ID

27906

Description

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 Source: Prof. Dr. med. Georg Heß Universitätsmedizin Mainz

Keywords

Versions (3)
  1. 12/4/17 12/4/17 -
  2. 12/4/17 12/4/17 -
  3. 1/4/18 1/4/18 -
Copyright Holder

Prof. Dr. med. Georg Heß

Uploaded on

December 4, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Screening Laboratory GOAL Trial B-cell Lymphoma NCT02499003

English

Laboratory GOAL Trial B-cell Lymphoma NCT02499003

1 forms  
Admininstrative data
Description

Admininstrative data

Subject ID
Description

Subject ID

Data type

text

Visit
Description

Visit

Data type

text

Laboratory: Hematology
Description

Laboratory: Hematology

Date
Description

Date

Data type

date

Hematocrit: Lab value
Description

Hematocrit lab value

Data type

text

Hematocrit: Unit
Description

Hematocrit unit

Data type

text

Hematocrit: Clin. significant?
Description

Hematocrit clinical significance

Data type

boolean

Hematocrit: CTCAE
Description

Hematocrit CTCAE

Data type

text

Hemoglobin: Lab value
Description

Hemoglobin lab value

Data type

text

Hemoglobin: Unit
Description

Hemoglobin unit

Data type

text

Hemoglobin: Clin. significant?
Description

Hemoglobin clinical significance

Data type

boolean

Hemoglobin: CTCAE
Description

Hemoglobin CTCAE

Data type

text

Red blood cells: Lab value
Description

Red blood cells lab value

Data type

text

Red blood cells: Unit
Description

Red blood cells unit

Data type

text

Red blood cells: Clin. significant?
Description

Red blood cells clinical significance

Data type

boolean

Red blood cells: CTCAE
Description

Red blood cells CTCAE

Data type

text

White blood cells: Lab value
Description

White blood cells lab value

Data type

text

White blood cells: Unit
Description

White blood cells unit

Data type

text

White blood cells: Clin. significant?
Description

White blood cells clinical significance

Data type

boolean

White blood cells: CTCAE
Description

White blood cells CTCAE

Data type

text

Platelets: Lab value
Description

Platelets lab value

Data type

text

Platelets: Unit
Description

Platelets unit

Data type

text

Platelets: Clin. significant?
Description

Platelets clinical significance

Data type

boolean

Platelets: CTCAE
Description

Platelets CTCAE

Data type

text

Neutrophils: Lab value
Description

Neutrophils lab value

Data type

text

Neutrophils: Unit
Description

Neutrophils unit

Data type

text

Neutrophils: Clin. significant?
Description

Neutrophils clinical significance

Data type

boolean

Neutrophils: CTCAE
Description

Neutrophils CTCAE

Data type

text

Eosinophils: Lab value
Description

Eosinophils lab value

Data type

text

Eosinophils: Unit
Description

Eosinophils unit

Data type

text

Eosinophils: Clin. significant?
Description

Eosinophils clinical significance

Data type

boolean

Eosinophils: CTCAE
Description

Eosinophils CTCAE

Data type

text

Basophils: Lab value
Description

Basophils lab value

Data type

text

Basophils: Unit
Description

Basophils unit

Data type

text

Basophils: Clin. significant?
Description

Basophils clinical significance

Data type

boolean

Basophils: CTCAE
Description

Basophils CTCAE

Data type

text

Monocytes: Lab value
Description

Monocytes lab value

Data type

text

Monocytes: Unit
Description

Monocytes unit

Data type

text

Monocytes: Clin. significant?
Description

Monocytes clinical significance

Data type

boolean

Monocytes: CTCAE
Description

Monocytes CTCAE

Data type

text

Lymphocytes: Lab value
Description

Lymphocytes lab value

Data type

text

Lymphocytes: Unit
Description

Lymphocytes unit

Data type

text

Lymphocytes: Clin. significant?
Description

Lymphocytes clinical significance

Data type

boolean

Lymphocytes: CTCAE
Description

Lymphocytes CTCAE

Data type

text

ANC: Lab value
Description

ANC lab value

Data type

text

ANC: Unit
Description

ANC unit

Data type

text

ANC: Clin. significant?
Description

ANC clinical significance

Data type

boolean

ANC: CTCAE
Description

ANC CTCAE

Data type

text

Laboratory: Blood chemistry
Description

Laboratory: Blood chemistry

Sodium: Lab value
Description

Sodium lab value

Data type

text

Sodium: Unit
Description

Sodium unit

Data type

text

Sodium: Clin. significant?
Description

Sodium clinical significance

Data type

boolean

Sodium: CTCAE
Description

Sodium CTCAE

Data type

text

Potassium: Lab value
Description

Potassium lab value

Data type

text

Potassium: Unit
Description

Potassium unit

Data type

text

Potassium: Clin. significant?
Description

Potassium clinical significance

Data type

boolean

Potassium: CTCAE
Description

Potassium CTCAE

Data type

text

Calcium: Lab value
Description

Calcium lab value

Data type

text

Calcium: Unit
Description

Calcium unit

Data type

text

Calcium: Clin. significant?
Description

Calcium clinical significance

Data type

boolean

Calcium: CTCAE
Description

Calcium CTCAE

Data type

text

Chloride: Lab value
Description

Chloride lab value

Data type

text

Chloride: Unit
Description

Chloride unit

Data type

text

Chloride: Clin. significant?
Description

Chloride clinical significance

Data type

boolean

Chloride: CTCAE
Description

Chloride CTCAE

Data type

text

Magnesium: Lab value
Description

Magnesium lab value

Data type

text

Magnesium: Unit
Description

Magnesium unit

Data type

text

Magnesium: Clin. significant?
Description

Magnesium clinical significance

Data type

boolean

Magnesium: CTCAE
Description

Magnesium CTCAE

Data type

text

Bilirubin (total): Lab value
Description

Bilirubin lab value

Data type

text

Bilirubin (total): Unit
Description

Bilirubin unit

Data type

text

Bilirubin (total): Clin. significant?
Description

Bilirubin clinical significance

Data type

boolean

Bilirubin: CTCAE
Description

Bilirubin (total) CTCAE

Data type

text

AST (GOT): Lab value
Description

AST GOT lab value

Data type

text

AST (GOT): Unit
Description

AST GOT unit

Data type

text

AST (GOT): Clin. significant?
Description

AST GOT clinical significance

Data type

boolean

AST (GOT): CTCAE
Description

AST GOT CTCAE

Data type

text

ALT (GPT): Lab value
Description

ALT GPT lab value

Data type

text

ALT (GPT): Unit
Description

ALT GPT unit

Data type

text

ALT (GPT): Clin. significant?
Description

ALT GPT clinical significance

Data type

boolean

ALT (GPT): CTCAE
Description

ALT GPT CTCAE

Data type

text

GGT: Lab value
Description

GGT lab value

Data type

text

GGT: Unit
Description

GGT unit

Data type

text

GGT: Clin. significant?
Description

GGT clinical significance

Data type

boolean

GGT: CTCAE
Description

GGT CTCAE

Data type

text

Lipase: Lab value
Description

Lipase lab value

Data type

text

Lipase: Unit
Description

Lipase unit

Data type

text

Lipase: Clin. significant?
Description

Lipase clinical significance

Data type

boolean

Lipase: CTCAE
Description

Lipase CTCAE

Data type

text

Amylase: Lab value
Description

Amylase lab value

Data type

text

Amylase: Unit
Description

Amylase unit

Data type

text

Amylase: Clin. significant?
Description

Amylase clinical significance

Data type

boolean

Amylase: CTCAE
Description

Amylase CTCAE

Data type

text

Creatinine: Lab value
Description

Creatinine lab value

Data type

text

Creatinine: Unit
Description

Creatinine unit

Data type

text

Creatinine: Clin. significant?
Description

Creatinine clinical significance

Data type

boolean

Creatinine: CTCAE
Description

Creatinine CTCAE

Data type

text

Uric acid: Lab value
Description

Uric acid lab value

Data type

text

Uric acid: Unit
Description

Uric acid unit

Data type

text

Uric acid: Clin. significant?
Description

Uric acid clinical significance

Data type

boolean

Uric acid: CTCAE
Description

Uric acid CTCAE

Data type

text

Troponin T: Lab value
Description

Troponin T or Troponin I

Data type

text

Troponin T: Unit
Description

Troponin T or Troponin I

Data type

text

Troponin T: Clin. significant?
Description

Troponin T or Troponin I

Data type

boolean

Troponin T: CTCAE
Description

Troponin T or Troponin I

Data type

text

Troponin I: Lab value
Description

Troponin T or Troponin I

Data type

text

Troponin I: Unit
Description

Troponin T or Troponin I

Data type

text

Troponin I: Clin. significant?
Description

Troponin T or Troponin I

Data type

boolean

Troponin I: CTCAE
Description

Troponin T or Troponin I

Data type

text

LDH: Lab value
Description

This item applies to the following visits: Day 1 of Cycles 1 - 6; Day 22 of Cycles 2 - 6; Interim Staging; End of Treatment; Follow Up 1 - 8.

Data type

text

LDH: Unit
Description

This item applies to the following visits: Day 1 of Cycles 1 - 6; Day 22 of Cycles 2 - 6; Interim Staging; End of Treatment; Follow Up 1 - 8.

Data type

text

LDH: Clin. significant?
Description

This item applies to the following visits: Day 1 of Cycles 1 - 6; Day 22 of Cycles 2 - 6; Interim Staging; End of Treatment; Follow Up 1 - 8.

Data type

boolean

LDH: CTCAE
Description

This item applies to the following visits: Day 1 of Cycles 1 - 6; Day 22 of Cycles 2 - 6; Interim Staging; End of Treatment; Follow Up 1 - 8.

Data type

text

BNP: Lab value
Description

BNP or NT-ProBNP. This item applies to the following visits: Days 8, 15, and 22 of Cycle 1; Day 1 of Cycles 2 - 6; Interim Staging; End of Treatment; Follow Up 1 - 8.

Data type

text

BNP: Unit
Description

BNP or NT-ProBNP. This item applies to the following visits: Days 8, 15, and 22 of Cycle 1; Day 1 of Cycles 2 - 6; Interim Staging; End of Treatment; Follow Up 1 - 8.

Data type

text

BNP: Clin. significant?
Description

BNP or NT-ProBNP. This item applies to the following visits: Days 8, 15, and 22 of Cycle 1; Day 1 of Cycles 2 - 6; Interim Staging; End of Treatment; Follow Up 1 - 8.

Data type

boolean

BNP: CTCAE
Description

BNP or NT-ProBNP. This item applies to the following visits: Days 8, 15, and 22 of Cycle 1; Day 1 of Cycles 2 - 6; Interim Staging; End of Treatment; Follow Up 1 - 8.

Data type

text

NT-ProBNP: Lab value
Description

BNP or NT-ProBNP. This item applies to the following visits: Days 8, 15, and 22 of Cycle 1; Day 1 of Cycles 2 - 6; Interim Staging; End of Treatment; Follow Up 1 - 8.

Data type

text

NT-ProBNP: Unit
Description

BNP or NT-ProBNP. This item applies to the following visits: Days 8, 15, and 22 of Cycle 1; Day 1 of Cycles 2 - 6; Interim Staging; End of Treatment; Follow Up 1 - 8.

Data type

text

NT-ProBNP: Clin. significant?
Description

BNP or NT-ProBNP. This item applies to the following visits: Days 8, 15, and 22 of Cycle 1; Day 1 of Cycles 2 - 6; Interim Staging; End of Treatment; Follow Up 1 - 8.

Data type

boolean

NT-ProBNP: CTCAE
Description

BNP or NT-ProBNP. This item applies to the following visits: Days 8, 15, and 22 of Cycle 1; Day 1 of Cycles 2 - 6; Interim Staging; End of Treatment; Follow Up 1 - 8.

Data type

text

sCD25: Lab value
Description

This item applies to the following visits: Cycle 1 Day 1, Interim Staging, and Follow Up 1 - 8.

Data type

text

sCD25: Unit
Description

This item applies to the following visits: Cycle 1 Day 1, Interim Staging, and Follow Up 1 - 8.

Data type

text

sCD25: Clin. significant?
Description

This item applies to the following visits: Cycle 1 Day 1, Interim Staging, and Follow Up 1 - 8.

Data type

boolean

sCD25: CTCAE
Description

This item applies to the following visits: Cycle 1 Day 1, Interim Staging, and Follow Up 1 - 8.

Data type

text

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Similar models

Laboratory GOAL Trial B-cell Lymphoma NCT02499003

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Admininstrative data
Subject ID
Item
Subject ID
text
Item
Visit
text
Visit
Code List
Visit
CL Item
Cycle 1 Day 1 (Cycle 1 Day 1)
CL Item
Cycle 1 Day 15 (Cycle 1 Day 15)
CL Item
Cycle 1 Day 22 (Cycle 1 Day 22)
CL Item
Cycle 2 Day 1 (Cycle 2 Day 1)
CL Item
Cycle 2 Day 8 (Cycle 2 Day 8)
CL Item
Cycle 2 Day 15 (Cycle 2 Day 15)
CL Item
Cycle 2 Day 22 (Cycle 2 Day 22)
CL Item
Cycle 3 Day 1 (Cycle 3 Day 1)
CL Item
Cycle 3 Day 8 (Cycle 3 Day 8)
CL Item
Cycle 3 Day 15 (Cycle 3 Day 15)
CL Item
Cycle 3 Day 22 (Cycle 3 Day 22)
CL Item
Interim Staging (Interim Staging)
CL Item
Cycle 4 Day 1 (Cycle 4 Day 1)
CL Item
Cycle 4 Day 8 (Cycle 4 Day 8)
CL Item
Cycle 4 Day 15 (Cycle 4 Day 15)
CL Item
Cycle 4 Day 22 (Cycle 4 Day 22)
CL Item
Cycle 5 Day 1 (Cycle 5 Day 1)
CL Item
Cycle 5 Day 8 (Cycle 5 Day 8)
CL Item
Cycle 5 Day 15 (Cycle 5 Day 15)
CL Item
Cycle 5 Day 22 (Cycle 5 Day 22)
CL Item
Cycle 6 Day 1 (Cycle 6 Day 1)
CL Item
Cycle 6 Day 8 (Cycle 6 Day 8)
CL Item
Cycle 6 Day 15 (Cycle 6 Day 15)
CL Item
Cycle 6 Day 22 (Cycle 6 Day 22)
CL Item
End of Treatment (End of Treatment)
CL Item
Follow Up 1 (Follow Up 1)
CL Item
Follow Up 2 (Follow Up 2)
CL Item
Follow Up 3 (Follow Up 3)
CL Item
Follow Up 4 (Follow Up 4)
CL Item
Follow Up 5 (Follow Up 5)
CL Item
Follow Up 6 (Follow Up 6)
CL Item
Follow Up 7 (Follow Up 7)
CL Item
Follow Up 8 (Follow Up 8)
CL Item
Cyce 1 Day 8 (Cycle 1 Day 8)
Item Group
Laboratory: Hematology
Date
Item
Date
date
Hematocrit lab value
Item
Hematocrit: Lab value
text
Hematocrit unit
Item
Hematocrit: Unit
text
Hematocrit clinical significance
Item
Hematocrit: Clin. significant?
boolean
Hematocrit CTCAE
Item
Hematocrit: CTCAE
text
Hemoglobin lab value
Item
Hemoglobin: Lab value
text
Hemoglobin unit
Item
Hemoglobin: Unit
text
Hemoglobin clinical significance
Item
Hemoglobin: Clin. significant?
boolean
Hemoglobin CTCAE
Item
Hemoglobin: CTCAE
text
Red blood cells lab value
Item
Red blood cells: Lab value
text
Red blood cells unit
Item
Red blood cells: Unit
text
Red blood cells clinical significance
Item
Red blood cells: Clin. significant?
boolean
Red blood cells CTCAE
Item
Red blood cells: CTCAE
text
White blood cells lab value
Item
White blood cells: Lab value
text
White blood cells unit
Item
White blood cells: Unit
text
White blood cells clinical significance
Item
White blood cells: Clin. significant?
boolean
White blood cells CTCAE
Item
White blood cells: CTCAE
text
Platelets lab value
Item
Platelets: Lab value
text
Platelets unit
Item
Platelets: Unit
text
Platelets clinical significance
Item
Platelets: Clin. significant?
boolean
Platelets CTCAE
Item
Platelets: CTCAE
text
Neutrophils lab value
Item
Neutrophils: Lab value
text
Neutrophils unit
Item
Neutrophils: Unit
text
Neutrophils clinical significance
Item
Neutrophils: Clin. significant?
boolean
Neutrophils CTCAE
Item
Neutrophils: CTCAE
text
Eosinophils lab value
Item
Eosinophils: Lab value
text
Eosinophils unit
Item
Eosinophils: Unit
text
Eosinophils clinical significance
Item
Eosinophils: Clin. significant?
boolean
Eosinophils CTCAE
Item
Eosinophils: CTCAE
text
Basophils lab value
Item
Basophils: Lab value
text
Basophils unit
Item
Basophils: Unit
text
Basophils clinical significance
Item
Basophils: Clin. significant?
boolean
Basophils CTCAE
Item
Basophils: CTCAE
text
Monocytes lab value
Item
Monocytes: Lab value
text
Monocytes unit
Item
Monocytes: Unit
text
Monocytes clinical significance
Item
Monocytes: Clin. significant?
boolean
Monocytes CTCAE
Item
Monocytes: CTCAE
text
Lymphocytes lab value
Item
Lymphocytes: Lab value
text
Lymphocytes unit
Item
Lymphocytes: Unit
text
Lymphocytes clinical significance
Item
Lymphocytes: Clin. significant?
boolean
Lymphocytes CTCAE
Item
Lymphocytes: CTCAE
text
ANC lab value
Item
ANC: Lab value
text
ANC unit
Item
ANC: Unit
text
ANC clinical significance
Item
ANC: Clin. significant?
boolean
ANC CTCAE
Item
ANC: CTCAE
text
Item Group
Laboratory: Blood chemistry
Sodium lab value
Item
Sodium: Lab value
text
Sodium unit
Item
Sodium: Unit
text
Sodium clinical significance
Item
Sodium: Clin. significant?
boolean
Sodium CTCAE
Item
Sodium: CTCAE
text
Potassium lab value
Item
Potassium: Lab value
text
Potassium unit
Item
Potassium: Unit
text
Potassium clinical significance
Item
Potassium: Clin. significant?
boolean
Potassium CTCAE
Item
Potassium: CTCAE
text
Calcium lab value
Item
Calcium: Lab value
text
Calcium unit
Item
Calcium: Unit
text
Calcium clinical significance
Item
Calcium: Clin. significant?
boolean
Calcium CTCAE
Item
Calcium: CTCAE
text
Chloride lab value
Item
Chloride: Lab value
text
Chloride unit
Item
Chloride: Unit
text
Chloride clinical significance
Item
Chloride: Clin. significant?
boolean
Chloride CTCAE
Item
Chloride: CTCAE
text
Magnesium lab value
Item
Magnesium: Lab value
text
Magnesium unit
Item
Magnesium: Unit
text
Magnesium clinical significance
Item
Magnesium: Clin. significant?
boolean
Magnesium CTCAE
Item
Magnesium: CTCAE
text
Bilirubin lab value
Item
Bilirubin (total): Lab value
text
Bilirubin unit
Item
Bilirubin (total): Unit
text
Bilirubin clinical significance
Item
Bilirubin (total): Clin. significant?
boolean
Bilirubin (total) CTCAE
Item
Bilirubin: CTCAE
text
AST GOT lab value
Item
AST (GOT): Lab value
text
AST GOT unit
Item
AST (GOT): Unit
text
AST GOT clinical significance
Item
AST (GOT): Clin. significant?
boolean
AST GOT CTCAE
Item
AST (GOT): CTCAE
text
ALT GPT lab value
Item
ALT (GPT): Lab value
text
ALT GPT unit
Item
ALT (GPT): Unit
text
ALT GPT clinical significance
Item
ALT (GPT): Clin. significant?
boolean
ALT GPT CTCAE
Item
ALT (GPT): CTCAE
text
GGT lab value
Item
GGT: Lab value
text
GGT unit
Item
GGT: Unit
text
GGT clinical significance
Item
GGT: Clin. significant?
boolean
GGT CTCAE
Item
GGT: CTCAE
text
Lipase lab value
Item
Lipase: Lab value
text
Lipase unit
Item
Lipase: Unit
text
Lipase clinical significance
Item
Lipase: Clin. significant?
boolean
Lipase CTCAE
Item
Lipase: CTCAE
text
Amylase lab value
Item
Amylase: Lab value
text
Amylase unit
Item
Amylase: Unit
text
Amylase clinical significance
Item
Amylase: Clin. significant?
boolean
Amylase CTCAE
Item
Amylase: CTCAE
text
Creatinine lab value
Item
Creatinine: Lab value
text
Creatinine unit
Item
Creatinine: Unit
text
Creatinine clinical significance
Item
Creatinine: Clin. significant?
boolean
Creatinine CTCAE
Item
Creatinine: CTCAE
text
Uric acid lab value
Item
Uric acid: Lab value
text
Uric acid unit
Item
Uric acid: Unit
text
Uric acid clinical significance
Item
Uric acid: Clin. significant?
boolean
Uric acid CTCAE
Item
Uric acid: CTCAE
text
Troponin T lab value
Item
Troponin T: Lab value
text
Troponin T unit
Item
Troponin T: Unit
text
Troponin T clinical significance
Item
Troponin T: Clin. significant?
boolean
Troponin T CTCAE
Item
Troponin T: CTCAE
text
Troponin I lab value
Item
Troponin I: Lab value
text
Troponin I unit
Item
Troponin I: Unit
text
Troponin I clinical significance
Item
Troponin I: Clin. significant?
boolean
Troponin I CTCAE
Item
Troponin I: CTCAE
text
LDH lab value
Item
LDH: Lab value
text
LDH unit
Item
LDH: Unit
text
LDH clinical significance
Item
LDH: Clin. significant?
boolean
LDH CTCAE
Item
LDH: CTCAE
text
BNP lab value
Item
BNP: Lab value
text
BNP unit
Item
BNP: Unit
text
BNP clinical significance
Item
BNP: Clin. significant?
boolean
BNP CTCAE
Item
BNP: CTCAE
text
NT-ProBNP lab value
Item
NT-ProBNP: Lab value
text
NT-ProBNP unit
Item
NT-ProBNP: Unit
text
NT-ProBNP clinical significance
Item
NT-ProBNP: Clin. significant?
boolean
NT-ProBNP CTCAE
Item
NT-ProBNP: CTCAE
text
sCD25 lab value
Item
sCD25: Lab value
text
sCD25 unit
Item
sCD25: Unit
text
sCD25 clinical significance
Item
sCD25: Clin. significant?
boolean
sCD25 CTCAE
Item
sCD25: CTCAE
text
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