ID

18877

Beskrivning

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).

Nyckelord

Versioner (2)
  1. 2016-11-20 2016-11-20 -
  2. 2016-11-23 2016-11-23 -
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23 november 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

Engelsk

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

1 Formulär  
Laboratory results hematology
Beskrivning

Laboratory results hematology

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

Evaluation

Datatyp

boolean

Alias
UMLS CUI [1]
C0220825
Date sample taken
Beskrivning

Date sample taken

Datatyp

date

Måttenheter
  • YYYY-MM-DD
Alias
UMLS CUI [1]
C1302413
YYYY-MM-DD
Name of laboratory
Beskrivning

Name of laboratory

Datatyp

text

Alias
UMLS CUI [1]
C3258037
WBC
Beskrivning

White Blood Count

Datatyp

float

Måttenheter
  • 10^9/ L
Alias
UMLS CUI [1]
C0023508
10^9/ L
RBC
Beskrivning

Red Blood Count

Datatyp

float

Måttenheter
  • 10^12/ L
Alias
UMLS CUI [1]
C1287262
10^12/ L
Hb
Beskrivning

Haemoglobin

Datatyp

float

Måttenheter
  • g/dL
Alias
UMLS CUI [1]
C0518015
g/dL
Haematocrit
Beskrivning

Haematocrit

Datatyp

float

Måttenheter
  • L/L
Alias
UMLS CUI [1]
C0018935
L/L
Platelets
Beskrivning

Platelets

Datatyp

float

Måttenheter
  • 10^9/ L
Alias
UMLS CUI [1]
C0005821
10^9/ L
Differential Count
Beskrivning

Differential Count

Datatyp

text

Alias
UMLS CUI [1]
C0009555
Neutrophils: Unit
Beskrivning

Neutrophils count unit

Datatyp

integer

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

Neutrophils

Datatyp

float

Alias
UMLS CUI [1]
C0948762
Lymphocytes: Unit
Beskrivning

Lymphocytes count unit

Datatyp

integer

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

Lymphocytes count

Datatyp

float

Alias
UMLS CUI [1]
C0200635
Eosinophils: Unit
Beskrivning

Eosinophils count unit

Datatyp

integer

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

Eosinophils count

Datatyp

float

Alias
UMLS CUI [1]
C0200638
Basophils: Unit
Beskrivning

Basophils count unit

Datatyp

integer

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

Basophils count

Datatyp

float

Alias
UMLS CUI [1]
C0200641
Monocytes: Unit
Beskrivning

Monocytes count unit

Datatyp

integer

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

Monocytes count

Datatyp

float

Alias
UMLS CUI [1]
C0200637
TSH value
Beskrivning

TSH value

Datatyp

float

Måttenheter
  • U/L
Alias
UMLS CUI [1]
C0202230
U/L
fT4 value: Unit
Beskrivning

fT4 value Unit

Datatyp

integer

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

fT4 value

Datatyp

float

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

Relevant findings within the laboratory

Datatyp

boolean

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

Pharmacokinetics (PK)

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

Time of administration (Imatinib)

Datatyp

time

Måttenheter
  • HH:NN
Alias
UMLS CUI [1,1]
C1317775
UMLS CUI [1,2]
C0935989
HH:NN
Date
Beskrivning

Date of administration (Imatinib)

Datatyp

date

Måttenheter
  • 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)
Beskrivning

Pharmacokinetics sample taken

Datatyp

boolean

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

Time Pharmacokinetics sample taken

Datatyp

time

Måttenheter
  • 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)
Beskrivning

Later pharmacokinetics sample taken

Datatyp

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)
Beskrivning

Later time pharmacokinetics sample taken

Datatyp

time

Måttenheter
  • 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
Beskrivning

Comment

Datatyp

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 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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