Sheet 1: AE

	
	
	
	
	
	
	
	

		
Library Member Name
		
Variable Name
		
Variable Type
		
Variable Length
		
Variable Label
		
Variable Format
		
Observations in Data Set
	
	

		
AE
		
AEACN
		
2
		
16
		
Action Taken with Study Treatment
		


		
19885
	
	

		
AE
		
AEBODSYS
		
2
		
200
		
Body System or Organ Class
		


		
19885
	
	

		
AE
		
AECONTRT
		
2
		
2
		
Concomitant or Additional Trtmnt Given
		


		
19885
	
	

		
AE
		
AEDECOD
		
2
		
200
		
Dictionary-Derived Term
		


		
19885
	
	

		
AE
		
AEENDY
		
1
		
8
		
Study Day of End of Adverse Event
		


		
19885
	
	

		
AE
		
AEENRF
		
2
		
15
		
End Relative to Reference Period
		


		
19885
	
	

		
AE
		
AEENRTPT
		
2
		
10
		
End Relative to Reference Time Point
		


		
19885
	
	

		
AE
		
AEOUT
		
2
		
30
		
Outcome of Adverse Event
		


		
19885
	
	

		
AE
		
AEREL
		
2
		
2
		
Causality
		


		
19885
	
	

		
AE
		
AERELNST
		
2
		
2
		
Relationship to Non-Study Treatment
		


		
19885
	
	

		
AE
		
AESCONG
		
2
		
2
		
Congenital Anomaly or Birth Defect
		


		
19885
	
	

		
AE
		
AESDISAB
		
2
		
2
		
Persist or Signif Disability/Incapacity
		


		
19885
	
	

		
AE
		
AESDTH
		
2
		
2
		
Results in Death
		


		
19885
	
	

		
AE
		
AESEQ
		
1
		
8
		
Sequence Number
		


		
19885
	
	

		
AE
		
AESER
		
2
		
2
		
Serious Event
		


		
19885
	
	

		
AE
		
AESHOSP
		
2
		
2
		
Requires or Prolongs Hospitalization
		


		
19885
	
	

		
AE
		
AESLIFE
		
2
		
2
		
Is Life Threatening
		


		
19885
	
	

		
AE
		
AESMIE
		
2
		
2
		
Other Medically Important Serious Event
		


		
19885
	
	

		
AE
		
AESPID
		
2
		
60
		
Sponsor-Defined Identifier
		


		
19885
	
	

		
AE
		
AESTDY
		
1
		
8
		
Study Day of Start of Adverse Event
		


		
19885
	
	

		
AE
		
AESTRF
		
2
		
15
		
Start Relative to Reference Period
		


		
19885
	
	

		
AE
		
AETOXGR
		
2
		
16
		
Standard Toxicity Grade
		


		
19885
	
	

		
AE
		
DOMAIN
		
2
		
2
		
Domain Abbreviation
		


		
19885
	
	

		
AE
		
STUDYID
		
2
		
20
		
Study Identifier
		


		
19885
	
	

		
AE
		
USUBJID
		
2
		
60
		
Unique Subject Identifier
		


		
19885
	



Sheet 2: CE

	
	
	
	
	
	
	

		
Library Member Name
		
Variable Name
		
Variable Type
		
Variable Length
		
Variable Label
		
Variable Format
		
Observations in Data Set
	
	

		
CE
		
CECAT
		
2
		
30
		
Category for Clinical Event
		


		
1230
	
	

		
CE
		
CEOCCUR
		
2
		
1
		
Clinical Event Occurrence
		


		
1230
	
	

		
CE
		
CEPRESP
		
2
		
1
		
Clinical Event Pre-Specified
		


		
1230
	
	

		
CE
		
CESEQ
		
1
		
8
		
Sequence Number
		


		
1230
	
	

		
CE
		
CESTDY
		


		


		
Study Day of Start of Clinical Event
		


		


	
	

		
CE
		
CETERM
		
2
		
30
		
Reported Term for the Clinical Event
		


		
1230
	
	

		
CE
		
DOMAIN
		
2
		
2
		
Domain Abbreviation
		


		
1230
	
	

		
CE
		
STUDYID
		
2
		
20
		
Study Identifier
		


		
1230
	
	

		
CE
		
USUBJID
		
2
		
60
		
Unique Subject Identifier
		


		
1230
	



Sheet 3: CM

	
	
	
	
	
	
	

		
Library Member Name
		
Variable Name
		
Variable Type
		
Variable Length
		
Variable Label
		
Variable Format
		
Observations in Data Set
	
	

		
CM
		
CMCAT
		
2
		
80
		
Category for Medication
		


		
35113
	
	

		
CM
		
CMDECOD
		
2
		
200
		
Standardized Medication Name
		


		
35113
	
	

		
CM
		
CMDOSE
		
1
		
8
		
Dose per Administration
		


		
35113
	
	

		
CM
		
CMDOSFRQ
		
2
		
30
		
Dosing Frequency per Interval
		


		
35113
	
	

		
CM
		
CMDOSTXT
		
2
		
10
		
Dose Description
		


		
35113
	
	

		
CM
		
CMDOSU
		
2
		
20
		
Dose Units
		


		
35113
	
	

		
CM
		
CMENDY
		
1
		
8
		
Study Day of End of Medication
		


		
35113
	
	

		
CM
		
CMENRTPT
		
2
		
10
		
End Relative to Reference Time Point
		


		
35113
	
	

		
CM
		
CMOCCUR
		
2
		
1
		
CM Occurrence
		


		
35113
	
	

		
CM
		
CMPRESP
		
2
		
1
		
CM Pre-Specified
		


		
35113
	
	

		
CM
		
CMROUTE
		
2
		
30
		
Route of Administration
		


		
35113
	
	

		
CM
		
CMSEQ
		
1
		
8
		
Sequence Number
		


		
35113
	
	

		
CM
		
CMSPID
		
2
		
50
		
Sponsor-Defined Identifier
		


		
35113
	
	

		
CM
		
CMSTDY
		
1
		
8
		
Study Day of Start of Medication
		


		
35113
	
	

		
CM
		
CMSTRTPT
		
2
		
10
		
Start Relative to Reference Time Point
		


		
35113
	
	

		
CM
		
DOMAIN
		
2
		
2
		
Domain Abbreviation
		


		
35113
	
	

		
CM
		
STUDYID
		
2
		
20
		
Study Identifier
		


		
35113
	
	

		
CM
		
USUBJID
		
2
		
60
		
Unique Subject Identifier
		


		
35113