ID

27238

Descrição

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

Palavras-chave

D013812

D007753

AML

Klinische Studie [Dokumenttyp]

Physical Examination

D001853

04/11/2017 04/11/2017 -

Titular dos direitos

PD Dr. Utz Krug

Transferido a

4 de novembro de 2017

DOI

Para um pedido faça login.

Licença

Creative Commons BY-NC 3.0

Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo

Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

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

model
Detalhes

Fourth cycle of therapy

1 Formulários

StudyEvent: ODM
1. Fourth cycle of therapy

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Physical examination

Item Group

Klinischer Befund

C0031809 (UMLS CUI-1)

Date of physical examination

Item

Untersuchungsdatum

date

C2826643 (UMLS CUI [1])

ECOG Status

Item

ECOG Status

integer

C1520224 (UMLS CUI [1])

ECOG Status

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])

physical examination

Item

Klinisch relevante körperliche Untersuchungsbefunde

integer

C0031809 (UMLS CUI [1])

physical examination

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])

Medication: AraC

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])

AraC Protocol

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])

Medication: BIBF 1120

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])

Dosis level BIBF 1120

Item

text

C2930789 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])

Dosis level BIBF 1120

Code List

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)

BIBF 1120 protocol

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])

Dosis level BIBF 1120

Item

text

C2930789 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])

Dosis level BIBF 1120

Code List

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])

BIBF 1120 stopped AE

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])

BIBF 1120 stopped AE

Code List

Sofern BIBF 1120 abgesetzt wurde: abgesetzt wegen AE

CL Item

ja (1)

CL Item

nein/nk (2)

Haematology

Item Group

Hämatologie

C0018941 (UMLS CUI-1)

Week number

Item

Woche

integer

C0439230 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])

Week number

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])

Hemoglobin unit of measurement

Item

Hämoglobin

integer

C0019046 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

Hemoglobin unit of measurement

Code List

Hämoglobin

CL Item

mmol/l (1)

CL Item

g/dl (2)

Hemoglobin Value

Item

Laborwert

float

C0019046 (UMLS CUI [1])

Thrombocytes unit

Item

Thrombozyten

integer

C0032181 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

Thrombocytes unit

Code List

Thrombozyten

CL Item

/μl (1)

CL Item

10^3/μl (2)

Thrombocytes value

Item

Laborwert

float

C0005821 (UMLS CUI [1])

Leukocytes unit

Item

Leukozyten

integer

C0023508 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

Leukocytes unit

Code List

Leukozyten

CL Item

/μl (1)

CL Item

10^3/μl (2)

Leukocytes value

Item

Laborwert

float

C1271681 (UMLS CUI [1])

Differential blood count

Item Group

Differentialblutbild

C0162401 (UMLS CUI-1)

Week number

Item

Woche

integer

C0439230 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])

Week number

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])

Clinical chemistry

Item Group

Klinische Chemie

C0008000 (UMLS CUI-1)
C0022885 (UMLS CUI-2)

Week number

Item

Woche

integer

C0439230 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])

Week number

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])

Bilirubin unit

Item

Bilirubin (gesamt) - Einheit

integer

C1278039 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

Bilirubin unit

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])

GOT unit

Item

GOT/AST - Einheit

integer

C0201899 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

GOT unit

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])

GPT/ALT unit

Item

GPT/ALT - Einheit

integer

C0001899 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

GPT/ALT unit

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])

AP unit

Item

AP - Einheit

integer

C0201850 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

AP unit

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])

Item

float

C0428332 (UMLS CUI [1])

LDH unit

Item

LDH - Einheit

integer

C0202113 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

LDH unit

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])

Total Protein unit

Item

Gesamteiweiß - Einheit

integer

C0555903 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

Total Protein unit

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])

Uric acid unit

Item

Harnsäure - Einheit

integer

C0041980 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

Uric acid unit

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])

Urea unit

Item

Harnstoff - Einheit

integer

C0523961 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

Urea unit

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])

Creatinine unit

Item

Kreatinin - Einheit

integer

C0201976 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

Creatinine unit

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])

CRP unit

Item

CRP - Einheit

integer

C0201657 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

CRP unit

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])

Fibrinogen unit

Item

Fibrinogen - Einheit

integer

C0016006 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

Fibrinogen unit

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])

Bone marrow examination

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])

sample shipping to

Item

Obligater Materialversand (Knochenmark und Blut) nach:

integer

C0178913 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C1524049 (UMLS CUI [1,3])

sample shipping to

Code List

Obligater Materialversand (Knochenmark und Blut) nach:

CL Item

Münster (1)

CL Item

Dresden (2)

CL Item

Frankfurt/Main (3)

Blasts in bone marrow

Item

Blastenanteil

integer

C1982687 (UMLS CUI [1])

Blasts in bone marrow

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])

Parameter examined from

Item

Parameter bestimmt aus

integer

C0022885 (UMLS CUI [1,1])
C0184921 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])

Parameter examined from

Code List

Parameter bestimmt aus

CL Item

Punktion (1)

CL Item

Stanze (2)

Extramedullary AML manifestation

Item

Extramedulläre AML-Manifestation

integer

C1868812 (UMLS CUI [1,1])
C0023467 (UMLS CUI [1,2])

Extramedullary AML manifestation

Code List

Extramedulläre AML-Manifestation

CL Item

ja (1)

CL Item

nein (2)

CL Item

nicht bekannt (3)

localisation of extra medullary AML manifestation

Item

Wenn ja, Lokalisation

integer

C1868812 (UMLS CUI [1,1])
C0023467 (UMLS CUI [1,2])
C0475264 (UMLS CUI [1,3])

localisation of extra medullary AML manifestation

Code List

Wenn ja, Lokalisation

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])

Remission status

Item

Remissionsstatus

integer

C0544452 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0023467 (UMLS CUI [1,3])

Remission status

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)

Therapy decision

Item

Therapieentscheidung

integer

C2348568 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])

Therapy decision

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)

investigator signature

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])

Voltar ao início da página

ID

Descrição

Link

Palavras-chave

Versões (1)

Titular dos direitos

Transferido a

DOI

Licença

Comentários do modelo :

Comentários do grupo de itens para :

Comentários do item para :

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

Fourth cycle of therapy

Descrição

Alias

Descrição

Tipo de dados

Alias

Descrição

Tipo de dados

Alias

Descrição

Tipo de dados

Unidades de medida

Alias

Descrição

Tipo de dados

Alias

Descrição

Tipo de dados

Alias

Descrição

Alias

Descrição

Tipo de dados

Alias

Descrição

Alias

Descrição

Tipo de dados

Alias

Descrição

Tipo de dados

Alias

Descrição

Tipo de dados

Alias

Descrição

Tipo de dados

Unidades de medida

Alias

Descrição

Alias

Descrição

Tipo de dados

Alias

Descrição

Tipo de dados

Alias

Descrição

Tipo de dados

Alias

Descrição

Alias

Descrição

Tipo de dados

Alias

Descrição

Tipo de dados

Alias

Descrição

Tipo de dados

Alias

Descrição

Tipo de dados

Alias

Descrição

Tipo de dados

Unidades de medida