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Adverse Event Multiple Sclerosis ALAIN01 NCT02419378

1 forms  
Adverse Event
Description

Adverse Event

Alias
UMLS CUI-1
C0877248
AE: Sheet number
Description

AE: Sheet number

Data type

integer

AE: Signature date
Description

AE: Signature date

Data type

date

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C0011008
AERQG
Description

AERQG

AE: Number
Description

AE: Number

Data type

integer

Alias
UMLS CUI [1]
C2826275
AE: Term
Description

AE: Term

Data type

text

Alias
UMLS CUI [1]
C0877248
AE: Start date
Description

AE: Start date

Data type

date

Alias
UMLS CUI [1]
C2697888
AE: Serious event
Description

AE: Serious event

Data type

text

Alias
UMLS CUI [1]
C1519255
AE: Toxicity (CTCAE) Grade
Description

AE: Toxicity (CTCAE) Grade

Data type

text

Alias
UMLS CUI [1]
C2985911
AE: Relationship to study treatment
Description

Adverse Event Attribution to Product or Procedure

Data type

text

Alias
UMLS CUI [1]
C1510821
AE: Action taken with study treatment
Description

AE: Action taken with study treatment

Data type

text

Alias
UMLS CUI [1]
C2981656
AE: End date
Description

AE: End date

Data type

date

Alias
UMLS CUI [1]
C2697886
AE: Ongoing
Description

AE: Ongoing

Data type

text

Alias
UMLS CUI [1]
C2826663
AE: Outcome
Description

AE: Outcome

Data type

text

Alias
UMLS CUI [1]
C1705586
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Similar models

Adverse Event Multiple Sclerosis ALAIN01 NCT02419378

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Adverse Event
C0877248 (UMLS CUI-1)
AE: Sheet number
Item
integer
AE: Signature date
Item
AE: Signature date
date
C1519316 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Adverse Event Number
Item
AE: Number
integer
C2826275 (UMLS CUI [1])
Adverse Event
Item
AE: Term
text
C0877248 (UMLS CUI [1])
Adverse event start date
Item
AE: Start date
date
C2697888 (UMLS CUI [1])
Item
AE: Serious event
text
C1519255 (UMLS CUI [1])
AE: Serious event
Code List
AE: Serious event
CL Item
No - AE of Special Interest (AESI) (1)
CL Item
No (0)
CL Item
Yes (2)
Item
AE: Toxicity (CTCAE) Grade
text
C2985911 (UMLS CUI [1])
AE: Toxicity (CTCAE) Grade
Code List
AE: Toxicity (CTCAE) Grade
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
0 (0)
Item
AE: Relationship to study treatment
text
C1510821 (UMLS CUI [1])
AE: Relationship to study treatment
Code List
AE: Relationship to study treatment
CL Item
No reasonable possibility (0)
CL Item
Reasonable possibility (1)
Item
AE: Action taken with study treatment
text
C2981656 (UMLS CUI [1])
AE: Action taken with study treatment
Code List
AE: Action taken with study treatment
CL Item
Dose not changed (0)
CL Item
Dose reduced (1)
CL Item
Dose increased (2)
CL Item
Drug withdrawn (3)
CL Item
Unknown (4)
CL Item
Not applicable (5)
Adverse event end date
Item
AE: End date
date
C2697886 (UMLS CUI [1])
Item
AE: Ongoing
text
C2826663 (UMLS CUI [1])
AE: Ongoing
Code List
AE: Ongoing
CL Item
yes (1)
Item
AE: Outcome
text
C1705586 (UMLS CUI [1])
AE: Outcome
Code List
AE: Outcome
CL Item
Recovered/Resolved (0)
CL Item
Recovering/Resolving (1)
CL Item
Not recovered/Not resolved (2)
CL Item
Recovered/Resolved with sequelae (3)
CL Item
Fatal (4)
CL Item
Unknown (5)
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