ID
44274
Description
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
Keywords
Versions (3)
- 10/24/17 10/24/17 - Julian Varghese
- 4/23/19 4/23/19 - Sarah Riepenhausen
- 9/20/21 9/20/21 -
Copyright Holder
PD Dr. med. Christoph Röllig, MSc
Uploaded on
September 20, 2021
DOI
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License
Creative Commons BY-NC 3.0
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Daunorubicin Acute Myeloid Leukemia NCT02140242
Adverse events and Death sheet
- StudyEvent: ODMjoin
- Visit Registration/Randomization I
- Visit 1 - Medical History
- Visit 1 Baseline
- Visit 2 (Day 1 Induction I)
- Visit 7 (Day 15 Induction I)
- Visit Randomization II
- Visit 3/4/5/6 (Day 2, 3, 4, 5 Induction I)
- Visit 8 (before Day 1 Induction II)
- Visit 9/10/11/12 (Day 2, 3, 4, 5 Induction II)
- Visit 13 (End of Study)
- Drop out Sheet and visit
- Adverse events and Death sheet
Description
Adverse Events specification
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C2348235
Description
AE line number
Data type
integer
Alias
- UMLS CUI [1]
- C2826275
Description
Adverse event
Data type
integer
Alias
- UMLS CUI [1]
- C0877248
Description
Adverse Event
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1521902
Description
Adverse Event
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1521902
Description
Adverse Event
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1521902
Description
Adverse Event
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1521902
Description
Adverse Event
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1521902
Description
Adverse Event
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1521902
Description
Adverse event Start date
Data type
date
Alias
- UMLS CUI [1]
- C2697888
Description
Adverse event End Date
Data type
date
Alias
- UMLS CUI [1]
- C2697886
Description
Adverse event seriousness
Data type
boolean
Alias
- UMLS CUI [1]
- C1710056
Description
SAE reported?
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0684224
Description
Actions taken
Data type
integer
Alias
- UMLS CUI [1]
- C2826626
Description
Causality
Data type
integer
Alias
- UMLS CUI [1,1]
- C0015127
- UMLS CUI [1,2]
- C0304229
Description
CTCAE-Grade
Data type
integer
Alias
- UMLS CUI [1]
- C3888020
Description
Outcome
Data type
integer
Alias
- UMLS CUI [1]
- C1705586
Description
Death Sheet
Alias
- UMLS CUI-1
- C0011065
- UMLS CUI-2
- C0684224
Description
2DAUNO - xxx(local trial center number) - xxx(patient inclusion number) - xx(treatment arm part I) - x(treatment arm part II)
Data type
integer
Alias
- UMLS CUI [1,1]
- C2348585
- UMLS CUI [1,2]
- C0034656
Description
please document until day 60 after commencement final study induction
Data type
boolean
Alias
- UMLS CUI [1]
- C0011065
Description
Date of death
Data type
date
Alias
- UMLS CUI [1]
- C1148348
Description
Cause of death
Data type
integer
Alias
- UMLS CUI [1]
- C0007465
Description
for death as a result of an AE
Data type
integer
Alias
- UMLS CUI [1]
- C2826275
Description
Cause of death description
Data type
text
Alias
- UMLS CUI [1,1]
- C0007465
- UMLS CUI [1,2]
- C1521902
Description
Death in aplasia
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0243065
- UMLS CUI [1,2]
- C0011065
Description
bone marrow assessment
Data type
integer
Alias
- UMLS CUI [1]
- C0005957
Description
Please fill in date of most recent bone marrow examination.
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0005954
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C0349707
Description
Examination of Bone Marrow
Data type
integer
Alias
- UMLS CUI [1]
- C0005957
Description
Response
Data type
text
Alias
- UMLS CUI [1]
- C1704632
Description
Remission
Data type
text
Alias
- UMLS CUI [1]
- C0544452
Description
Investigators signature
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Date of completion
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0850287
Description
Comments
Alias
- UMLS CUI-1
- C0947611
Description
Comments
Data type
integer
Alias
- UMLS CUI [1]
- C0947611
Description
Comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Further comments
Data type
boolean
Alias
- UMLS CUI [1]
- C1830770
Similar models
Adverse events and Death sheet
- StudyEvent: ODMjoin
- Visit Registration/Randomization I
- Visit 1 - Medical History
- Visit 1 Baseline
- Visit 2 (Day 1 Induction I)
- Visit 7 (Day 15 Induction I)
- Visit Randomization II
- Visit 3/4/5/6 (Day 2, 3, 4, 5 Induction I)
- Visit 8 (before Day 1 Induction II)
- Visit 9/10/11/12 (Day 2, 3, 4, 5 Induction II)
- Visit 13 (End of Study)
- Drop out Sheet and visit
- Adverse events and Death sheet
C0034656 (UMLS CUI [1,2])
C2348235 (UMLS CUI-2)
C1521902 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0034656 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C0011065 (UMLS CUI [1,2])
C0005954 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C0349707 (UMLS CUI [2,2])
C0850287 (UMLS CUI [1,2])