ID

36226

Beschreibung

Randomized Comparison Between Two Dose Levels of Daunorubicin and Between One Versus Two Cycles of Induction Therapy for Adult Patients With Acute Myeloid Leukemia <=60 Years. See further details on: https://www.clinicaltrials.gov/ct2/show/NCT02140242 Principal Investigator: PD Dr. med. Christoph Röllig, MSc Source:PD Dr. med. Christoph Röllig, MSc Universitätsklinikum Dresden

Link

https://www.clinicaltrials.gov/ct2/show/NCT02140242

Stichworte

Versionen (3)
  1. 24.10.17 24.10.17 - Julian Varghese
  2. 23.04.19 23.04.19 - Sarah Riepenhausen
  3. 20.09.21 20.09.21 -
Rechteinhaber

PD Dr. med. Christoph Röllig, MSc

Hochgeladen am

23. April 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Daunorubicin Acute Myeloid Leukemia NCT02140242

Englisch

Adverse events and Death sheet

12 Formulare  
Adverse Events
Beschreibung

Adverse Events

Alias
UMLS CUI-1
C0877248
Randomization number
Beschreibung

2DAUNO - xxx(local trial center number) - xxx(patient inclusion number) - xx(treatment arm part I) - x(treatment arm part II)

Datentyp

integer

Alias
UMLS CUI [1,1]
C2348585
UMLS CUI [1,2]
C0034656
Adverse event
Beschreibung

Please document AEs according to NCI-CTCAE version 4.0 Please document each NEW AE which occurs until (date of last administration Daunorubicin in trial plus 28 days).

Datentyp

boolean

Alias
UMLS CUI [1]
C0877248
Adverse Events specification
Beschreibung

Adverse Events specification

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C2348235
Consecutively numbered AEs
Beschreibung

AE line number

Datentyp

integer

Alias
UMLS CUI [1]
C2826275
Adverse event
Beschreibung

Adverse event

Datentyp

integer

Alias
UMLS CUI [1]
C0877248
Specify localization of hematoma
Beschreibung

Adverse Event

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1521902
Specify hemorrhaging organ
Beschreibung

Adverse Event

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1521902
Specify infected organ
Beschreibung

Adverse Event

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1521902
Specify organ with mucositis
Beschreibung

Adverse Event

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1521902
Specify painful organ
Beschreibung

Adverse Event

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1521902
Specify other adverse event
Beschreibung

Adverse Event

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1521902
Date START
Beschreibung

Adverse event Start date

Datentyp

date

Alias
UMLS CUI [1]
C2697888
Date END or Date of final Assessment AE
Beschreibung

Adverse event End Date

Datentyp

date

Alias
UMLS CUI [1]
C2697886
Serious?
Beschreibung

Adverse event seriousness

Datentyp

boolean

Alias
UMLS CUI [1]
C1710056
SAE reported?
Beschreibung

SAE reported?

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0684224
Actions taken regarding study medication?
Beschreibung

Actions taken

Datentyp

integer

Alias
UMLS CUI [1]
C2826626
Relatedness to study medication?
Beschreibung

Causality

Datentyp

integer

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0304229
max. CTCAE-Grade
Beschreibung

CTCAE-Grade

Datentyp

integer

Alias
UMLS CUI [1]
C3888020
Outcome
Beschreibung

Outcome

Datentyp

integer

Alias
UMLS CUI [1]
C1705586
Death Sheet
Beschreibung

Death Sheet

Alias
UMLS CUI-1
C0011065
UMLS CUI-2
C0684224
Randomization number
Beschreibung

2DAUNO - xxx(local trial center number) - xxx(patient inclusion number) - xx(treatment arm part I) - x(treatment arm part II)

Datentyp

integer

Alias
UMLS CUI [1,1]
C2348585
UMLS CUI [1,2]
C0034656
Death?
Beschreibung

please document until day 60 after commencement final study induction

Datentyp

boolean

Alias
UMLS CUI [1]
C0011065
Date of death
Beschreibung

Date of death

Datentyp

date

Alias
UMLS CUI [1]
C1148348
Reasons
Beschreibung

Cause of death

Datentyp

integer

Alias
UMLS CUI [1]
C0007465
Number of AE in database documentation
Beschreibung

for death as a result of an AE

Datentyp

integer

Alias
UMLS CUI [1]
C2826275
If death did NOT occur as a result of an AE Description
Beschreibung

Cause of death description

Datentyp

text

Alias
UMLS CUI [1,1]
C0007465
UMLS CUI [1,2]
C1521902
Death in aplasia
Beschreibung

Death in aplasia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243065
UMLS CUI [1,2]
C0011065
Last available bone marrow assessment before death
Beschreibung

bone marrow assessment

Datentyp

integer

Alias
UMLS CUI [1]
C0005957
Date of aspiration or biopsy
Beschreibung

Please fill in date of most recent bone marrow examination.

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0005954
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C0349707
Examination of Bone Marrow
Beschreibung

Examination of Bone Marrow

Datentyp

integer

Alias
UMLS CUI [1]
C0005957
Response
Beschreibung

Response

Datentyp

text

Alias
UMLS CUI [1]
C1704632
Remission
Beschreibung

Remission

Datentyp

text

Alias
UMLS CUI [1]
C0544452
With my signature I hereby confirm, that all data are correct and complete.
Beschreibung

Investigators signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date
Beschreibung

Date of completion

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0850287
Comments
Beschreibung

Comments

Alias
UMLS CUI-1
C0947611
Comments to visit
Beschreibung

Comments

Datentyp

integer

Alias
UMLS CUI [1]
C0947611
Comment
Beschreibung

Comment

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Any further comments?
Beschreibung

Further comments

Datentyp

boolean

Alias
UMLS CUI [1]
C1830770
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Ähnliche Modelle

Adverse events and Death sheet

12 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Adverse Events
C0877248 (UMLS CUI-1)
Randomization number
Item
Randomization number
integer
C2348585 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Adverse event
Item
Adverse event
boolean
C0877248 (UMLS CUI [1])
Item Group
Adverse Events specification
C0877248 (UMLS CUI-1)
C2348235 (UMLS CUI-2)
AE line number
Item
Consecutively numbered AEs
integer
C2826275 (UMLS CUI [1])
Item
Adverse event
integer
C0877248 (UMLS CUI [1])
Adverse event
Code List
Adverse event
CL Item
Diarrhea (1)
CL Item
Epistaxis (2)
CL Item
Fatigue (3)
CL Item
Fever (4)
CL Item
Headache (5)
CL Item
Hematoma (specify Localization) (6)
CL Item
Hematuria (7)
CL Item
Hemorrhage (specify Organ) (8)
CL Item
Infection (specify Organ) (9)
CL Item
Mucositis (specify Organ) (10)
CL Item
Nausea (11)
CL Item
Pain (specify Organ) (12)
CL Item
Purpura (13)
CL Item
Rash (14)
CL Item
Vomiting (15)
CL Item
other (specify) (16)
Adverse Event
Item
Specify localization of hematoma
text
C0877248 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Adverse Event
Item
Specify hemorrhaging organ
text
C0877248 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Adverse Event
Item
Specify infected organ
text
C0877248 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Adverse Event
Item
Specify organ with mucositis
text
C0877248 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Adverse Event
Item
Specify painful organ
text
C0877248 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Adverse Event
Item
Specify other adverse event
text
C0877248 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Adverse event Start date
Item
Date START
date
C2697888 (UMLS CUI [1])
Adverse event End Date
Item
Date END or Date of final Assessment AE
date
C2697886 (UMLS CUI [1])
Adverse event seriousness
Item
Serious?
boolean
C1710056 (UMLS CUI [1])
Item
SAE reported?
integer
C1519255 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
SAE reported?
Code List
SAE reported?
CL Item
NO (1)
CL Item
YES (2)
CL Item
not necassary according to protocoll (3)
Item
Actions taken regarding study medication?
integer
C2826626 (UMLS CUI [1])
Actions taken
Code List
Actions taken regarding study medication?
CL Item
None (0)
CL Item
Study drug interrupted (1)
CL Item
Study drug reduced (2)
CL Item
Study drug withdrawn (3)
CL Item
Unknown/ not applicable (4)
Item
Relatedness to study medication?
integer
C0015127 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Causality
Code List
Relatedness to study medication?
CL Item
Unlikely (1)
CL Item
Possibly (2)
Item
max. CTCAE-Grade
integer
C3888020 (UMLS CUI [1])
CTCAE-Grade
Code List
max. CTCAE-Grade
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Life threatening (4)
CL Item
Death (5)
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Completely recovered (0)
CL Item
Recovered with sequelae (1)
CL Item
Recovering (2)
CL Item
Not Recovered (3)
CL Item
Death (4)
CL Item
Unknown (5)
Item Group
Death Sheet
C0011065 (UMLS CUI-1)
C0684224 (UMLS CUI-2)
Randomization number
Item
Randomization number
integer
C2348585 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Death
Item
Death?
boolean
C0011065 (UMLS CUI [1])
Date of death
Item
Date of death
date
C1148348 (UMLS CUI [1])
Item
Reasons
integer
C0007465 (UMLS CUI [1])
Cause of death
Code List
Reasons
CL Item
Adverse event (1)
CL Item
Death did NOT occur as a result of an AE (2)
Adverse event number
Item
Number of AE in database documentation
integer
C2826275 (UMLS CUI [1])
Cause of death description
Item
If death did NOT occur as a result of an AE Description
text
C0007465 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Death in aplasia
Item
Death in aplasia
boolean
C0243065 (UMLS CUI [1,1])
C0011065 (UMLS CUI [1,2])
Item
Last available bone marrow assessment before death
integer
C0005957 (UMLS CUI [1])
bone marrow assessment
Code List
Last available bone marrow assessment before death
CL Item
at V7 (1)
CL Item
at V13 (2)
CL Item
another date (please fill in the next two entry masks) (3)
CL Item
unknown (4)
Date of aspiration or biopsy
Item
Date of aspiration or biopsy
date
C0011008 (UMLS CUI [1,1])
C0005954 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C0349707 (UMLS CUI [2,2])
Item
Examination of Bone Marrow
integer
C0005957 (UMLS CUI [1])
Examination of Bone Marrow
Code List
Examination of Bone Marrow
CL Item
for early response assessment (1)
CL Item
for remission assessment (after completion Induction II) (2)
Item
Response
text
C1704632 (UMLS CUI [1])
Response
Code List
Response
CL Item
Good Response (early assessment, no peripheral blood count regeneration,blast count < 5%, aspirate with marrow spicules) (1)
(Comment:en)
CL Item
Refractory Disease (early assessment, no peripheral blood count regeneration,increase in bone marrow blast count compared to baseline or no change in bone marrow cellularity with unchanged blast count.) (3)
(Comment:en)
CL Item
Moderate Response (early assessment, no peripheral blood count regeneration, (2)
(Comment:en)
CL Item
5%, reduction in blast count and/or bone marrow cellularity) (blast count >)
Item
Remission
text
C0544452 (UMLS CUI [1])
Remission
Code List
Remission
CL Item
Morphological complete remission (CR) (1)
CL Item
Complete remission with incomplete recovery (CRi) (2)
CL Item
Cytogenetic complete remission (CRc) (3)
CL Item
Molecular complete remission (CRm) (4)
CL Item
Treatment failure (No CR)
CL Item
Morphologic relapse (6)
Investigators signature
Item
With my signature I hereby confirm, that all data are correct and complete.
text
C2346576 (UMLS CUI [1])
Date of completion
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0850287 (UMLS CUI [1,2])
Item Group
Comments
C0947611 (UMLS CUI-1)
Item
Comments to visit
integer
C0947611 (UMLS CUI [1])
Comments
Code List
Comments to visit
CL Item
Registration/RandoI (1)
CL Item
V1 (2)
CL Item
V2 (3)
CL Item
V3 (4)
CL Item
V4 (5)
CL Item
V5 (6)
CL Item
V6 (7)
CL Item
Induction I -Drug Administration (8)
CL Item
V7 (9)
CL Item
Rando II (10)
CL Item
V8 (11)
CL Item
V9 (12)
CL Item
V10 (13)
CL Item
V11 (14)
CL Item
V12 (15)
CL Item
Induction II-Drug Administration (16)
CL Item
V13 (17)
CL Item
AE (18)
CL Item
Drop-Out Visit (19)
CL Item
Death (20)
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Further comments
Item
Any further comments?
boolean
C1830770 (UMLS CUI [1])
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