Country No.
Item
Country No.
integer
C0454664 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Centre No.
Item
Centre No.
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Clinical Trial Subject Unique Identifier
Item
Subject No.
integer
C2348585 (UMLS CUI [1])
Subject Initials
Item
Subject Initials
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
AE form number
Item
AE form No.
integer
C0877248 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
SAE Description
Item
Detailed Description
text
C1519255 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Treatment number
Item
Treatment number
integer
C1522541 (UMLS CUI [1])
Date/Time first administration of study drug
Item
Date and time of the FIRST administration of Study Drug
datetime
C0304229 (UMLS CUI [1,1])
C3899436 (UMLS CUI [1,2])
Date/Time last administration of study drug before SAE
Item
Date and time of the LAST administration of Study Drug prior to the event
datetime
C0304229 (UMLS CUI [1,1])
C3899434 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])
Study drug ongoing
Item
Study drug ongoing (at the time of report)
boolean
C0304229 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Previous and Concomitant Medication
Item
Previous and Concomitant Medication
boolean
C0205156 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2])
Medical History and Concomitant Disease
Item
Medical History and Concomitant Disease
boolean
C0262926 (UMLS CUI [1])
C0243087 (UMLS CUI [2])
Adverse Event
Item
Adverse Event
text
C0877248 (UMLS CUI [1])
Date of Evaluation
Item
Date of Evaluation
date
C2985720 (UMLS CUI [1])
Additional information and Comments
Item
Additional information and Comments
text
C1546922 (UMLS CUI [1])
C0947611 (UMLS CUI [2])
Investigator name
Item
Investigator name
text
C2826892 (UMLS CUI [1])
Date of report
Item
Date of report
date
C1302584 (UMLS CUI [1])
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Monitor's name
Item
Monitor's name
text
C0027365 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
Monitor date of receipt
Item
Monitor date of receipt
date
C2985846 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
PV date of receipt
Item
PV corporate date of receipt
date
C3178990 (UMLS CUI [1,1])
C2985846 (UMLS CUI [1,2])