ID

18877

Description

Phase I study of panobinostat and imatinib in patients with treatment-refractory metastatic gastrointestinal stromal tumors WTZ-GIST-09-01 (EudraCT number: 2009-011417-24; German Clinical Trials Register: DRKS00000657) was approved by the institutional ethics committees of the two participating centers and the German Federal Regulatory Drug Agency (BfArM; 4035954).

Keywords

Versions (2)
  1. 11/20/16 11/20/16 -
  2. 11/23/16 11/23/16 -
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November 23, 2016

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Creative Commons BY-NC-ND 3.0
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WTZ-GIST-09-01 (Imatinib + LBH589) Cycle 1 laboratory results (V2) Haematology 2009-011417-24 DRKS00000657

English

WTZ-GIST-09-01 (Imatinib + LBH589) Cycle 1 laboratory results (V2) Haematology 2009-011417-24

1 forms  
Laboratory results hematology
Description

Laboratory results hematology

Alias
UMLS CUI-1
C1254595
UMLS CUI-2
C0018943
Please mark if evaluation was not done
Description

Evaluation

Data type

boolean

Alias
UMLS CUI [1]
C0220825
Date sample taken
Description

Date sample taken

Data type

date

Measurement units
  • YYYY-MM-DD
Alias
UMLS CUI [1]
C1302413
YYYY-MM-DD
Name of laboratory
Description

Name of laboratory

Data type

text

Alias
UMLS CUI [1]
C3258037
WBC
Description

White Blood Count

Data type

float

Measurement units
  • 10^9/ L
Alias
UMLS CUI [1]
C0023508
10^9/ L
RBC
Description

Red Blood Count

Data type

float

Measurement units
  • 10^12/ L
Alias
UMLS CUI [1]
C1287262
10^12/ L
Hb
Description

Haemoglobin

Data type

float

Measurement units
  • g/dL
Alias
UMLS CUI [1]
C0518015
g/dL
Haematocrit
Description

Haematocrit

Data type

float

Measurement units
  • L/L
Alias
UMLS CUI [1]
C0018935
L/L
Platelets
Description

Platelets

Data type

float

Measurement units
  • 10^9/ L
Alias
UMLS CUI [1]
C0005821
10^9/ L
Differential Count
Description

Differential Count

Data type

text

Alias
UMLS CUI [1]
C0009555
Neutrophils: Unit
Description

Neutrophils count unit

Data type

integer

Alias
UMLS CUI [1,1]
C0948762
UMLS CUI [1,2]
C1519795
Neutrophils
Description

Neutrophils

Data type

float

Alias
UMLS CUI [1]
C0948762
Lymphocytes: Unit
Description

Lymphocytes count unit

Data type

integer

Alias
UMLS CUI [1,1]
C0200635
UMLS CUI [1,2]
C1519795
Lymphocytes
Description

Lymphocytes count

Data type

float

Alias
UMLS CUI [1]
C0200635
Eosinophils: Unit
Description

Eosinophils count unit

Data type

integer

Alias
UMLS CUI [1,1]
C0200638
UMLS CUI [1,2]
C1519795
Eosinophils
Description

Eosinophils count

Data type

float

Alias
UMLS CUI [1]
C0200638
Basophils: Unit
Description

Basophils count unit

Data type

integer

Alias
UMLS CUI [1,1]
C0200641
UMLS CUI [1,2]
C1519795
Basophils
Description

Basophils count

Data type

float

Alias
UMLS CUI [1]
C0200641
Monocytes: Unit
Description

Monocytes count unit

Data type

integer

Alias
UMLS CUI [1,1]
C0200637
UMLS CUI [1,2]
C1519795
Monocytes
Description

Monocytes count

Data type

float

Alias
UMLS CUI [1]
C0200637
TSH value
Description

TSH value

Data type

float

Measurement units
  • U/L
Alias
UMLS CUI [1]
C0202230
U/L
fT4 value: Unit
Description

fT4 value Unit

Data type

integer

Alias
UMLS CUI [1,1]
C0202225
UMLS CUI [1,2]
C1519795
fT4 value
Description

fT4 value

Data type

float

Alias
UMLS CUI [1]
C0202225
Relevant findings within the laboratory
Description

Relevant findings within the laboratory

Data type

boolean

Alias
UMLS CUI [1]
C0587081
Pharmacokinetics (PK)
Description

Pharmacokinetics (PK)

Alias
UMLS CUI-1
C0031327
Time of administration (Imatinib)
Description

Time of administration (Imatinib)

Data type

time

Measurement units
  • HH:NN
Alias
UMLS CUI [1,1]
C1317775
UMLS CUI [1,2]
C0935989
HH:NN
Date
Description

Date of administration (Imatinib)

Data type

date

Measurement units
  • YYYY-MM-DD
Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0935989
YYYY-MM-DD
PK sample taken (0h prior to therapy)
Description

Pharmacokinetics sample taken

Data type

boolean

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0031327
Time PK sample taken (0h prior to therapy)
Description

Time Pharmacokinetics sample taken

Data type

time

Measurement units
  • HH:NN
Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0031327
UMLS CUI [2]
C0040223
HH:NN
PK sample taken (4h prior to therapy)
Description

Later pharmacokinetics sample taken

Data type

boolean

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0031327
UMLS CUI [1,3]
C0205087
Time PK sample taken (4h prior to therapy)
Description

Later time pharmacokinetics sample taken

Data type

time

Measurement units
  • HH:NN
Alias
UMLS CUI [1,1]
C0205087
UMLS CUI [1,2]
C1277698
UMLS CUI [1,3]
C0031327
UMLS CUI [2]
C0040223
HH:NN
If PK sample was not taken please comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
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Similar models

WTZ-GIST-09-01 (Imatinib + LBH589) Cycle 1 laboratory results (V2) Haematology 2009-011417-24

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Laboratory results hematology
C1254595 (UMLS CUI-1)
C0018943 (UMLS CUI-2)
Evaluation
Item
Please mark if evaluation was not done
boolean
C0220825 (UMLS CUI [1])
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Name of laboratory
Item
Name of laboratory
text
C3258037 (UMLS CUI [1])
White Blood Count
Item
WBC
float
C0023508 (UMLS CUI [1])
Red Blood Count
Item
RBC
float
C1287262 (UMLS CUI [1])
Haemoglobin
Item
Hb
float
C0518015 (UMLS CUI [1])
Haematocrit
Item
Haematocrit
float
C0018935 (UMLS CUI [1])
Platelets
Item
Platelets
float
C0005821 (UMLS CUI [1])
Differential Count
Item
Differential Count
text
C0009555 (UMLS CUI [1])
Item
Neutrophils: Unit
integer
C0948762 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Neutrophils count unit
Code List
Neutrophils: Unit
CL Item
% (1)
CL Item
10^9/L (2)
Neutrophils
Item
Neutrophils
float
C0948762 (UMLS CUI [1])
Item
Lymphocytes: Unit
integer
C0200635 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Lymphocytes count unit
Code List
Lymphocytes: Unit
CL Item
% (1)
CL Item
10^9/L (2)
Lymphocytes count
Item
Lymphocytes
float
C0200635 (UMLS CUI [1])
Item
Eosinophils: Unit
integer
C0200638 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Eosinophils count unit
Code List
Eosinophils: Unit
CL Item
% (1)
CL Item
10^9/L (2)
Eosinophils count
Item
Eosinophils
float
C0200638 (UMLS CUI [1])
Item
Basophils: Unit
integer
C0200641 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Basophils count unit
Code List
Basophils: Unit
CL Item
% (1)
CL Item
10^9/L (2)
Basophils count
Item
Basophils
float
C0200641 (UMLS CUI [1])
Item
Monocytes: Unit
integer
C0200637 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Monocytes count unit
Code List
Monocytes: Unit
CL Item
% (1)
CL Item
10^9/L (2)
Monocytes count
Item
Monocytes
float
C0200637 (UMLS CUI [1])
TSH value
Item
TSH value
float
C0202230 (UMLS CUI [1])
Item
fT4 value: Unit
integer
C0202225 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
fT4 value Unit
Code List
fT4 value: Unit
CL Item
U/L (1)
CL Item
pmol/L (2)
fT4 value
Item
fT4 value
float
C0202225 (UMLS CUI [1])
Relevant findings within the laboratory
Item
Relevant findings within the laboratory
boolean
C0587081 (UMLS CUI [1])
Item Group
Pharmacokinetics (PK)
C0031327 (UMLS CUI-1)
Time of administration (Imatinib)
Item
Time of administration (Imatinib)
time
C1317775 (UMLS CUI [1,1])
C0935989 (UMLS CUI [1,2])
Date of administration (Imatinib)
Item
Date
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0935989 (UMLS CUI [1,3])
Pharmacokinetics sample taken
Item
PK sample taken (0h prior to therapy)
boolean
C1277698 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
Time Pharmacokinetics sample taken
Item
Time PK sample taken (0h prior to therapy)
time
C1277698 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2])
Later pharmacokinetics sample taken
Item
PK sample taken (4h prior to therapy)
boolean
C1277698 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
C0205087 (UMLS CUI [1,3])
Later time pharmacokinetics sample taken
Item
Time PK sample taken (4h prior to therapy)
time
C0205087 (UMLS CUI [1,1])
C1277698 (UMLS CUI [1,2])
C0031327 (UMLS CUI [1,3])
C0040223 (UMLS CUI [2])
Comment
Item
If PK sample was not taken please comment
text
C0947611 (UMLS CUI [1])
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