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Adverse Event Form

1 forms  
  1. StudyEvent: ODM
    1. Adverse Event Form
Adverse Event
Description

Adverse Event

Alias
UMLS CUI-1
C0877248
AE nr
Description

AE nr

Data type

float

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0237753
System Organ Class
Description

System Organ Class

Data type

integer

Alias
UMLS CUI [1,1]
C2347091
UMLS CUI [1,2]
C1140263
UMLS CUI [1,3]
C1705313
UMLS CUI [1,4]
C0027365
Adverse Event Term (please use CTCAE Short Name plus Select term if applicable)
Description

Adverse Event Term

Data type

text

Alias
UMLS CUI [1]
C2826934
CTCAE grade
Description

CTCAE grade

Data type

float

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C0441800
SAE
Description

SAE

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Relationship to protocol treatment
Description

Relationship to protocol treatment

Data type

integer

Alias
UMLS CUI [1]
C0041755
Related to
Description

Related to

Data type

integer

Alias
UMLS CUI [1,1]
C0041755
UMLS CUI [1,2]
C0013227
Treatment changed
Description

Treatment changed

Data type

boolean

Alias
UMLS CUI [1]
C1299575
AE date start
Description

AE date start

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0808070
dd/mm/yyyy
AE Outcome
Description

AE Outcome

Data type

integer

Alias
UMLS CUI [1]
C1705586
Date end
Description

AE Date end

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0806020
dd/mm/yyyy
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Similar models

Adverse Event Form

1 forms
  1. StudyEvent: ODM
    1. Adverse Event Form
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C0877248 (UMLS CUI-1)
AE nr
Item
float
C0877248 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item
System Organ Class
integer
C2347091 (UMLS CUI [1,1])
C1140263 (UMLS CUI [1,2])
C1705313 (UMLS CUI [1,3])
C0027365 (UMLS CUI [1,4])
System Organ Class
Code List
System Organ Class
CL Item
Blood and lymphatic system disorders  (1)
CL Item
Cardiac disorders  (2)
CL Item
Congenital, familial and genetic disorders  (3)
CL Item
Ear and labyrinth disorders  (4)
CL Item
Endocrine disorders  (5)
CL Item
Eye disorders  (6)
CL Item
Gastrointestinal disorders  (7)
CL Item
General disorders and administration site conditions  (8)
CL Item
Hepatobiliary disorders  (9)
CL Item
Immune system disorders  (10)
CL Item
Infections and infestations  (11)
CL Item
Injury, poisoning and procedural complications  (12)
CL Item
Investigations  (13)
CL Item
Metabolism and nutrition disorders  (14)
CL Item
Musculoskeletal and connective tissue disorders  (15)
CL Item
Neoplasms benign, malignant and unspecified (incl cysts and polyps)  (16)
CL Item
Nervous system disorders  (17)
CL Item
Pregnancy, puerperium and perinatal conditions  (18)
CL Item
Psychiatric disorders  (19)
CL Item
Renal and urinary disorders  (20)
CL Item
Reproductive system and breast disorders  (21)
CL Item
Respiratory, thoracic and mediastinal disorders  (22)
CL Item
Skin and subcutaneous tissue disorders  (23)
CL Item
Social circumstances  (24)
CL Item
Surgical and medical procedures  (25)
CL Item
Vascular disorders (26)
Adverse Event Term
Item
Adverse Event Term (please use CTCAE Short Name plus Select term if applicable)
text
C2826934 (UMLS CUI [1])
CTCAE grade
Item
CTCAE grade
float
C1516728 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
SAE
Item
boolean
C1519255 (UMLS CUI [1])
Item
integer
C0041755 (UMLS CUI [1])
Relationship to protocol treatment
Code List
Relationship to protocol treatment
CL Item
unrelated  (0)
CL Item
unlikely  (1)
CL Item
possibly  (2)
CL Item
probably  (3)
CL Item
definitely  (4)
CL Item
unknown (5)
Item
Related to
integer
C0041755 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Related to
Code List
Related to
CL Item
Lenalidomide  (1)
C1144149 (UMLS CUI-1)
CL Item
other trial medication/SCT  (2)
CL Item
Lenalidomide + other trial medication/SCT  (3)
CL Item
unknown (9)
C0439673 (UMLS CUI-1)
Treatment changed
Item
Treatment changed
boolean
C1299575 (UMLS CUI [1])
AE date start
Item
AE date start
date
C0877248 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
AE Outcome
integer
C1705586 (UMLS CUI [1])
AE Outcome
Code List
AE Outcome
CL Item
resolved completely  (1)
M (UMLS CUI-1)
CL Item
resolved to baseline  (2)
M (UMLS CUI-1)
CL Item
resolved with sequelae  (3)
M (UMLS CUI-1)
CL Item
ongoing (pending)  (4)
M (UMLS CUI-1)
CL Item
ongoing with higher CTCAE grade  (5)
M (UMLS CUI-1)
CL Item
ongoing (closed)  (6)
M (UMLS CUI-1)
CL Item
death (7)
M (UMLS CUI-1)
AE Date end
Item
Date end
date
C0877248 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
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