ID

44476

Description

NCT00180102 AML2003 is a prospective randomized trial, to investigate the value of early allogeneic stem cell transplantation in aplasia after induction therapy for high risk patients with acute myeloid leukemia. Phase 4 Study Type:Interventional Study Design:Allocation: Randomized Intervention Model:Factorial Assignment Masking:None (Open Label) Primary Purpose:Treatment Medical Department I, University Hospital Carl Gustav Carus Dresden, Germany, 01307 Sponsors and Collaborators Technische Universität Dresden Principal Investigator:Gerhard Ehninger, MD University Hospital Carl Gustav Carus Dresden

Keywords

Versions (2)
  1. 1/19/18 1/19/18 -
  2. 9/27/21 9/27/21 -
Copyright Holder

Technische Universität Dresden,Dr. Röllig

Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY-NC 3.0
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AML2003 - Standard-Therapy vs Intensified Therapy for Adult Acute Myeloid Leukemia Patients NCT00180102

German

2. Induktionstherapie - Unerwünschte Ereignisse CTC 3.0 -

25 forms  
Unerwünschte Ereignisse
Description

Unerwünschte Ereignisse

Alias
UMLS CUI-1
C0877248
Klinik-Nr.:
Description

Hospital number

Data type

integer

Alias
UMLS CUI [1]
C0806432
Patienten-Nr.:
Description

Patient number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Patienten-Initialen:
Description

Patient initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Ereignis
Description

Wenn schwerwiegendes unerwünschtes Ereignis, SUE-Bogen ausfüllen!

Data type

integer

Alias
UMLS CUI [1]
C0877248
Sonstiges
Description

Other adverse event

Data type

boolean

Alias
UMLS CUI [1]
C0877248
Sonstiges, bitte spezifizieren
Description

Specify other adverse event

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1521902
Beginn
Description

Adverse event start date

Data type

date

Alias
UMLS CUI [1]
C2697888
Ende
Description

Adverse event end date

Data type

date

Alias
UMLS CUI [1]
C2697886
Intensität
Description

Intensity

Data type

integer

Alias
UMLS CUI [1]
C0522510
Kausalität (mit Studienmedikation)
Description

causality

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
Bestätigung
Description

Bestätigung

Alias
UMLS CUI-1
C0750484
Datum
Description

Date of completion

Data type

date

Alias
UMLS CUI [1]
C0011008
Name des Studienarztes
Description

Investigator name

Data type

text

Alias
UMLS CUI [1]
C2826892
Unterschrift
Description

Investigator Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
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Similar models

2. Induktionstherapie - Unerwünschte Ereignisse CTC 3.0 -

25 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Unerwünschte Ereignisse
C0877248 (UMLS CUI-1)
Hospital number
Item
Klinik-Nr.:
integer
C0806432 (UMLS CUI [1])
Patient number
Item
Patienten-Nr.:
integer
C2348585 (UMLS CUI [1])
Patient initials
Item
Patienten-Initialen:
text
C2986440 (UMLS CUI [1])
Item
Ereignis
integer
C0877248 (UMLS CUI [1])
Advers event
Code List
Ereignis
CL Item
allergische Reaktion (1)
(Comment:de)
CL Item
Hämoglobin (2)
(Comment:de)
CL Item
Leukozyten (3)
(Comment:de)
CL Item
Neutrophile (4)
(Comment:de)
CL Item
Thrombozyten (5)
(Comment:de)
CL Item
Arrhythmien (6)
(Comment:de)
CL Item
kardiale Ischämie/Myokardinfarkt (7)
(Comment:de)
CL Item
Hypertonie (8)
(Comment:de)
CL Item
Hypotonie (9)
(Comment:de)
CL Item
linksventrik. systolische Dysfunktion (10)
(Comment:de)
CL Item
Perikarditis (11)
CL Item
pulmonale Hypertonie (12)
CL Item
DIC (13)
CL Item
Fibrinogen (14)
CL Item
Fieber (Neutrophile > 1,0 GPt/l) (15)
CL Item
neutropenisches Fieber > 38,5 °C (Neutrophile < 1,0 GPt/l) (16)
CL Item
Ausschlag/Schuppung (17)
CL Item
Pankreas endokrin (Glukoseintoleranz) (18)
CL Item
Diarrhoe (19)
CL Item
Dysphagie/Ösophagitis/Gastritis/Ileus (20)
CL Item
Enteritis (21)
CL Item
Mukositis/Stomatitis (22)
CL Item
Übelkeit/Erbrechen (23)
CL Item
Blutung (24)
CL Item
Pankreatitis (25)
CL Item
Infektion (26)
CL Item
Alkalische Phosphatase (27)
CL Item
ALAT, GPT (28)
CL Item
ASAT, GOT (29)
CL Item
Bilirubin (30)
CL Item
Kreatinin (31)
CL Item
GGT (32)
CL Item
Ataxie (33)
CL Item
motorische Neuropathie (34)
CL Item
sensorische Neuropathie (35)
CL Item
Krampfanfälle (36)
CL Item
Nystagmus (37)
CL Item
Augenerkrankung (38)
CL Item
Schmerzen (39)
CL Item
Dyspnoe (40)
CL Item
Hypoxie (41)
CL Item
Pleuraerguss - ohne maligne Genese (42)
CL Item
Pneumonitis/Lungeninfiltrate (43)
CL Item
Zystitis (44)
CL Item
Tumorlyse-Syndrom (45)
CL Item
Thrombose/Embolie (46)
Other adverse event
Item
Sonstiges
boolean
C0877248 (UMLS CUI [1])
Specify other adverse event
Item
Sonstiges, bitte spezifizieren
text
C0877248 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Adverse event start date
Item
Beginn
date
C2697888 (UMLS CUI [1])
Adverse event end date
Item
Ende
date
C2697886 (UMLS CUI [1])
Item
Intensität
integer
C0522510 (UMLS CUI [1])
Intensity
Code List
Intensität
CL Item
leicht (1)
CL Item
mäßig (2)
CL Item
schwer (3)
CL Item
lebensbedrohlich (4)
Item
Kausalität (mit Studienmedikation)
integer
C0304229 (UMLS CUI [1,1])
causality
Code List
Kausalität (mit Studienmedikation)
CL Item
unbekannt (0)
CL Item
nein (1)
CL Item
möglich (2)
CL Item
ja (sicher) (3)
Item Group
Bestätigung
C0750484 (UMLS CUI-1)
Date of completion
Item
Datum
date
C0011008 (UMLS CUI [1])
Investigator name
Item
Name des Studienarztes
text
C2826892 (UMLS CUI [1])
Investigator Signature
Item
Unterschrift
text
C2346576 (UMLS CUI [1])
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