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ID

36226

Beskrivning

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

Länk

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

Nyckelord

2017-10-24 2017-10-24 - Julian Varghese
2019-04-23 2019-04-23 - Sarah Riepenhausen
2021-09-20 2021-09-20 -

Rättsinnehavare

PD Dr. med. Christoph Röllig, MSc

Uppladdad den

23 april 2019

DOI

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Licens

Creative Commons BY-NC 3.0

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Daunorubicin Acute Myeloid Leukemia NCT02140242

model
Detaljer

Adverse events and Death sheet

StudyEvent: ODMjoin

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

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])

Adverse Events specification

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])

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])

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])

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])

Code List

Relatedness to study medication?

CL Item

Unlikely (1)

CL Item

Possibly (2)

Item

max. CTCAE-Grade

integer

C3888020 (UMLS CUI [1])

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])

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])

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])

bone marrow assessment

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])

Examination of Bone Marrow

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])

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])

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])

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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