ID

18887

Beschreibung

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).

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  1. 23.11.16 23.11.16 -
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23. November 2016

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WTZ-GIST-09-01 (Imatinib + LBH589) Cycle 1 laboratory results (V5) Haematology 2009-011417-24 DRKS00000657

Englisch

WTZ-GIST-09-01 (Imatinib + LBH589) Cycle 1 laboratory results (V5) Haematology 2009-011417-24

1 Formulare  
Laboratory results hematology
Beschreibung

Laboratory results hematology

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

Evaluation

Datentyp

boolean

Alias
UMLS CUI [1]
C0220825
Date sample taken
Beschreibung

Date sample taken

Datentyp

date

Maßeinheiten
  • YYYY-MM-DD
Alias
UMLS CUI [1]
C1302413
YYYY-MM-DD
Name of laboratory
Beschreibung

Name of laboratory

Datentyp

text

Alias
UMLS CUI [1]
C3258037
WBC
Beschreibung

White Blood Count

Datentyp

float

Maßeinheiten
  • 10^9/ L
Alias
UMLS CUI [1]
C0023508
10^9/ L
RBC
Beschreibung

Red Blood Count

Datentyp

float

Maßeinheiten
  • 10^12/ L
Alias
UMLS CUI [1]
C1287262
10^12/ L
Hb
Beschreibung

Haemoglobin

Datentyp

float

Maßeinheiten
  • g/dL
Alias
UMLS CUI [1]
C0518015
g/dL
Haematocrit
Beschreibung

Haematocrit

Datentyp

float

Maßeinheiten
  • L/L
Alias
UMLS CUI [1]
C0018935
L/L
Platelets
Beschreibung

Platelets

Datentyp

float

Maßeinheiten
  • 10^9/ L
Alias
UMLS CUI [1]
C0005821
10^9/ L
Differential Count
Beschreibung

Differential Count

Datentyp

text

Alias
UMLS CUI [1]
C0009555
Neutrophils: Unit
Beschreibung

Neutrophils count unit

Datentyp

integer

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

Neutrophils

Datentyp

float

Alias
UMLS CUI [1]
C0948762
Lymphocytes: Unit
Beschreibung

Lymphocytes count unit

Datentyp

integer

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

Lymphocytes count

Datentyp

float

Alias
UMLS CUI [1]
C0200635
Eosinophils: Unit
Beschreibung

Eosinophils count unit

Datentyp

integer

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

Eosinophils count

Datentyp

float

Alias
UMLS CUI [1]
C0200638
Basophils: Unit
Beschreibung

Basophils count unit

Datentyp

integer

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

Basophils count

Datentyp

float

Alias
UMLS CUI [1]
C0200641
Monocytes: Unit
Beschreibung

Monocytes count unit

Datentyp

integer

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

Monocytes count

Datentyp

float

Alias
UMLS CUI [1]
C0200637
Relevant findings within the laboratory
Beschreibung

Relevant findings within the laboratory

Datentyp

boolean

Alias
UMLS CUI [1]
C0587081
Pharmacokinetics (PK) - Cycle 1 Day 15
Beschreibung

Pharmacokinetics (PK) - Cycle 1 Day 15

Alias
UMLS CUI-1
C0031327
Time of administration (LBH)
Beschreibung

Time of administration (LBH)

Datentyp

time

Maßeinheiten
  • HH:NN
Alias
UMLS CUI [1,1]
C1317775
UMLS CUI [1,2]
C1566164
HH:NN
Time of administration (Imatinib)
Beschreibung

Time of administration (Imatinib)

Datentyp

time

Maßeinheiten
  • HH:NN
Alias
UMLS CUI [1,1]
C1317775
UMLS CUI [1,2]
C0935989
HH:NN
Date
Beschreibung

Date of administration

Datentyp

date

Maßeinheiten
  • YYYY-MM-DD
Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
YYYY-MM-DD
PK sample taken (0h prior to therapy, 4h after therapy, 24h after therapy)
Beschreibung

Pharmacokinetics sample taken

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0031327
Time PK sample taken (0h prior to therapy, 4h after therapy, 24h after therapy)
Beschreibung

Time Pharmacokinetics sample taken

Datentyp

time

Maßeinheiten
  • HH:NN
Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0031327
UMLS CUI [2]
C0040223
HH:NN
End Date
Beschreibung

End Date

Datentyp

text

Maßeinheiten
  • YYYY-MM-DD
Alias
UMLS CUI [1]
C0806020
YYYY-MM-DD
If PK sample was not taken please comment
Beschreibung

Comment

Datentyp

text

Alias
UMLS CUI [1]
C0947611
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Ähnliche Modelle

WTZ-GIST-09-01 (Imatinib + LBH589) Cycle 1 laboratory results (V5) Haematology 2009-011417-24

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Relevant findings within the laboratory
Item
Relevant findings within the laboratory
boolean
C0587081 (UMLS CUI [1])
Item Group
Pharmacokinetics (PK) - Cycle 1 Day 15
C0031327 (UMLS CUI-1)
Time of administration (LBH)
Item
Time of administration (LBH)
time
C1317775 (UMLS CUI [1,1])
C1566164 (UMLS CUI [1,2])
Time of administration (Imatinib)
Item
Time of administration (Imatinib)
time
C1317775 (UMLS CUI [1,1])
C0935989 (UMLS CUI [1,2])
Date of administration
Item
Date
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Pharmacokinetics sample taken
Item
PK sample taken (0h prior to therapy, 4h after therapy, 24h after 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, 4h after therapy, 24h after therapy)
time
C1277698 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2])
End Date
Item
End Date
text
C0806020 (UMLS CUI [1])
Comment
Item
If PK sample was not taken please comment
text
C0947611 (UMLS CUI [1])
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