ID

27685

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

Lien

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

Mots-clés

  1. 26/11/2017 26/11/2017 -
Détendeur de droits

PD Dr. Utz Krug

Téléchargé le

26 novembre 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0

Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With AML NCT01488344

Adverse events

  1. StudyEvent: ODM
    1. Adverse events
Adverse event
Description

Adverse event

Alias
UMLS CUI-1
C0877248
Number of AE
Description

Number of AE

Type de données

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0449788
Adverse event (AE)
Description

Adverse event (AE)

Type de données

text

Alias
UMLS CUI [1]
C0877248
Adverse event start date
Description

Adverse event start date

Type de données

date

Alias
UMLS CUI [1]
C2697888
severity of AE
Description

severity of AE

Type de données

integer

Alias
UMLS CUI [1]
C1710066
AE Action taken concerning therapy
Description

AE Action taken concerning therapy

Type de données

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1704758
AE study withdrawal
Description

AE study withdrawal

Type de données

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0422727
AE connected to study medication
Description

AE connected to study medication

Type de données

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2930789
AE connected to AraC
Description

AE connected to AraC

Type de données

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0010711
CTCAE-Grading
Description

CTCAE-Grading

Type de données

integer

Alias
UMLS CUI [1]
C1516728
End of AE
Description

End of AE

Type de données

date

Alias
UMLS CUI [1]
C2697886
AE continuous
Description

AE continuous

Type de données

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0549178
Adverse event course
Description

Adverse event course

Type de données

integer

Alias
UMLS CUI [1]
C1705586
investigator signature
Description

investigator signature

Alias
UMLS CUI-1
C2346576
Date of investigator signature
Description

Date of investigator signature

Type de données

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Investigator name
Description

Investigator name

Type de données

text

Alias
UMLS CUI [1]
C2826892
Investigator signature
Description

Investigator signature

Type de données

text

Alias
UMLS CUI [1]
C2346576

Similar models

Adverse events

  1. StudyEvent: ODM
    1. Adverse events
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C0877248 (UMLS CUI-1)
Number of AE
Item
integer
C0877248 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Adverse event (AE)
Item
text
C0877248 (UMLS CUI [1])
Adverse event start date
Item
date
C2697888 (UMLS CUI [1])
Item
integer
C1710066 (UMLS CUI [1])
Code List
severity of AE
CL Item
 (0)
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
Item
integer
C0877248 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Code List
AE Action taken concerning therapy
CL Item
 (0)
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
Item
text
C1519255 (UMLS CUI [1,1])
C0422727 (UMLS CUI [1,2])
Code List
AE study withdrawal
CL Item
 (j)
CL Item
 (n)
Item
text
C0877248 (UMLS CUI [1,1])
C2930789 (UMLS CUI [1,2])
Code List
AE connected to study medication
CL Item
 (j)
CL Item
 (n)
Item
text
C0877248 (UMLS CUI [1,1])
C0010711 (UMLS CUI [1,2])
Code List
AE connected to AraC
CL Item
 (j)
CL Item
 (n)
CTCAE-Grading
Item
integer
C1516728 (UMLS CUI [1])
End of AE
Item
date
C2697886 (UMLS CUI [1])
AE continuous
Item
boolean
C0877248 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item
integer
C1705586 (UMLS CUI [1])
Code List
Adverse event course
CL Item
 (0)
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
CL Item
 (4)
CL Item
 (5)
Item Group
C2346576 (UMLS CUI-1)
Date of investigator signature
Item
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator name
Item
text
C2826892 (UMLS CUI [1])
Investigator signature
Item
text
C2346576 (UMLS CUI [1])

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial