Informatie:
Fout:
ID
26206
Beschrijving
A sample trial to demonstrate the end-to-end application of the CDISC Standards and transformations from ADL
Trefwoorden
Versies (1)
- 11-10-17 11-10-17 - Philipp Bruland
Houder van rechten
Unknown
Geüploaded op
11 oktober 2017
DOI
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Licentie
Creative Commons BY-NC-ND 3.0
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Sample Study
Adverse Events
- StudyEvent: Baseline
- StudyEvent: Week 1 Visit
- StudyEvent: Week 2 Visit
- StudyEvent: Patient Diary Event
- StudyEvent: Adverse Event
Similar models
Adverse Events
- StudyEvent: Baseline
- StudyEvent: Week 1 Visit
- StudyEvent: Week 2 Visit
- StudyEvent: Patient Diary Event
- StudyEvent: Adverse Event
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Site Number
Item
Site number
integer
SITEID (SDTM)
Subject ID
Item
Subject ID
text
USUBJID (SDTM)
Visit Date
Item
Visit Date
date
Visit Time
Item
Visit Start Time
time
CL Item
No (0)
CL Item
Yes (1)
Adverse Event Number
Item
Event No.
integer
Adverse Event Term
Item
Adverse event
text
Adverse Event Start Date
Item
Start Date
date
CL Item
No (0)
CL Item
Yes (1)
Adverse Event Stop Date
Item
Stop Date
date
AE duration
Item
Duration of the adverse event
durationDatetime
CL Item
No (0)
CL Item
Yes (1)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Is there a reasonable possibility that the AE may have been caused by the study drug
integer
Code List
Is there a reasonable possibility that the AE may have been caused by the study drug
CL Item
No (0)
CL Item
Yes (1)
CL Item
None (1)
CL Item
Study drug regimen changed (2)
CL Item
Temporarily stopped study drug (3)
CL Item
Study drug discontinued (4)
CL Item
Subject remains in study (1)
CL Item
Withdrawn from study (2)
CL Item
Lost to follow-up (3)
CL Item
Death (4)