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

Schweres unerwünschtes Ereignis - SUE

25 forms  
Demografie
Description

Demografie

Alias
UMLS CUI-1
C0011298
Klinik-Nr
Description

Hospital number

Data type

integer

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

Patient ID

Data type

integer

Alias
UMLS CUI [1]
C2348585
Patienten-Initialen
Description

Patient initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Geburtsdatum
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Geschlecht
Description

Gender

Data type

integer

Alias
UMLS CUI [1]
C0079399
Größe
Description

Patient height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0489786
cm
Gewicht
Description

Patient weight

Data type

integer

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
SUE
Description

SUE

Alias
UMLS CUI-1
C1519255
Beschreibung des unerwünschten Ereignisses
Description

Adverse event description

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0678257
Beginn des Ereignisses
Description

Start date of SAE

Data type

date

Alias
UMLS CUI [1]
C2697888
Ende des Ereignisses
Description

End date of SAE

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1519255
SUE fortbestehend
Description

SAE ongoing

Data type

boolean

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C1519255
Kausalität (mit Studienmedikation)
Description

Besteht ein Zusammenhang zwischen dem Ereignis und der Studientherapie?

Data type

integer

Alias
UMLS CUI [1]
C3641099
Verlauf
Description

Verlauf

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0750729
Verlauf
Description

Tod=(jeder Todesfall während oder innerhalb von 30 Tagen nach Abschluss der vorangegangenen protokollgemäßen Therapie)

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0750729
Patient verstorben
Description

Patient verstorben

Alias
UMLS CUI-1
C1555024
Autopsie
Description

(bitte Autopsiebericht nachsenden)

Data type

boolean

Alias
UMLS CUI [1]
C0004398
Todesursache
Description

Cause of Death

Data type

integer

Alias
UMLS CUI [1]
C0007465
Andere Todesursache
Description

Other cause of death

Data type

text

Alias
UMLS CUI [1,1]
C0007465
UMLS CUI [1,2]
C1521902
Verdächtige Präparate
Description

Verdächtige Präparate

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0750493
Verdächtige Präparate
Description

(inkl. Oberbegriff)

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0750493
Tagesdosis
Description

Daily dose

Data type

integer

Alias
UMLS CUI [1]
C2348070
Applikation
Description

Route of administration

Data type

text

Alias
UMLS CUI [1]
C0013153
Therapiedaten
Description

von-bis

Data type

durationDatetime

Alias
UMLS CUI [1]
C0444921
Bemerkungen
Description

comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Behandlung des SUE
Description

SAE treatment

Data type

text

Alias
UMLS CUI [1,1]
C2981656
UMLS CUI [1,2]
C1519255
Ausgang des SUE
Description

Wenn noch nicht bekannt, Folgebericht verschicken

Data type

text

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1519255
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

Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
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Similar models

Schweres unerwünschtes Ereignis - SUE

25 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Demografie
C0011298 (UMLS CUI-1)
Hospital number
Item
Klinik-Nr
integer
C0806432 (UMLS CUI [1])
Patient ID
Item
Patienten-Nr.:
integer
C2348585 (UMLS CUI [1])
Patient initials
Item
Patienten-Initialen
text
C2986440 (UMLS CUI [1])
Date of birth
Item
Geburtsdatum
date
C0421451 (UMLS CUI [1])
Item
Geschlecht
integer
C0079399 (UMLS CUI [1])
Gender
Code List
Geschlecht
CL Item
männlich (1)
CL Item
weiblich (2)
Patient height
Item
Größe
integer
C0489786 (UMLS CUI [1])
Patient weight
Item
Gewicht
integer
C0005910 (UMLS CUI [1])
Item Group
SUE
C1519255 (UMLS CUI-1)
Adverse event description
Item
Beschreibung des unerwünschten Ereignisses
text
C0877248 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Start date of SAE
Item
Beginn des Ereignisses
date
C2697888 (UMLS CUI [1])
End date of SAE
Item
Ende des Ereignisses
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE ongoing
Item
SUE fortbestehend
boolean
C0549178 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Kausalität (mit Studienmedikation)
integer
C3641099 (UMLS CUI [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
Verlauf
C1519255 (UMLS CUI-1)
C0750729 (UMLS CUI-2)
Item
Verlauf
integer
C1519255 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
SAE Course
Code List
Verlauf
CL Item
Tod (1)
CL Item
lebensbedrohlich (2)
CL Item
persistierende oder schwere Folgeschäden (Behinderung) (3)
CL Item
Krankenhausaufenthalt oder Verlängerung desselben notwendig (4)
CL Item
symptomatische Medikamentenüberdosierung (5)
CL Item
Entwicklung eines Medikamentenmissbrauchs oder einer Medikamentenabhängigkeit (6)
Item Group
Patient verstorben
C1555024 (UMLS CUI-1)
Autopsy
Item
Autopsie
boolean
C0004398 (UMLS CUI [1])
Item
Todesursache
integer
C0007465 (UMLS CUI [1])
Cause of Death
Code List
Todesursache
CL Item
Grunderkrankung (1)
CL Item
Therapiekomplikationen (2)
CL Item
sonstige (3)
Other cause of death
Item
Andere Todesursache
text
C0007465 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item Group
Verdächtige Präparate
C0013227 (UMLS CUI-1)
C0750493 (UMLS CUI-2)
Suspicious pharmaceutical preparations
Item
Verdächtige Präparate
text
C0013227 (UMLS CUI [1,1])
C0750493 (UMLS CUI [1,2])
Daily dose
Item
Tagesdosis
integer
C2348070 (UMLS CUI [1])
Route of administration
Item
Applikation
text
C0013153 (UMLS CUI [1])
Duration of treatment
Item
Therapiedaten
durationDatetime
C0444921 (UMLS CUI [1])
comment
Item
Bemerkungen
text
C0947611 (UMLS CUI [1])
SAE treatment
Item
Behandlung des SUE
text
C2981656 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE outcome
Item
Ausgang des SUE
text
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Date of completion
Item
Datum
date
C0011008 (UMLS CUI [1])
Investigator name
Item
Name des Studienarztes
text
C2826892 (UMLS CUI [1])
Signature
Item
Unterschrift
text
C2346576 (UMLS CUI [1])
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