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
C1705236 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
DVSEQ (SDTMIG 3.3)
C87994 (NCIt V19.10d)
REFID
Item
Reference ID
text
C1705236 (UMLS CUI [1,1])
C2826265 (UMLS CUI [1,2])
DVREFID (SDTMIG 3.3)
C87993 (NCIt V19.10d)
SPID
Item
Sponsor-Defined Identifier
text
C1705236 (UMLS CUI [1,1])
C2347796 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
DVSPID (SDTMIG 3.3)
C83077 (NCIt V19.10d)
TERM
Item
Protocol Deviation Term
text
C1705236 (UMLS CUI [1])
DVTERM (SDTMIG 3.3)
C50996 (NCIt V19.10d)
DECOD
Item
Protocol Deviation Coded Term
text
C1705236 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])
DVDECOD (SDTMIG 3.3)
C83123 (NCIt V19.10d)
CAT
Item
Category for Protocol Deviation
text
C1705236 (UMLS CUI [1,1])
C0683312 (UMLS CUI [1,2])
DVCAT (SDTMIG 3.3)
C87990 (NCIt V19.10d)
SCAT
Item
Subcategory for Protocol Deviation
text
C1705236 (UMLS CUI [1,1])
C1515010 (UMLS CUI [1,2])
DVSCAT (SDTMIG 3.3)
C87996 (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)
STDTC
Item
Start Date/Time of Deviation
datetime
C0808070 (UMLS CUI [1,1])
C1705236 (UMLS CUI [1,2])
C1301880 (UMLS CUI [2,1])
C1705236 (UMLS CUI [2,2])
DVSTDTC (SDTMIG 3.3)
C87995 (NCIt V19.10d)
ENDTC
Item
End Date/Time of Deviation
datetime
C0806020 (UMLS CUI [1,1])
C1705236 (UMLS CUI [1,2])
C1522314 (UMLS CUI [2,1])
C1705236 (UMLS CUI [2,2])
DVENDTC (SDTMIG 3.3)
C1522314 (NCIt V19.10d)
STDY
Item
Study Day of Start of Deviation Event
text
C2826182 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C1705236 (UMLS CUI [1,3])
DVSTDY (SDTMIG 3.3)
C82570 (NCIt V19.10d)
C49585 (NCIt V19.10d-2)
ENDY
Item
Study Day of End of Observation
text
C2826182 (UMLS CUI [1,1])
C0444930 (UMLS CUI [1,2])
C1705236 (UMLS CUI [1,3])
DVENDY (SDTMIG 3.3)
C82569 (NCIt V19.10d)
C49585 (NCIt V19.10d-2)