Adverse events GOAL Trial B-cell Lymphoma NCT02499003

Admininstrative data
Description

Admininstrative data

Subject ID
Description

Subject ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Page
Description

Page

Data type

integer

Adverse events
Description

Adverse events

No.
Description

adverse event number

Data type

integer

AE Term (based on CTCAE 4.0)
Description

Adverse event

Data type

text

SAE?
Description

Serious adverse event

Data type

text

Study termination
Description

Study termination

Data type

text

Start date
Description

Start date

Data type

date

Stop date
Description

Stop date

Data type

date

Ongoing at End of Treatment?
Description

Ongoing adverse event at End of Treatment

Data type

boolean

Max. CTCAE grade
Description

Maximum CTCAE grade

Data type

integer

Causality with Obinutuzumab
Description

Causality with Obinutuzumab

Data type

integer

Causality with Pixantrone
Description

Causality with Pixantrone

Data type

integer

Action taken with Obinutuzumab
Description

Action taken with Obinutuzumab

Data type

integer

Action taken with Pixantrone
Description

Action taken with Pixantrone

Data type

integer

Treatment given?
Description

Treatment

Data type

text

Outcome
Description

Treatment Outcome

Data type

integer

I have reviewed the AEs on this page and have assessed them for seriousness, causality, severity and outcome and confirm that, to the best of my knowledge, they accurately reflect the study information obtained for this patient.
Description

I have reviewed the AEs on this page and have assessed them for seriousness, causality, severity and outcome and confirm that, to the best of my knowledge, they accurately reflect the study information obtained for this patient.

Data correct?
Description

Data correct

Data type

boolean

Date of signature
Description

Date of signature

Data type

date

Name of investigator
Description

Name of investigator

Data type

text

Similar models

Adverse events GOAL Trial B-cell Lymphoma NCT02499003

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Admininstrative data
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Page
Item
Page
integer
Item Group
Adverse events
Item
No.
integer
CL Item
01 (1)
CL Item
02 (2)
CL Item
03 (3)
CL Item
04 (4)
CL Item
05 (5)
CL Item
06 (6)
CL Item
07 (7)
CL Item
08 (8)
CL Item
09 (9)
CL Item
10 (10)
Adverse event
Item
AE Term (based on CTCAE 4.0)
text
CL Item
Yes (Y)
CL Item
No (N)
Item
Study termination
text
Code List
Study termination
CL Item
Yes (Y)
CL Item
No (N)
Start date
Item
Start date
date
Stop date
Item
Stop date
date
Ongoing adverse event at End of Treatment
Item
Ongoing at End of Treatment?
boolean
Maximum CTCAE grade
Item
Max. CTCAE grade
integer
Item
Causality with Obinutuzumab
integer
Code List
Causality with Obinutuzumab
CL Item
Not related (1)
CL Item
Related (2)
Item
Causality with Pixantrone
integer
Code List
Causality with Pixantrone
CL Item
Not related (1)
CL Item
Related (2)
Item
Action taken with Obinutuzumab
integer
Code List
Action taken with Obinutuzumab
CL Item
Unchanged (1)
CL Item
Reduced (2)
CL Item
Interrupted (3)
CL Item
Discontinued (4)
CL Item
Not applicable (5)
Item
Action taken with Pixantrone
integer
Code List
Action taken with Pixantrone
CL Item
Unchanged (1)
CL Item
Reduced (2)
CL Item
Interrupted (3)
CL Item
Discontinued (4)
CL Item
Not applicable (5)
Item
Treatment given?
text
Code List
Treatment given?
CL Item
Yes (Y)
CL Item
No (N)
Item
Outcome
integer
Code List
Outcome
CL Item
Recovered (1)
CL Item
Recovered with sequelae (2)
CL Item
Recovering (3)
CL Item
Not recovered (4)
CL Item
Fatal (5)
CL Item
Unknown (6)
Item Group
I have reviewed the AEs on this page and have assessed them for seriousness, causality, severity and outcome and confirm that, to the best of my knowledge, they accurately reflect the study information obtained for this patient.
Data correct
Item
Data correct?
boolean
Date of signature
Item
Date of signature
date
Name of investigator
Item
Name of investigator
text