STUDYID
Item
Study Identifier
text
C2826693 (UMLS CUI [1])
STUDYID (SDTMIG 3.3)
C83082 (NCIt V19.10d)
DOMAIN
Item
Domain Abbreviation
text
C1883204 (UMLS CUI [1,1])
C0000723 (UMLS CUI [1,2])
DOMAIN (SDTMIG 3.3)
C49556 (NCIt V19.10d)
USUBJID
Item
Unique Subject Identifier
text
C1710548 (UMLS CUI [1,1])
C2826693 (UMLS CUI [1,2])
USUBJID (SDTMIG 3.3)
C70731 (NCIt V19.10d)
SEQ
Item
Sequence Number
integer
C0681850 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
SSSEQ (SDTMIG 3.3)
C117656 (NCIt V19.10d)
GRPID
Item
Group ID
text
C0681850 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0441833 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,4])
SSGRPID (SDTMIG 3.3)
C117657 (NCIt V19.10d)
SPID
Item
Sponsor-Defined Identifier
text
C0681850 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C2347796 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,4])
SSSPID (SDTMIG 3.3)
C117658 (NCIt V19.10d)
Item
Status Short Name
text
C0681850 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C1806781 (UMLS CUI [1,3])
C0027365 (UMLS CUI [1,4])
SSTESTCD (SDTMIG 3.3)
C117659 (NCIt V19.10d)
Code List
Status Short Name
CL Item
Survival Status (SURVSTAT)
Item
Status Name
text
C0681850 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C2826273 (UMLS CUI [1,3])
SSTEST (SDTMIG 3.3)
C117660 (NCIt V19.10d)
CL Item
Survival Status (Survival Status)
CAT
Item
Category for Assessment
text
C0681850 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0683312 (UMLS CUI [1,3])
C1516048 (UMLS CUI [1,4])
SSCAT (SDTMIG 3.3)
C117661 (NCIt V19.10d)
SCAT
Item
Subcategory for Assessment
text
C0681850 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C1515010 (UMLS CUI [1,4])
SSSCAT (SDTMIG 3.3)
C117662 (NCIt V19.10d)
ORRES
Item
Result or Finding Original Result
text
C0681850 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0205313 (UMLS CUI [1,4])
SSORRES (SDTMIG 3.3)
C117221 (NCIt V19.10d)
Item
Character Result/Finding in Std Format
text
C0681850 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
C1442989 (UMLS CUI [1,5])
C1301627 (UMLS CUI [1,6])
SSSTRESC (SDTMIG 3.3)
C117664 (NCIt V19.10d)
Code List
Character Result/Finding in Std Format
CL Item
U; UNK; Unknown (UNKNOWN)
STAT
Item
Completion Status
text
C0681850 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C0805732 (UMLS CUI [1,4])
SSSTAT (SDTMIG 3.3)
C117665 (NCIt V19.10d)
REASND
Item
Reason Assessment Not Performed
text
C0681850 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C2826287 (UMLS CUI [1,4])
SSREASND (SDTMIG 3.3)
C117666 (NCIt V19.10d)
Item
Evaluator
text
C0681850 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C1707957 (UMLS CUI [1,3])
SSEVAL (SDTMIG 3.3)
C117667 (NCIt V19.10d)
CL Item
ADJUDICATION COMMITTEE (ADJUDICATION COMMITTEE )
CL Item
ADJUDICATOR (ADJUDICATOR )
CL Item
Caregiver (CAREGIVER)
CL Item
Research Associate (CLINICAL RESEARCH ASSOCIATE)
CL Item
CRC (CLINICAL RESEARCH COORDINATOR)
CL Item
Clinical Study Sponsor; Sponsor; Study Sponsor (CLINICAL STUDY SPONSOR)
CL Item
Domestic Partner (DOMESTIC PARTNER)
CL Item
Family Member (FAMILY MEMBER)
CL Item
GUARDIAN (GUARDIAN )
CL Item
HEALTH CARE PROFESSIONAL (HEALTH CARE PROFESSIONAL )
CL Item
INDEPENDENT ASSESSOR (INDEPENDENT ASSESSOR )
CL Item
INTERVIEWER (INTERVIEWER )
CL Item
INVESTIGATOR (INVESTIGATOR )
CL Item
SIBLING (SIBLING )
CL Item
SIGNIFICANT OTHER (SIGNIFICANT OTHER )
CL Item
STUDY SUBJECT (STUDY SUBJECT )
VISITNUM
Item
Visit Number
integer
C1549755 (UMLS CUI [1])
VISITNUM (SDTMIG 3.3)
C83101 (NCIt V19.10d)
VISIT
Item
Visit Name
text
C2826704 (UMLS CUI [1])
VISIT (SDTMIG 3.3)
C83093 (NCIt V19.10d)
VISITDY
Item
Planned Study Day of Visit
integer
C1301732 (UMLS CUI [1,1])
C2826182 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
VISITDY (SDTMIG 3.3)
C83450 (NCIt V19.10d)
TAETORD
Item
Planned Order of Element within Arm
integer
C1301732 (UMLS CUI [1,1])
C1705175 (UMLS CUI [1,2])
C3812827 (UMLS CUI [1,3])
C1522541 (UMLS CUI [1,4])
TAETORD (SDTMIG 3.3)
C83438 (NCIt V19.10d)
Item
Epoch
text
C2347803 (UMLS CUI [1])
EPOCH (SDTMIG 3.3)
C71738 (NCIt V19.10d)
CL Item
BASELINE (BASELINE )
CL Item
BLINDED TREATMENT (BLINDED TREATMENT )
CL Item
Continuation Phase (CONTINUATION TREATMENT)
CL Item
FOLLOW-UP (FOLLOW-UP )
CL Item
Induction Phase; Intensive Phase (INDUCTION TREATMENT)
CL Item
LONG-TERM FOLLOW-UP (LONG-TERM FOLLOW-UP )
CL Item
OPEN LABEL TREATMENT (OPEN LABEL TREATMENT )
CL Item
SCREENING (SCREENING )
CL Item
TREATMENT (TREATMENT )
CL Item
WASHOUT (WASHOUT )
DTC
Item
Date/Time of Assessment
datetime
C1264639 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
C0449438 (UMLS CUI [1,4])
SSDTC (SDTMIG 3.3)
C117668 (NCIt V19.10d)
DY
Item
Study Day of Assessment
integer
C0681850 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C2826182 (UMLS CUI [1,3])
C0392366 (UMLS CUI [1,4])
SSDY (SDTMIG 3.3)
C117669 (NCIt V19.10d)