
| LBSTRESU | Standard Units | text | Variable Qualifier | 7 | Standard Units for LB [14 Terms] | Assigned | |
| LBSTNRLO | Reference Range Lower Limit-Std Units | float | Variable Qualifier | 8 | Assigned | ||
| LBSTNRHI | Reference Range Upper Limit-Std Units | float | Variable Qualifier | 8 | Assigned | ||
| LBSTNRC | Reference Range for Char Rslt-Std Units | text | Variable Qualifier | 8 | Assigned | ||
| LBNRIND | Reference Range Indicator | text | Variable Qualifier | 8 | Reference Range Indicator in LB
| Derived 'LOW' when the Standard Character Result (LBSTRESC - remove "<" sign when necessary for compare) is less than the Reference Range Standard Lower Limit (LBSTNRLO). 'HIGH' when the Standard Character Result (LBSTRESC) is greater than the Reference Range Standard Upper Limit (LBSTNRHI) or for Lab Tests 'Poikilocytes' and 'Anisocytes' when a positive result is obtained. 'ABNORMAL' when the Standard Character Result (LBSTRESC) indicates presence of cells or a positive result (e.g. '+') when the Reference Range for Standard Character Result (LBSTNRC) is 'NONE', 'NORMAL', or 'NEGATIVE'. | |
| LBSTAT | Completion Status | text | Record Qualifier | 1 | Not Done
| CRF | |
| LBREASND | Reason Test Not Done | text | Record Qualifier | 1 | CRF | ||
| LBNAM | Vendor Name | text | Record Qualifier | 44 | Vendor Name for LB
| eDT | |
| LBLOINC | LOINC Code | text | Synonym Qualifier | 7 | Assigned | ||
| LBSPEC | Specimen Type | text | Record Qualifier | 11 | Specimen Type in LB
| CRF | |
| LBMETHOD | Method of Test or Examination | text | Record Qualifier | 36 | Method of Test or Examination in LB [10 Terms] | eDT | |
| LBBLFL | Baseline Flag | text | Record Qualifier | 1 | No Yes Response (Yes only)
| Derived LB.LBBLFL = 'Y' per unique USUBJID/LBTESTCD for the last non-null LBORRES where LB.LBDTC <= DM.RFSTDTC; else LB.LBBLFL = null. | |
| LBFAST | Fasting Status | text | Record Qualifier | 1 | No Yes Response
| CRF Annotated Case Report Form [13 ] | |
| VISITNUM | Visit Number | float | Timing | 5 | Assigned Numeric value assigned to VISIT variable | ||
| VISIT | Visit Name | text | Timing | 28 | Assigned Assigned from raw data visit variable collected on CRF | ||
| EPOCH | Epoch | text | Timing | 9 | Epoch
| Derived Set to EPOCH value from the record in SE for the given USUBJID meeting the following criteria: If the observation date or event start date (--DTC / --STDTC) is prior to the element start date (SESTDTC) for the record with ETCD='PREDOSE', set to 'SCREENING'. Otherwise, if the observation date / event start date is prior to element start date for the record with ETCD='VXxxxxxP', set to 'BASELINE'. Otherwise, if the observation date / event start date is prior to element start date for the record with ETCD='FUP' or if the 'FUP' record does not exist, set to 'TREATMENT'. Otherwise, set to 'FUP'. | |
| LBDTC | Date/Time of Specimen Collection | partialDatetime | Timing | ISO 8601 | CRF | ||
| LBDY | Study Day of Specimen Collection | integer | Timing | 3 | Derived Study day of observation relative to the Subject Reference Start Date/Time (DM.RFSTDTC).
--DY = (date portion of --DTC) - (date portion of DM.RFSTDTC) + 1 where date portion of --DTC is on or after date portion of DM.RFSTDTC; Otherwise --DY = (date portion of --DTC) - (date portion of DM.RFSTDTC). | ||
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Microbiology Specimen (MB)
| Variable | Where Condition | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | ||
| DOMAIN | Domain Abbreviation | text | Identifier | 2 | Assigned Domain abbreviation of dataset. | ||
| USUBJID | Unique Subject Identifier | text | Identifier | 21 | Derived Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) | ||
| MBSEQ | Sequence Number | integer | Identifier | 8 | Derived Unique sequence number within a subject when dataset is sorted by the key variables. | ||
| MBGRPID | Group ID | text | Identifier | 1 | Assigned | ||
| MBTESTCD | Microbiology Test or Finding Short Name | text | Topic | 8 | Microbiology Specimen Test Code [8 Terms] | Assigned | |
| MBTESTVLM | Microbiology Test or Finding Name | text | Synonym Qualifier | 40 | |||
| MBCAT = "SARS-CoV-2 Test (Oral Swipe)" | SARS-CoV-2 Test (Oral Swipe) | text | 40 | Microbiology Specimen Test Name
| CRF Annotated Case Report Form [16 ] | ||
| MBCAT = "SARS-CoV-2 Antibodies" | SARS-CoV-2 Antibodies | text | 23 | Microbiology Specimen Test Name
| eDT | ||
| MBCAT = "SEROLOGY" | SEROLOGY | text | 36 | Microbiology Specimen Test Name
| CRF Annotated Case Report Form [16 ] | ||
| MBTSTDTL | Measurement, Test or Examination Detail | text | Variable Qualifier | 9 | CRF Annotated Case Report Form [16 ] | ||
| MBCAT | Category for Microbiology Finding | text | Grouping Qualifier | 28 | Category for Microbiology Finding
| Assigned | |
| MBORRESVLM | Result or Finding in Original Units | text | Result Qualifier | 8 | |||
| MBTESTCD = "SARSCOV2" (Severe Acute Resp Syndrome Coronavirus 2) | Severe Acute Resp Syndrome Coronavirus 2 | text | 8 | Negative/Positive Result
| CRF Annotated Case Report Form [16 ] | ||
| MBTESTCD = "SAR2IGA" (SARS-CoV-2 IgA Antibody) | SARS-CoV-2 IgA Antibody | float | 4 | eDT | |||
| MBTESTCD = "SAR2IGG" (SARS-CoV-2 IgG Antibody) | SARS-CoV-2 IgG Antibody | float | 4 | eDT | |||
| MBTESTCD = "HBCAB" (Hepatitis B Virus Core Antibody) | Hepatitis B Virus Core Antibody | text | 8 | eDT | |||
| MBTESTCD = "HBSAG" (Hepatitis B Virus Surface Antigen) | Hepatitis B Virus Surface Antigen | text | 8 | eDT | |||
| MBTESTCD = "HBSAGQ" (Hepatitis B Virus Surface Antigen - Quantitative) | Hepatitis B Virus Surface Antigen - Quantitative | text | 5 | eDT | |||
| MBTESTCD = "HCAB" (Hepatitis C Virus Antibody) | Hepatitis C Virus Antibody | text | 8 | eDT | |||
| MBTESTCD = "HIV12P24" (HIV-1/2 Antibody + HIV-1 p24 Antigen) | HIV-1/2 Antibody + HIV-1 p24 Antigen | text | 8 | eDT | |||
| MBORNRHI | Normal Range Upper Limit-Original Units | text | Variable Qualifier | 5 | eDT | ||
| MBSTRESC | Character Result/Finding in Std Format | text | Result Qualifier | 8 | Derived --STRESC = --ORRES | ||
| MBSTNRHI | Normal Range Upper Limit-Standard Units | float | Variable Qualifier | 8 | Assigned | ||
| MBSTNRC | Normal Range for Character Results | text | Variable Qualifier | 8 | Assigned | ||
| MBNRIND | Normal/Reference Range Indicator | text | Variable Qualifier | 4 | Reference Range Indicator in MB
| Derived For MBTEST='SARS-CoV-2 IgA Antibody' if MB.MBORRES>0.80 then MB.MBNRIND='HIGH' else MB.MBNRIND is set to missing | |
| MBRESCAT | Result Category | text | Variable Qualifier | 1 | Assigned | ||
| MBSTAT | Completion Status | text | Record Qualifier | 1 | Not Done
| CRF | |
| MBREASND | Reason Microbiology Not Performed | text | Record Qualifier | 1 | CRF | ||
| MBNAMVLM | Vendor Name | text | Record Qualifier | 44 | |||
| MBTESTCD = "SARSCOV2" (Severe Acute Resp Syndrome Coronavirus 2) | Vendor Name for Severe Acute Resp Syndrome Coronavirus 2 Test | text | 44 | Vendor Name for MB
| Assigned | ||
| MBTESTCD ≠"SARSCOV2" (Severe Acute Resp Syndrome Coronavirus 2) | Vendor Name for Other Microbiology Tests | text | 3 | Vendor Name for MB
| eDT | ||
| MBSPECVLM | Specimen Type | text | Record Qualifier | 16 | |||
| MBTESTCD = "SARSCOV2" (Severe Acute Resp Syndrome Coronavirus 2) | Specimen Type for Severe Acute Resp Syndrome Coronavirus 2 Test | text | 16 | Specimen Type (MB - SARSCOV2)
| CRF Annotated Case Report Form [16 ] | ||
| MBTESTCD ≠"SARSCOV2" (Severe Acute Resp Syndrome Coronavirus 2) | Specimen Type for Other Microbiology Tests | text | 5 | Specimen Type (MB)
| CRF Annotated Case Report Form [13 ] | ||
| MBLOC | Specimen Collection Location | text | Record Qualifier | 11 | Anatomical Location (MB)
| CRF Annotated Case Report Form [16 ] | |
| MBMETHODVLM | Method of Test or Examination | text | Record Qualifier | 60 | |||
| MBTESTCD = "SARSCOV2" (Severe Acute Resp Syndrome Coronavirus 2) | Method for Severe Acute Resp Syndrome Coronavirus 2 Test | text | 60 | Method (MB - SARSCOV2)
| CRF Annotated Case Report Form [16 ] | ||
| MBTESTCD ≠"SARSCOV2" (Severe Acute Resp Syndrome Coronavirus 2) | Method for Other Microbiology Tests | text | 36 | Method (MB)
| eDT | ||
| MBBLFL | Baseline Flag | text | Record Qualifier | 1 | No Yes Response (Yes only)
| Derived If MB.MBTESTCD in('SAR2IGA' ,'SAR2IGG') then MB.MBBLFL= 'Y' per unique USUBJID/MBTESTCD for the last non-null MBORRES where MB.MBDTC <= DM.RFSTDTC; else MB.MBBLFL = null. | |
| VISITNUM | Visit Number | float | Timing | 5 | Assigned Numeric value assigned to VISIT variable | ||
| VISIT | Visit Name | text | Timing | 22 | Assigned Assigned from raw data visit variable collected on CRF | ||
| EPOCH | Epoch | text | Timing | 9 | Epoch
| Derived Set to EPOCH value from the record in SE for the given USUBJID meeting the following criteria: If the observation date or event start date (--DTC / --STDTC) is prior to the element start date (SESTDTC) for the record with ETCD='PREDOSE', set to 'SCREENING'. Otherwise, if the observation date / event start date is prior to element start date for the record with ETCD='VXxxxxxP', set to 'BASELINE'. Otherwise, if the observation date / event start date is prior to element start date for the record with ETCD='FUP' or if the 'FUP' record does not exist, set to 'TREATMENT'. Otherwise, set to 'FUP'. | |
| MBDTC | Date/Time of Specimen Collection | partialDatetime | Timing | ISO 8601 | CRF | ||
| MBDY | Study Day of MB Specimen Collection | integer | Timing | 8 | Derived Study day of observation relative to the Subject Reference Start Date/Time (DM.RFSTDTC).
--DY = (date portion of --DTC) - (date portion of DM.RFSTDTC) + 1 where date portion of --DTC is on or after date portion of DM.RFSTDTC; Otherwise --DY = (date portion of --DTC) - (date portion of DM.RFSTDTC). |
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Physical Examination (PE)
| Related Supplemental Qualifiers Dataset: SUPPPE (Supplemental Qualifiers for PE) | |||||||
| Variable | Where Condition | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | ||
| DOMAIN | Domain Abbreviation | text | Identifier | 2 | Assigned Domain abbreviation of dataset. | ||
| USUBJID | Unique Subject Identifier | text | Identifier | 21 | Derived Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) | ||
| PESEQ | Sequence Number | integer | Identifier | 8 | Derived Unique sequence number within a subject when dataset is sorted by the key variables. | ||
| PESPID | Sponsor-Defined Identifier | text | Identifier | 2 | CRF Annotated Case Report Form [6 15 ] System generated unique identifier. | ||
| PETESTCD | Body System Examined Short Name | text | Topic | 8 | Body System Test Code [15 Terms] | Assigned | |
| PETEST | Body System Examined | text | Synonym Qualifier | 39 | Body System Test Name [15 Terms] | CRF | |
| PECAT | Category for Examination | text | Grouping Qualifier | 7 | Category for Examination
| Assigned | |
| PEORRESVLM | Verbatim Examination Finding | text | Result Qualifier | 89 | |||
| PETESTCD = "HEALTHY" (Overall Health Judgement-Subj. healthy?) | Overall Health Judgement-Subj. healthy? | text | 1 | No Yes Response
| CRF Annotated Case Report Form [15 ] | ||
| PETESTCD = "GENCON" (General condition/psyche) | General condition/psyche | text | 6 | CRF | |||
| PETESTCD = "SKIN" (Skin) | Skin | text | 87 | CRF | |||
| PETESTCD = "LYMPHN" (Lymph nodes) | Lymph nodes | text | 34 | CRF | |||
| PETESTCD = "HEAD" (Head (eyes, ears, mouth)) | Head (eyes, ears, mouth) | text | 37 | CRF | |||
| PETESTCD = "NECK" (Neck/thyroid gland) | Neck/thyroid gland | text | 6 | CRF | |||
| PETESTCD = "LUNGS" (Lungs) | Lungs | text | 42 | CRF | |||
| PETESTCD = "HEART" (Heart) | Heart | text | 6 | CRF | |||
| PETESTCD = "ABDOMEN" (Abdomen) | Abdomen | text | 6 | CRF | |||
| PETESTCD = "MUSCULO" (Musculoskeletal system) | Musculoskeletal system | text | 89 | CRF | |||
| PETESTCD = "NEUROL" (Neurological system) | Neurological system | text | 26 | CRF | |||
| PETESTCD = "VASCUL" (Vascular system) | Vascular system | text | 79 | CRF | |||
| PETESTCD = "CARDVASC" (Cardiovascular) | Cardiovascular | text | 6 | CRF | |||
| PETESTCD = "GASTRO" (Gastrointestinal) | Gastrointestinal | text | 15 | CRF | |||
| PETESTCD = "OTHER" (Other) | Other | text | 67 | CRF | |||
| PESTRESC | Result or Finding in Standard Format | text | Result Qualifier | 89 | Derived --STRESC = --ORRES | ||
| PESTAT | Completion Status | text | Record Qualifier | 8 | Not Done
| CRF | |
| PEREASND | Reason Not Examined | text | Record Qualifier | 19 | CRF | ||
| VISITNUM | Visit Number | float | Timing | 5 | Assigned Numeric value assigned to VISIT variable | ||
| VISIT | Visit Name | text | Timing | 28 | Assigned Assigned from raw data visit variable collected on CRF | ||
| EPOCH | Epoch | text | Timing | 9 | Epoch
| Derived Set to EPOCH value from the record in SE for the given USUBJID meeting the following criteria: If the observation date or event start date (--DTC / --STDTC) is prior to the element start date (SESTDTC) for the record with ETCD='PREDOSE', set to 'SCREENING'. Otherwise, if the observation date / event start date is prior to element start date for the record with ETCD='VXxxxxxP', set to 'BASELINE'. Otherwise, if the observation date / event start date is prior to element start date for the record with ETCD='FUP' or if the 'FUP' record does not exist, set to 'TREATMENT'. Otherwise, set to 'FUP'. | |
| PEDTC | Date/Time of Examination | partialDatetime | Timing | ISO 8601 | CRF | ||
| PEDY | Study Day of Examination | integer | Timing | 8 | Derived Study day of observation relative to the Subject Reference Start Date/Time (DM.RFSTDTC).
--DY = (date portion of --DTC) - (date portion of DM.RFSTDTC) + 1 where date portion of --DTC is on or after date portion of DM.RFSTDTC; Otherwise --DY = (date portion of --DTC) - (date portion of DM.RFSTDTC). | ||
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Reproductive System Findings (RP)
| Related Supplemental Qualifiers Dataset: SUPPRP (Supplemental Qualifiers for RP) | |||||||
| Variable | Where Condition | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | ||
| DOMAIN | Domain Abbreviation | text | Identifier | 2 | Assigned Domain abbreviation of dataset. | ||
| USUBJID | Unique Subject Identifier | text | Identifier | 21 | Derived Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) | ||
| RPSEQ | Sequence Number | integer | Identifier | 8 | Derived Unique sequence number within a subject when dataset is sorted by the key variables. | ||
| RPTESTCD | Repro System Findings Test Short Name | text | Topic | 8 | Repro System Findings Test Short Name
| Assigned | |
| RPTEST | Reproductive System Findings Test Name | text | Synonym Qualifier | 37 | Reproductive System Findings Test Name
| CRF Annotated Case Report Form [4 ] | |
| RPORRESVLM | Result or Finding in Original Units | text | Result Qualifier | 50 | |||
| RPTESTCD = "CHILDPOT" (Childbearing Potential) | Childbearing Potential | text | 3 | No Yes Text
| CRF Annotated Case Report Form [4 ] | ||
| RPTESTCD = "NON_REAS" (Reason for Non-childbearing potential) | Reason for Non-childbearing potential | text | 50 | Reason for Non-childbearing potential
| CRF Annotated Case Report Form [4 ] | ||
| RPTESTCD = "LMPSTDTC" (Last Menstrual Period Start Date) | Last Menstrual Period Start Date | text | 10 | CRF Annotated Case Report Form [4 ] | |||
| RPTESTCD = "STER_DTC" (Date of Sterilization) | Date of Sterilization | text | 10 | CRF Annotated Case Report Form [4 ] | |||
| RPORRESU | Original Units | text | Variable Qualifier | 1 | eDT | ||
| RPSTRESC | Character Result/Finding in Std. Format | text | Result Qualifier | 50 | Derived --STRESC = --ORRES | ||
| RPSTRESN | Numeric Result/Finding in Standard Units | integer | Result Qualifier | 8 | Derived The numeric equivalent of xxSTRESC. | ||
| RPSTRESU | Standard Units | text | Variable Qualifier | 1 | Derived RP.RPSTRESU = RP.RPORRESU | ||
| VISITNUM | Visit Number | float | Timing | 5 | Assigned Numeric value assigned to VISIT variable | ||
| VISIT | Visit Name | text | Timing | 22 | Assigned Assigned from raw data visit variable collected on CRF | ||
| EPOCH | Epoch | text | Timing | 9 | Epoch
| Derived Set to EPOCH value from the record in SE for the given USUBJID meeting the following criteria: If the observation date or event start date (--DTC / --STDTC) is prior to the element start date (SESTDTC) for the record with ETCD='PREDOSE', set to 'SCREENING'. Otherwise, if the observation date / event start date is prior to element start date for the record with ETCD='VXxxxxxP', set to 'BASELINE'. Otherwise, if the observation date / event start date is prior to element start date for the record with ETCD='FUP' or if the 'FUP' record does not exist, set to 'TREATMENT'. Otherwise, set to 'FUP'. | |
| RPDTC | Date/Time of Measurements | date | Timing | ISO 8601 | Derived RP.RPDTC=SV.SVSTDTC if RP.VISITNUM=SV.VISITNUM | ||
| RPDY | Study Day of Repro System Findings | integer | Timing | 8 | Derived Study day of observation relative to the Subject Reference Start Date/Time (DM.RFSTDTC).
--DY = (date portion of --DTC) - (date portion of DM.RFSTDTC) + 1 where date portion of --DTC is on or after date portion of DM.RFSTDTC; Otherwise --DY = (date portion of --DTC) - (date portion of DM.RFSTDTC). | ||
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Vital Signs (VS)
| Related Supplemental Qualifiers Dataset: SUPPVS (Supplemental Qualifiers for VS) | |||||||
| Variable | Where Condition | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | ||
| DOMAIN | Domain Abbreviation | text | Identifier | 2 | Assigned Domain abbreviation of dataset. | ||
| USUBJID | Unique Subject Identifier | text | Identifier | 21 | Derived Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) | ||
| VSSEQ | Sequence Number | integer | Identifier | 3 | Derived Unique sequence number within a subject when dataset is sorted by the key variables. | ||
| VSLNKID | Link ID | text | Identifier | 43 | Derived Set to VSLNKGRP. | ||
| VSLNKGRP | Link Group ID | text | Identifier | 37 | Derived Populated only on records collected for Reactogenicity analyses [i.e. where Category for Vital Signs (VSCAT) is 'REACTOGENICITY']. These records are used to populate CE domain. Note that only those records representing a fever occurring within the Day 1 to Day 8 assessment period are considered when populating the CEOCCUR value. Set VSLNKGRP to the concatenation of Time Point Reference (VSTPTREF), 'STUDY SUBJECT' (representing the evaluator, since these records are obtained from diary data), and 'Fever' (representing the reactogenicity event), separated by '-' (Ex. PRIME VACCINATION-STUDY SUBJECT-Fever). Used to link the records from the FACE and VS domains which are used to populate records in the "flat model" reactogenicity CE domain. | ||
| VSTESTCD | Vital Signs Test Short Name | text | Topic | 6 | Vital Signs Test Code [8 Terms] | Assigned | |
| VSTEST | Vital Signs Test Name | text | Synonym Qualifier | 24 | Vital Signs Test Name [8 Terms] | CRF | |
| VSCAT | Category for Vital Signs | text | Grouping Qualifier | 14 | Category for Vital Signs
| Assigned | |
| VSSCAT | Subcategory for Vital Signs | text | Grouping Qualifier | 8 | Subcategory for Vital Signs
| Assigned | |
| VSPOS | Vital Signs Position of Subject | text | Record Qualifier | 6 | Vital Signs Position of Subject
| CRF Annotated Case Report Form [7 ] | |
| VSORRESVLM | Result or Finding in Original Units | text | Result Qualifier | 5 | |||
| VSTESTCD = "BMI" (Body Mass Index) | Body Mass Index | float | 5 | CRF Annotated Case Report Form [3 ] | |||
| VSTESTCD = "DIABP" (Diastolic Blood Pressure) | Diastolic Blood Pressure | integer | 3 | CRF Annotated Case Report Form [7 ] | |||
| VSTESTCD = "HEIGHT" (Height) | Height | integer | 3 | CRF Annotated Case Report Form [3 ] | |||
| VSTESTCD = "PULSE" (Pulse Rate) | Pulse Rate | integer | 3 | CRF Annotated Case Report Form [7 ] | |||
| VSTESTCD = "RESP" (Respiratory Rate) | Respiratory Rate | integer | 2 | CRF Annotated Case Report Form [7 ] | |||
| VSTESTCD = "SYSBP" (Systolic Blood Pressure) | Systolic Blood Pressure | integer | 3 | CRF Annotated Case Report Form [7 ] | |||
| VSTESTCD = "TEMP" (Temperature) | Temperature | float | 5 | CRF | |||
| VSTESTCD = "WEIGHT" (Weight) | Weight | float | 6 | CRF Annotated Case Report Form [3 ] | |||
| VSORRESUVLM | Original Units | text | Variable Qualifier | 11 | Original Units for VS [7 Terms] | CRF | |
| VSTESTCD = "BMI" (Body Mass Index) | Body Mass Index | text | 5 | CRF Annotated Case Report Form [3 ] | |||
| VSTESTCD = "DIABP" (Diastolic Blood Pressure) | Diastolic Blood Pressure | text | 4 | CRF Annotated Case Report Form [7 ] | |||
| VSTESTCD = "HEIGHT" (Height) | Height | text | 2 | CRF Annotated Case Report Form [3 ] | |||
| VSTESTCD = "PULSE" (Pulse Rate) | Pulse Rate | text | 9 | CRF Annotated Case Report Form [7 ] | |||
| VSTESTCD = "RESP" (Respiratory Rate) | Respiratory Rate | text | 11 | CRF Annotated Case Report Form [7 ] | |||
| VSTESTCD = "SYSBP" (Systolic Blood Pressure) | Systolic Blood Pressure | text | 4 | CRF Annotated Case Report Form [7 ] | |||
| VSTESTCD = "TEMP" (Temperature) | Temperature | text | 1 | CRF | |||
| VSTESTCD = "WEIGHT" (Weight) | Weight | text | 2 | CRF Annotated Case Report Form [3 ] | |||
| VSSTRESC | Character Result/Finding in Std Format | text | Result Qualifier | 5 | Derived --STRESC = --ORRES | ||
| VSSTRESN | Numeric Result/Finding in Standard Units | float | Result Qualifier | 8 | Derived The numeric equivalent of xxSTRESC. | ||
| VSSTRESU | Standard Units | text | Variable Qualifier | 11 | Standard Units for VS [7 Terms] | Derived VSSTRESU = VSORRESU | |
| VSSTAT | Completion Status | text | Record Qualifier | 8 | Not Done
| CRF | |
| VSREASND | Reason Not Performed | text | Record Qualifier | 9 | CRF | ||
| VSLOCVLM | Location of Vital Signs Measurement | text | Record Qualifier | 11 | |||
| VSTESTCD = "TEMP" (Temperature) | Location of Temperature Measurement | text | 11 | Anatomical Location (VS - Temperature)
| CRF Annotated Case Report Form [8 ] | ||
| VSTESTCD ≠"TEMP" (Temperature) | Location of Vitals Measurement | text | 3 | Anatomical Location (VS)
| CRF Annotated Case Report Form [7 ] | ||
| VSLAT | Laterality | text | Result Qualifier | 5 | Laterality in VS
| CRF Annotated Case Report Form [7 ] | |
| VSBLFL | Baseline Flag | text | Record Qualifier | 1 | No Yes Response (Yes only)
| Derived Y on the closest non-missing result before the reference start date (DM.RFSTDTC) for each test. | |
| VISITNUM | Visit Number | float | Timing | 5 | Assigned Numeric value assigned to VISIT variable | ||
| VISIT | Visit Name | text | Timing | 28 | Assigned Assigned from raw data visit variable collected on CRF | ||
| EPOCH | Epoch | text | Timing | 9 | Epoch
| Derived Set to EPOCH value from the record in SE for the given USUBJID meeting the following criteria: If the observation date or event start date (--DTC / --STDTC) is prior to the element start date (SESTDTC) for the record with ETCD='PREDOSE', set to 'SCREENING'. Otherwise, if the observation date / event start date is prior to element start date for the record with ETCD='VXxxxxxP', set to 'BASELINE'. Otherwise, if the observation date / event start date is prior to element start date for the record with ETCD='FUP' or if the 'FUP' record does not exist, set to 'TREATMENT'. Otherwise, set to 'FUP'. | |
| VSDTC | Date/Time of Measurements | partialDatetime | Timing | ISO 8601 | CRF | ||
| VSDY | Study Day of Vital Signs | integer | Timing | 3 | Derived Study day of observation relative to the Subject Reference Start Date/Time (DM.RFSTDTC).
--DY = (date portion of --DTC) - (date portion of DM.RFSTDTC) + 1 where date portion of --DTC is on or after date portion of DM.RFSTDTC; Otherwise --DY = (date portion of --DTC) - (date portion of DM.RFSTDTC). | ||
| VSTPTVLM | Planned Time Point Name | text | Timing | 7 | |||
| VSTPT IN ( "PREDOSE", "1 HOUR", "3 HOURS", "6 HOURS" ) | Planned Time Point Name - Investigator Evaluated on Day 1 of Assessment Period | text | 7 | Planned Time Point Name - Day 1
| CRF Annotated Case Report Form [7 ] | ||
| VSTPT NOT IN ( "PREDOSE", "1 HOUR", "3 HOURS", "6 HOURS" ) | Planned Time Point Name - Subject Diary Records | text | 6 | Derived Concatenation of 'DAY ' with the number of days between the Date/Time of Collection and the Date/Time of Reference Time Point [date part of VSDTC - date part of VSRFTDTC + 1]. | |||
| VSTPTNUM | Planned Time Point Number | float | Timing | 4 | Assigned -1 when VSTPT = 'PREDOSE', 0.1 when VSTPT = '1 HOUR', 0.3 when VSTPT = '3 HOURS', and 0.6 when VSTPT = '6 HOURS'. | ||
| VSTPTREFVLM | Time Point Reference | text | Timing | 17 | Time Point Reference
| ||
| VSTPT IN ( "PREDOSE", "1 HOUR", "3 HOURS", "6 HOURS" ) | Time Point Reference - Investigator Evaluated on Day 1 of Assessment Period Records | text | 17 | Derived 'PRIME VACCINATION' when VISITNUM = 2 (Day 1 Visit). 'BOOST VACCINATION' when VISITNUM = 6 (Day 22 Visit). | |||
| VSTPT NOT IN ( "PREDOSE", "1 HOUR", "3 HOURS", "6 HOURS" ) | Time Point Reference - Subject Diary Records | text | 17 | Derived 'PRIME VACCINATION' when Date/Time of Measurements (VSDTC) is prior to the Start Date/Time of Treatment at the Day 22 Visit (EX.EXSTDTC where VISITNUM = 6) or when the subject has not received a boost vaccination (record does not exist in EX with VISITNUM = 6 and non-missing EXSTDTC). 'BOOST VACCINATION' when Date/Time of Measurements is on or after the Start Date/Time of Treatment at the Day 22 Visit. | |||
| VSRFTDTC | Date/Time of Reference Time Point | partialDatetime | Timing | ISO 8601 | Derived Start Date/Time of Treatment at the Day 1 Visit (EX.EXSTDTC where EX.VISITNUM = 2) when VSTPTREF="PRIME VACCINATION". Start Date/Time of Treatment at the Day 22 Visit (EX.EXSTDTC where EX.VISITNUM = 6) when VSTPTREF="BOOST VACCINATION". | ||
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Ancillary Analysis and Visit Details (XA)
| Related Supplemental Qualifiers Dataset: SUPPXA (Supplemental Qualifiers for XA) | |||||||
| Variable | Where Condition | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | ||
| DOMAIN | Domain Abbreviation | text | Identifier | 2 | Assigned Domain abbreviation of dataset. | ||
| USUBJID | Unique Subject Identifier | text | Identifier | 21 | Derived Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) | ||
| XASEQ | Sequence Number | integer | 8 | Derived Unique sequence number within a subject when dataset is sorted by the key variables. | |||
| XATESTCD | Test or Examination Short Name | text | 8 | XA Test Code
| Assigned | ||
| XATEST | Test or Examination Name | text | 22 | XA Test Name
| CRF | ||
| XACAT | Category | text | 27 | Category for XA
| Assigned | ||
| XAORRESVLM | Result or Finding in Original Units | text | 166 | ||||
| XATESTCD = "VACCIN_V" (Vaccination Visit) | Vaccination Visit | text | 3 | No Yes Text
| CRF Annotated Case Report Form [28 ] | ||
| XATESTCD = "OUT_CALL" (Outcome of the call) | Outcome of the call | text | 166 | CRF Annotated Case Report Form [24 ] | |||
| XATESTCD = "IC_GIVEN" (Informed Consent given) | Informed Consent given | text | 3 | No Yes Text
| CRF | ||
| XATESTCD = "ND" (Not Done) | Not Done | text | 3 | No Yes Text
| CRF Annotated Case Report Form [24 ] | ||
| XATESTCD = "REAS_ND" (Reason not Done) | Reason not Done | text | 9 | CRF Annotated Case Report Form [24 ] | |||
| XASTRESC | Result or Finding in Standard Format | text | 166 | Derived --STRESC = --ORRES | |||
| XABLFL | Baseline Flag | text | 1 | Derived Y on the closest non-missing result before the reference start date (DM.RFSTDTC) for each test. | |||
| VISITNUM | Visit Number | float | Timing | 5 | Assigned Numeric value assigned to VISIT variable | ||
| VISIT | Visit Name | text | Timing | 30 | CRF Annotated Case Report Form [28 ] Assigned from raw data visit variable collected on CRF | ||
| EPOCH | Epoch | text | Timing | 9 | Epoch
| Derived Set to EPOCH value from the record in SE for the given USUBJID meeting the following criteria: If the observation date or event start date (--DTC / --STDTC) is prior to the element start date (SESTDTC) for the record with ETCD='PREDOSE', set to 'SCREENING'. Otherwise, if the observation date / event start date is prior to element start date for the record with ETCD='VXxxxxxP', set to 'BASELINE'. Otherwise, if the observation date / event start date is prior to element start date for the record with ETCD='FUP' or if the 'FUP' record does not exist, set to 'TREATMENT'. Otherwise, set to 'FUP'. | |
| XADTC | Date/Time of Collection | partialDatetime | ISO 8601 | CRF | |||
| XADY | Study Day of Start of Treatment | integer | 8 | Derived Study day of observation relative to the Subject Reference Start Date/Time (DM.RFSTDTC).
--DY = (date portion of --DTC) - (date portion of DM.RFSTDTC) + 1 where date portion of --DTC is on or after date portion of DM.RFSTDTC; Otherwise --DY = (date portion of --DTC) - (date portion of DM.RFSTDTC). | |||
| XATPT | Planned Time Point Name | text | 8 | CRF Annotated Case Report Form [28 ] | |||
| XATPTNUM | Planned Time Point Number | integer | 8 | Assigned Assigned to the number preceding ' hours' in XATPT. | |||
| XATPTREF | Time Point Reference | text | 17 | Derived 'PRIME VACCINATION' when VISITNUM = 2 (Day 1 Visit). 'BOOST VACCINATION' when VISITNUM = 6 (Day 22 Visit). | |||
| XARFTDTC | Date/Time of Reference Time Point | partialDatetime | ISO 8601 | Derived Start Date/Time of Treatment at the Day 1 Visit (EX.EXSTDTC where EX.VISITNUM = 2) when XATPTREF="PRIME VACCINATION". Start Date/Time of Treatment at the Day 22 Visit (EX.EXSTDTC where EX.VISITNUM = 6) when XATPTREF="BOOST VACCINATION". | |||
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HLA Typing (XB)
| Variable | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | |
| DOMAIN | Domain Abbreviation | text | Identifier | 2 | Assigned Domain abbreviation of dataset. | |
| USUBJID | Unique Subject Identifier | text | Identifier | 21 | Derived Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) | |
| XBSEQ | Sequence Number | integer | 1 | Derived Unique sequence number within a subject when dataset is sorted by the key variables. | ||
| XBTESTCD | Test or Examination Short Name | text | 7 | XB Test Code
| Assigned | |
| XBTEST | Test or Examination Name | text | 20 | XB Test Name
| eDT | |
| XBCAT | Category | text | 10 | Category for XB
| Assigned | |
| XBORRES | Result or Finding in Original Units | text | 30 | eDT | ||
| XBSTRESC | Result or Finding in Standard Format | text | 30 | Derived --STRESC = --ORRES | ||
| XBBLFL | Baseline Flag | text | 1 | Derived Y on the closest non-missing result before the reference start date (DM.RFSTDTC) for each test. | ||
| EPOCH | Epoch | text | Timing | 9 | Epoch
| Derived Set to EPOCH value from the record in SE for the given USUBJID meeting the following criteria: If the observation date or event start date (--DTC / --STDTC) is prior to the element start date (SESTDTC) for the record with ETCD='PREDOSE', set to 'SCREENING'. Otherwise, if the observation date / event start date is prior to element start date for the record with ETCD='VXxxxxxP', set to 'BASELINE'. Otherwise, if the observation date / event start date is prior to element start date for the record with ETCD='FUP' or if the 'FUP' record does not exist, set to 'TREATMENT'. Otherwise, set to 'FUP'. |
| XBDTC | Date/Time of Collection | partialDatetime | ISO 8601 | eDT | ||
| XBDY | Study Day of Start of Treatment | integer | 2 | Derived Study day of observation relative to the Subject Reference Start Date/Time (DM.RFSTDTC).
--DY = (date portion of --DTC) - (date portion of DM.RFSTDTC) + 1 where date portion of --DTC is on or after date portion of DM.RFSTDTC; Otherwise --DY = (date portion of --DTC) - (date portion of DM.RFSTDTC). |
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Related Records (RELREC)
| Variable | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment |
|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | |
| RDOMAIN | Related Domain Abbreviation | text | Identifier | 2 | Related Domain Abbreviation in Related Records
| Assigned Abbreviation for the domain of the parent record(s). |
| USUBJID | Unique Subject Identifier | text | Identifier | 1 | Derived Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) | |
| IDVAR | Identifying Variable | text | Record Qualifier | 8 | Identifying Variable in Related Records
| Assigned Identifying variable in the related dataset that identifies the related record(s). |
| IDVARVAL | Identifying Variable Value | text | Record Qualifier | 1 | Assigned Value of variable specified by IDVAR on the parent record(s). | |
| RELTYPE | Relationship Type | text | Identifier | 4 | Relationship Type
| Assigned |
| RELID | Relationship Identifier | text | Identifier | 1 | Derived Derived as unique value within USUBJID that identifies the relationship within the RELREC dataset to identify the related/associated Domain records. |
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Supplemental Qualifiers for AE (SUPPAE)
| Related Parent Dataset: AE (Adverse Events) | |||||||
| Variable | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment | |
|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | ||
| RDOMAIN | Related Domain Abbreviation | text | Identifier | 2 | Assigned Abbreviation for the domain of the parent record(s). | ||
| USUBJID | Unique Subject Identifier | text | Identifier | 21 | Derived Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) | ||
| IDVAR | Identifying Variable | text | Record Qualifier | 5 | Identifying Variable in SUPPAE
| Assigned Identifying variable in the related dataset that identifies the related record(s). | |
| IDVARVAL | Identifying Variable Value | text | Record Qualifier | 2 | Assigned Value of variable specified by IDVAR on the parent record(s). | ||
| QNAM | Qualifier Variable Name | text | Topic | 8 | Qualifier Variable Name for SUPPAE
| Assigned Variable name of the supplemental qualifer. | |
| QLABEL | Qualifier Variable Label | text | Synonym Qualifier | 30 | Assigned Value of identifying variable described in QNAM. | ||
| QVALVLM | Data Value | text | Result Qualifier | 1 | |||
➤ QNAM = "AEEPRELI" | Epi/Pandemic Related Indicator | text | 1 | No Yes Response
| CRF Annotated Case Report Form [34 ] | ||
➤ QNAM = "AETRTEM" | Treatment Emergent Flag | text | 1 | No Yes Response
| CRF Annotated Case Report Form [34 ] | ||
➤ QNAM = "AE_DLT" | Dose limiting Toxicity | text | 1 | No Yes Response
| CRF Annotated Case Report Form [34 ] | ||
| QORIG | Origin | text | Result Qualifier | 3 | Assigned Origin of supplemental qualifier. | ||
| QEVAL | Evaluator | text | Result Qualifier | 1 | Assigned Evaluator of supplemental qualifier. | ||
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Supplemental Qualifiers for CM (SUPPCM)
| Related Parent Dataset: CM (Concomitant/Prior Medications) | |||||||
| Variable | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment | |
|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | ||
| RDOMAIN | Related Domain Abbreviation | text | Identifier | 2 | Assigned Abbreviation for the domain of the parent record(s). | ||
| USUBJID | Unique Subject Identifier | text | Identifier | 21 | Derived Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) | ||
| IDVAR | Identifying Variable | text | Record Qualifier | 5 | Identifying Variable in SUPPCM
| Assigned Identifying variable in the related dataset that identifies the related record(s). | |
| IDVARVAL | Identifying Variable Value | text | Record Qualifier | 2 | Assigned Value of variable specified by IDVAR on the parent record(s). | ||
| QNAM | Qualifier Variable Name | text | Topic | 8 | Qualifier Variable Name for SUPPCM [14 Terms] | Assigned Variable name of the supplemental qualifer. | |
| QLABEL | Qualifier Variable Label | text | Synonym Qualifier | 24 | Assigned Value of identifying variable described in QNAM. | ||
| QVALVLM | Data Value | text | Result Qualifier | 78 | |||
➤ QNAM = "AE_NO1" | Corresponding AE No 1 | integer | 2 | CRF Annotated Case Report Form [36 ] | |||
➤ QNAM = "CMATC1" | ATC Level 1 Description | text | 78 | Assigned | |||
➤ QNAM = "CMATC1CD" | ATC Level 1 Code | text | 4 | Assigned | |||
➤ QNAM = "CMATC2" | ATC Level 2 Description | text | 64 | Assigned | |||
➤ QNAM = "CMATC2CD" | ATC Level 2 Code | text | 8 | Assigned | |||
➤ QNAM = "CMATC3" | ATC Level 3 Description | text | 71 | Assigned | |||
➤ QNAM = "CMATC3CD" | ATC Level 3 Code | text | 10 | Assigned | |||
➤ QNAM = "CMATC4" | ATC Level 4 Description | text | 66 | Assigned | |||
➤ QNAM = "CMATC4CD" | ATC Level 4 Code | text | 12 | Assigned | |||
➤ QNAM = "O_UNIT" | Other unit, specify | text | 16 | CRF Annotated Case Report Form [36 ] | |||
➤ QNAM = "AE_NO2" | Corresponding AE No 2 | integer | 2 | CRF Annotated Case Report Form [36 ] | |||
➤ QNAM = "O_FREQ" | Other frequency, specify | text | 19 | CRF Annotated Case Report Form [36 ] | |||
➤ QNAM = "AE_NO3" | Corresponding AE No 3 | integer | 2 | CRF Annotated Case Report Form [36 ] | |||
➤ QNAM = "O_ROUTE" | Other route, specify | text | 5 | CRF Annotated Case Report Form [36 ] | |||
| QORIG | Origin | text | Result Qualifier | 8 | Assigned Origin of supplemental qualifier. | ||
| QEVAL | Evaluator | text | Result Qualifier | 13 | Evaluator for SUPPCM
| Assigned Evaluator of supplemental qualifier. | |
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Supplemental Qualifiers for DM (SUPPDM)
| Related Parent Dataset: DM (Demographics) | |||||||
| Variable | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment | |
|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | ||
| RDOMAIN | Related Domain Abbreviation | text | Identifier | 2 | Assigned Abbreviation for the domain of the parent record(s). | ||
| USUBJID | Unique Subject Identifier | text | Identifier | 21 | Derived Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) | ||
| IDVAR | Identifying Variable | text | Record Qualifier | 1 | Assigned Identifying variable in the related dataset that identifies the related record(s). | ||
| IDVARVAL | Identifying Variable Value | text | Record Qualifier | 1 | Assigned Value of variable specified by IDVAR on the parent record(s). | ||
| QNAM | Qualifier Variable Name | text | Topic | 5 | Qualifier Variable Name for SUPPDM
| Assigned Variable name of the supplemental qualifer. | |
| QLABEL | Qualifier Variable Label | text | Synonym Qualifier | 36 | Assigned Value of identifying variable described in QNAM. | ||
| QVALVLM | Data Value | text | Result Qualifier | 2 | |||
➤ QNAM = "AGE_M" | Add. months to Age in years (months) | integer | 2 | CRF Annotated Case Report Form [2 ] | |||
➤ QNAM = "RACE1" | Race 1 | text | 1 | CRF Annotated Case Report Form [2 ] | |||
➤ QNAM = "RACE2" | Race 2 | text | 1 | CRF Annotated Case Report Form [2 ] | |||
➤ QNAM = "RACEOTH" | Race, Other | text | 1 | CRF Annotated Case Report Form [2 ] | |||
| QORIG | Origin | text | Result Qualifier | 3 | Assigned Origin of supplemental qualifier. | ||
| QEVAL | Evaluator | text | Result Qualifier | 1 | Assigned Evaluator of supplemental qualifier. | ||
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Supplemental Qualifiers for DS (SUPPDS)
| Related Parent Dataset: DS (Disposition) | |||||||
| Variable | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment | |
|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | ||
| RDOMAIN | Related Domain Abbreviation | text | Identifier | 2 | Assigned Abbreviation for the domain of the parent record(s). | ||
| USUBJID | Unique Subject Identifier | text | Identifier | 21 | Derived Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) | ||
| IDVAR | Identifying Variable | text | Record Qualifier | 5 | Identifying Variable in SUPPDS
| Assigned Identifying variable in the related dataset that identifies the related record(s). | |
| IDVARVAL | Identifying Variable Value | text | Record Qualifier | 1 | Assigned Value of variable specified by IDVAR on the parent record(s). | ||
| QNAM | Qualifier Variable Name | text | Topic | 8 | Qualifier Variable Name for SUPPDS [6 Terms] | Assigned Variable name of the supplemental qualifer. | |
| QLABEL | Qualifier Variable Label | text | Synonym Qualifier | 30 | Assigned Value of identifying variable described in QNAM. | ||
| QVALVLM | Data Value | text | Result Qualifier | 16 | |||
➤ QNAM = "PROTVERS" | Protocol Version | text | 16 | Protocol Version
| CRF | ||
➤ QNAM = "COHORT" | Subject is allocated to Cohort | text | 9 | Allocation Cohort [10 Terms] | CRF Annotated Case Report Form [17 ] | ||
➤ QNAM = "GROUP" | Subject is allocated to Group | text | 12 | Allocation Group
| CRF Annotated Case Report Form [17 ] | ||
➤ QNAM = "DSEPRELI" | Epi/Pandemic Related Indicator | text | 1 | No Yes Response
| CRF Annotated Case Report Form [25 ] | ||
➤ QNAM = "LASTCONT" | Date of last visit/contact | date | ISO 8601 | CRF Annotated Case Report Form [25 ] | |||
➤ QNAM = "PREV_TSN" | Previous TSNs | text | 11 | CRF Annotated Case Report Form [1 ] | |||
| QORIG | Origin | text | Result Qualifier | 3 | Assigned Origin of supplemental qualifier. | ||
| QEVAL | Evaluator | text | Result Qualifier | 1 | Assigned Evaluator of supplemental qualifier. | ||
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Supplemental Qualifiers for DV (SUPPDV)
| Related Parent Dataset: DV (Protocol Deviations) | |||||||
| Variable | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment | |
|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | ||
| RDOMAIN | Related Domain Abbreviation | text | Identifier | 2 | Assigned Abbreviation for the domain of the parent record(s). | ||
| USUBJID | Unique Subject Identifier | text | Identifier | 21 | Derived Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) | ||
| IDVAR | Identifying Variable | text | Record Qualifier | 5 | Identifying Variable in SUPPDV
| Assigned Identifying variable in the related dataset that identifies the related record(s). | |
| IDVARVAL | Identifying Variable Value | text | Record Qualifier | 1 | Assigned Value of variable specified by IDVAR on the parent record(s). | ||
| QNAM | Qualifier Variable Name | text | Topic | 6 | Qualifier Variable Name for SUPPDV
| Assigned Variable name of the supplemental qualifer. | |
| QLABEL | Qualifier Variable Label | text | Synonym Qualifier | 20 | Assigned Value of identifying variable described in QNAM. | ||
| QVALVLM | Data Value | text | Result Qualifier | 200 | |||
➤ QNAM = "DVREAS" | Reason for Deviation | text | 200 | CRF Annotated Case Report Form [38 ] | |||
➤ QNAM = "DVEPRELI" | Covid 19 IMPACT | text | 2 | CRF Annotated Case Report Form [38 ] | |||
| QORIG | Origin | text | Result Qualifier | 3 | Assigned Origin of supplemental qualifier. | ||
| QEVAL | Evaluator | text | Result Qualifier | 1 | Assigned Evaluator of supplemental qualifier. | ||
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Supplemental Qualifiers for EC (SUPPEC)
| Related Parent Dataset: EC (Exposure as Collected) | |||||||
| Variable | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment | |
|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | ||
| RDOMAIN | Related Domain Abbreviation | text | Identifier | 2 | Assigned Abbreviation for the domain of the parent record(s). | ||
| USUBJID | Unique Subject Identifier | text | Identifier | 21 | Derived Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) | ||
| IDVAR | Identifying Variable | text | Record Qualifier | 5 | Identifying Variable in SUPPEC
| Assigned Identifying variable in the related dataset that identifies the related record(s). | |
| IDVARVAL | Identifying Variable Value | text | Record Qualifier | 1 | Assigned Value of variable specified by IDVAR on the parent record(s). | ||
| QNAM | Qualifier Variable Name | text | Topic | 8 | Qualifier Variable Name for SUPPEC [8 Terms] | Assigned Variable name of the supplemental qualifer. | |
| QLABEL | Qualifier Variable Label | text | Synonym Qualifier | 40 | Assigned Value of identifying variable described in QNAM. | ||
| QVALVLM | Data Value | text | Result Qualifier | 114 | |||
➤ QNAM = "ADMPPROT" | Administration according to protocol? | text | 3 | No Yes Text
| CRF Annotated Case Report Form [21 ] | ||
➤ QNAM = "MED_NO" | Medication Number | integer | 5 | CRF Annotated Case Report Form [20 ] | |||
➤ QNAM = "TOTDOS" | Total Dose given? | text | 3 | No Yes Text
| CRF Annotated Case Report Form [20 ] | ||
➤ QNAM = "ECREASOC" | Reason for Occur Value | text | 72 | CRF Annotated Case Report Form [20 ] | |||
➤ QNAM = "RESTVOL" | Rest of Volume | float | 1 | CRF Annotated Case Report Form [20 ] | |||
➤ QNAM = "ADMNPPSP" | Reasons administration not according to protocol | text | 114 | CRF Annotated Case Report Form [21 ] | |||
➤ QNAM = "ECEPADJI" | Epi/Pandemic related adjustment | text | 1 | No Yes Response
| CRF Annotated Case Report Form [21 ] | ||
➤ QNAM = "ECEPINTI" | Epi/Pandemic related interruption | text | 1 | No Yes Response
| CRF Annotated Case Report Form [21 ] | ||
| QORIG | Origin | text | Result Qualifier | 3 | Assigned Origin of supplemental qualifier. | ||
| QEVAL | Evaluator | text | Result Qualifier | 1 | Assigned Evaluator of supplemental qualifier. | ||
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Supplemental Qualifiers for EG (SUPPEG)
| Related Parent Dataset: EG (ECG Test Results) | |||||||
| Variable | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment | |
|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | ||
| RDOMAIN | Related Domain Abbreviation | text | Identifier | 2 | Assigned Abbreviation for the domain of the parent record(s). | ||
| USUBJID | Unique Subject Identifier | text | Identifier | 21 | Derived Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) | ||
| IDVAR | Identifying Variable | text | Record Qualifier | 5 | Identifying Variable in SUPPEG
| Assigned Identifying variable in the related dataset that identifies the related record(s). | |
| IDVARVAL | Identifying Variable Value | text | Record Qualifier | 1 | Assigned Value of variable specified by IDVAR on the parent record(s). | ||
| QNAM | Qualifier Variable Name | text | Topic | 7 | Qualifier Variable Name for SUPPEG
| Assigned Variable name of the supplemental qualifer. | |
| QLABEL | Qualifier Variable Label | text | Synonym Qualifier | 22 | Assigned Value of identifying variable described in QNAM. | ||
| QVALVLM | Data Value | text | Result Qualifier | 3 | |||
➤ QNAM = "EGCLSIG" | Clinically Significant | text | 1 | No Yes Response
| CRF Annotated Case Report Form [9 ] | ||
➤ QNAM = "CODE" | Code of ECG Finding | integer | 3 | Code of ECG Finding [17 Terms] | CRF Annotated Case Report Form [9 ] | ||
| QORIG | Origin | text | Result Qualifier | 3 | Assigned Origin of supplemental qualifier. | ||
| QEVAL | Evaluator | text | Result Qualifier | 12 | Evaluator for SUPPEG
| Assigned Evaluator of supplemental qualifier. | |
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Supplemental Qualifiers for EX (SUPPEX)
| Related Parent Dataset: EX (Exposure) | |||||||
| Variable | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment | |
|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | ||
| RDOMAIN | Related Domain Abbreviation | text | Identifier | 2 | Assigned Abbreviation for the domain of the parent record(s). | ||
| USUBJID | Unique Subject Identifier | text | Identifier | 21 | Derived Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) | ||
| IDVAR | Identifying Variable | text | Record Qualifier | 5 | Identifying Variable in SUPPEX
| Assigned Identifying variable in the related dataset that identifies the related record(s). | |
| IDVARVAL | Identifying Variable Value | text | Record Qualifier | 1 | Assigned Value of variable specified by IDVAR on the parent record(s). | ||
| QNAM | Qualifier Variable Name | text | Topic | 8 | Qualifier Variable Name for SUPPEX [7 Terms] | Assigned Variable name of the supplemental qualifer. | |
| QLABEL | Qualifier Variable Label | text | Synonym Qualifier | 40 | Assigned Value of identifying variable described in QNAM. | ||
| QVALVLM | Data Value | text | Result Qualifier | 114 | |||
➤ QNAM = "ADMPPROT" | Administration according to protocol? | text | 3 | No Yes Text
| CRF Annotated Case Report Form [21 ] | ||
➤ QNAM = "MED_NO" | Medication Number | integer | 5 | CRF Annotated Case Report Form [20 ] | |||
➤ QNAM = "TOTDOS" | Total Dose given? | text | 3 | No Yes Text
| CRF Annotated Case Report Form [20 ] | ||
➤ QNAM = "RESTVOL" | Rest of Volume | float | 1 | CRF Annotated Case Report Form [20 ] | |||
➤ QNAM = "ADMNPPSP" | Reasons administration not according to protocol | text | 114 | CRF Annotated Case Report Form [21 ] | |||
➤ QNAM = "EXEPADJI" | Epi/Pandemic related adjustment | text | 1 | No Yes Response
| CRF Annotated Case Report Form [21 ] | ||
➤ QNAM = "EXEPINTI" | Epi/Pandemic related interruption | text | 1 | No Yes Response
| CRF Annotated Case Report Form [21 ] | ||
| QORIG | Origin | text | Result Qualifier | 3 | Assigned Origin of supplemental qualifier. | ||
| QEVAL | Evaluator | text | Result Qualifier | 1 | Assigned Evaluator of supplemental qualifier. | ||
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Supplemental Qualifiers for FACE (SUPPFACE)
| Related Parent Dataset: FACE (Findings About Clinical Events) | |||||||
| Variable | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment | |
|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | ||
| RDOMAIN | Related Domain Abbreviation | text | Identifier | 2 | Assigned Abbreviation for the domain of the parent record(s). | ||
| USUBJID | Unique Subject Identifier | text | Identifier | 21 | Derived Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) | ||
| IDVAR | Identifying Variable | text | Record Qualifier | 5 | Identifying Variable in SUPPFACE
| Assigned Identifying variable in the related dataset that identifies the related record(s). | |
| IDVARVAL | Identifying Variable Value | text | Record Qualifier | 3 | Assigned Value of variable specified by IDVAR on the parent record(s). | ||
| QNAM | Qualifier Variable Name | text | Topic | 8 | Qualifier Variable Name for SUPPFACE
| Assigned Variable name of the supplemental qualifer. | |
| QLABEL | Qualifier Variable Label | text | Synonym Qualifier | 32 | Assigned Value of identifying variable described in QNAM. | ||
| QVALVLM | Data Value | text | Result Qualifier | 2 | |||
➤ QNAM = "STUDYDAY" | Reported Study Day of Collection | integer | 2 | CRF | |||
| QORIG | Origin | text | Result Qualifier | 3 | Assigned Origin of supplemental qualifier. | ||
| QEVAL | Evaluator | text | Result Qualifier | 13 | Evaluator for SUPPFACE
| Assigned Evaluator of supplemental qualifier. | |
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Supplemental Qualifiers for LB (SUPPLB)
| Related Parent Dataset: LB (Laboratory Test Results) | |||||||
| Variable | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment | |
|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | ||
| RDOMAIN | Related Domain Abbreviation | text | Identifier | 2 | Assigned Abbreviation for the domain of the parent record(s). | ||
| USUBJID | Unique Subject Identifier | text | Identifier | 21 | Derived Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) | ||
| IDVAR | Identifying Variable | text | Record Qualifier | 5 | Identifying Variable in SUPPLB
| Assigned Identifying variable in the related dataset that identifies the related record(s). | |
| IDVARVAL | Identifying Variable Value | text | Record Qualifier | 3 | Assigned Value of variable specified by IDVAR on the parent record(s). | ||
| QNAM | Qualifier Variable Name | text | Topic | 8 | Qualifier Variable Name for SUPPLB [7 Terms] | Assigned Variable name of the supplemental qualifer. | |
| QLABEL | Qualifier Variable Label | text | Synonym Qualifier | 36 | Assigned Value of identifying variable described in QNAM. | ||
| QVALVLM | Data Value | text | Result Qualifier | 24 | |||
➤ QNAM = "LBCLSIG" | Clinically Significant | text | 1 | No Yes Response
| eDT | ||
➤ QNAM = "LBLOINC1" | LOINC Code for Identification | text | 7 | eDT | |||
➤ QNAM = "LBORRES1" | Identification for Result | text | 24 | eDT | |||
➤ QNAM = "LBLOINC2" | LOINC Code for second Identification | text | 6 | eDT | |||
➤ QNAM = "LBORRES2" | Second Identification for Result | text | 21 | eDT | |||
➤ QNAM = "RBB" | Report Blood Count | text | 21 | eDT | |||
➤ QNAM = "RBB2" | Report Blood Count 2 | text | 21 | eDT | |||
| QORIG | Origin | text | Result Qualifier | 3 | Assigned Origin of supplemental qualifier. | ||
| QEVAL | Evaluator | text | Result Qualifier | 12 | Evaluator for SUPPLB
| Assigned Evaluator of supplemental qualifier. | |
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Supplemental Qualifiers for PE (SUPPPE)
| Related Parent Dataset: PE (Physical Examination) | |||||||
| Variable | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment | |
|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | ||
| RDOMAIN | Related Domain Abbreviation | text | Identifier | 2 | Assigned Abbreviation for the domain of the parent record(s). | ||
| USUBJID | Unique Subject Identifier | text | Identifier | 21 | Derived Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) | ||
| IDVAR | Identifying Variable | text | Record Qualifier | 5 | Identifying Variable in SUPPPE
| Assigned Identifying variable in the related dataset that identifies the related record(s). | |
| IDVARVAL | Identifying Variable Value | text | Record Qualifier | 2 | Assigned Value of variable specified by IDVAR on the parent record(s). | ||
| QNAM | Qualifier Variable Name | text | Topic | 7 | Qualifier Variable Name for SUPPPE
| Assigned Variable name of the supplemental qualifer. | |
| QLABEL | Qualifier Variable Label | text | Synonym Qualifier | 22 | Assigned Value of identifying variable described in QNAM. | ||
| QVALVLM | Data Value | text | Result Qualifier | 1 | |||
➤ QNAM = "PECLSIG" | Clinically Significant | text | 1 | No Yes Response
| CRF | ||
| QORIG | Origin | text | Result Qualifier | 3 | Assigned Origin of supplemental qualifier. | ||
| QEVAL | Evaluator | text | Result Qualifier | 12 | Evaluator for SUPPPE
| Assigned Evaluator of supplemental qualifier. | |
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Supplemental Qualifiers for RP (SUPPRP)
| Related Parent Dataset: RP (Reproductive System Findings) | |||||||
| Variable | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment | |
|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | ||
| RDOMAIN | Related Domain Abbreviation | text | Identifier | 2 | Assigned Abbreviation for the domain of the parent record(s). | ||
| USUBJID | Unique Subject Identifier | text | Identifier | 21 | Derived Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) | ||
| IDVAR | Identifying Variable | text | Record Qualifier | 5 | Identifying Variable in SUPPRP
| Assigned Identifying variable in the related dataset that identifies the related record(s). | |
| IDVARVAL | Identifying Variable Value | text | Record Qualifier | 1 | Assigned Value of variable specified by IDVAR on the parent record(s). | ||
| QNAM | Qualifier Variable Name | text | Topic | 8 | Qualifier Variable Name for SUPPRP
| Assigned Variable name of the supplemental qualifer. | |
| QLABEL | Qualifier Variable Label | text | Synonym Qualifier | 30 | Assigned Value of identifying variable described in QNAM. | ||
| QVALVLM | Data Value | text | Result Qualifier | 23 | |||
➤ QNAM = "OTH_SPEC" | Specification for Other Reason | text | 23 | CRF Annotated Case Report Form [4 ] | |||
| QORIG | Origin | text | Result Qualifier | 3 | Assigned Origin of supplemental qualifier. | ||
| QEVAL | Evaluator | text | Result Qualifier | 1 | Assigned Evaluator of supplemental qualifier. | ||
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Supplemental Qualifiers for VS (SUPPVS)
| Related Parent Dataset: VS (Vital Signs) | |||||||
| Variable | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment | |
|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | ||
| RDOMAIN | Related Domain Abbreviation | text | Identifier | 2 | Assigned Abbreviation for the domain of the parent record(s). | ||
| USUBJID | Unique Subject Identifier | text | Identifier | 21 | Derived Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) | ||
| IDVAR | Identifying Variable | text | Record Qualifier | 5 | Identifying Variable in SUPPVS
| Assigned Identifying variable in the related dataset that identifies the related record(s). | |
| IDVARVAL | Identifying Variable Value | text | Record Qualifier | 3 | Assigned Value of variable specified by IDVAR on the parent record(s). | ||
| QNAM | Qualifier Variable Name | text | Topic | 8 | Qualifier Variable Name for SUPPVS
| Assigned Variable name of the supplemental qualifer. | |
| QLABEL | Qualifier Variable Label | text | Synonym Qualifier | 32 | Assigned Value of identifying variable described in QNAM. | ||
| QVALVLM | Data Value | text | Result Qualifier | 3 | |||
➤ QNAM = "STUDYDAY" | Reported Study Day of Collection | integer | 3 | CRF Annotated Case Report Form [31 ] | |||
➤ QNAM = "VSCLSIG" | Clinically Significant | text | 1 | No Yes Response
| CRF | ||
| QORIG | Origin | text | Result Qualifier | 3 | Assigned Origin of supplemental qualifier. | ||
| QEVAL | Evaluator | text | Result Qualifier | 13 | Evaluator for SUPPVS
| Assigned Evaluator of supplemental qualifier. | |
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Supplemental Qualifiers for XA (SUPPXA)
| Related Parent Dataset: XA (Ancillary Analysis and Visit Details) | |||||||
| Variable | Label / Description | Type | Role | Length or Display Format | Controlled Terms or ISO Format | Origin / Source / Method / Comment | |
|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Identifier | 9 | Protocol | ||
| RDOMAIN | Related Domain Abbreviation | text | Identifier | 2 | Assigned Abbreviation for the domain of the parent record(s). | ||
| USUBJID | Unique Subject Identifier | text | Identifier | 21 | Derived Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) | ||
| IDVAR | Identifying Variable | text | Record Qualifier | 5 | Identifying Variable in SUPPXA
| Assigned Identifying variable in the related dataset that identifies the related record(s). | |
| IDVARVAL | Identifying Variable Value | text | Record Qualifier | 1 | Assigned Value of variable specified by IDVAR on the parent record(s). | ||
| QNAM | Qualifier Variable Name | text | Topic | 7 | Qualifier Variable Name for SUPPXA [6 Terms] | Assigned Variable name of the supplemental qualifer. | |
| QLABEL | Qualifier Variable Label | text | Synonym Qualifier | 36 | Assigned Value of identifying variable described in QNAM. | ||
| QVALVLM | Data Value | text | Result Qualifier | 16 | |||
➤ QNAM = "RES_BS" | Blood Sampling for Research Purposes | datetime | ISO 8601 | CRF Annotated Case Report Form [41 ] | |||
➤ QNAM = "HLA_BS" | Separate Blood Sampling for HLA | datetime | ISO 8601 | CRF Annotated Case Report Form [39 ] | |||
➤ QNAM = "ACT_TPT" | Actual observation period | text | 2 | CRF Annotated Case Report Form [28 ] | |||
➤ QNAM = "REASON" | Reason | text | 15 | CRF Annotated Case Report Form [28 ] | |||
➤ QNAM = "PG_CMI" | PG Aliquot from previous CMI | text | 1 | CRF Annotated Case Report Form [39 ] | |||
➤ QNAM = "HLA_CMI" | HLA Aliquot from previous CMI | text | 1 | CRF Annotated Case Report Form [39 ] | |||
| QORIG | Origin | text | Result Qualifier | 3 | Assigned Origin of supplemental qualifier. | ||
| QEVAL | Evaluator | text | Result Qualifier | 1 | Assigned Evaluator of supplemental qualifier. | ||
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CodeLists
Description of Actual Arm
| Permitted Value (Code) |
|---|
| BNT162b1 Cohort 01 10 ug |
| BNT162b1 Cohort 02 30 ug |
| BNT162b1 Cohort 03 1 ug |
| BNT162b1 Cohort 04 60 ug |
| BNT162b1 Cohort 05 50 ug |
| BNT162b1 Cohort 06 3 ug |
| BNT162b1 Cohort 07 20 ug |
| BNT162b1 Cohort 08 10 ug |
| BNT162b1 Cohort 09 20 ug |
| BNT162b1 Cohort 10 30 ug |
| BNT162b2 Cohort 01 10 ug |
| BNT162b2 Cohort 02 30 ug |
| BNT162b2 Cohort 03 1 ug |
| BNT162b2 Cohort 05 20 ug |
| BNT162b2 Cohort 06 3 ug |
| BNT162b2 Cohort 08 10 ug |
| BNT162b2 Cohort 09 20 ug |
| BNT162b2 Cohort 10 30 ug |
Actual Arm Code
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| BNT162b1-01-10 | BNT162b1 Cohort 01 10 ug |
| BNT162b1-02-30 | BNT162b1 Cohort 02 30 ug |
| BNT162b1-03-1 | BNT162b1 Cohort 03 1 ug |
| BNT162b1-04-60 | BNT162b1 Cohort 04 60 ug |
| BNT162b1-05-50 | BNT162b1 Cohort 05 50 ug |
| BNT162b1-06-3 | BNT162b1 Cohort 06 3 ug |
| BNT162b1-07-20 | BNT162b1 Cohort 07 20 ug |
| BNT162b1-08-10 | BNT162b1 Cohort 08 10 ug |
| BNT162b1-09-20 | BNT162b1 Cohort 09 20 ug |
| BNT162b1-10-30 | BNT162b1 Cohort 10 30 ug |
| BNT162b2-01-10 | BNT162b2 Cohort 01 10 ug |
| BNT162b2-02-30 | BNT162b2 Cohort 02 30 ug |
| BNT162b2-03-1 | BNT162b2 Cohort 03 1 ug |
| BNT162b2-05-20 | BNT162b2 Cohort 05 20 ug |
| BNT162b2-06-3 | BNT162b2 Cohort 06 3 ug |
| BNT162b2-08-10 | BNT162b2 Cohort 08 10 ug |
| BNT162b2-09-20 | BNT162b2 Cohort 09 20 ug |
| BNT162b2-10-30 | BNT162b2 Cohort 10 30 ug |
Action Taken with Study Treatment [C66767]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| DOSE NOT CHANGED [C49504] | Dose Not Changed |
| DOSE REDUCED [C49505] | Dose Reduced |
| DRUG INTERRUPTED [C49501] | Drug Interrupted |
| DRUG WITHDRAWN [C49502] | Drug Withdrawn |
| NOT APPLICABLE [C48660] | Not Applicable |
| UNKNOWN [C17998] | Unknown |
Category for Adverse Event
| Permitted Value (Code) |
|---|
| GENERAL |
| SPECIAL INTEREST |
Outcome of Event in AE [C66768]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| NOT RECOVERED/NOT RESOLVED [C49494] | Not Recovered or Not Resolved |
| RECOVERED/RESOLVED [C49498] | Recovered or Resolved |
| RECOVERED/RESOLVED WITH SEQUELAE [C49495] | Recovered or Resolved with Sequelae |
| RECOVERING/RESOLVING [C49496] | Recovering or Resolving |
| FATAL [C48275] | Death Related to Adverse Event |
| UNKNOWN [C17998] | Unknown |
Causality
| Permitted Value (Code) |
|---|
| NOT RELATED |
| RELATED |
Severity/Intensity Scale for AE [C66769]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| MILD [C41338] | Mild Adverse Event |
| MODERATE [C41339] | Moderate Adverse Event |
| SEVERE [C41340] | Severe Adverse Event |
Standard Toxicity Grade in Adverse Events
| Permitted Value (Code) |
|---|
| MILD |
| MODERATE |
| SEVERE |
| POTENTIALLY LIFE THREATENING |
Age Unit [C66781]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| YEARS [C29848] | Year |
Description of Planned Arm
| Permitted Value (Code) |
|---|
| BNT162b1 Cohort 01 10 ug |
| BNT162b1 Cohort 02 30 ug |
| BNT162b1 Cohort 03 1 ug |
| BNT162b1 Cohort 04 60 ug |
| BNT162b1 Cohort 05 50 ug |
| BNT162b1 Cohort 06 3 ug |
| BNT162b1 Cohort 07 20 ug |
| BNT162b1 Cohort 08 10 ug |
| BNT162b1 Cohort 09 20 ug |
| BNT162b1 Cohort 10 30 ug |
| BNT162b2 Cohort 01 10 ug |
| BNT162b2 Cohort 02 30 ug |
| BNT162b2 Cohort 03 1 ug |
| BNT162b2 Cohort 05 20 ug |
| BNT162b2 Cohort 06 3 ug |
| BNT162b2 Cohort 08 10 ug |
| BNT162b2 Cohort 09 20 ug |
| BNT162b2 Cohort 10 30 ug |
Planned Arm Code
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| BNT162b1-01-10 | BNT162b1 Cohort 01 10 ug |
| BNT162b1-02-30 | BNT162b1 Cohort 02 30 ug |
| BNT162b1-03-1 | BNT162b1 Cohort 03 1 ug |
| BNT162b1-04-60 | BNT162b1 Cohort 04 60 ug |
| BNT162b1-05-50 | BNT162b1 Cohort 05 50 ug |
| BNT162b1-06-3 | BNT162b1 Cohort 06 3 ug |
| BNT162b1-07-20 | BNT162b1 Cohort 07 20 ug |
| BNT162b1-08-10 | BNT162b1 Cohort 08 10 ug |
| BNT162b1-09-20 | BNT162b1 Cohort 09 20 ug |
| BNT162b1-10-30 | BNT162b1 Cohort 10 30 ug |
| BNT162b2-01-10 | BNT162b2 Cohort 01 10 ug |
| BNT162b2-02-30 | BNT162b2 Cohort 02 30 ug |
| BNT162b2-03-1 | BNT162b2 Cohort 03 1 ug |
| BNT162b2-05-20 | BNT162b2 Cohort 05 20 ug |
| BNT162b2-06-3 | BNT162b2 Cohort 06 3 ug |
| BNT162b2-08-10 | BNT162b2 Cohort 08 10 ug |
| BNT162b2-09-20 | BNT162b2 Cohort 09 20 ug |
| BNT162b2-10-30 | BNT162b2 Cohort 10 30 ug |
Category for Clinical Event
| Permitted Value (Code) |
|---|
| REACTOGENICITY |
Evalutation Interval Text (CE)
| Permitted Value (Code) |
|---|
| SINCE VACCINATION |
Group ID (CE)
| Permitted Value (Code) |
|---|
| PRIME VACCINATION-ADMINISTRATION SITE |
| PRIME VACCINATION-SYSTEMIC |
| BOOST VACCINATION-ADMINISTRATION SITE |
| BOOST VACCINATION-SYSTEMIC |
Subcategory for Clinical Event
| Permitted Value (Code) |
|---|
| ADMINISTRATION SITE |
| SYSTEMIC |
Reported Term for the Clinical Event
| Permitted Value (Code) |
|---|
| Injection site reaction - Pain |
| Injection site reaction - Tenderness |
| Injection site reaction - Erythema/Redness |
| Injection site reaction - Induration/Swelling |
| Nausea |
| Vomiting |
| Diarrhea |
| Headache |
| Fatigue |
| Myalgia |
| Arthralgia |
| Chills |
| Loss of Appetite |
| Malaise |
| Fever |
Planned Time Point Name
| Permitted Value (Code) |
|---|
| DAY 8 |
Evaluator for CO [C78735]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| INVESTIGATOR [C25936] | Investigator |
| LABORATORY [*] | LABORATORY |
* Extended Value
Allocation Cohort
| Permitted Value (Code) |
|---|
| Cohort 1 |
| Cohort 2 |
| Cohort 3 |
| Cohort 4 |
| Cohort 5 |
| Cohort 6 |
| Cohort 7 |
| Cohort 8 |
| Cohort 9 |
| Cohort 10 |
Identifying Variable in Comments
| Permitted Value (Code) |
|---|
| LBSEQ |
Country
| Permitted Value (Code) |
|---|
| DEU |
SDTM Domain Abbreviation (CO) [C66734]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| LB [C49592] | Laboratory Test Results |
Category for Disposition Event [C74558]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| DISPOSITION EVENT [C74590] | Protocol Disposition Event |
| PROTOCOL MILESTONE [C74588] | Protocol Milestone |
Subcategory for Disposition Event [C170443]
| Permitted Value (Code) |
|---|
| END OF TRIAL [*] |
| END OF FOLLOW-UP [*] |
* Extended Value
Protocol Deviation Coded Term
| Permitted Value (Code) |
|---|
| Inclusion-/Exclusion Criteria |
| Treatment Compliance |
| Visit Schedule Compliance |
| Laboratory Data, ECG Data, Pregnancy Data |
| Medical History and Concomitant Diseases |
| Prior and Concomitant Medication |
| Covid19 Impact |
| Other |
Directionality in EC [C99074]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| UPPER [C25355] | Upper |
Dose Form in EC [C66726]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| INJECTION [C42946] | Injectable Dosage Form |
Dose Units in EC [C71620]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| mL [C28254] | Milliliter |
Laterality in EC [C99073]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| LEFT [C25229] | Left |
| RIGHT [C25228] | Right |
Location of Dose Administration for EC [C74456]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| ARM [C32141] | Arm |
Route of Administration in EC [C66729]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| INTRAMUSCULAR [C28161] | Intramuscular Route of Administration |
Category for ECG
| Permitted Value (Code) |
|---|
| FINDING |
| MEASUREMENT |
Evaluator for EG [C78735]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| INVESTIGATOR [C25936] | Investigator |
ECG Test Method [C71151]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 12 LEAD STANDARD [C71102] | 12 Lead Placement Standard |
Original Units for EG [C71620]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| beats/min [C49673] | Beats per Minute |
ECG Position of Subject [C71148]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| SUPINE [C62167] | Supine Position |
ECG Result [C71150]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1ST DEGREE AV BLOCK [C111088] | AV Block First Degree by ECG Finding |
| SHORT PR INTERVAL [C62246] | Short PR Interval by ECG Finding |
| Q AXIS, LEFT AXIS DEVIATION [C71094] | Q Axis Left Axis Deviation |
| QRS COMPLEX ABNORMALITY [C90440] | QRS Complex Abnormality by ECG Finding |
| INTRAVENTRICULAR CONDUCTION DELAY, NONSPECIFIC [C62271] | Nonspecific Intraventricular Conduction Delay by ECG Finding |
| BRADYCARDIA [C111120] | Bradycardia by ECG Finding |
| SINUS ARRHYTHMIA [C62239] | Sinus Arrhythmia by ECG Finding |
| SINUS BRADYCARDIA [C111097] | Sinus Bradycardia by ECG Finding |
| PROLONGED QT [C71034] | Prolonged QT Interval by ECG Finding |
| QTC PROLONGATION [C83817] | Corrected Prolonged QT Interval by ECG Finding |
| QTCB PROLONGATION [C107098] | QTcB Prolongation |
| T WAVE INVERSION [C71085] | T Wave Inversion by ECG Finding |
| PREMATURE ATRIAL COMPLEXES [C62257] | Atrial Premature Complex by ECG Finding |
| POOR QUALITY ECG [C114172] | Poor Quality ECG |
| PREMATURE VENTRICULAR COMPLEX [C62256] | Ventricular Premature Complex by ECG Finding |
| VENTRICULAR ESCAPE BEAT [C90483] | Ventricular Escape Beat by ECG Finding |
| SUPRAVENTRICULAR PREMATURE COMPLEX, ORIGIN UNKNOWN [C142246] | Supraventricular Premature Complex With Unknown Origin by ECG Finding |
Standard Units for EG [C71620]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| beats/min [C49673] | Beats per Minute |
ECG Test Name [C71152]
| Permitted Value (Code) |
|---|
| Atrioventricular Conduction [C111131] |
| Axis and Voltage [C111132] |
| ECG Mean Heart Rate [C119259] |
| Interpretation [C41255] |
| Intraventricular-Intraatrial Conduction [C111238] |
| Rhythm Not Otherwise Specified [C111307] |
| ST Segment, T wave, and U wave [C111363] |
| Sinus Node Rhythms and Arrhythmias [C111312] |
| Supraventricular Arrhythmias [C111320] |
| Technical Quality [C117807] |
| Ventricular Arrhythmias [C111330] |
ECG Test Code [C71153]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| AVCOND [C111131] | Atrioventricular Conduction |
| AXISVOLT [C111132] | Axis and Voltage |
| EGHRMN [C119259] | ECG Mean Heart Rate |
| INTP [C41255] | Interpretation |
| IVTIACD [C111238] | Intraventricular-Intraatrial Conduction |
| RHYNOS [C111307] | Rhythm Not Otherwise Specified |
| SNRARRY [C111312] | Sinus Node Rhythms and Arrhythmias |
| SPRARRY [C111320] | Supraventricular Arrhythmias |
| STSTWUW [C111363] | ST Segment, T wave, and U wave |
| TECHQUAL [C117807] | Technical Quality |
| VTARRY [C111330] | Ventricular Arrhythmias |
Description of Element
| Permitted Value (Code) |
|---|
| Screening |
| Pre-dose assessments |
| BNT162b1 cohort 1 boost vaccine |
| BNT162b1 cohort 1 prime vaccine |
| BNT162b1 cohort 2 boost vaccine |
| BNT162b1 cohort 2 prime vaccine |
| BNT162b1 cohort 3 boost vaccine |
| BNT162b1 cohort 3 prime vaccine |
| BNT162b1 cohort 4 boost vaccine |
| BNT162b1 cohort 4 prime vaccine |
| BNT162b1 cohort 5 boost vaccine |
| BNT162b1 cohort 5 prime vaccine |
| BNT162b1 cohort 6 boost vaccine |
| BNT162b1 cohort 6 prime vaccine |
| BNT162b1 cohort 7 boost vaccine |
| BNT162b1 cohort 7 prime vaccine |
| BNT162b1 cohort 8 boost vaccine |
| BNT162b1 cohort 8 prime vaccine |
| BNT162b1 cohort 9 boost vaccine |
| BNT162b1 cohort 9 prime vaccine |
| BNT162b1 cohort 10 boost vaccine |
| BNT162b1 cohort 10 prime vaccine |
| BNT162b2 cohort 1 boost vaccine |
| BNT162b2 cohort 1 prime vaccine |
| BNT162b2 cohort 2 boost vaccine |
| BNT162b2 cohort 2 prime vaccine |
| BNT162b2 cohort 3 boost vaccine |
| BNT162b2 cohort 3 prime vaccine |
| BNT162b2 cohort 5 boost vaccine |
| BNT162b2 cohort 5 prime vaccine |
| BNT162b2 cohort 6 boost vaccine |
| BNT162b2 cohort 6 prime vaccine |
| BNT162b2 cohort 8 boost vaccine |
| BNT162b2 cohort 8 prime vaccine |
| BNT162b2 cohort 9 boost vaccine |
| BNT162b2 cohort 9 prime vaccine |
| BNT162b2 cohort 10 boost vaccine |
| BNT162b2 cohort 10 prime vaccine |
| Follow-up |
End Reference Time Point
| Permitted Value (Code) |
|---|
| END OF STUDY |
End Reference Time Point (MH)
| Permitted Value (Code) |
|---|
| SCREENING |
Epoch [C99079]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| SCREENING [C48262] | Trial Screening |
| BASELINE [C125938] | Baseline Epoch |
| TREATMENT [C101526] | Treatment Epoch |
| FOLLOW-UP [C99158] | Clinical Study Follow-up |
Element Code
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| SCRN | Screening |
| PREDOSE | Pre-dose assessments |
| VXB1C1B | BNT162b1 cohort 1 boost vaccine |
| VXB1C1P | BNT162b1 cohort 1 prime vaccine |
| VXB1C2B | BNT162b1 cohort 2 boost vaccine |
| VXB1C2P | BNT162b1 cohort 2 prime vaccine |
| VXB1C3B | BNT162b1 cohort 3 boost vaccine |
| VXB1C3P | BNT162b1 cohort 3 prime vaccine |
| VXB1C4B | BNT162b1 cohort 4 boost vaccine |
| VXB1C4P | BNT162b1 cohort 4 prime vaccine |
| VXB1C5B | BNT162b1 cohort 5 boost vaccine |
| VXB1C5P | BNT162b1 cohort 5 prime vaccine |
| VXB1C6B | BNT162b1 cohort 6 boost vaccine |
| VXB1C6P | BNT162b1 cohort 6 prime vaccine |
| VXB1C7B | BNT162b1 cohort 7 boost vaccine |
| VXB1C7P | BNT162b1 cohort 7 prime vaccine |
| VXB1C8B | BNT162b1 cohort 8 boost vaccine |
| VXB1C8P | BNT162b1 cohort 8 prime vaccine |
| VXB1C9B | BNT162b1 cohort 9 boost vaccine |
| VXB1C9P | BNT162b1 cohort 9 prime vaccine |
| VXB1C10B | BNT162b1 cohort 10 boost vaccine |
| VXB1C10P | BNT162b1 cohort 10 prime vaccine |
| VXB2C1B | BNT162b2 cohort 1 boost vaccine |
| VXB2C1P | BNT162b2 cohort 1 prime vaccine |
| VXB2C2B | BNT162b2 cohort 2 boost vaccine |
| VXB2C2P | BNT162b2 cohort 2 prime vaccine |
| VXB2C3B | BNT162b2 cohort 3 boost vaccine |
| VXB2C3P | BNT162b2 cohort 3 prime vaccine |
| VXB2C5B | BNT162b2 cohort 5 boost vaccine |
| VXB2C5P | BNT162b2 cohort 5 prime vaccine |
| VXB2C6B | BNT162b2 cohort 6 boost vaccine |
| VXB2C6P | BNT162b2 cohort 6 prime vaccine |
| VXB2C8B | BNT162b2 cohort 8 boost vaccine |
| VXB2C8P | BNT162b2 cohort 8 prime vaccine |
| VXB2C9B | BNT162b2 cohort 9 boost vaccine |
| VXB2C9P | BNT162b2 cohort 9 prime vaccine |
| VXB2C10B | BNT162b2 cohort 10 boost vaccine |
| VXB2C10P | BNT162b2 cohort 10 prime vaccine |
| FUP | Follow-up |
Ethnic Group [C66790]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| HISPANIC OR LATINO [C17459] | Hispanic or Latino |
| NOT HISPANIC OR LATINO [C41222] | Not Hispanic or Latino |
| NOT REPORTED [C43234] | Not Reported |
| UNKNOWN [C17998] | Unknown |
Directionality in EX [C99074]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| UPPER [C25355] | Upper |
Dose Form in EX [C66726]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| INJECTION [C42946] | Injectable Dosage Form |
Dose Units in EX [C71620]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| ug [C48152] | Microgram |
Laterality in EX [C99073]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| LEFT [C25229] | Left |
| RIGHT [C25228] | Right |
Location of Dose Administration for EX [C74456]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| ARM [C32141] | Arm |
Route of Administration in EX [C66729]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| INTRAMUSCULAR [C28161] | Intramuscular Route of Administration |
Category for FACE
| Permitted Value (Code) |
|---|
| REACTOGENICITY |
Evaluator for FACE [C78735]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| INVESTIGATOR [C25936] | Investigator |
| STUDY SUBJECT [C41189] | Study Subject |
Subcategory for FACE
| Permitted Value (Code) |
|---|
| ADMINISTRATION SITE |
| SYSTEMIC |
Object of the Observation
| Permitted Value (Code) |
|---|
| All Objects of the Observation |
| Injection site reaction - Pain |
| Injection site reaction - Tenderness |
| Injection site reaction - Erythema/Redness |
| Injection site reaction - Induration/Swelling |
| Nausea |
| Vomiting |
| Diarrhea |
| Headache |
| Fatigue |
| Myalgia |
| Arthralgia |
| Chills |
| Loss of Appetite |
| Malaise |
| Fever |
Frequency (CM) [C71113]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| QD [C25473] | Daily |
| BID [C64496] | Twice Daily |
| TID [C64527] | Three Times Daily |
| QID [C64530] | Four Times Daily |
| 5 TIMES PER DAY [C98849] | Five Times Daily |
| 6 TIMES PER DAY [C98855] | Six Times Daily |
| 7 TIMES PER DAY [C139180] | Seven Times Per Day |
| 8 TIMES PER DAY [C139181] | Eight Times Per Day |
| 9 TIMES PER DAY [C139182] | Nine Times Per Day |
| QH [C64510] | Every Hour |
| 1 TIME PER WEEK [C64526] | Once Weekly |
| 2 TIMES PER WEEK [C64497] | Twice Weekly |
| 3 TIMES PER WEEK [C64528] | Three Times Weekly |
| 4 TIMES PER WEEK [C64531] | Four Times Weekly |
| 7 TIMES PER WEEK [C98854] | Seven Times Weekly |
| BIM [C71129] | Twice Per Month |
| 3 TIMES PER MONTH [C98859] | Three Times Monthly |
| 4 TIMES PER MONTH [C98852] | Four Times Monthly |
| 5 TIMES PER MONTH [C98850] | Five Times Monthly |
| 6 TIMES PER MONTH [C98856] | Six Times Monthly |
| 10 DAYS PER MONTH [C139179] | Ten Days Per Month |
| 2 TIMES PER YEAR [C98861] | Two Times Yearly |
| 3 TIMES PER YEAR [C98860] | Three Times Yearly |
| 4 TIMES PER YEAR [C98853] | Four Times Yearly |
| 5 TIMES PER YEAR [C98851] | Five Times Yearly |
| 6 TIMES PER YEAR [C98858] | Six Times Yearly |
| EVERY WEEK [C67069] | Weekly |
| EVERY 2 WEEKS [C71127] | Every Two Weeks |
| EVERY 3 WEEKS [C64535] | Every Three Weeks |
| EVERY 4 WEEKS [C64529] | Every Four Weeks |
| EVERY 5 WEEKS [C103390] | Every Five Weeks |
| EVERY 6 WEEKS [C89788] | Every Six Weeks |
| EVERY 7 WEEKS [C116149] | Every Seven Weeks |
| EVERY 8 WEEKS [C103389] | Every Eight Weeks |
| Q2H [C64516] | Every Two Hours |
| Q3H [C64517] | Every Three Hours |
| Q4H [C64518] | Every Four Hours |
| Q5H [C64519] | Every Five Hours |
| Q6H [C64520] | Every Six Hours |
| Q7H [C64521] | Every Seven Hours |
| Q8H [C64523] | Every Eight Hours |
| Q9H [C64524] | Every Nine Hours |
| Q10H [C64500] | Every Ten Hours |
| Q11H [C64501] | Every Eleven Hours |
| Q12H [C64502] | Every Twelve Hours |
| Q13H [C64503] | Every Thirteen Hours |
| Q14H [C64504] | Every Fourteen Hours |
| Q15H [C64505] | Every Fifteen Hours |
| Q16H [C64506] | Every Sixteen Hours |
| Q17H [C64507] | Every Seventeen Hours |
| Q18H [C64508] | Every Eighteen Hours |
| Q19H [C64509] | Every Nineteen Hours |
| Q20H [C64511] | Every Twenty Hours |
| Q21H [C64512] | Every Twenty-One Hours |
| Q22H [C64513] | Every Twenty-Two Hours |
| Q23H [C64514] | Every Twenty-Three Hours |
| Q24H [C64515] | Every Twenty-Four Hours |
| Q36H [C89791] | Every Thrity-six Hours |
| Q48H [C89790] | Every Forty-eight Hours |
| Q45MIN [C139183] | Every Forty-Five Minutes |
| Q4S [*] | Every Four Weeks |
| Q3D [C64533] | Every Three Days |
| Q4D [C64534] | Every Four Days |
| Q5D [C71124] | Every Five Days |
| Q7D [C139177] | Every Seven Days |
| Q2M [C64536] | Every Two Months |
| Q3M [C64537] | Every Three Months |
| Q4M [C64538] | Every Four Months |
| Q6M [C89789] | Every Six Months |
| AD LIBITUM [C64636] | As Much as Desired |
| CONTINUOUS [C53279] | Continue |
| INTERMITTENT [C71325] | Intermittent |
| NOT APPLICABLE [*] | NOT APPLICABLE |
| OCCASIONAL [C64954] | Infrequent |
| ONCE [C64576] | Once |
| OTHER [*] | OTHER |
| PA [C74924] | Per Year |
| PRN [C64499] | As Needed |
| QAM [C64595] | Every Morning |
| QM [C64498] | Monthly |
| QN [C139178] | Every Night |
| QOD [C64525] | Every Other Day |
| QPM [C64596] | QPM |
| THRICE [C156502] | Thrice |
| TWICE [C65134] | Twice |
| UNKNOWN [C17998] | Unknown |
* Extended Value
Allocation Group
| Permitted Value (Code) |
|---|
| A (BNT162a1) |
| B (BNT162b1) |
| C (BNT162b2) |
| D (BNT162c2) |
| E (BNT162c2 P/B) |
Category for Inclusion/Exclusion [C66797]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| EXCLUSION [C25370] | Exclusion Criteria |
| INCLUSION [C25532] | Inclusion Criteria |
Inclusion/Exclusion Test Code
| Permitted Value (Code) |
|---|
| Had acute illness, with or without fever, within 72h prior to 1st immunization. Acute illness resolved with minor symptoms, in opinion of the invest., symptoms will not compromise their well-being. |
| Are breastfeeding on the day of Visit 0 or who plan to breastfeed during the trial, starting after Visit 0 and continuously until at least 90 d after receiving the last immunization. |
| Have a known allergy, hypersensitivity, or intolerance to the planned IMP including any excipients of the IMP. |
| Had any major surgery within past 5 years, in opinion of the invest., could compromise their well-being if they participate in trial, or that prevent, limit, or confound prot. specified assessments. |
| Have any surgery planned during the trial, starting after Visit 0 and continuously until at least 90 d after receiving the last immunization. |
| Chronic use (>14 days) of systemic meds., including immunosuppressant, 6mo prior to Visit 0, unless med. would not prevent, limit, confound the prot. specified assessments or compromise safety. |
| Chronic use (>14 days) of systemic meds., including immunosuppressants, 6mo prior to Visit 0, unless med. would not prevent, limit, confound the prot. specified assessments or compromise safety. |
| Chronic use (>21 days) of systemic meds., including immunosuppressants, 6mo prior to Visit 0, unless med. would not prevent, limit, confound the prot. specified assessments or compromise safety. |
| Chronic use (>21 days) of systemic meds., including immunosuppressants (except for Cohort 13), 6mo prior to Visit 0, unless med. would not prevent, limit, confound assessments or compromise safety. |
| Received any vaccination within the 28 d prior to Visit 0. |
| Had administration of any immunoglobulins and/or any blood products within the 3 months prior to Visit 0. |
| Had administration of another investigational product including vaccines within 60 d or 5 half-lives (whichever is longer), prior to Visit 0. |
| Had administration of another investigational medicinal product including vaccines within 60 d or 5 half-lives (whichever is longer), prior to Visit 0. |
| Have a known history or a positive test of any of HIV 1 or 2, Hepatitis B, or Hepatitis C, within the 30 d prior to Visit 0. |
| Have a known history or a positive test of any of the following: HIV 1 or 2, Hepatitis B, Hepatitis C. |
| Have a known history or a positive test of any of HIV 1 or 2, Hepatitis B, or Hepatitis C (except for Cohort 13), within the 30 d prior to Visit 0. |
| Have a positive PCR-based test for anti-SARS-CoV-2 within the 30 d prior to Visit 0. |
| Have a positive PCR-based test for anti-SARS-CoV-2 within the 30 d prior to Visit 1. |
| Positive drugs of abuse (amphetamines, benzodiazepines, barbiturates, cocaine, cannabinoids, opiates, methadone, methamphetamines, phencyclidine, and tricyclic antidepressants) result at Visit 0 or 1. |
| Have a positive breath alcohol test at Visit 0 or Visit 1. |
| Previously participated in an investigational trial involving lipid nanoparticles. |
| Are subject to exclusion periods from other investigational trials or simultaneous participation in another clinical trial. |
| Are subject to exclusion periods from other investigational trials or simultaneous participation in another clinical trial. Allowed participation in non-COVID-19 trials after entering follow-up phase. |
| Have any affiliation with the trial site (e.g., are close relative of the investigator or dependent person, such as an employee or student of the trial site). |
| History (past 5 years) of substance abuse or known medical, psycho., or social conditions which compromise well-being as trial subjects, or prevent, limit, or confound the prot. specified assessments. |
| Have a history of hypersensitivity or serious reactions to previous vaccinations. |
| Have a history of Guillain-Barre Syndrome within 6 wks following a previous vaccination. |
| Have a history of narcolepsy. |
| Have history of alcohol abuse or drug addiction within 1 year before Visit 0. |
| Have a history of or suspected immunosuppressive condition, acquired or congenital, as determined by medical history and/or physical examination at Visit 0. |
| (Except for Cohort 13) Have a history of or suspected immunosuppressive condition, acquired or congenital, as determined by medical history and/or physical examination at Visit 0. |
| Have any abnormality or permanent body art (e.g., tattoo) that, in the opinion of the investigator, would obstruct the ability to observe local reactions at the injection site. |
| Had any blood loss >450 mL, within the 7d prior to Visit 0 or plan to donate blood during the trial, starting after Visit 0 and continuously until at least 7 d after receiving the last immunization. |
| They were in any country with a high SARS-CoV-2 infection risk (as defined by the RKI at the time Visit 0) within the 14 d prior to Visit 0. |
| They plan to visit any country with a high SARS-CoV-2 infection risk (as defined by the RKI at the time Visit 0), from Visit 0 until 14 d after receiving the last immunization. |
| Symptoms of COVID-19, e.g., respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. |
| (Once commercially available in Germany) Have a positive test for anti-SARS-CoV-2 antibodies. |
| Have had contact with persons tested positive for SARS-CoV-2 antibodies within the 30 d prior to Visit 0. |
| Are soldiers, subjects in detention, CRO or sponsor staff or their family members. |
| Are vulnerable persons, i.e., soldiers, subjects in detention, CRO or sponsor staff or their family members. |
| Regular receipt of inhaled/nebulized corticosteroids. |
| For older adults only: Have a condition known to put them at high risk for severe COVID-19. |
| For older adults only: Have a condition known to put them at high risk for severe COVID-19. (BMI removed as risk factor.) |
| For older adults and Cohort 13 only: Have a condition known to put them at high risk for severe COVID-19. |
| Have given informed consent by signing the ICF before initiation of any trial-specific procedures. |
| Have given informed consent by signing the informed consent form (ICF) before initiation of any trial-specific procedures. |
| They must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions (e.g., to reduce COVID-19 exposure), and other requirements of the trial. |
| They must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions, and other requirements of the trial. |
| They must be able to understand and follow trial-related instructions. |
| They must be aged from 18 to 55 years, have a body mass index of over 19 kg/m2 and under 30 kg/m2, and weigh at least 50 kg at Visit 0. |
| They must be aged 18 <= 55 years and weigh at least 50 kg at Visit 0. |
| They must be aged from 18 to 55 years (Cohorts 1 to 8) or 65 to 85 years (elderly subject cohorts), have a body mass index over 19 kg/m2 and under 30 kg/m2, and weigh at least 50 kg at Visit 0. |
| For younger cohorts, must be aged from 18-55 years. For older cohorts, must be aged 56-85 years. Must have a body mass index over 19 kg/m2 and under 30 kg/m2, and weigh at least 50 kg at Visit 0. |
| Must be healthy based on MH, PE, 12-lead ECG, VS (systolic/diastolic BP, pulse rate, temp., respiratory rate), and clinical lab tests (blood chemistry, hematology, and urine chemistry) at Visit 0. |
| Must be healthy based on MH, PE, ECG, VS (BP, pulse rate, temp., respiratory rate), and clinical lab tests at Visit 0. Healthy volunteers with pre-existing stable disease can be included. |
| Must be healthy in clinical judgment of investigator at Visit 0. For cohort 13, volunteers must be immunocompromised but otherwise healthy. |
| WOCBP have a negative beta-human chorionic gonadotropin urine test at Visit 0 and Visit 1. Women that are postmenopausal or permanently sterilized be considered as not having reproductive potential. |
| WOCBP must agree to practice one highly effective form of contraception during the trial, starting after Visit 0 and continuously until 60 d after receiving the last immunization. |
| WOCBP must agree to practice two highly effective forms of contraception during the trial, starting after Visit 0 and continuously until 60 d after receiving the last immunization. |
| WOCBP must agree to practice a highly effective form of contraception during the trial, starting after Visit 0 and continuously until 60 d after receiving the last immunization. |
| WOCBP must practice a highly effective form of contraception, starting after Visit 0 and continuously until 60 d after receiving the last immunization, and must require male partners to use condoms. |
| WOCBP must confirm that they practiced one highly effective form of contraception for the 14 d prior to Visit 0. |
| WOCBP must confirm that they practiced at least one highly effective form of contraception for the 14 d prior to Visit 0. |
| WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during trial, starting after Visit 0 and continuously until 60 d after receiving the last immunization. |
| Men sexually active with WOCBP and not had a vasectomy must agree to practice a contraception with female of childbearing potential, after Visit 0 and until 60d after receiving the last immunization. |
| Men must be willing to refrain from sperm donation, starting after Visit 0 and continuously until 60 d after receiving the last immunization. |
| They must have confirmation of their health insurance coverage prior to Visit 0. |
| They must agree to not be vaccinated during the trial, starting after Visit 0 and continuously until 28 d after receiving the last immunization. |
Investigator Identifier
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 01 | Armin Schultz - CRS Mannheim |
| 02 | Armin Schultz - CRS Berlin |
Investigator Name
| Permitted Value (Code) |
|---|
| Armin Schultz |
Category for Immunogenicity Specimen Assessments
| Permitted Value (Code) |
|---|
| Immunogenicity |
Vendor Name for IS
| Permitted Value (Code) |
|---|
| Pfizer Vaccine Research and Development |
| VisMederi srl |
Original Units for Immunogenicity Specimen Assessments [C71620]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| NA [*] | NA |
| U/mL [C77607] | Unit per Milliliter |
* Extended Value
Specimen Type in IS [C78734]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| SERUM [C13325] | Serum |
Standard Units for Immunogenicity Specimen Assessments [C71620]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| NA [*] | NA |
| U/mL [C77607] | Unit per Milliliter |
* Extended Value
Immunogenicity Test or Examination Name [C120526]
| Permitted Value (Code) |
|---|
| COVID-19 RBD IgG [*] |
| COVID-19 S1 IgG [*] |
| Immunogenicity Data [*] |
| SARS-CoV-2 Serum Neutralizing Titer 50 [*] |
| SARS-CoV-2 Serum Neutralizing Titer 90 [*] |
* Extended Value
Immunogenicity Test/Exam Short Name [C120525]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| C19RBDIG [*] | COVID-19 RBD IgG |
| C19S1IGG [*] | COVID-19 S1 IgG |
| C2NGNT50 [*] | SARS-CoV-2 Serum Neutralizing Titer 50 |
| C2NGNT90 [*] | SARS-CoV-2 Serum Neutralizing Titer 90 |
| ISALL [*] | Immunogenicity Data |
* Extended Value
Category for Lab Test
| Permitted Value (Code) |
|---|
| CHEMISTRY |
| HEMATOLOGY |
| URINALYSIS |
Method of Test or Examination in LB [C85492]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| CALCULATION [C54125] | Calculation |
| COLORIMETRY [C111096] | Colorimetry |
| DIPSTICK [C106516] | Dipstick |
| ELECTROCHEMILUMINESCENCE IMMUNOASSAY [C111194] | Electrochemiluminescence Immunoassay |
| FLOW CYTOMETRY [C16585] | Flow Cytometry |
| JAFFE REACTION [C120694] | Jaffe Reaction |
| MICROSCOPY [C16853] | Microscopy |
| PHOTOMETRY [C65109] | Photometry |
| POTENTIOMETRY [C142343] | POTENTIOMETRY |
| TURBIDIMETRY [C111328] | Turbidimetry |
Vendor Name for LB
| Permitted Value (Code) |
|---|
| CRS CLINICAL RESEARCH SERVICES BERLIN GMBH |
| CRS CLINICAL RESEARCH SERVICES MANNHEIM GMBH |
| MLM |
Reference Range Indicator in LB [C78736]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| ABNORMAL [C78802] | Abnormal Reference Range |
| HIGH [C78800] | Value Above Reference Range |
| LOW [C78801] | Value Below Reference Range |
Original Units for LB [C71620]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| % [C25613] | Percentage |
| /HPF [C96619] | Per High Powered Field |
| 10^12/L [C67308] | Million per Microliter |
| 10^6/L [C67452] | Thousand per Milliliter |
| 10^9/L [C67255] | Billion per Liter |
| IU/L [C67376] | International Unit per Liter |
| L/L [C105495] | Liter Per Liter |
| U/L [C67456] | Unit per Liter |
| fL [C64780] | Femtoliter |
| fmol [C68854] | Femtomole |
| g/L [C42576] | Kilogram per Cubic Meter |
| mg/L [C64572] | Microgram per Milliliter |
| mmol/L [C64387] | Millimole per Liter |
| ug/L [C67306] | Microgram per Liter |
| umol/L [C48508] | Micromole per Liter |
Subcategory for Lab Test
| Permitted Value (Code) |
|---|
| DRUG OF ABUSE |
| PREGNANCY |
Specimen Type in LB [C78734]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| BLOOD [C12434] | Blood |
| BLOOD SMEAR [*] | BLOOD SMEAR |
| EXPIRED AIR [C78741] | Expired Air |
| SERUM [C13325] | Serum |
| URINE [C13283] | Urine |
* Extended Value
Standard Units for LB [C71620]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| % [C25613] | Percentage |
| /HPF [C96619] | Per High Powered Field |
| 10^12/L [C67308] | Million per Microliter |
| 10^9/L [C67255] | Billion per Liter |
| IU/L [C67376] | International Unit per Liter |
| L/L [C105495] | Liter Per Liter |
| U/L [C67456] | Unit per Liter |
| fL [C64780] | Femtoliter |
| fmol [C68854] | Femtomole |
| g/L [C42576] | Kilogram per Cubic Meter |
| mg/L [C64572] | Microgram per Milliliter |
| mmol/L [C64387] | Millimole per Liter |
| ug/L [C67306] | Microgram per Liter |
| umol/L [C48508] | Micromole per Liter |
Laboratory Test Code [C65047]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| ALB [C64431] | Albumin |
| ALP [C64432] | Alkaline Phosphatase |
| ALT [C64433] | Alanine Aminotransferase |
| AMPHET [C74687] | Amphetamine |
| AMYLASE [C64434] | Amylase |
| ANISO [C74797] | Anisocytes |
| AST [C64467] | Aspartate Aminotransferase |
| BACT [C64469] | Bacteria |
| BARB [C74688] | Barbiturates |
| BASO [C64470] | Basophils |
| BASOLE [C64471] | Basophils/Leukocytes |
| BILI [C38037] | Bilirubin |
| BNZDZPN [C74692] | Benzodiazepine |
| CA [C64488] | Calcium |
| CANNAB [C74689] | Cannabinoids |
| CASTS [C74763] | Casts |
| CK [C64489] | Creatine Kinase |
| COCAINE [C74690] | Cocaine |
| CREAT [C64547] | Creatinine |
| CRP [C64548] | C Reactive Protein |
| CRYSTALS [C74673] | Crystals |
| EOS [C64550] | Eosinophils |
| EOSLE [C64604] | Eosinophils/Leukocytes |
| EPIC [C64605] | Epithelial Cells |
| EPIROCE [C74698] | Round Epithelial Cells |
| ETHANOL [C74693] | Ethanol |
| FERRITIN [C74737] | Ferritin |
| FSH [C74783] | Follicle Stimulating Hormone |
| GGT [C64847] | Gamma Glutamyl Transferase |
| GLUC [C105585] | Glucose |
| GRANBCE [C127615] | Granulocytes Band Form/Total Cells |
| HCG [C64851] | Choriogonadotropin Beta |
| HCT [C64796] | Hematocrit |
| HGB [C64848] | Hemoglobin |
| K [C64853] | Potassium |
| KETONES [C64854] | Ketones |
| LIPASET [C117748] | Lipase |
| LYM [C51949] | Lymphocytes |
| LYMATLE [C64819] | Lymphocytes Atypical/Leukocytes |
| LYMLE [C64820] | Lymphocytes/Leukocytes |
| MACROCY [C64821] | Macrocytes |
| MCH [C64797] | Ery. Mean Corpuscular Hemoglobin |
| MCHC [C64798] | Ery. Mean Corpuscular HGB Concentration |
| MCV [C64799] | Ery. Mean Corpuscular Volume |
| METHAMPH [C75348] | Methamphetamine |
| METHDN [C74881] | Methadone |
| MICROCY [C64822] | Microcytes |
| MONO [C64823] | Monocytes |
| MONOLE [C64824] | Monocytes/Leukocytes |
| MYCY [C74662] | Myelocytes |
| NEUT [C63321] | Neutrophils |
| NEUTLE [C64827] | Neutrophils/Leukocytes |
| NITRITE [C64810] | Nitrite |
| OPIATE [C74796] | Opiate |
| PCP [C74694] | Phencyclidine |
| PH [C45997] | pH |
| PLAT [C51951] | Platelets |
| POIKILO [C79602] | Poikilocytes |
| PROT [C64858] | Protein |
| RBC [C51946] | Erythrocytes |
| SMDGCELE [C119294] | Smudge Cells/Leukocytes |
| SODIUM [C64809] | Sodium |
| SPGRAV [C64832] | Specific Gravity |
| TRCYANDP [C100420] | Tricyclic Antidepressants |
| UREAN [C125949] | Urea Nitrogen |
| UROBIL [C64816] | Urobilinogen |
| WBC [C51948] | Leukocytes |
| YEAST [C74664] | Yeast Cells |
Laboratory Test Name (Chemistry) [C67154]
| Permitted Value (Code) |
|---|
| Alanine Aminotransferase [C64433] |
| Albumin [C64431] |
| Alkaline Phosphatase [C64432] |
| Amylase [C64434] |
| Aspartate Aminotransferase [C64467] |
| Bilirubin [C38037] |
| C Reactive Protein [C64548] |
| Calcium [C64488] |
| Creatine Kinase [C64489] |
| Creatinine [C64547] |
| Ferritin [C74737] |
| Follicle Stimulating Hormone [C74783] |
| Gamma Glutamyl Transferase [C64847] |
| Glucose [C105585] |
| Lipase [C117748] |
| Potassium [C64853] |
| Sodium [C64809] |
| Urea Nitrogen [C125949] |
Laboratory Test Name (Chemistry - Drug of Abuse) [C67154]
| Permitted Value (Code) |
|---|
| Ethanol [C74693] |
Laboratory Test Name (Hematology) [C67154]
| Permitted Value (Code) |
|---|
| Anisocytes [C74797] |
| Basophils [C64470] |
| Basophils/Leukocytes [C64471] |
| Eosinophils [C64550] |
| Eosinophils/Leukocytes [C64604] |
| Ery. Mean Corpuscular Hemoglobin [C64797] |
| Ery. Mean Corpuscular HGB Concentration [C64798] |
| Ery. Mean Corpuscular Volume [C64799] |
| Erythrocytes [C51946] |
| Granulocytes Band Form/Total Cells [C127615] |
| Hematocrit [C64796] |
| Hemoglobin [C64848] |
| Leukocytes [C51948] |
| Lymphocytes [C51949] |
| Lymphocytes Atypical/Leukocytes [C64819] |
| Lymphocytes/Leukocytes [C64820] |
| Macrocytes [C64821] |
| Microcytes [C64822] |
| Monocytes [C64823] |
| Monocytes/Leukocytes [C64824] |
| Myelocytes [C74662] |
| Neutrophils [C63321] |
| Neutrophils/Leukocytes [C64827] |
| Platelets [C51951] |
| Poikilocytes [C79602] |
| Smudge Cells/Leukocytes [C119294] |
Laboratory Test Name (Pregnancy) [C67154]
| Permitted Value (Code) |
|---|
| Choriogonadotropin Beta [C64851] |
Laboratory Test Name (Urinalysis) [C67154]
| Permitted Value (Code) |
|---|
| Bacteria [C64469] |
| Bilirubin [C38037] |
| Casts [C74763] |
| Crystals [C74673] |
| Epithelial Cells [C64605] |
| Erythrocytes [C51946] |
| Glucose [C105585] |
| Hemoglobin [C64848] |
| Ketones [C64854] |
| Nitrite [C64810] |
| Protein [C64858] |
| Round Epithelial Cells [C74698] |
| Leukocytes [C51948] |
| Specific Gravity [C64832] |
| Urobilinogen [C64816] |
| Yeast Cells [C74664] |
| pH [C45997] |
Laboratory Test Name (Urinalysis - Drug of Abuse) [C67154]
| Permitted Value (Code) |
|---|
| Amphetamine [C74687] |
| Barbiturates [C74688] |
| Benzodiazepine [C74692] |
| Cannabinoids [C74689] |
| Cocaine [C74690] |
| Methadone [C74881] |
| Methamphetamine [C75348] |
| Opiate [C74796] |
| Phencyclidine [C74694] |
| Tricyclic Antidepressants [C100420] |
Anatomical Location (MB) [C74456]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| ORAL CAVITY [C12421] | Oral Cavity |
Anatomical Location (VS) [C74456]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| ARM [C32141] | Arm |
Anatomical Location (VS - Temperature) [C74456]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| ORAL CAVITY [C12421] | Oral Cavity |
| EAR, OUTER [C12292] | External Ear |
| AXILLA [C12674] | Axilla |
| RECTUM [C12390] | Rectum |
| OTHER [*] | OTHER |
* Extended Value
Category for Microbiology Finding
| Permitted Value (Code) |
|---|
| SARS-CoV-2 Antibodies |
| SARs-CoV-2 Test (Oral Swipe) |
| SEROLOGY |
Vendor Name for MB
| Permitted Value (Code) |
|---|
| MLM |
Vendor Name for MB
| Permitted Value (Code) |
|---|
| CRS CLINICAL RESEARCH SERVICES BERLIN GMBH |
| CRS CLINICAL RESEARCH SERVICES MANNHEIM GMBH |
Reference Range Indicator in MB [C78736]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| HIGH [C78800] | Value Above Reference Range |
Microbiology Specimen Test Code [C120527]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| HBCAB [C96660] | Hepatitis B Virus Core Antibody |
| HBSAG [C64850] | Hepatitis B Virus Surface Antigen |
| HBSAGQ [*] | Hepatitis B Virus Surface Antigen - Quantitative |
| HCAB [C92535] | Hepatitis C Virus Antibody |
| HIV12P24 [C139085] | HIV-1/2 Antibody + HIV-1 p24 Antigen |
| SAR2IGA [C171527] | SARS-CoV-2 IgA Antibody |
| SAR2IGG [C171528] | SARS-CoV-2 IgG Antibody |
| SARSCOV2 [C171532] | Severe Acute Resp Syndrome Coronavirus 2 |
* Extended Value
Microbiology Specimen Test Name [C120528]
| Permitted Value (Code) |
|---|
| SARS-CoV-2 IgA Antibody [C171527] |
| SARS-CoV-2 IgG Antibody [C171528] |
Microbiology Specimen Test Name [C120528]
| Permitted Value (Code) |
|---|
| Severe Acute Resp Syndrome Coronavirus 2 [C171532] |
Microbiology Specimen Test Name [C120528]
| Permitted Value (Code) |
|---|
| HIV-1/2 Antibody + HIV-1 p24 Antigen [C139085] |
| Hepatitis B Virus Core Antibody [C96660] |
| Hepatitis B Virus Surface Antigen [C64850] |
| Hepatitis B Surface Antigen-Quantitative [*] |
| Hepatitis C Virus Antibody [C92535] |
* Extended Value
Method (MB) [C85492]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| ELECTROCHEMILUMINESCENCE IMMUNOASSAY [C111194] | Electrochemiluminescence Immunoassay |
| ELISA [C16553] | ELISA |
| IMMUNOCHEMILUMINOMETRIC ASSAY [C111235] | Immunochemiluminometric Assay |
Method (MB - SARSCOV2) [C85492]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| QUANTITATIVE REVERSE TRANSCRIPTASE POLYMERASE CHAIN REACTION [C28408] | Quantitative Reverse Transcriptase PCR |
Completion/Reason for Non-Completion [C66727]
| Permitted Value (Code) |
|---|
| COMPLETED [C25250] |
| ADVERSE EVENT [C41331] |
| DEATH [C28554] |
| LOST TO FOLLOW-UP [C48227] |
| PHYSICIAN DECISION [C48250] |
| PREGNANCY [C25742] |
| PROTOCOL DEVIATION [C50996] |
| SCREEN FAILURE [C49628] |
| SITE TERMINATED BY SPONSOR [C106576] |
| STUDY TERMINATED BY SPONSOR [C49632] |
| TECHNICAL PROBLEMS [C49633] |
| WITHDRAWAL BY SUBJECT [C49634] |
| OTHER [C17649] |
Not Done [C66789]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| NOT DONE [C49484] | Not Done |
Negative/Positive Result
| Permitted Value (Code) |
|---|
| Negative |
| Positive |
Reason for Non-childbearing potential
| Permitted Value (Code) |
|---|
| Postmenopausal (>=12 months) |
| Postmenopausal (>=12 months),Other |
| Postmenopausal (>=12 months),Surgically sterilized |
| Surgically sterilized |
| Other |
Normal Abnormal Response [C101834]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| Normal [C14165] | Normal |
| Abnormal [C25401] | Abnormal |
No Yes Text
| Permitted Value (Code) |
|---|
| No |
| Yes |
No Yes Response [C66742]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| N [C49487] | No |
| Y [C49488] | Yes |
Category for Examination
| Permitted Value (Code) |
|---|
| GENERAL |
Body System Test Name
| Permitted Value (Code) |
|---|
| Overall Health Judgement-Subj. healthy? |
| Abdomen |
| Cardiovascular |
| Gastrointestinal |
| General condition/psyche |
| Head (eyes, ears, mouth) |
| Heart |
| Lungs |
| Lymph nodes |
| Musculoskeletal system |
| Neck/thyroid gland |
| Neurological system |
| Skin |
| Vascular system |
| Other |
Body System Test Code
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| HEALTHY | Overall Health Judgement-Subj. healthy? |
| ABDOMEN | Abdomen |
| CARDVASC | Cardiovascular |
| GASTRO | Gastrointestinal |
| GENCON | General condition/psyche |
| HEAD | Head (eyes, ears, mouth) |
| HEART | Heart |
| LUNGS | Lungs |
| LYMPHN | Lymph nodes |
| MUSCULO | Musculoskeletal system |
| NECK | Neck/thyroid gland |
| NEUROL | Neurological system |
| SKIN | Skin |
| VASCUL | Vascular system |
| OTHER | Other |
Protocol Milestone [C114118]
| Permitted Value (Code) |
|---|
| ALLOCATED [*] |
| INFORMED CONSENT OBTAINED [C16735] |
| FIRST INFORMED CONSENT OBTAINED [*] |
| INFORMED CONSENT RECONSENTED [*] |
* Extended Value
Protocol Version
| Permitted Value (Code) |
|---|
| 3.0, 17 Apr 2020 |
| 5.0, 26 MAY 2020 |
| 7.0, 26 JUN 2020 |
| 8.0, 21 JUL 2020 |
Race [C74457]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| WHITE [C41261] | White |
| BLACK OR AFRICAN AMERICAN [C16352] | Black or African American |
| ASIAN [C41260] | Asian |
| AMERICAN INDIAN OR ALASKA NATIVE [C41259] | American Indian or Alaska Native |
| NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER [C41219] | Native Hawaiian or Other Pacific Islander |
| NOT REPORTED [C43234] | Not Reported |
| UNKNOWN [C17998] | Unknown |
| OTHER [*] | Other |
| MULTIPLE [*] | Multiple |
* Extended Value
Identifying Variable in Related Records
| Permitted Value (Code) |
|---|
| CELNKGRP |
| FALNKGRP |
| VSLNKGRP |
Related Domain Abbreviation in Related Records
| Permitted Value (Code) |
|---|
| CE |
| FA |
| VS |
Relationship Type [C78737]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| MANY [C170512] | Many |
| ONE [C66832] | One |
Route of Administration Response (CM) [C66729]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| AURICULAR (OTIC) [C38192] | Auricular Route of Administration |
| BUCCAL [C38193] | Buccal Route of Administration |
| CONJUNCTIVAL [C38194] | Conjunctival Route of Administration |
| CUTANEOUS [C38675] | Cutaneous Route of Administration |
| DENTAL [C38197] | Dental Route of Administration |
| DIETARY [C78373] | Dietary Route of Administration |
| ELECTRO-OSMOSIS [C38633] | Electro-osmosis Route of Administration |
| ENDOCERVICAL [C38205] | Endocervical Route of Administration |
| ENDOSINUSIAL [C38206] | Endosinusial Route of Administration |
| ENDOTRACHEAL [C38208] | Endotracheal Route of Administration |
| ENTERAL [C38209] | Enteral Route of Administration |
| EPIDURAL [C38210] | Epidural Route of Administration |
| EXTRA-AMNIOTIC [C38211] | Extraamniotic Route of Administration |
| EXTRACORPOREAL [C38212] | Extracorporeal Circulation Route of Administration |
| HEMODIALYSIS [C38200] | Administration via Hemodialysis |
| INFILTRATION [C38215] | Infiltration Route of Administration |
| INTERSTITIAL [C38219] | Interstitial Route of Administration |
| INTRA-ABDOMINAL [C38220] | Intraabdominal Route of Administration |
| INTRA-AMNIOTIC [C38221] | Intraamniotic Route of Administration |
| INTRA-ARTERIAL [C38222] | Intraarterial Route of Administration |
| INTRA-ARTICULAR [C38223] | Intraarticular Route of Administration |
| INTRABILIARY [C38224] | Intrabiliary Route of Administration |
| INTRABRONCHIAL [C38225] | Intrabronchial Route of Administration |
| INTRABURSAL [C38226] | Intrabursal Route of Administration |
| INTRACAMERAL [C64984] | Intracameral Route of Administration |
| INTRACARDIAC [C38227] | Intracardiac Route of Administration |
| INTRACARTILAGINOUS [C38228] | Intracartilaginous Route of Administration |
| INTRACAUDAL [C38229] | Intracaudal Route of Administration |
| INTRACAVERNOUS [C38230] | Intracavrenous Route of Administration |
| INTRACAVITARY [C38231] | Intracavitary Route of Administration |
| INTRACEREBRAL [C38232] | Intracerebral Route of Administration |
| INTRACISTERNAL [C38233] | Intracisternal Route of Administration |
| INTRACORNEAL [C38234] | Intracorneal Route of Administration |
| INTRACORONAL, DENTAL [C38217] | Intracoronal Dental Route of Administration |
| INTRACORONARY [C38218] | Intracoronary Route of Administration |
| INTRACORPORUS CAVERNOSUM [C38235] | Intracorporus Cavernosum Route of Administration |
| INTRADERMAL [C38238] | Intradermal Route of Administration |
| INTRADISCAL [C38239] | Intradiscal Route of Administration |
| INTRADUCTAL [C38240] | Intraductal Route of Administration |
| INTRADUODENAL [C38241] | Intraduodenal Route of Administration |
| INTRADURAL [C38242] | Intradural Route of Administration |
| INTRAEPIDERMAL [C38243] | Intraepidermal Route of Administration |
| INTRAESOPHAGEAL [C38245] | Intraesophageal Route of Administration |
| INTRAGASTRIC [C38246] | Intragastric Route of Administration |
| INTRAGINGIVAL [C38247] | Intragingival Route of Administration |
| INTRAHEPATIC [C38248] | Intrahepatic Route of Administration |
| INTRAILEAL [C38249] | Intraileal Route of Administration |
| INTRAJEJUNAL [C102399] | Intrajejunal Route of Administration |
| INTRALESIONAL [C38250] | Intralesional Route of Administration |
| INTRALUMINAL [C38251] | Intraluminal Route of Administration |
| INTRALYMPHATIC [C38252] | Intralymphatic Route of Administration |
| INTRAMANDIBULAR [C156590] | Intramandibular Route of Administration |
| INTRAMEDULLARY [C38253] | Intramedullary Route of Administration |
| INTRAMENINGEAL [C38254] | Intrameningeal Route of Administration |
| INTRAMUSCULAR [C28161] | Intramuscular Route of Administration |
| INTRANODAL [C79141] | Intranodal Route of Administration |
| INTRAOCULAR [C38255] | Intraocular Route of Administration |
| INTRAOSSEOUS [C64987] | Intraosseous Route of Administration |
| INTRAOVARIAN [C38256] | Intraovarian Route of Administration |
| INTRAPALATAL [C102400] | Intrapalatal Route of Administration |
| INTRAPARENCHYMAL [C119548] | Intraparenchymal Route of Administration |
| INTRAPERICARDIAL [C38257] | Intrapericardial Route of Administration |
| INTRAPERITONEAL [C38258] | Intraperitoneal Route of Administration |
| INTRAPLEURAL [C38259] | Intrapleural Route of Administration |
| INTRAPROSTATIC [C38260] | Intraprostatic Route of Administration |
| INTRAPULMONARY [C38261] | Intrapulmonary Route of Administration |
| INTRASINAL [C38262] | Intrasinal Route of Administration |
| INTRASPINAL [C38263] | Intraspinal Route of Administration |
| INTRASTOMAL [C65138] | Intrastomal Route of Administration |
| INTRASURGICAL SITE [C142365] | Intrasurgical Site Route of Administration |
| INTRASYNOVIAL [C38264] | Intrasynovial Route of Administration |
| INTRATENDINOUS [C38265] | Intratendinous Route of Administration |
| INTRATESTICULAR [C38266] | Intratesticular Route of Administration |
| INTRATHALAMIC [C128995] | Intrathalamic Route of Administration |
| INTRATHECAL [C38267] | Intrathecal Route of Administration |
| INTRATHORACIC [C38207] | Intrathoracic Route of Administration |
| INTRATUBULAR [C38268] | Intratubular Route of Administration |
| INTRATUMOR [C38269] | Intratumoral Route of Administration |
| INTRATYMPANIC [C38270] | Intratympanic Route of Administration |
| INTRAUTERINE [C38272] | Intrauterine Route of Administration |
| INTRAVAGINAL [C128996] | Intravaginal Route of Administration |
| INTRAVASCULAR [C38273] | Intravascular Route of Administration |
| INTRAVENOUS [C38276] | Intravenous Route of Administration |
| INTRAVENOUS BOLUS [C38274] | Intravenous Bolus |
| INTRAVENOUS DRIP [C38279] | Intravenous Drip |
| INTRAVENTRICULAR [C38277] | Intraventricular Route of Administration |
| INTRAVESICAL [C38278] | Intravesical Route of Administration |
| INTRAVITREAL [C38280] | Intravitreal Route of Administration |
| IONTOPHORESIS [C38203] | Iontophoresis Route of Administration |
| IRRIGATION [C38281] | Irrigation Route of Administration |
| LARYNGEAL [C38282] | Laryngeal Route of Administration |
| MICRODIALYSIS [C150889] | Microdialysis Route of Administration |
| NASAL [C38284] | Nasal Route of Administration |
| NASOGASTRIC [C38285] | Nasogatric Route of Administration |
| NOT APPLICABLE [C48623] | Route of Administration Not Applicable |
| OCCLUSIVE DRESSING TECHNIQUE [C38286] | Occlusive Dressing Technique |
| OPHTHALMIC [C38287] | Ophthalmic Route of Administration |
| ORAL [C38288] | Oral Route of Administration |
| ORAL GAVAGE [C78374] | Oral Gavage Route of Administration |
| OROMUCOSAL [C64906] | Oromucosal Route of Administration |
| OROPHARYNGEAL [C38289] | Oropharyngeal Route of Administration |
| OTHER [*] | OTHER |
| PARENTERAL [C38291] | Parenteral Route of Administration |
| PERCUTANEOUS [C38676] | Percutaneous Route of Administration |
| PERIARTICULAR [C38292] | Periarticular Route of Administration |
| PERIDURAL [C38677] | Peridural Route of Administration |
| PERINEURAL [C38293] | Perineural Route of Administration |
| PERIODONTAL [C38294] | Periodontal Route of Administration |
| PERIVENOUS [C112396] | Perivenous Route of Administration |
| RECTAL [C38295] | Rectal Route of Administration |
| RESPIRATORY (INHALATION) [C38216] | Inhalation Route of Administration |
| RETROBULBAR [C38296] | Retrobulbar Route of Administration |
| SOFT TISSUE [C38198] | Soft Tissue Route of Administration |
| SUBARACHNOID [C38297] | Subarachnoid Route of Administration |
| SUBCONJUNCTIVAL [C38298] | Subconjunctival Route of Administration |
| SUBCUTANEOUS [C38299] | Subcutaneous Route of Administration |
| SUBLINGUAL [C38300] | Sublingual Route of Administration |
| SUBMUCOSAL [C38301] | Submucosal Route of Administration |
| SUBRETINAL [C79143] | Subretinal Route of Administration |
| SUBTENON [C94636] | Subtenon Route of Administration |
| SUPRACHOROIDAL [C128997] | Suprachoroidal Route of Administration |
| TOPICAL [C38304] | Topical Route of Administration |
| TRANSDERMAL [C38305] | Transdermal Route of Administration |
| TRANSMAMMARY [C111326] | Transmammary Route of Administration |
| TRANSMUCOSAL [C38283] | Mucosal Route of Administration |
| TRANSPLACENTAL [C38307] | Transplacental Route of Administration |
| TRANSTRACHEAL [C38308] | Transtracheal Route of Administration |
| TRANSTYMPANIC [C38309] | Transtympanic Route of Administration |
| UNASSIGNED [C38310] | Unassigned Route of Administration |
| UNKNOWN [C38311] | Unknown Route of Administration |
| URETERAL [C38312] | Ureteral Route of Administration |
| URETHRAL [C38271] | Intraurethral Route of Administration |
| VAGINAL [C38313] | Vaginal Route of Administration |
* Extended Value
Reproductive System Findings Test Name [C106478]
| Permitted Value (Code) |
|---|
| Childbearing Potential [C106508] |
| Reason for Non-childbearing potential [*] |
| Last Menstrual Period Start Date [C81257] |
| Date of Sterilization [*] |
* Extended Value
Repro System Findings Test Short Name [C106479]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| CHILDPOT [C106508] | Childbearing Potential |
| NON_REAS [*] | Reason for Non-childbearing potential |
| LMPSTDTC [C81257] | Last Menstrual Period Start Date |
| STER_DTC [*] | Date of Sterilization |
* Extended Value
Severity Response - CE [C165643]
| Permitted Value (Code) |
|---|
| MILD [C70666] |
| MODERATE [C61376] |
| SEVERE [C70667] |
| POTENTIALLY LIFE THREATENING [*] |
* Extended Value
Severity Response - FACE
| Permitted Value (Code) |
|---|
| None |
| Mild |
| Moderate |
| Severe |
| Potentially Life Threatening |
Sex [C66731]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| F [C16576] | Female |
| M [C20197] | Male |
Study Site Identifier
| Permitted Value (Code) |
|---|
| CRS Mannheim |
| CRS Berlin |
Specimen Type (MB) [C78734]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| SERUM [C13325] | Serum |
Specimen Type (MB - SARSCOV2) [C78734]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| SWABBED MATERIAL [C150895] | Swabbed Material |
Relation to Reference Period (CM Start) [C66728]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| AFTER [C38008] | Post |
| BEFORE [C25629] | Prior |
Relation to Reference Period (End) [C66728]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| ONGOING [C53279] | Continue |
Relation to Reference Period (MH End) [C66728]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| BEFORE [C25629] | Prior |
| ONGOING [C53279] | Continue |
Start Reference Time Point
| Permitted Value (Code) |
|---|
| STUDY START |
Identifying Variable in SUPPAE
| Permitted Value (Code) |
|---|
| AESEQ |
Qualifier Variable Name for SUPPAE
| Permitted Value (Code) |
|---|
| AEEPRELI |
| AETRTEM |
| AE_DLT |
Evaluator for SUPPCM [C78735]
| Permitted Value (Code) |
|---|
| MEDICAL CODER [*] |
* Extended Value
Identifying Variable in SUPPCM
| Permitted Value (Code) |
|---|
| CMSEQ |
Qualifier Variable Name for SUPPCM
| Permitted Value (Code) |
|---|
| AE_NO1 |
| AE_NO2 |
| AE_NO3 |
| CMATC1 |
| CMATC1CD |
| CMATC2 |
| CMATC2CD |
| CMATC3 |
| CMATC3CD |
| CMATC4 |
| CMATC4CD |
| O_FREQ |
| O_ROUTE |
| O_UNIT |
Qualifier Variable Name for SUPPDM
| Permitted Value (Code) |
|---|
| AGE_M |
| RACE1 |
| RACE2 |
| RACEOTH |
Identifying Variable in SUPPDS
| Permitted Value (Code) |
|---|
| DSSEQ |
Qualifier Variable Name for SUPPDS
| Permitted Value (Code) |
|---|
| COHORT |
| DSEPRELI |
| GROUP |
| LASTCONT |
| PREV_TSN |
| PROTVERS |
Identifying Variable in SUPPDV
| Permitted Value (Code) |
|---|
| DVSEQ |
Qualifier Variable Name for SUPPDV
| Permitted Value (Code) |
|---|
| DVREAS |
| DVEPRELI |
Identifying Variable in SUPPEC
| Permitted Value (Code) |
|---|
| ECSEQ |
Qualifier Variable Name for SUPPEC
| Permitted Value (Code) |
|---|
| ADMPPROT |
| ECREASOC |
| MED_NO |
| TOTDOS |
| RESTVOL |
| ADMNPPSP |
| ECEPADJI |
| ECEPINTI |
Code of ECG Finding
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| 1 | 1ST DEGREE AV BLOCK |
| 12 | SHORT PR INTERVAL |
| 22 | Q AXIS, LEFT AXIS DEVIATION |
| 24 | QRS COMPLEX ABNORMALITY |
| 39 | INTRAVENTRICULAR CONDUCTION DELAY, NONSPECIFIC |
| 100 | BRADYCARDIA |
| 109 | SINUS ARRHYTHMIA |
| 110 | SINUS BRADYCARDIA |
| 120 | PROLONGED QT |
| 122 | QTC PROLONGATION |
| 123 | QTCB PROLONGATION |
| 135 | T WAVE INVERSION |
| 149 | PREMATURE ATRIAL COMPLEXES |
| 187 | POOR QUALITY ECG |
| 204 | PREMATURE VENTRICULAR COMPLEX |
| 211 | VENTRICULAR ESCAPE BEAT |
| 227 | SUPRAVENTRICULAR PREMATURE COMPLEX, ORIGIN UNKNOWN |
Evaluator for SUPPEG [C78735]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| INVESTIGATOR [C25936] | Investigator |
Identifying Variable in SUPPEG
| Permitted Value (Code) |
|---|
| EGSEQ |
Qualifier Variable Name for SUPPEG
| Permitted Value (Code) |
|---|
| CODE |
| EGCLSIG |
Identifying Variable in SUPPEX
| Permitted Value (Code) |
|---|
| EXSEQ |
Qualifier Variable Name for SUPPEX
| Permitted Value (Code) |
|---|
| ADMPPROT |
| MED_NO |
| TOTDOS |
| RESTVOL |
| ADMNPPSP |
| EXEPADJI |
| EXEPINTI |
Evaluator for SUPPFACE [C78735]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| STUDY SUBJECT [C41189] | Study Subject |
Identifying Variable in SUPPFACE
| Permitted Value (Code) |
|---|
| FASEQ |
Qualifier Variable Name for SUPPFACE
| Permitted Value (Code) |
|---|
| STUDYDAY |
Evaluator for SUPPLB [C78735]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| INVESTIGATOR [C25936] | Investigator |
Identifying Variable in SUPPLB
| Permitted Value (Code) |
|---|
| LBSEQ |
Qualifier Variable Name for SUPPLB
| Permitted Value (Code) |
|---|
| LBCLSIG |
| LBLOINC1 |
| LBLOINC2 |
| LBORRES1 |
| LBORRES2 |
| RBB |
| RBB2 |
Evaluator for SUPPPE [C78735]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| INVESTIGATOR [C25936] | Investigator |
Identifying Variable in SUPPPE
| Permitted Value (Code) |
|---|
| PESEQ |
Qualifier Variable Name for SUPPPE
| Permitted Value (Code) |
|---|
| PECLSIG |
Identifying Variable in SUPPRP
| Permitted Value (Code) |
|---|
| RPSEQ |
Qualifier Variable Name for SUPPRP
| Permitted Value (Code) |
|---|
| OTH_SPEC |
Evaluator for SUPPVS [C78735]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| INVESTIGATOR [C25936] | Investigator |
| STUDY SUBJECT [C41189] | Study Subject |
Identifying Variable in SUPPVS
| Permitted Value (Code) |
|---|
| VSSEQ |
Qualifier Variable Name for SUPPVS
| Permitted Value (Code) |
|---|
| STUDYDAY |
| VSCLSIG |
Identifying Variable in SUPPXA
| Permitted Value (Code) |
|---|
| XASEQ |
Qualifier Variable Name for SUPPXA
| Permitted Value (Code) |
|---|
| HLA_BS |
| RES_BS |
| ACT_TPT |
| REASON |
| PG_CMI |
| HLA_CMI |
Inclusion/Exclusion Test Code
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| EX01 | Had acute illness, with or without fever, within 72h prior to 1st immunization. Acute illness resolved with minor symptoms, in opinion of the invest., symptoms will not compromise their well-being. |
| EX02 | Are breastfeeding on the day of Visit 0 or who plan to breastfeed during the trial, starting after Visit 0 and continuously until at least 90 d after receiving the last immunization. |
| EX03 | Have a known allergy, hypersensitivity, or intolerance to the planned IMP including any excipients of the IMP. |
| EX04 | Had any major surgery within past 5 years, in opinion of the invest., could compromise their well-being if they participate in trial, or that prevent, limit, or confound prot. specified assessments. |
| EX05 | Have any surgery planned during the trial, starting after Visit 0 and continuously until at least 90 d after receiving the last immunization. |
| EX06 | Chronic use (>14 days) of systemic meds., including immunosuppressant, 6mo prior to Visit 0, unless med. would not prevent, limit, confound the prot. specified assessments or compromise safety. |
| EX06_4 | Chronic use (>14 days) of systemic meds., including immunosuppressants, 6mo prior to Visit 0, unless med. would not prevent, limit, confound the prot. specified assessments or compromise safety. |
| EX06_7 | Chronic use (>21 days) of systemic meds., including immunosuppressants, 6mo prior to Visit 0, unless med. would not prevent, limit, confound the prot. specified assessments or compromise safety. |
| EX06_9 | Chronic use (>21 days) of systemic meds., including immunosuppressants (except for Cohort 13), 6mo prior to Visit 0, unless med. would not prevent, limit, confound assessments or compromise safety. |
| EX07 | Received any vaccination within the 28 d prior to Visit 0. |
| EX08 | Had administration of any immunoglobulins and/or any blood products within the 3 months prior to Visit 0. |
| EX09 | Had administration of another investigational product including vaccines within 60 d or 5 half-lives (whichever is longer), prior to Visit 0. |
| EX09_4 | Had administration of another investigational medicinal product including vaccines within 60 d or 5 half-lives (whichever is longer), prior to Visit 0. |
| EX10 | Have a known history or a positive test of any of HIV 1 or 2, Hepatitis B, or Hepatitis C, within the 30 d prior to Visit 0. |
| EX10_1 | Have a known history or a positive test of any of the following: HIV 1 or 2, Hepatitis B, Hepatitis C. |
| EX10_9 | Have a known history or a positive test of any of HIV 1 or 2, Hepatitis B, or Hepatitis C (except for Cohort 13), within the 30 d prior to Visit 0. |
| EX11 | Have a positive PCR-based test for anti-SARS-CoV-2 within the 30 d prior to Visit 0. |
| EX11_3 | Have a positive PCR-based test for anti-SARS-CoV-2 within the 30 d prior to Visit 1. |
| EX12 | Positive drugs of abuse (amphetamines, benzodiazepines, barbiturates, cocaine, cannabinoids, opiates, methadone, methamphetamines, phencyclidine, and tricyclic antidepressants) result at Visit 0 or 1. |
| EX13 | Have a positive breath alcohol test at Visit 0 or Visit 1. |
| EX14 | Previously participated in an investigational trial involving lipid nanoparticles. |
| EX15 | Are subject to exclusion periods from other investigational trials or simultaneous participation in another clinical trial. |
| EX15_9 | Are subject to exclusion periods from other investigational trials or simultaneous participation in another clinical trial. Allowed participation in non-COVID-19 trials after entering follow-up phase. |
| EX16 | Have any affiliation with the trial site (e.g., are close relative of the investigator or dependent person, such as an employee or student of the trial site). |
| EX17 | History (past 5 years) of substance abuse or known medical, psycho., or social conditions which compromise well-being as trial subjects, or prevent, limit, or confound the prot. specified assessments. |
| EX18 | Have a history of hypersensitivity or serious reactions to previous vaccinations. |
| EX19 | Have a history of Guillain-Barre Syndrome within 6 wks following a previous vaccination. |
| EX20 | Have a history of narcolepsy. |
| EX21 | Have history of alcohol abuse or drug addiction within 1 year before Visit 0. |
| EX22 | Have a history of or suspected immunosuppressive condition, acquired or congenital, as determined by medical history and/or physical examination at Visit 0. |
| EX22_9 | (Except for Cohort 13) Have a history of or suspected immunosuppressive condition, acquired or congenital, as determined by medical history and/or physical examination at Visit 0. |
| EX23 | Have any abnormality or permanent body art (e.g., tattoo) that, in the opinion of the investigator, would obstruct the ability to observe local reactions at the injection site. |
| EX24 | Had any blood loss >450 mL, within the 7d prior to Visit 0 or plan to donate blood during the trial, starting after Visit 0 and continuously until at least 7 d after receiving the last immunization. |
| EX24A | They were in any country with a high SARS-CoV-2 infection risk (as defined by the RKI at the time Visit 0) within the 14 d prior to Visit 0. |
| EX24B | They plan to visit any country with a high SARS-CoV-2 infection risk (as defined by the RKI at the time Visit 0), from Visit 0 until 14 d after receiving the last immunization. |
| EX25 | Symptoms of COVID-19, e.g., respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. |
| EX25A | (Once commercially available in Germany) Have a positive test for anti-SARS-CoV-2 antibodies. |
| EX26 | Have had contact with persons tested positive for SARS-CoV-2 antibodies within the 30 d prior to Visit 0. |
| EX27 | Are soldiers, subjects in detention, CRO or sponsor staff or their family members. |
| EX27_1 | Are vulnerable persons, i.e., soldiers, subjects in detention, CRO or sponsor staff or their family members. |
| EX28 | Regular receipt of inhaled/nebulized corticosteroids. |
| EX29 | For older adults only: Have a condition known to put them at high risk for severe COVID-19. |
| EX29_8 | For older adults only: Have a condition known to put them at high risk for severe COVID-19. (BMI removed as risk factor.) |
| EX29_9 | For older adults and Cohort 13 only: Have a condition known to put them at high risk for severe COVID-19. |
| IN01 | Have given informed consent by signing the ICF before initiation of any trial-specific procedures. |
| IN01_3 | Have given informed consent by signing the informed consent form (ICF) before initiation of any trial-specific procedures. |
| IN02 | They must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions (e.g., to reduce COVID-19 exposure), and other requirements of the trial. |
| IN02_1 | They must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions, and other requirements of the trial. |
| IN03 | They must be able to understand and follow trial-related instructions. |
| IN04 | They must be aged from 18 to 55 years, have a body mass index of over 19 kg/m2 and under 30 kg/m2, and weigh at least 50 kg at Visit 0. |
| IN04_1 | They must be aged 18 <= 55 years and weigh at least 50 kg at Visit 0. |
| IN04_6 | They must be aged from 18 to 55 years (Cohorts 1 to 8) or 65 to 85 years (elderly subject cohorts), have a body mass index over 19 kg/m2 and under 30 kg/m2, and weigh at least 50 kg at Visit 0. |
| IN04_7 | For younger cohorts, must be aged from 18-55 years. For older cohorts, must be aged 56-85 years. Must have a body mass index over 19 kg/m2 and under 30 kg/m2, and weigh at least 50 kg at Visit 0. |
| IN05 | Must be healthy based on MH, PE, 12-lead ECG, VS (systolic/diastolic BP, pulse rate, temp., respiratory rate), and clinical lab tests (blood chemistry, hematology, and urine chemistry) at Visit 0. |
| IN05_7 | Must be healthy based on MH, PE, ECG, VS (BP, pulse rate, temp., respiratory rate), and clinical lab tests at Visit 0. Healthy volunteers with pre-existing stable disease can be included. |
| IN05_9 | Must be healthy in clinical judgment of investigator at Visit 0. For cohort 13, volunteers must be immunocompromised but otherwise healthy. |
| IN06 | WOCBP have a negative beta-human chorionic gonadotropin urine test at Visit 0 and Visit 1. Women that are postmenopausal or permanently sterilized be considered as not having reproductive potential. |
| IN07 | WOCBP must agree to practice one highly effective form of contraception during the trial, starting after Visit 0 and continuously until 60 d after receiving the last immunization. |
| IN07_3 | WOCBP must agree to practice two highly effective forms of contraception during the trial, starting after Visit 0 and continuously until 60 d after receiving the last immunization. |
| IN07_4 | WOCBP must agree to practice a highly effective form of contraception during the trial, starting after Visit 0 and continuously until 60 d after receiving the last immunization. |
| IN07_7 | WOCBP must practice a highly effective form of contraception, starting after Visit 0 and continuously until 60 d after receiving the last immunization, and must require male partners to use condoms. |
| IN08 | WOCBP must confirm that they practiced one highly effective form of contraception for the 14 d prior to Visit 0. |
| IN08_3 | WOCBP must confirm that they practiced at least one highly effective form of contraception for the 14 d prior to Visit 0. |
| IN09 | WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during trial, starting after Visit 0 and continuously until 60 d after receiving the last immunization. |
| IN10 | Men sexually active with WOCBP and not had a vasectomy must agree to practice a contraception with female of childbearing potential, after Visit 0 and until 60d after receiving the last immunization. |
| IN11 | Men must be willing to refrain from sperm donation, starting after Visit 0 and continuously until 60 d after receiving the last immunization. |
| IN12 | They must have confirmation of their health insurance coverage prior to Visit 0. |
| IN13 | They must agree to not be vaccinated during the trial, starting after Visit 0 and continuously until 28 d after receiving the last immunization. |
Time Point Reference
| Permitted Value (Code) |
|---|
| PRIME VACCINATION |
| BOOST VACCINATION |
Planned Time Point Name - Day 1
| Permitted Value (Code) |
|---|
| PREDOSE |
| 1 HOUR |
| 3 HOURS |
| 6 HOURS |
Name of Treatment
| Permitted Value (Code) |
|---|
| BNT162b1 |
| BNT162b2 |
Trial Summary Parameter Test Name [C67152]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| Actual Number of Subjects [C98703] | Actual Subject Number |
| Adaptive Design [C146995] | Adaptive Design |
| Added on to Existing Treatments [C49703] | Test Product Added to Existing Treatment |
| Clinical Study Sponsor [C70793] | Clinical Study Sponsor |
| Control Type [C49647] | Control Type |
| Data Cutoff Date [C98717] | Data Cutoff Date |
| Data Cutoff Description [C98718] | Data Cutoff Date Description |
| Diagnosis Group [C49650] | Diagnosis Group |
| Dose Units [C73558] | Dosage Form Unit |
| Exploratory Outcome Measure [C98724] | Exploratory Outcome Measure |
| Extension Trial Indicator [C139274] | Extension Trial Indicator |
| Healthy Subject Indicator [C98737] | Healthy Subject Indicator |
| Intervention Model [C98746] | Intervention Model |
| Intervention Type [C98747] | Intervention Type |
| Investigational Therapy or Treatment [C41161] | Protocol Agent |
| Number of Groups/Cohorts [C126063] | Number of Groups or Cohorts |
| Pediatric Investigation Plan Indicator [C126069] | Pediatric Investigation Plan Indicator |
| Pediatric Postmarket Study Indicator [C123631] | Pediatric Postmarket Study Indicator |
| Pediatric Study Indicator [C123632] | Pediatric Study Indicator |
| Pharmacologic Class [C98768] | Pharmacological Class of Investigational Therapy |
| Planned Country of Investigational Sites [C98770] | Planned Country of Investigational Site |
| Planned Maximum Age of Subjects [C49694] | Planned Maximum Age of Subjects |
| Planned Minimum Age of Subjects [C49693] | Planned Minimum Age of Subjects |
| Planned Number of Arms [C98771] | Planned Number of Arms |
| Planned Number of Subjects [C49692] | Planned Subject Number |
| Primary Outcome Measure [C98772] | Primary Outcome Measure |
| Rare Disease Indicator [C126070] | Rare Disease Indicator |
| Registry Identifier [C98714] | Clinical Trial Registry Identifier |
| Route of Administration [C38114] | Route of Administration |
| SDTM IG Version [C156604] | SDTM IG Version |
| SDTM Version [C156605] | SDTM Version |
| Secondary Outcome Measure [C98781] | Secondary Outcome Measure |
| Sex of Participants [C49696] | Sex of Study Group |
| Stratification Factor [C16153] | Stratification Factors |
| Study End Date [C90462] | Study End Date |
| Study Start Date [C69208] | Study Start Date |
| Study Stop Rules [C49698] | Study Stop Rule |
| Study Type [C142175] | Study Design |
| Therapeutic Area [C101302] | Therapeutic Area |
| Trial Blinding Schema [C49658] | Trial Blinding Schema |
| Trial Disease/Condition Indication [C112038] | Trial Disease/Condition Indication |
| Trial Exploratory Objective [C163559] | Trial Exploratory Objective |
| Trial Intent Type [C49652] | Trial Intent Type |
| Trial Length [C49697] | Trial Length |
| Trial Phase Classification [C48281] | Trial Phase |
| Trial Primary Objective [C85826] | Trial Primary Objective |
| Trial Secondary Objective [C85827] | Trial Secondary Objective |
| Trial Title [C49802] | Trial Title |
| Trial Type [C49660] | Trial Type |
| Trial is Randomized [C25196] | Randomization |
Trial Summary Parameter Test Code [C66738]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| ACTSUB [C98703] | Actual Number of Subjects |
| ADAPT [C146995] | Adaptive Design |
| ADDON [C49703] | Added on to Existing Treatments |
| AGEMAX [C49694] | Planned Maximum Age of Subjects |
| AGEMIN [C49693] | Planned Minimum Age of Subjects |
| DCUTDESC [C98718] | Data Cutoff Description |
| DCUTDTC [C98717] | Data Cutoff Date |
| DOSU [C73558] | Dose Units |
| EXTTIND [C139274] | Extension Trial Indicator |
| FCNTRY [C98770] | Planned Country of Investigational Sites |
| HLTSUBJI [C98737] | Healthy Subject Indicator |
| INDIC [C112038] | Trial Disease/Condition Indication |
| INTMODEL [C98746] | Intervention Model |
| INTTYPE [C98747] | Intervention Type |
| LENGTH [C49697] | Trial Length |
| NARMS [C98771] | Planned Number of Arms |
| NCOHORT [C126063] | Number of Groups/Cohorts |
| OBJEXP [C163559] | Trial Exploratory Objective |
| OBJPRIM [C85826] | Trial Primary Objective |
| OBJSEC [C85827] | Trial Secondary Objective |
| OUTMSEXP [C98724] | Exploratory Outcome Measure |
| OUTMSPRI [C98772] | Primary Outcome Measure |
| OUTMSSEC [C98781] | Secondary Outcome Measure |
| PCLAS [C98768] | Pharmacologic Class |
| PDPSTIND [C123631] | Pediatric Postmarket Study Indicator |
| PDSTIND [C123632] | Pediatric Study Indicator |
| PIPIND [C126069] | Pediatric Investigation Plan Indicator |
| PLANSUB [C49692] | Planned Number of Subjects |
| RANDOM [C25196] | Trial is Randomized |
| RDIND [C126070] | Rare Disease Indicator |
| REGID [C98714] | Registry Identifier |
| ROUTE [C38114] | Route of Administration |
| SDTIGVER [C156604] | SDTM IG Version |
| SDTMVER [C156605] | SDTM Version |
| SENDTC [C90462] | Study End Date |
| SEXPOP [C49696] | Sex of Participants |
| SPONSOR [C70793] | Clinical Study Sponsor |
| SSTDTC [C69208] | Study Start Date |
| STOPRULE [C49698] | Study Stop Rules |
| STRATFCT [C16153] | Stratification Factor |
| STYPE [C142175] | Study Type |
| TBLIND [C49658] | Trial Blinding Schema |
| TCNTRL [C49647] | Control Type |
| TDIGRP [C49650] | Diagnosis Group |
| THERAREA [C101302] | Therapeutic Area |
| TINDTP [C49652] | Trial Intent Type |
| TITLE [C49802] | Trial Title |
| TPHASE [C48281] | Trial Phase Classification |
| TRT [C41161] | Investigational Therapy or Treatment |
| TTYPE [C49660] | Trial Type |
Unit (CM) [C71620]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| AMPULE [C48473] | Ampule Dosing Unit |
| CAPSULE [C48480] | Capsule Dosing Unit |
| g [C48155] | Gram |
| g/L [C42576] | Gram per Liter |
| gtt [C48491] | Metric Drop |
| IU [C48579] | International Unit |
| mg [C28253] | Milligram |
| mL [C28254] | Milliliter |
| mm [C28251] | Millimeter |
| NOT APPLICABLE [*] | NOT APPLICABLE |
| OTHER [*] | OTHER |
| PATCH [C48524] | Patch Dosing Unit |
| PUFF [C65060] | Puff Dosing Unit |
| SPRAY [C48537] | Spray Dosing Unit |
| STRIP [C48538] | Strip Dosing Unit |
| SUPPOSITORY [C48539] | Suppository Dosing Unit |
| TABLET [C48542] | Tablet Dosing Unit |
| Tbsp [C48541] | Tablespoon Dosing Unit |
| tsp [C48544] | Teaspoon Dosing Unit |
| ug [C48152] | Microgram |
* Extended Value
Vaccines Findings About Test Name [C142189]
| Permitted Value (Code) |
|---|
| Occurrence Indicator [C127786] |
| Severity/Intensity [C25676] |
Vaccines Findings About Test Code [C142187]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| OCCUR [C127786] | Occurrence Indicator |
| SEV [C25676] | Severity/Intensity |
Category for Vital Signs
| Permitted Value (Code) |
|---|
| REACTOGENICITY |
Laterality in VS [C99073]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| LEFT [C25229] | Left |
| RIGHT [C25228] | Right |
Original Units for VS [C66770]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| C [C42559] | Degree Celsius |
| beats/min [C49673] | Beats per Minute |
| breaths/min [C49674] | Breaths per Minute |
| cm [C49668] | Centimeter |
| kg [C28252] | Kilogram |
| kg/m2 [C49671] | Kilogram per Square Meter |
| mmHg [C49670] | Millimeter of Mercury |
Vital Signs Position of Subject [C71148]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| SUPINE [C62167] | Supine Position |
Subcategory for Vital Signs
| Permitted Value (Code) |
|---|
| SYSTEMIC |
Standard Units for VS [C66770]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| C [C42559] | Degree Celsius |
| beats/min [C49673] | Beats per Minute |
| breaths/min [C49674] | Breaths per Minute |
| cm [C49668] | Centimeter |
| kg [C28252] | Kilogram |
| kg/m2 [C49671] | Kilogram per Square Meter |
| mmHg [C49670] | Millimeter of Mercury |
Vital Signs Test Name [C67153]
| Permitted Value (Code) |
|---|
| Body Mass Index [C16358] |
| Diastolic Blood Pressure [C25299] |
| Height [C25347] |
| Pulse Rate [C49676] |
| Respiratory Rate [C49678] |
| Systolic Blood Pressure [C25298] |
| Temperature [C25206] |
| Weight [C25208] |
Vital Signs Test Code [C66741]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| BMI [C16358] | Body Mass Index |
| DIABP [C25299] | Diastolic Blood Pressure |
| HEIGHT [C25347] | Height |
| PULSE [C49676] | Pulse Rate |
| RESP [C49678] | Respiratory Rate |
| SYSBP [C25298] | Systolic Blood Pressure |
| TEMP [C25206] | Temperature |
| WEIGHT [C25208] | Weight |
Category for XA
| Permitted Value (Code) |
|---|
| BLOOD SAMPLING FOR RESEARCH |
| HLA TYPING SAMPLING |
| OBSERVATION PERIOD |
| PHARMACOGENETIC ANALYSIS |
| PHONE CALL |
XA Test Name
| Permitted Value (Code) |
|---|
| Informed Consent given |
| Not Done |
| Outcome of the call |
| Reason not Done |
| Vaccination Visit |
XA Test Code
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| IC_GIVEN | Informed Consent given |
| ND | Not Done |
| OUT_CALL | Outcome of the call |
| REAS_ND | Reason not Done |
| VACCIN_V | Vaccination Visit |
Category for XB
| Permitted Value (Code) |
|---|
| HLA-TYPING |
XB Test Name
| Permitted Value (Code) |
|---|
| HLA Class IA Antigen |
| HLA Class IB Antigen |
| HLA Class IC Antigen |
| HLA DQ Beta1 Antigen |
| HLA DR Beta1 Antigen |
XB Test Code
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| HLAA | HLA Class IA Antigen |
| HLAB | HLA Class IB Antigen |
| HLAC | HLA Class IC Antigen |
| HLADQB1 | HLA DQ Beta1 Antigen |
| HLADRB1 | HLA DR Beta1 Antigen |
No Yes Response (Yes only) [C66742]
| Permitted Value (Code) | Display Value (Decode) |
|---|---|
| Y [C49488] | Yes |
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External Dictionaries
| Reference Name | External Dictionary | Dictionary Version |
|---|---|---|
| Medication Reference Terminology | MED-RT | 2020-10-05 |
| Medical Dictionary for Regulatory Activities | MedDRA | 23.0 |
| National Drug File - Reference Terminology | NDF-RT | 2020-10-05 |
| Systematized Nomenclature of Medicine | SNOMED | 2020-09-01 |
| Unique Ingredient Identifier | UNII | 2020-08-18 |
| Medications Dictionary | WHODD | GLOBALB3Mar20 |
| Drug Dictionary | WHODRUG GLOBAL B3 | GLOBALB3Mar20 |
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Methods
| Method | Type | Description |
|---|---|---|
| Algorithm: BLFL | Computation | Y on the closest non-missing result before the reference start date (DM.RFSTDTC) for each test. |
| Algorithm: DY | Computation | Study day of observation relative to the Subject Reference Start Date/Time (DM.RFSTDTC).
--DY = (date portion of --DTC) - (date portion of DM.RFSTDTC) + 1 where date portion of --DTC is on or after date portion of DM.RFSTDTC; Otherwise --DY = (date portion of --DTC) - (date portion of DM.RFSTDTC). |
| Algorithm: ENDY | Computation | Study day of end of event relative to the Subject Reference Start Date/Time (DM.RFSTDTC).
--ENDY = (date portion of --ENDTC) - (date portion of DM.RFSTDTC) + 1 when date portion of --ENDTC is on or after date portion of DM.RFSTDTC; Otherwise --ENDY = (date portion of --ENDTC) - (date portion of DM.RFSTDTC). |
| Algorithm: EPOCH | Computation | Set to EPOCH value from the record in SE for the given USUBJID meeting the following criteria: If the observation date or event start date (--DTC / --STDTC) is prior to the element start date (SESTDTC) for the record with ETCD='PREDOSE', set to 'SCREENING'. Otherwise, if the observation date / event start date is prior to element start date for the record with ETCD='VXxxxxxP', set to 'BASELINE'. Otherwise, if the observation date / event start date is prior to element start date for the record with ETCD='FUP' or if the 'FUP' record does not exist, set to 'TREATMENT'. Otherwise, set to 'FUP'. |
| Algorithm: SEQ | Computation | Unique sequence number within a subject when dataset is sorted by the key variables. |
| Algorithm: STDY | Computation | Study day of start of event relative to the Subject Reference Start Date/Time (DM.RFSTDTC).
--STDY = (date portion of --STDTC) - (date portion of DM.RFSTDTC) + 1 when date portion of --STDTC is on or after date portion of DM.RFSTDTC; Otherwise --STDY = (date portion of --STDTC) - (date portion of DM.RFSTDTC). |
| Algorithm: STRESC | Computation | --STRESC = --ORRES |
| Algorithm: STRESN | Computation | The numeric equivalent of xxSTRESC. |
| Algorithm: STRESU | Computation | --STRESU = --ORRESU |
| Algorithm: USUBJID | Computation | Concatenation of Study Identifier (STUDYID), '276', Investigator Identifier (INVID), and Subject Number (SUBJID), separated by '-'.
(Ex. BNT162-01-276-01-0001) |
| Algorithm: CE.CEDUR | Computation | Difference between the date part of the End Date/Time of Clinical Event (CEENDTC) or the end of the assessment period (date part of CERFTDTC + 7 days), whichever is earlier, and the date part of the Start Date/Time of Clinical Event (CESTDTC) + 1 day. Populated only when CEOCCUR = 'Y'. |
| Algorithm: CE.CEENDTC | Computation | Latest reported date of the symptom [i.e. maximum FADTC or VSDTC for given subject, time point reference, and term]. Populated only when CEOCCUR = 'Y'. |
| Algorithm: CE.CEENRTPT | Computation | ONGOING' when End Date/Time of Clinical Event (CEENDTC) is after the end of the assessment period [i.e. when date part of CEENDTC is greater than or equal to date part of CERFTDTC + 8 days]. |
| Algorithm: CE.CEGRPID | Computation | Concatenation of Time Point Reference (CETPTREF) and Subcategory for Clinical Event (CESCAT), separated by '-'. |
| Algorithm: CELNKGRP | Computation | Set to VS.VSLNKGRP on records having CETERM = 'Fever', and set to FA.FALNKGRP on all other records. |
| Algorithm: CERFTDTC | Computation | Set to VS.VSRFTDTC on records having CETERM = 'Fever', and set to FA.FARFTDTC on all other records. |
| CE Severity/Intensity | Computation | Populated when CEOCCUR = 'Y' as the maximum severity reported for the reactogenicity event during the assessment period. For records with a Reported Term (CETERM) of 'Fever', severity is derived from the VS.VSSTRESN as follows: 'MILD' when VSSTRESN <= 38.4; else 'MODERATE' when VSSTRESN <= 38.9; else 'SEVERE' when VSSTRESN <= 40.0; else 'POTENTIALLY LIFE THREATENING' when VSSTRESN. For all other records (CETERM is not 'Fever'), severity is obtained from FACE.FASTRESC. |
| Algorithm: CE.CESTDTC | Computation | Earliest reported date of the symptom [i.e. minimum FADTC or VSDTC for given subject, time point reference, and term]. Populated only when CEOCCUR = 'Y'. |
| Algorithm: CETPTREF | Computation | Set to VS.VSTPTREF on records having CETERM = 'Fever', and set to FA.FATPTREF on all other records. |
| Algorithm: CE.EPOCH | Computation | Always 'TREATMENT' since reactogenicity events are captured only in the assessment period following a vaccine. |
| Algorithm: DM.ACTARM | Computation | DM.ACTARM=DM.ARM |
| Algorithm: DM.DTHFL | Computation | DTHFL='Y' when disposition reason is 'Death' |
| Algorithm: DM.RFENDTC | Computation | Date of last dose equal to DS.DSSTDTC when DSSCAT='END OF TRIAL' and dsdecod='COMPLETED' else if DS.DSCAT='DISPOSITION EVENT' and DSDECOD ne 'COMPLETED' then RFENDTC =SUPPDS.LASTCONT. |
| Algorithm: DM.RFPENDTC | Computation | if DS.DSCAT='DISPOSITION EVENT' and DSDECOD ne 'COMPLETED' then RFPENDTC =SUPPDS.LASTCONT. |
| Algorithm: DM.RFSTDTC | Computation | Date of First Dose in ISO8601 format. |
| Algorithm: DM.RFXENDTC | Computation | Date of last dose equal to last non-missing value of EX.EXENDTC in ISO8601 format. |
| Algorithm: DM.RFXSTDTC | Computation | Date of First Dose in ISO8601 format. |
| Algorithm: EC.ECENDTC | Computation | EC.ECENDTC=EX.EXENDTC where EX.VISITNUM=EC.VISITNUM |
| Algorithm: EG.EGBLFL | Computation | EG.EGBLFL = 'Y' per unique USUBJID/EGTESTCD for the last non-null EGORRES where EG.EGDTC <= DM.RFSTDTC; else EG.EGBLFL = null. |
| Algorithm: EG.EGORRES | Computation | Mapped from abnormality code entered on CRF (SUPPEG.CODE). See Codelist for SUPPEG.CODE for decode information. |
| Algorithm: EG.EGTEST_FINDING | Computation | 'Interpretation' when Normal/Abnormal result is obtained from CRF. Otherwise, derived from code entered on CRF (SUPPEG.CODE) to describe abnormal finding: 'Atrioventricular Conduction' when CODE is '1' or '12'; 'Axis and Voltage' when CODE is '24'; 'Intraventricular-Intraatrial Conduction' when CODE is '39'; 'Rhythm Not Otherwise Specified' when CODE is '100'; 'Sinus Node Rhythms and Arrhythmias' when CODE is '109' or '110'; ST Segment, T wave, and U wave' when CODE is '120', '122', '123', or '135'; 'Supraventricular Arrhythmias' when CODE is '149'; 'Technical Quality' when CODE is '187'; 'Ventricular Arrhythmias' when CODE is '204', '211'. |
| Algorithm: EX.EXDOSE | Computation | When total dose is not given, computed as the total dose (EC.ECDOSE) - (rest of dose (SUPPEX.RESTVOL) * planned dose / total dose). |
| Algorithm: EX.EXENDTC | Computation | EX.EXENDTC=EX.EXSTDTC |
| Algorithm: FA.EPOCH | Computation | Always 'TREATMENT' since reactogenicity events are captured only in the assessment period following a vaccine. |
| Algorithm: FACE.FAGRPID | Computation | Concatenation of Time Point Reference (FATPTREF) and Subcategory for Findings About (FASCAT), separated by '-'. Null when FATPTREF is null. |
| Algorithm: FACE.FALNKGRP | Computation | Populated only on records used to populate CEOCCUR values on the CE domain, which includes those obtained from diary data collected on Days 1 through 8 following each vaccination or those collected after Day 8 but representing an occurrence [i.e. where the Evaluator (FAEVAL) is 'STUDY SUBJECT' and either (a) the Planned Time Point Number (FATPTNUM) is less than or equal to 8 and the Completion Status (FASTAT) is null or (b) FATPTNUM > 8 and FAORRES has a value other than 'N' or 'None']. FALNKGRP is set to the concatenation of Time Point Reference (FATPTREF), Evaluator (FAEVAL), and Object of the Observation (FAOBJ), separated by '-' (Ex. PRIME VACCINATION-STUDY SUBJECT-Headache). |
| Algorithm: FACE.FALNKID | Computation | Concatenation of Link Group ID (FALNKGRP) and Planned Time Point Name (FATPT), separated by '-' (Ex. PRIME VACCINATION-STUDY SUBJECT-Headache-DAY 1). Null when FALNKGRP is null. |
| Algorithm: FACE.FARFTDTC | Computation | Start Date/Time of Treatment at the Day 1 Visit (EX.EXSTDTC where EX.VISITNUM = 2) when FATPTREF="PRIME VACCINATION". Start Date/Time of Treatment at the Day 22 Visit (EX.EXSTDTC where EX.VISITNUM = 6) when FATPTREF="BOOST VACCINATION". |
| Algorithm: FACE.FASTRESC | Computation | FAORRES in upper case. |
| Algorithm: FACE.FATPT | Computation | Concatenation of 'DAY ' with the number of days between the Date/Time of Collection and the Date/Time of Reference Time Point [date part of FADTC - date part of FARFTDTC + 1]. |
| Algorithm: FACE.FATPTREF.DAY | Computation | PRIME VACCINATION' when (i) Date of Collection (date part of FADTC) is prior to the Start Date of Treatment at the Day 22 Visit (date part of EX.EXSTDTC where VISITNUM = 6), (ii) when the subject has not received a boost vaccination (record does not exist in EX with VISITNUM = 6 and non-missing EXSTDTC), or (iii) when the Date of Collection is missing and the Completion Status (FASTAT) is null (not flagged as 'NOT DONE'). 'BOOST VACCINATION' when Date of Collection is on or after the Start Date of Treatment at the Day 22 Visit. Null, otherwise. |
| Algorithm: FACE.FATPTREF.NEDAY | Computation | PRIME VACCINATION' when VISITNUM = 2 (Day 1 Visit). 'BOOST VACCINATION' when VISITNUM = 6 (Day 22 Visit). Null, otherwise. |
| Algorithm: LB.LBBLFL | Computation | LB.LBBLFL = 'Y' per unique USUBJID/LBTESTCD for the last non-null LBORRES where LB.LBDTC <= DM.RFSTDTC; else LB.LBBLFL = null. |
| Algorithm: LB.LBNRIND | Computation | 'LOW' when the Standard Character Result (LBSTRESC - remove "<" sign when necessary for compare) is less than the Reference Range Standard Lower Limit (LBSTNRLO). 'HIGH' when the Standard Character Result (LBSTRESC) is greater than the Reference Range Standard Upper Limit (LBSTNRHI) or for Lab Tests 'Poikilocytes' and 'Anisocytes' when a positive result is obtained. 'ABNORMAL' when the Standard Character Result (LBSTRESC) indicates presence of cells or a positive result (e.g. '+') when the Reference Range for Standard Character Result (LBSTNRC) is 'NONE', 'NORMAL', or 'NEGATIVE'. |
| Algorithm: LB.LBSTRESC | Computation | Lab value converted to standard units. |
| Algorithm: MB.MBBLFL | Computation | If MB.MBTESTCD in('SAR2IGA' ,'SAR2IGG') then MB.MBBLFL= 'Y' per unique USUBJID/MBTESTCD for the last non-null MBORRES where MB.MBDTC <= DM.RFSTDTC; else MB.MBBLFL = null. |
| Algorithm: MB.MBNRIND | Computation | For MBTEST='SARS-CoV-2 IgA Antibody' if MB.MBORRES>0.80 then MB.MBNRIND='HIGH' else MB.MBNRIND is set to missing |
| Algorithm: RELREC.RELID | Computation | Derived as unique value within USUBJID that identifies the relationship within the RELREC dataset to identify the related/associated Domain records. |
| Algorithm: RP.RPDTC | Computation | RP.RPDTC=SV.SVSTDTC if RP.VISITNUM=SV.VISITNUM |
| Algorithm: RP.RPSTRESU | Computation | RP.RPSTRESU = RP.RPORRESU |
| Algorithm: SE.ETCD | Imputation | Record created with ETCD = 'SCRN' when record exists in DS with DSDECOD = 'INFORMED CONSENT OBTAINED'. Record created with ETCD = 'PREDOSE' when record exists in SV with VISITNUM = 2 (Day 1 visit). Record created with ETCD = 'VAXB#C#P' when record exists in EX with VISITNUM = 2 (Day 1 visit). Record created with ETCD = 'VAXB#C#B' when record exists in EX with VISITNUM = 6 (Day 22 visit). Record created with ETCD = 'FUP' when record exists in SV with VISITNUM = 9 (EoT visit). Note: In the VAXB#C#P/VAXB#C#B elements, B# represents the name of the vaccine (B1 or B2) and C# represents the name of the cohort (C1-C5) to which the subject is allocated. This information is found in SUPPDS.GROUP and SUPPDS.COHORT. |
| Algorithm: SE.SEENDTC | Computation | Set to SESTDTC of the succeeding element for all values of ETCD except 'FUP'. When ETCD = 'FUP', set to DS.DSSTDTC where DSDECOD = 'END OF FOLLOW-UP COMPLETED'. |
| Algorithm: SE.SESTDTC | Computation | Set to DS.DSSTDTC where DSDECOD = 'INFORMED CONSENT OBTAINED' when ETCD = 'SCRN'. Set to date part of SV.SVSTDTC where VISITNUM = 2 + 00:00 for time when ETCD = 'PREDOSE'. Set to EX.EXSTDTC where VISITNUM = 2 when ETCD = 'VAXB#C#P'. Set to EX.EXSTDTC where VISITNUM = 6 when ETCD = 'VAXB#C#B'. Set to SV.SVENDTC where VISITNUM = 9 when ETCD = 'FUP'. |
| Algorithm: SV.SVENDTC | Computation | Populated with the most recent date/time combination found at a given visit using the following SDTM variables: xx.xxDTC, xx.xxENDTC |
| Algorithm: SV.SVSTDTC | Computation | Populated with the most historic date/time combination found at a given visit using the following SDTM variables: xx.xxDTC, xx.xxSTDTC |
| Algorithm: SV.VISIT | Computation | Populated with the complete list of visits that a subject attended, excluding any unscheduled visits. |
| Algorithm: TS.TSSEQ | Computation | Sequential number uniquely identifying the records within the domain by TSPARMCD. |
| Algorithm: VS.VSLNKGRP | Computation | Populated only on records collected for Reactogenicity analyses [i.e. where Category for Vital Signs (VSCAT) is 'REACTOGENICITY']. These records are used to populate CE domain. Note that only those records representing a fever occurring within the Day 1 to Day 8 assessment period are considered when populating the CEOCCUR value. Set VSLNKGRP to the concatenation of Time Point Reference (VSTPTREF), 'STUDY SUBJECT' (representing the evaluator, since these records are obtained from diary data), and 'Fever' (representing the reactogenicity event), separated by '-' (Ex. PRIME VACCINATION-STUDY SUBJECT-Fever). |
| Algorithm: VS.VSLNKID | Computation | Set to VSLNKGRP. |
| Algorithm: VS.VSRFTDTC | Computation | Start Date/Time of Treatment at the Day 1 Visit (EX.EXSTDTC where EX.VISITNUM = 2) when VSTPTREF="PRIME VACCINATION". Start Date/Time of Treatment at the Day 22 Visit (EX.EXSTDTC where EX.VISITNUM = 6) when VSTPTREF="BOOST VACCINATION". |
| Algorithm: VS.VSSTRESU | Computation | VSSTRESU = VSORRESU |
| Algorithm: VS.VSTPT | Computation | Concatenation of 'DAY ' with the number of days between the Date/Time of Collection and the Date/Time of Reference Time Point [date part of VSDTC - date part of VSRFTDTC + 1]. |
| Algorithm: VS.VSTPTREF.TPT.DAY1 | Computation | 'PRIME VACCINATION' when VISITNUM = 2 (Day 1 Visit). 'BOOST VACCINATION' when VISITNUM = 6 (Day 22 Visit). |
| Algorithm: VS.VSTPTREF.TPT.REACT | Computation | 'PRIME VACCINATION' when Date/Time of Measurements (VSDTC) is prior to the Start Date/Time of Treatment at the Day 22 Visit (EX.EXSTDTC where VISITNUM = 6) or when the subject has not received a boost vaccination (record does not exist in EX with VISITNUM = 6 and non-missing EXSTDTC). 'BOOST VACCINATION' when Date/Time of Measurements is on or after the Start Date/Time of Treatment at the Day 22 Visit. |
| Algorithm: XA.XARFTDTC | Computation | Start Date/Time of Treatment at the Day 1 Visit (EX.EXSTDTC where EX.VISITNUM = 2) when XATPTREF="PRIME VACCINATION". Start Date/Time of Treatment at the Day 22 Visit (EX.EXSTDTC where EX.VISITNUM = 6) when XATPTREF="BOOST VACCINATION". |
| Algorithm: XA.XATPTREF | Computation | 'PRIME VACCINATION' when VISITNUM = 2 (Day 1 Visit). 'BOOST VACCINATION' when VISITNUM = 6 (Day 22 Visit). |
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