Early Withdrawal - ESR; PK Blood Sample; Biomarker Samples; Transcriptomic Research Sample Collection; Liver Events; Investigational Product Discontinuation

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
ESR
C1176468 (UMLS CUI-1)
ESR Date
Item
ESR Date
date
C1176468 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
ESR
integer
C1176468 (UMLS CUI [1])
Code List
ESR
CL Item
Numeric result  (97)
CL Item
No result (99)
ESR numeric result
Item
ESR numeric result
integer
C1176468 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Item Group
PK Blood Sample - Point in Time Collection
C0201734 (UMLS CUI-1)
C0178913 (UMLS CUI-2)
C1516698 (UMLS CUI-3)
Sample taken before infusion?
Item
Sample taken?
boolean
C0201734 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
Sample taken - Actual date and time
Item
Sample taken - Actual date and time
datetime
C0201734 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1264639 (UMLS CUI [2])
Sample taken - Sample Identifier/ Sample Number
Item
Sample taken - Sample Identifier/ Sample Number
text
C0201734 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1299222 (UMLS CUI [2])
PK Type Code
Item
PK Type Code
text
C0031328 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Item Group
Biomarker Samples
C0005516 (UMLS CUI-1)
C0370003 (UMLS CUI-2)
Has sample been collected?
Item
Has sample been collected?
boolean
C0005834 (UMLS CUI [1])
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Item
If sample has not been collected, provide reason
text
C0200345 (UMLS CUI [1,1])
C0005516 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
Code List
If sample has not been collected, provide reason
CL Item
Subject not asked by investigator  (2)
CL Item
Other, specify (OT)
If other reason for sample has not been collected, specify
Item
If other reason for sample has not been collected, specify
text
C0200345 (UMLS CUI [1,1])
C0005516 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Sample Type
Item
Sample Type
text
C2347029 (UMLS CUI [1])
Sample Number
Item
Sample Number
text
C1299222 (UMLS CUI [1])
Item Group
Transcriptomic Research Sample Collection Details
C3178810 (UMLS CUI-1)
C0035168 (UMLS CUI-2)
C0005834 (UMLS CUI-3)
C1522508 (UMLS CUI-4)
Has a blood sample been collected for transcriptomic research?
Item
Has a blood sample been collected for transcriptomic research?
boolean
C3178810 (UMLS CUI [1,1])
C0035168 (UMLS CUI [1,2])
C0005834 (UMLS CUI [2,1])
C1522508 (UMLS CUI [2,2])
Transcriptomic Research - Date and time sample taken
Item
Transcriptomic Research - Date and time sample taken
date
C3178810 (UMLS CUI [1,1])
C0035168 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C0200345 (UMLS CUI [2,3])
PGm-T Type
Item
PGm-T Type
text
C1831759 (UMLS CUI [1])
Transcriptomic Research - Sample Type
Item
Transcriptomic Research - Sample Type
text
C3178810 (UMLS CUI [1,1])
C0035168 (UMLS CUI [1,2])
C2347029 (UMLS CUI [2])
Item Group
Liver Event Assessment
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
Item
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2746065 (UMLS CUI [1,5])
C0243161 (UMLS CUI [1,6])
Item Group
Investigational Product Discontinuation
C0304229 (UMLS CUI-1)
C0457454 (UMLS CUI-2)
Was the subject withdrawn from future infusions of investigational product?
Item
Was the subject withdrawn from future infusions of investigational product?
boolean
C0422727 (UMLS CUI [1])
C0574032 (UMLS CUI [2,1])
C0016884 (UMLS CUI [2,2])
C0304229 (UMLS CUI [3])
Date of early investigational product withdrawal
Item
Date of early investigational product withdrawal
date
C2349954 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Select primary reason the investigational product was stopped
integer
C0392360 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,3])
Code List
Select primary reason the investigational product was stopped
CL Item
Adverse event (1)
CL Item
Lack of efficacy (2)
CL Item
Protocol deviation (3)
CL Item
Subject reached protocol-defined stopping criteria (4)
CL Item
Study closed/terminated (5)
CL Item
Lost to follow-up (6)
CL Item
Investigator discretion, specify (7)
CL Item
Withdrew consent, specify (8)
CL Item
Prohibited medication use  (002)
Specify investigator discretion
Item
Specify investigator discretion
text
C2348235 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
C0022423 (UMLS CUI [1,3])
Specify withdrew consent
Item
Specify withdrew consent
text
C1707492 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])

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