ID

28021

Descripción

NCT02499003 The GOAL Trial: Rescue Treatment With the Monoclonal Anti CD20-antibody Obinutuzumab (GA101) in Combination With Pixantrone for the Treatment of Patients With Relapsed Aggressive B-cell Lymphoma. Visit: All visits. Source: Prof. Dr. med. Georg Heß Universitätsmedizin Mainz

Palabras clave

Versiones (2)
  1. 10/12/17 10/12/17 -
  2. 2/1/18 2/1/18 -
Titular de derechos de autor

Prof. Dr. med. Georg Heß

Subido en

10 de diciembre de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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Adverse events GOAL Trial B-cell Lymphoma NCT02499003

Inglés

Adverse events GOAL Trial B-cell Lymphoma NCT02499003

1 formularios  
Admininstrative data
Descripción

Admininstrative data

Subject ID
Descripción

Subject ID

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Page
Descripción

Page

Tipo de datos

integer

Adverse events
Descripción

Adverse events

No.
Descripción

adverse event number

Tipo de datos

integer

AE Term (based on CTCAE 4.0)
Descripción

Adverse event

Tipo de datos

text

SAE?
Descripción

Serious adverse event

Tipo de datos

text

Study termination
Descripción

Study termination

Tipo de datos

text

Start date
Descripción

Start date

Tipo de datos

date

Stop date
Descripción

Stop date

Tipo de datos

date

Ongoing at End of Treatment?
Descripción

Ongoing adverse event at End of Treatment

Tipo de datos

boolean

Max. CTCAE grade
Descripción

Maximum CTCAE grade

Tipo de datos

integer

Causality with Obinutuzumab
Descripción

Causality with Obinutuzumab

Tipo de datos

integer

Causality with Pixantrone
Descripción

Causality with Pixantrone

Tipo de datos

integer

Action taken with Obinutuzumab
Descripción

Action taken with Obinutuzumab

Tipo de datos

integer

Action taken with Pixantrone
Descripción

Action taken with Pixantrone

Tipo de datos

integer

Treatment given?
Descripción

Treatment

Tipo de datos

text

Outcome
Descripción

Treatment Outcome

Tipo de datos

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.
Descripción

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?
Descripción

Data correct

Tipo de datos

boolean

Date of signature
Descripción

Date of signature

Tipo de datos

date

Name of investigator
Descripción

Name of investigator

Tipo de datos

text

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Similar models

Adverse events GOAL Trial B-cell Lymphoma NCT02499003

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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
adverse event number
Code List
No.
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
Serious adverse event
Code List
SAE?
CL Item
Yes (Y)
CL Item
No (N)
Item
Study termination
text
Serious adverse event
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
Causality with Obinutuzumab
Code List
Causality with Obinutuzumab
CL Item
Not related (1)
CL Item
Related (2)
Item
Causality with Pixantrone
integer
Causality with Obinutuzumab
Code List
Causality with Pixantrone
CL Item
Not related (1)
CL Item
Related (2)
Item
Action taken with Obinutuzumab
integer
Action taken with Obinutuzumab
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
Action taken with Obinutuzumab
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
Serious adverse event
Code List
Treatment given?
CL Item
Yes (Y)
CL Item
No (N)
Item
Outcome
integer
Treatment Outcome
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
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