Date
Item
Date to submitted to BMS:
date
C0011008 (UMLS CUI [1])
Institution
Item
Name of institution:
text
C1301943 (UMLS CUI [1])
Address
Item
Address:
text
C1442065 (UMLS CUI [1])
Country
Item
Country:
text
C0454664 (UMLS CUI [1])
birth date
Item
Date of birth:
date
C0421451 (UMLS CUI [1])
Item
Gender at birth:
text
C0079399 (UMLS CUI [1])
Code List
Gender at birth:
Item
Race:
text
C0034510 (UMLS CUI [1])
CL Item
American indian or Alaska native (4)
CL Item
Native Hawaiian or other pacific islander (5)
Specification
Item
If "Other", please specify:
text
C2348235 (UMLS CUI [1])
Ctc code
Item
Ctc code:
text
C0805701 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Item
Event:
text
C0441471 (UMLS CUI [1])
CL Item
Life threatening (2)
CL Item
Congenital anomaly (4)
CL Item
Hospitalization/ Prolongation (5)
CL Item
Persistent/ Significant disability (6)
CL Item
Important medical event (7)
CL Item
Drug dependency/ Abuse (8)
specification
Item
If "Other", please specify:
text
C2348235 (UMLS CUI [1])
date and time
Item
Onset date and time:
datetime
C0011008 (UMLS CUI [1])
date and time
Item
Resolution date and time:
datetime
C0011008 (UMLS CUI [1])
CTC grade
Item
CTC grade:
text
C2985911 (UMLS CUI [1])
Item
Relationship to study drug:
text
C0013227 (UMLS CUI [1])
Code List
Relationship to study drug:
Item
Action taken regarding study drug
text
C0013227 (UMLS CUI [1])
Code List
Action taken regarding study drug
Item
Outcome:
text
C1705586 (UMLS CUI [1])
CL Item
Did not resolve (1)
CL Item
Resolved W/ Sequela (3)
Treatment required
Item
Treatment required?
boolean
C1512698 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
death date
Item
Date of death:
date
C0011008 (UMLS CUI [1,1])
C0011065 (UMLS CUI [1,2])
Death cause
Item
Cause of death:
text
C0007465 (UMLS CUI [1])
SERIOUS ADVERSE EVENT
Item
Description of serious adverse event/ relevant medical history; If unrelated to study drug, specify cause:
text
C1519255 (UMLS CUI [1])
Drug
Item
Study drug:
text
C0013227 (UMLS CUI [1])
Item
Phase:
text
C0205390 (UMLS CUI [1])
Drug
Item
Suspect drug:
boolean
C0013227 (UMLS CUI [1])
start date
Item
Therapy start date:
date
C0808070 (UMLS CUI [1])
stop date
Item
Therapy stop date:
date
C0011008 (UMLS CUI [1,1])
C1947925 (UMLS CUI [1,2])
dose
Item
Total dose daily:
float
C3174092 (UMLS CUI [1])
course
Item
No of course:
integer
C0750729 (UMLS CUI [1])
Route
Item
Route:
text
C0013153 (UMLS CUI [1])
Concomitant medication
Item
Concomitant medication (exclude any medication used to treat the SAE):
text
C2347852 (UMLS CUI [1])
start date
Item
Concomitant medication therapy start date:
date
C0808070 (UMLS CUI [1])
stop date
Item
Concomitant medication therapy stop date:
date
C0011008 (UMLS CUI [1])
Laboratory test
Item
Laboratory test (Relevant to SAE only):
text
C0022885 (UMLS CUI [1])
date
Item
Date of test:
date
C0011008 (UMLS CUI [1])
Result
Item
Results:
text
C2826772 (UMLS CUI [1])
Baseline
Item
Baseline:
text
C1442488 (UMLS CUI [1])