ID

27238

Description

Phase I/II Trial: BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With Acute Myeloid Leukemia (AML) - NCT01488344 https://clinicaltrials.gov/ct2/show/NCT01488344 Principal Investigator PD Dr. Utz Krug RATIONALE: Low-dose cytarabine works in a minority of elderly patients with an acute myeloid leukemia unfit for intensive induction therapy by killing of leukemia cells. Addition of BIBF1120 to low-dose cytarabine might enhance the killing of leukemia cells. PURPOSE: This phase I / II trial is studying how safe BIBF1120 can be combined with low-dose cytarabine (phase I) and how well the combination of low-dose cytarabine and BIBF1120 works in elderly patients with acute myeloid leukemia unfit for intensive chemotherapy (phase II). Study Type: Interventional Study Design: Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Single-arm, Open Label, Multi-center Phase I/II Trial to Assess the Safety and Efficacy of BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With AML Unfit for an Intensive Induction Therapy

Link

https://clinicaltrials.gov/ct2/show/NCT01488344

Keywords

  1. 11/4/17 11/4/17 -
Copyright Holder

PD Dr. Utz Krug

Uploaded on

November 4, 2017

DOI

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License

Creative Commons BY-NC 3.0

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Fourth cycle of therapy- BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With AML NCT01488344

Fourth cycle of therapy

Klinischer Befund
Description

Klinischer Befund

Alias
UMLS CUI-1
C0031809
Untersuchungsdatum
Description

Date of physical examination

Data type

date

Alias
UMLS CUI [1]
C2826643
ECOG Status
Description

ECOG Status

Data type

integer

Alias
UMLS CUI [1]
C1520224
Gewicht
Description

Weight

Data type

float

Measurement units
  • Kg
Alias
UMLS CUI [1]
C0005910
Kg
Klinisch relevante körperliche Untersuchungsbefunde
Description

physical examination

Data type

integer

Alias
UMLS CUI [1]
C0031809
Auffällig, bitte spezifizieren
Description

Specify physical examination

Data type

text

Alias
UMLS CUI [1]
C0747585
Medication: AraC
Description

Medication: AraC

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0010711
AraC wurde gemäß Protokoll (2 x 20mg s.c. Tag 1 - 10; ges. 400mg) appliziert.
Description

AraC following protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0010711
UMLS CUI [1,2]
C1507394
AraC Protocol
Description

AraC Protocol

Alias
UMLS CUI-1
C0010711
UMLS CUI-2
C1507394
Nr.
Description

Number

Data type

integer

Alias
UMLS CUI [1]
C0750480
Start
Description

Start date AraC

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0010711
Ende
Description

End Date AraC

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0010711
tägliche Gabe s.c.
Description

daily dose s.c.

Data type

integer

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0021499
mg
Medikation: BIBF 1120
Description

Medikation: BIBF 1120

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C2930789
BIBF 1120 wurde in diesem Zyklus durchgehend in einer Dosierung appliziert
Description

BIBF 1120 following protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C2930789
UMLS CUI [1,2]
C1507394
Start: Tag 1(= Tag 1 AraC) und Ende:
Description

End date BIBF 1120

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C2930789
DL
Description

Dosis level BIBF 1120

Data type

text

Alias
UMLS CUI [1,1]
C2930789
UMLS CUI [1,2]
C3174092
BIBF 1120 protocol
Description

BIBF 1120 protocol

Alias
UMLS CUI-1
C2930789
UMLS CUI-2
C1507394
Nr.
Description

Number

Data type

integer

Alias
UMLS CUI [1]
C0750480
Start
Description

Start date BIBF 1120

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C2930789
Ende
Description

End date BIBF 1120

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C2930789
DL
Description

Dosis level BIBF 1120

Data type

text

Alias
UMLS CUI [1,1]
C2930789
UMLS CUI [1,2]
C3174092
Falls abweichend von DL: tägliche Gabe
Description

daily dose BIBF 1120

Data type

text

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C2930789
mg
Sofern BIBF 1120 abgesetzt wurde: abgesetzt wegen AE
Description

falls wegen AE abgesetzt: AE und ggf. SAE dokumentieren

Data type

integer

Alias
UMLS CUI [1,1]
C2930789
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0877248
Hämatologie
Description

Hämatologie

Alias
UMLS CUI-1
C0018941
Woche
Description

Week number

Data type

integer

Alias
UMLS CUI [1,1]
C0439230
UMLS CUI [1,2]
C0449788
Datum
Description

Date of laboratory evaluation

Data type

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0011008
Hämoglobin
Description

Hemoglobin unit of measurement

Data type

integer

Alias
UMLS CUI [1,1]
C0019046
UMLS CUI [1,2]
C1519795
Laborwert
Description

Hemoglobin Value

Data type

float

Alias
UMLS CUI [1]
C0019046
Thrombozyten
Description

Thrombocytes unit

Data type

integer

Alias
UMLS CUI [1,1]
C0032181
UMLS CUI [1,2]
C1519795
Laborwert
Description

Thrombocytes value

Data type

float

Alias
UMLS CUI [1]
C0005821
Leukozyten
Description

Leukocytes unit

Data type

integer

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C1519795
Laborwert
Description

Leukocytes value

Data type

float

Alias
UMLS CUI [1]
C1271681
Differentialblutbild
Description

Differentialblutbild

Alias
UMLS CUI-1
C0162401
Woche
Description

Week number

Data type

integer

Alias
UMLS CUI [1,1]
C0439230
UMLS CUI [1,2]
C0449788
Datum
Description

Date of laboratory evaluation

Data type

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0011008
Neutrophile
Description

Neutrophiles

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0200633
%
Blasten
Description

Blasts

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1,1]
C0587348
UMLS CUI [1,2]
C0005767
%
Monozyten normal
Description

Monocytes normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0026473
UMLS CUI [1,2]
C0205307
Monozyten
Description

Monocytes %

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0026473
%
Eosinophile normal
Description

Eosinophiles normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0750879
UMLS CUI [1,2]
C0205307
Eosinophile
Description

Eosinophiles %

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0750879
%
Basophile normal
Description

Basophiles normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0200641
UMLS CUI [1,2]
C0205307
Basophile
Description

Basophiles %

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0200641
%
Lymphozyten normal
Description

Lymphocytes normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0200635
UMLS CUI [1,2]
C0205307
Lymphozyten
Description

Lymphocytes %

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0200635
%
keine Promyelozyten
Description

Promyelocytes

Data type

boolean

Alias
UMLS CUI [1]
C0455279
Promyelozyten
Description

Promyelocytes

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0455279
%
keine Myelozyten
Description

Myelocytes

Data type

boolean

Alias
UMLS CUI [1]
C0455284
Myelozyten
Description

Myelocytes

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0455284
%
keine Metamyelozyten
Description

Metamyelocytes

Data type

boolean

Alias
UMLS CUI [1]
C0229635
Metamyelozyten
Description

Metamyelocytes

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0229635
%
keine sonstigen Zellen
Description

Other cells in differential blood count

Data type

boolean

Alias
UMLS CUI [1,1]
C0162401
UMLS CUI [1,2]
C0086574
Sonstige Zellen
Description

Other cells in differential blood cell count

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1,1]
C0162401
UMLS CUI [1,2]
C0086574
%
Klinische Chemie
Description

Klinische Chemie

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0022885
Woche
Description

Week number

Data type

integer

Alias
UMLS CUI [1,1]
C0439230
UMLS CUI [1,2]
C0449788
Datum
Description

Date of laboratory evaluation

Data type

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0011008
Bilirubin (gesamt) - Einheit
Description

Bilirubin unit

Data type

integer

Alias
UMLS CUI [1,1]
C1278039
UMLS CUI [1,2]
C1519795
Bilirubin normal
Description

Bei Patienten mit normalen Bilirubin, GOT und GPT-Werten bei Ersterhebung: Falls Bilirubin > 2 x ULN und GOT und/oder GPT > 3 x ULN bitte als AE of special interest dokumentieren und un- verzüglich auf SAE-Bogen melden.

Data type

boolean

Alias
UMLS CUI [1]
C0858307
Bilirubin bis 2xULN
Description

Bilirubin <= 2xULN

Data type

boolean

Alias
UMLS CUI [1,1]
C0201913
UMLS CUI [1,2]
C1519815
Bilirubin >2xULN
Description

Bilirubin >2xULN

Data type

boolean

Alias
UMLS CUI [1,1]
C0201913
UMLS CUI [1,2]
C1519815
Bilirubin (gesamt)
Description

total bilirubin

Data type

float

Alias
UMLS CUI [1]
C0201913
GOT/AST - Einheit
Description

GOT unit

Data type

integer

Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C1519795
GOT/AST normal
Description

Bei Patienten mit normalen Bilirubin, GOT und GPT-Werten bei Ersterhebung: Falls Bilirubin > 2 x ULN und GOT und/oder GPT > 3 x ULN bitte als AE of special interest dokumentieren und un- verzüglich auf SAE-Bogen melden.

Data type

boolean

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0201899
GOT bis 3xULN
Description

GOT <= 3xULN

Data type

boolean

Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C1519815
GOT >3xULN
Description

GOT >3xULN

Data type

boolean

Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C1519815
GOT/AST
Description

GOT

Data type

float

Alias
UMLS CUI [1]
C0201899
GPT/ALT - Einheit
Description

GPT/ALT unit

Data type

integer

Alias
UMLS CUI [1,1]
C0001899
UMLS CUI [1,2]
C1519795
GPT/ALT normal
Description

Bei Patienten mit normalen Bilirubin, GOT und GPT-Werten bei Ersterhebung: Falls Bilirubin > 2 x ULN und GOT und/oder GPT > 3 x ULN bitte als AE of special interest dokumentieren und un- verzüglich auf SAE-Bogen melden.

Data type

boolean

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C0205307
GPT/ALT bis 3xULN
Description

GPT/ALT <=3xULN

Data type

boolean

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C1519815
GPT/ALT >3xULN
Description

GPT/ALT >3xULN

Data type

boolean

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C1519815
GPT/ALT
Description

GPT/ALT

Data type

float

Alias
UMLS CUI [1]
C0201836
AP - Einheit
Description

AP unit

Data type

integer

Alias
UMLS CUI [1,1]
C0201850
UMLS CUI [1,2]
C1519795
AP normal
Description

AP normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0201850
UMLS CUI [1,2]
C0205307
AP
Description

AP

Data type

float

Alias
UMLS CUI [1]
C0428332
LDH - Einheit
Description

LDH unit

Data type

integer

Alias
UMLS CUI [1,1]
C0202113
UMLS CUI [1,2]
C1519795
LDH normal
Description

LDH normal

Data type

boolean

Alias
UMLS CUI [1]
C0853788
LDH
Description

LDH

Data type

float

Alias
UMLS CUI [1]
C0202113
Natrium normal
Description

Natrium normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0523891
UMLS CUI [1,2]
C0205307
Natrium
Description

Natrium

Data type

float

Measurement units
  • mmol/l
Alias
UMLS CUI [1]
C0523891
mmol/l
Kalium normal
Description

Potassium normal

Data type

boolean

Alias
UMLS CUI [1]
C0580477
Kalium
Description

Potassium

Data type

float

Measurement units
  • mmol/l
Alias
UMLS CUI [1]
C0202194
mmol/l
Gesamteiweiß - Einheit
Description

Total Protein unit

Data type

integer

Alias
UMLS CUI [1,1]
C0555903
UMLS CUI [1,2]
C1519795
Gesamteiweiß normal
Description

Total protein normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0555903
UMLS CUI [1,2]
C0205307
Gesamteiweiß
Description

Total protein

Data type

float

Alias
UMLS CUI [1]
C0036836
Harnsäure - Einheit
Description

Uric acid unit

Data type

integer

Alias
UMLS CUI [1,1]
C0041980
UMLS CUI [1,2]
C1519795
Harnsäure normal
Description

Uric acid normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0041980
UMLS CUI [1,2]
C0205307
Harnsäure
Description

Uric acid

Data type

float

Alias
UMLS CUI [1]
C0041980
Harnstoff - Einheit
Description

Urea unit

Data type

integer

Alias
UMLS CUI [1,1]
C0523961
UMLS CUI [1,2]
C1519795
Harnstoff normal
Description

Urea normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0523961
UMLS CUI [1,2]
C0205307
Harnstoff
Description

Urea

Data type

float

Alias
UMLS CUI [1]
C0523961
Kreatinin - Einheit
Description

Creatinine unit

Data type

integer

Alias
UMLS CUI [1,1]
C0201976
UMLS CUI [1,2]
C1519795
Kreatinin normal
Description

Creatinine normal

Data type

boolean

Alias
UMLS CUI [1]
C0860945
Kreatinin
Description

Creatinine

Data type

float

Alias
UMLS CUI [1]
C0201976
CRP - Einheit
Description

CRP unit

Data type

integer

Alias
UMLS CUI [1,1]
C0201657
UMLS CUI [1,2]
C1519795
CRP normal
Description

CRP normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0201657
UMLS CUI [1,2]
C0205307
CRP
Description

C-reactive protein

Data type

float

Alias
UMLS CUI [1]
C0006560
INR normal
Description

INR normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0525032
UMLS CUI [1,2]
C0205307
INR
Description

INR

Data type

integer

Alias
UMLS CUI [1]
C0525032
PTT normal
Description

PTT normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0030605
UMLS CUI [1,2]
C0205307
PTT
Description

PTT

Data type

integer

Measurement units
  • sek
Alias
UMLS CUI [1]
C0030605
sek
Fibrinogen - Einheit
Description

Fibrinogen unit

Data type

integer

Alias
UMLS CUI [1,1]
C0016006
UMLS CUI [1,2]
C1519795
Fibrinogen normal
Description

Fibrinogen normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0016006
UMLS CUI [1,2]
C0205307
Fibrinogen
Description

Fibrinogen

Data type

float

Alias
UMLS CUI [1]
C0016006
AT III normal
Description

AT III normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0200416
UMLS CUI [1,2]
C0205307
AT III
Description

AT III

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0200416
%
Knochenmarksuntersuchung Tag 26 +/- 2
Description

Knochenmarksuntersuchung Tag 26 +/- 2

Alias
UMLS CUI-1
C0005957
Datum
Description

Date of Bone marrow examination

Data type

date

Alias
UMLS CUI [1,1]
C0005957
UMLS CUI [1,2]
C0011008
Obligater Materialversand (Knochenmark und Blut) nach:
Description

sample shipping to

Data type

integer

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C1524049
Blastenanteil
Description

Blasts in bone marrow

Data type

integer

Alias
UMLS CUI [1]
C1982687
wenn ≥ 5 %, dann bitte angeben:
Description

Blasts in bone marrow >5%

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C1982687
%
Parameter bestimmt aus
Description

Parameter examined from

Data type

integer

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0184921
UMLS CUI [1,3]
C0332307
Extramedulläre AML-Manifestation
Description

Extramedullary AML manifestation

Data type

integer

Alias
UMLS CUI [1,1]
C1868812
UMLS CUI [1,2]
C0023467
Wenn ja, Lokalisation
Description

localisation of extra medullary AML manifestation

Data type

integer

Alias
UMLS CUI [1,1]
C1868812
UMLS CUI [1,2]
C0023467
UMLS CUI [1,3]
C0475264
andere Lokalisation
Description

other location

Data type

text

Alias
UMLS CUI [1,1]
C1868812
UMLS CUI [1,2]
C0450429
UMLS CUI [1,3]
C0205394
Remissionsstatus
Description

CR: < 5% KM-Blasten, Neutrophile > 1.000/μl, Thrombozyten > 100.000/μl CRp: < 5% KM-Blasten, Neutrophile > 1.000/μl, Thrombozyten < 100.000/μl CRi: < 5% KM-Blasten, Neutrophile < 1.000/μl, unabhängig von der Thrombozytenzahl

Data type

integer

Alias
UMLS CUI [1,1]
C0544452
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C0023467
Therapieentscheidung
Description

Therapy decision

Data type

integer

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0679006
Unterschrift
Description

Unterschrift

Alias
UMLS CUI-1
C2346576
Datum
Description

Date of investigator signature

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Name
Description

Investigator name

Data type

text

Alias
UMLS CUI [1]
C2826892
Unterschrift
Description

Investigator signature

Data type

text

Alias
UMLS CUI [1]
C2346576

Similar models

Fourth cycle of therapy

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Klinischer Befund
C0031809 (UMLS CUI-1)
Date of physical examination
Item
Untersuchungsdatum
date
C2826643 (UMLS CUI [1])
Item
ECOG Status
integer
C1520224 (UMLS CUI [1])
Code List
ECOG Status
CL Item
ECOG Status 0 (Normale Leistungsfähigkeit) (0)
CL Item
ECOG Status 1 (Ambulante Betreuung, leichte Arbeiten möglich) (1)
CL Item
ECOG Status 2 (Weniger als 50% am Tage bettlägerig, Selbstversorgung möglich, aber nicht arbeitsfähig) (2)
CL Item
ECOG Status 3 (Mehr als 50% am Tage bettlägerig, begrenzte Selbstversorgung noch möglich) (3)
CL Item
ECOG Status 4 (Ständig bettlägerig) (4)
Weight
Item
Gewicht
float
C0005910 (UMLS CUI [1])
Item
Klinisch relevante körperliche Untersuchungsbefunde
integer
C0031809 (UMLS CUI [1])
Code List
Klinisch relevante körperliche Untersuchungsbefunde
CL Item
unauffällig/keine Änderung zur Vorvisite (1)
(Comment:de-DE)
CL Item
auffällig, bitte spezifzieren (2)
(Comment:de-DE)
Specify physical examination
Item
Auffällig, bitte spezifizieren
text
C0747585 (UMLS CUI [1])
Item Group
Medication: AraC
C0013227 (UMLS CUI-1)
C0010711 (UMLS CUI-2)
AraC following protocol
Item
AraC wurde gemäß Protokoll (2 x 20mg s.c. Tag 1 - 10; ges. 400mg) appliziert.
boolean
C0010711 (UMLS CUI [1,1])
C1507394 (UMLS CUI [1,2])
Item Group
AraC Protocol
C0010711 (UMLS CUI-1)
C1507394 (UMLS CUI-2)
Number
Item
Nr.
integer
C0750480 (UMLS CUI [1])
Start date AraC
Item
Start
date
C0808070 (UMLS CUI [1,1])
C0010711 (UMLS CUI [1,2])
End Date AraC
Item
Ende
date
C0806020 (UMLS CUI [1,1])
C0010711 (UMLS CUI [1,2])
daily dose s.c.
Item
tägliche Gabe s.c.
integer
C2348070 (UMLS CUI [1,1])
C0021499 (UMLS CUI [1,2])
Item Group
Medikation: BIBF 1120
C0013227 (UMLS CUI-1)
C2930789 (UMLS CUI-2)
BIBF 1120 following protocol
Item
BIBF 1120 wurde in diesem Zyklus durchgehend in einer Dosierung appliziert
boolean
C2930789 (UMLS CUI [1,1])
C1507394 (UMLS CUI [1,2])
End date BIBF 1120
Item
Start: Tag 1(= Tag 1 AraC) und Ende:
date
C0806020 (UMLS CUI [1,1])
C2930789 (UMLS CUI [1,2])
Item
DL
text
C2930789 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
CL Item
1 x 100 mg (DL 0)
CL Item
2 x 100 mg (DL 1)
CL Item
2 x 150 mg (DL 2)
CL Item
2 x 200 mg (DL 3)
Item Group
BIBF 1120 protocol
C2930789 (UMLS CUI-1)
C1507394 (UMLS CUI-2)
Number
Item
Nr.
integer
C0750480 (UMLS CUI [1])
Start date BIBF 1120
Item
Start
date
C0808070 (UMLS CUI [1,1])
C2930789 (UMLS CUI [1,2])
End date BIBF 1120
Item
Ende
date
C0806020 (UMLS CUI [1,1])
C2930789 (UMLS CUI [1,2])
Item
DL
text
C2930789 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
CL Item
1 x 100 mg (DL 0)
CL Item
2 x 100 mg (DL 1)
CL Item
2 x 150 mg (DL 2)
CL Item
2 x 200 mg (DL 3)
daily dose BIBF 1120
Item
Falls abweichend von DL: tägliche Gabe
text
C2348070 (UMLS CUI [1,1])
C2930789 (UMLS CUI [1,2])
Item
Sofern BIBF 1120 abgesetzt wurde: abgesetzt wegen AE
integer
C2930789 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Code List
Sofern BIBF 1120 abgesetzt wurde: abgesetzt wegen AE
CL Item
ja (1)
CL Item
nein/nk (2)
Item Group
Hämatologie
C0018941 (UMLS CUI-1)
Item
Woche
integer
C0439230 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Code List
Woche
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Date of laboratory evaluation
Item
Datum
date
C0022885 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Hämoglobin
integer
C0019046 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Code List
Hämoglobin
CL Item
mmol/l (1)
CL Item
g/dl (2)
Hemoglobin Value
Item
Laborwert
float
C0019046 (UMLS CUI [1])
Item
Thrombozyten
integer
C0032181 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Code List
Thrombozyten
CL Item
/μl  (1)
CL Item
10^3/μl (2)
Thrombocytes value
Item
Laborwert
float
C0005821 (UMLS CUI [1])
Item
Leukozyten
integer
C0023508 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Code List
Leukozyten
CL Item
/μl  (1)
CL Item
10^3/μl (2)
Leukocytes value
Item
Laborwert
float
C1271681 (UMLS CUI [1])
Item Group
Differentialblutbild
C0162401 (UMLS CUI-1)
Item
Woche
integer
C0439230 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Code List
Woche
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Date of laboratory evaluation
Item
Datum
date
C0022885 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Neutrophiles
Item
Neutrophile
float
C0200633 (UMLS CUI [1])
Blasts
Item
Blasten
float
C0587348 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
Monocytes normal
Item
Monozyten normal
boolean
C0026473 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
Monocytes %
Item
Monozyten
float
C0026473 (UMLS CUI [1])
Eosinophiles normal
Item
Eosinophile normal
boolean
C0750879 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
Eosinophiles %
Item
Eosinophile
float
C0750879 (UMLS CUI [1])
Basophiles normal
Item
Basophile normal
boolean
C0200641 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
Basophiles %
Item
Basophile
float
C0200641 (UMLS CUI [1])
Lymphocytes normal
Item
Lymphozyten normal
boolean
C0200635 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
Lymphocytes %
Item
Lymphozyten
float
C0200635 (UMLS CUI [1])
Promyelocytes
Item
keine Promyelozyten
boolean
C0455279 (UMLS CUI [1])
Promyelocytes
Item
Promyelozyten
float
C0455279 (UMLS CUI [1])
Myelocytes
Item
keine Myelozyten
boolean
C0455284 (UMLS CUI [1])
Myelocytes
Item
Myelozyten
float
C0455284 (UMLS CUI [1])
Metamyelocytes
Item
keine Metamyelozyten
boolean
C0229635 (UMLS CUI [1])
Metamyelocytes
Item
Metamyelozyten
float
C0229635 (UMLS CUI [1])
Other cells in differential blood count
Item
keine sonstigen Zellen
boolean
C0162401 (UMLS CUI [1,1])
C0086574 (UMLS CUI [1,2])
Other cells in differential blood cell count
Item
Sonstige Zellen
float
C0162401 (UMLS CUI [1,1])
C0086574 (UMLS CUI [1,2])
Item Group
Klinische Chemie
C0008000 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
Item
Woche
integer
C0439230 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Code List
Woche
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Date of laboratory evaluation
Item
Datum
date
C0022885 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Bilirubin (gesamt) - Einheit
integer
C1278039 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Code List
Bilirubin (gesamt) - Einheit
CL Item
mg/dl  (1)
CL Item
μmol/l (2)
Bilirubin normal
Item
Bilirubin normal
boolean
C0858307 (UMLS CUI [1])
Bilirubin <= 2xULN
Item
Bilirubin bis 2xULN
boolean
C0201913 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
Bilirubin >2xULN
Item
Bilirubin >2xULN
boolean
C0201913 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
total bilirubin
Item
Bilirubin (gesamt)
float
C0201913 (UMLS CUI [1])
Item
GOT/AST - Einheit
integer
C0201899 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Code List
GOT/AST - Einheit
CL Item
U/l  (1)
CL Item
μmol/s*l (2)
GOT normal
Item
GOT/AST normal
boolean
C0036743 (UMLS CUI [1,1])
C0201899 (UMLS CUI [1,2])
GOT <= 3xULN
Item
GOT bis 3xULN
boolean
C0201899 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
GOT >3xULN
Item
GOT >3xULN
boolean
C0201899 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
GOT
Item
GOT/AST
float
C0201899 (UMLS CUI [1])
Item
GPT/ALT - Einheit
integer
C0001899 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Code List
GPT/ALT - Einheit
CL Item
U/l  (1)
CL Item
μmol/s*l (2)
GPT normal
Item
GPT/ALT normal
boolean
C0201836 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
GPT/ALT <=3xULN
Item
GPT/ALT bis 3xULN
boolean
C0201836 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
GPT/ALT >3xULN
Item
GPT/ALT >3xULN
boolean
C0201836 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
GPT/ALT
Item
GPT/ALT
float
C0201836 (UMLS CUI [1])
Item
AP - Einheit
integer
C0201850 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Code List
AP - Einheit
CL Item
U/l  (1)
CL Item
μmol/s*l (2)
AP normal
Item
AP normal
boolean
C0201850 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
AP
Item
AP
float
C0428332 (UMLS CUI [1])
Item
LDH - Einheit
integer
C0202113 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Code List
LDH - Einheit
CL Item
U/l  (1)
CL Item
μmol/s*l (2)
LDH normal
Item
LDH normal
boolean
C0853788 (UMLS CUI [1])
LDH
Item
LDH
float
C0202113 (UMLS CUI [1])
Natrium normal
Item
Natrium normal
boolean
C0523891 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
Natrium
Item
Natrium
float
C0523891 (UMLS CUI [1])
Potassium normal
Item
Kalium normal
boolean
C0580477 (UMLS CUI [1])
Potassium
Item
Kalium
float
C0202194 (UMLS CUI [1])
Item
Gesamteiweiß - Einheit
integer
C0555903 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Code List
Gesamteiweiß - Einheit
CL Item
g/l  (1)
CL Item
g/dl (2)
Total protein normal
Item
Gesamteiweiß normal
boolean
C0555903 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
Total protein
Item
Gesamteiweiß
float
C0036836 (UMLS CUI [1])
Item
Harnsäure - Einheit
integer
C0041980 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Code List
Harnsäure - Einheit
CL Item
mg/dl  (1)
CL Item
μmol/l (2)
Uric acid normal
Item
Harnsäure normal
boolean
C0041980 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
Uric acid
Item
Harnsäure
float
C0041980 (UMLS CUI [1])
Item
Harnstoff - Einheit
integer
C0523961 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Code List
Harnstoff - Einheit
CL Item
mg/dl  (1)
CL Item
mmol/l (2)
Urea normal
Item
Harnstoff normal
boolean
C0523961 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
Urea
Item
Harnstoff
float
C0523961 (UMLS CUI [1])
Item
Kreatinin - Einheit
integer
C0201976 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Code List
Kreatinin - Einheit
CL Item
mg/dl  (1)
CL Item
μmol/l (2)
Creatinine normal
Item
Kreatinin normal
boolean
C0860945 (UMLS CUI [1])
Creatinine
Item
Kreatinin
float
C0201976 (UMLS CUI [1])
Item
CRP - Einheit
integer
C0201657 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Code List
CRP - Einheit
CL Item
mg/l  (1)
CL Item
mg/dl (2)
CRP normal
Item
CRP normal
boolean
C0201657 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C-reactive protein
Item
CRP
float
C0006560 (UMLS CUI [1])
INR normal
Item
INR normal
boolean
C0525032 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
INR
Item
INR
integer
C0525032 (UMLS CUI [1])
PTT normal
Item
PTT normal
boolean
C0030605 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
PTT
Item
PTT
integer
C0030605 (UMLS CUI [1])
Item
Fibrinogen - Einheit
integer
C0016006 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Code List
Fibrinogen - Einheit
CL Item
mg/dl  (1)
CL Item
μmol/l  (2)
CL Item
g/l (3)
Fibrinogen normal
Item
Fibrinogen normal
boolean
C0016006 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
Fibrinogen
Item
Fibrinogen
float
C0016006 (UMLS CUI [1])
AT III normal
Item
AT III normal
boolean
C0200416 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
AT III
Item
AT III
float
C0200416 (UMLS CUI [1])
Item Group
Knochenmarksuntersuchung Tag 26 +/- 2
C0005957 (UMLS CUI-1)
Date of Bone marrow examination
Item
Datum
date
C0005957 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Obligater Materialversand (Knochenmark und Blut) nach:
integer
C0178913 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C1524049 (UMLS CUI [1,3])
Code List
Obligater Materialversand (Knochenmark und Blut) nach:
CL Item
Münster (1)
CL Item
Dresden (2)
CL Item
Frankfurt/Main (3)
Item
Blastenanteil
integer
C1982687 (UMLS CUI [1])
Code List
Blastenanteil
CL Item
<5% (1)
CL Item
>= 5% (2)
CL Item
nicht beurteilbar (3)
CL Item
nicht untersucht (weil z.B. P. sicca) (4)
Blasts in bone marrow >5%
Item
wenn ≥ 5 %, dann bitte angeben:
integer
C1982687 (UMLS CUI [1])
Item
Parameter bestimmt aus
integer
C0022885 (UMLS CUI [1,1])
C0184921 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Code List
Parameter bestimmt aus
CL Item
Punktion (1)
CL Item
Stanze (2)
Item
Extramedulläre AML-Manifestation
integer
C1868812 (UMLS CUI [1,1])
C0023467 (UMLS CUI [1,2])
Code List
Extramedulläre AML-Manifestation
CL Item
ja  (1)
CL Item
nein (2)
CL Item
nicht bekannt (3)
Item
Wenn ja, Lokalisation
integer
C1868812 (UMLS CUI [1,1])
C0023467 (UMLS CUI [1,2])
C0475264 (UMLS CUI [1,3])
CL Item
ZNS (1)
CL Item
andere (2)
other location
Item
andere Lokalisation
text
C1868812 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item
Remissionsstatus
integer
C0544452 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0023467 (UMLS CUI [1,3])
Code List
Remissionsstatus
CL Item
CR (1)
CL Item
CRp (2)
CL Item
CRi (3)
CL Item
partielle Remission  (4)
CL Item
stabile Erkrankung (5)
CL Item
Progression (Abbruchkriterium) (6)
Item
Therapieentscheidung
integer
C2348568 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Code List
Therapieentscheidung
CL Item
Ende der Behandlung, da CR, CRp, CRi (Dokumentation des regulären Studienendes 28 Tage nach letzter BIBF 1120- oder AraC-Gabe ab S. 44) (1)
CL Item
Fortsetzung der Behandlung (Dokumentation des nächsten Therapiezyklus) (2)
CL Item
Abbruch wegen Progression, intolerabler Toxizität oder Tod (Dokumentation des Studienabbruchs auf S. 46) (Sofern erforderlich: bitte AE und ggf. SAE dokumentieren) (3)
Item Group
Unterschrift
C2346576 (UMLS CUI-1)
Date of investigator signature
Item
Datum
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator name
Item
Name
text
C2826892 (UMLS CUI [1])
Investigator signature
Item
Unterschrift
text
C2346576 (UMLS CUI [1])

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