Patientennummer (derived)
Item
Patient number (derived)
text
C2348585 (UMLS CUI [1])
AE: Sheet number
Item
AE: Sheet number
integer
C0877248 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
AE: Signature date
Item
AE: Signature date
date
C0807937 (UMLS CUI [1])
Item
AE: Signature date Status
text
C2346576 (UMLS CUI [1,1])
C2985875 (UMLS CUI [1,2])
Code List
AE: Signature date Status
Item
AE: Signature Investigator
text
C2346576 (UMLS CUI [1])
Code List
AE: Signature Investigator
Kommentar Adverse Event
Item
Comment adverse event
text
C0947611 (UMLS CUI [1])
Adverse Event Number
Item
AE: Nummer
integer
C0877248 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Adverse Event Term
Item
AE: Term
text
C2826934 (UMLS CUI [1])
Adverse Event Start Date
Item
AE: Start Datum
date
C2697888 (UMLS CUI [1])
Item
AE: Start date Status
text
C2697888 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Code List
AE: Start date Status
SAE
Item
Serious adverse event
boolean
C1519255 (UMLS CUI [1])
Item
AE: Toxizität (CTCAE) Grad
text
C2985911 (UMLS CUI [1])
Code List
AE: Toxizität (CTCAE) Grad
Item
AE: Relationship to study treatment XXX
text
C3828190 (UMLS CUI [1])
Code List
AE: Relationship to study treatment XXX
Item
AE: Action taken with study treatment XXX
text
C1299575 (UMLS CUI [1])
Code List
AE: Action taken with study treatment XXX
Item
AE: AE that caused study discontinuation
text
C0877248 (UMLS CUI [1,1])
C1518546 (UMLS CUI [1,2])
Code List
AE: AE that caused study discontinuation
AE End date
Item
AE: Endedatum
date
C2697886 (UMLS CUI [1])
Item
AE: End date Status
text
C2697886 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Code List
AE: End date Status
Item
AE: Ongoing
text
C2826663 (UMLS CUI [1])
Item
AE: Outcome XXX
text
C1705586 (UMLS CUI [1])
Code List
AE: Outcome XXX
Item
AE: Toxicity (CTCAE) Grade
text
C1516728 (UMLS CUI [1])
Code List
AE: Toxicity (CTCAE) Grade
CL Item
mild (1)
C2945599 (UMLS CUI-1)
CL Item
moderate (2)
C0205081 (UMLS CUI-1)
CL Item
severe (3)
C0205082 (UMLS CUI-1)
CL Item
life threatening (4)
C1517874 (UMLS CUI-1)
CL Item
death (5)
C0011065 (UMLS CUI-1)
CL Item
none (0)
C0549184 (UMLS CUI-1)
Item
AE: Relationship to study treatment
text
C3828190 (UMLS CUI [1])
Code List
AE: Relationship to study treatment
CL Item
no rational possibility of a relation (0)
CL Item
rational possibility of a relation (1)
Item
AE: Action taken with study treatment
text
C1299575 (UMLS CUI [1])
Code List
AE: Action taken with study treatment
CL Item
change of dose (1)
CL Item
Medication discharged temporarily (2)
CL Item
Medication discharged (3)
Item
AE: Outcome
text
C1705586 (UMLS CUI [1])
CL Item
not yet improved (2)
CL Item
Recovery with permanent disability (3)
CL Item
death (4)
C0011065 (UMLS CUI-1)
CL Item
unknown (5)
C0439673 (UMLS CUI-1)