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)
C1148433 (UMLS CUI-1)
C25717 (NCIt V19.10d)
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)
C1148433 (UMLS CUI-1)
C25717 (NCIt V19.10d)
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
ALIVE (ALIVE)
C0376558 (UMLS CUI-1)
C37987 (NCIt V19.10d)
CL Item
Died (DEAD)
C0011065 (UMLS CUI-1)
C28554 (NCIt V19.10d)
CL Item
U; UNK; Unknown (UNKNOWN)
C0439673 (UMLS CUI-1)
C17998 (NCIt V19.10d)
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)
C2700368 (UMLS CUI-1)
C78726 (NCIt V19.10d)
CL Item
ADJUDICATOR (ADJUDICATOR)
C0401783 (UMLS CUI-1)
C96561 (NCIt V19.10d)
CL Item
Caregiver (CAREGIVER)
C0085537 (UMLS CUI-1)
C17445 (NCIt V19.10d)
CL Item
CHILD (CHILD)
C0680063 (UMLS CUI-1)
C42708 (NCIt V19.10d)
CL Item
Research Associate (CLINICAL RESEARCH ASSOCIATE)
C1516627 (UMLS CUI-1)
C25465 (NCIt V19.10d)
CL Item
CRC (CLINICAL RESEARCH COORDINATOR)
C1710220 (UMLS CUI-1)
C51811 (NCIt V19.10d)
CL Item
Clinical Study Sponsor; Sponsor; Study Sponsor (CLINICAL STUDY SPONSOR)
C2347796 (UMLS CUI-1)
C70793 (NCIt V19.10d)
CL Item
Domestic Partner (DOMESTIC PARTNER)
C1549111 (UMLS CUI-1)
C53262 (NCIt V19.10d)
CL Item
Family Member (FAMILY MEMBER)
C0086282 (UMLS CUI-1)
C41256 (NCIt V19.10d)
CL Item
FRIEND (FRIEND)
C0079382 (UMLS CUI-1)
C72884 (NCIt V19.10d)
CL Item
GUARDIAN (GUARDIAN)
C0023226 (UMLS CUI-1)
C51828 (NCIt V19.10d)
CL Item
HEALTH CARE PROFESSIONAL (HEALTH CARE PROFESSIONAL)
C1704312 (UMLS CUI-1)
C53287 (NCIt V19.10d)
CL Item
INDEPENDENT ASSESSOR (INDEPENDENT ASSESSOR)
C2697672 (UMLS CUI-1)
C78720 (NCIt V19.10d)
CL Item
INTERVIEWER (INTERVIEWER)
C0021821 (UMLS CUI-1)
C63759 (NCIt V19.10d)
CL Item
INVESTIGATOR (INVESTIGATOR)
C0035173 (UMLS CUI-1)
C25936 (NCIt V19.10d)
CL Item
PARENT (PARENT)
C0030551 (UMLS CUI-1)
C42709 (NCIt V19.10d)
CL Item
PROXY (PROXY)
C3897813 (UMLS CUI-1)
C119264 (NCIt V19.10d)
CL Item
SIBLING (SIBLING)
C0037047 (UMLS CUI-1)
C25204 (NCIt V19.10d)
CL Item
SIGNIFICANT OTHER (SIGNIFICANT OTHER)
C0682323 (UMLS CUI-1)
C119265 (NCIt V19.10d)
CL Item
Spouse (SPOUSE)
C0162409 (UMLS CUI-1)
C62649 (NCIt V19.10d)
CL Item
STUDY SUBJECT (STUDY SUBJECT)
C0681850 (UMLS CUI-1)
C41189 (NCIt V19.10d)
CL Item
VENDOR (VENDOR)
C0042462 (UMLS CUI-1)
C68608 (NCIt V19.10d)
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)
C1552824 (UMLS CUI-1)
C125938 (NCIt V19.10d)
CL Item
BLINDED TREATMENT (BLINDED TREATMENT)
C3640651 (UMLS CUI-1)
C102255 (NCIt V19.10d)
CL Item
Continuation Phase (CONTINUATION TREATMENT)
C4055184 (UMLS CUI-1)
C123452 (NCIt V19.10d)
CL Item
FOLLOW-UP (FOLLOW-UP)
C3274571 (UMLS CUI-1)
C99158 (NCIt V19.10d)
CL Item
Induction Phase; Intensive Phase (INDUCTION TREATMENT)
C4049995 (UMLS CUI-1)
C123453 (NCIt V19.10d)
CL Item
LONG-TERM FOLLOW-UP (LONG-TERM FOLLOW-UP)
C1517942 (UMLS CUI-1)
C16032 (NCIt V19.10d)
CL Item
OPEN LABEL TREATMENT (OPEN LABEL TREATMENT)
C3640652 (UMLS CUI-1)
C102256 (NCIt V19.10d)
CL Item
RUN-IN (RUN-IN)
C3274438 (UMLS CUI-1)
C98779 (NCIt V19.10d)
CL Item
SCREENING (SCREENING)
C1710477 (UMLS CUI-1)
C48262 (NCIt V19.10d)
CL Item
TREATMENT (TREATMENT)
C3538994 (UMLS CUI-1)
C101526 (NCIt V19.10d)
CL Item
WASHOUT (WASHOUT)
C1710661 (UMLS CUI-1)
C42872 (NCIt V19.10d)
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)