ID

27846

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. 11/30/17 11/30/17 -
  2. 12/7/17 12/7/17 -
  3. 12/31/17 12/31/17 -
Copyright Holder

Prof. Dr. med. Georg Heß

Uploaded on

November 30, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Cycle 1 Day 8 GOAL Trial B-cell Lymphoma NCT02499003

English

Cycle 1 Day 8 GOAL Trial B-cell Lymphoma NCT02499003

1 forms  
Admininstrative data
Description

Admininstrative data

Subject ID
Description

Subject ID

Data type

text

Vital signs
Description

Vital signs

Date
Description

Date

Data type

date

Cycle day not done
Description

Cycle day not done

Data type

boolean

Blood Pressure Systolic
Description

Blood Pressure Systolic

Data type

integer

Alias
UMLS CUI [1]
C0871470
Blood Pressure Diastolic
Description

Blood Pressure Diastolic

Data type

integer

Alias
UMLS CUI [1]
C0428883
Pulse
Description

Pulse

Data type

integer

Alias
UMLS CUI [1]
C0232117
Body Temperature
Description

Body Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
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

BNP: Lab value
Description

BNP or NT-ProBNP

Data type

text

BNP: Unit
Description

BNP or NT-ProBNP

Data type

text

BNP: Clin. significant?
Description

BNP or NT-ProBNP

Data type

boolean

BNP: CTCAE
Description

BNP or NT-ProBNP

Data type

text

NT-ProBNP: Lab value
Description

BNP or NT-ProBNP

Data type

text

NT-ProBNP: Unit
Description

BNP or NT-ProBNP

Data type

text

NT-ProBNP: Clin. significant?
Description

BNP or NT-ProBNP

Data type

boolean

NT-ProBNP: CTCAE
Description

BNP or NT-ProBNP

Data type

text

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Similar models

Cycle 1 Day 8 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 Group
Vital signs
Date
Item
Date
date
Cycle day not done
Item
Cycle day not done
boolean
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Body Temperature
Item
Body Temperature
float
C0005903 (UMLS CUI [1])
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
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
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