ID
44274
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
Versioner (3)
- 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
20 september 2021
DOI
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Licens
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
Beskrivning
Adverse Events specification
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C2348235
Beskrivning
AE line number
Datatyp
integer
Alias
- UMLS CUI [1]
- C2826275
Beskrivning
Adverse event
Datatyp
integer
Alias
- UMLS CUI [1]
- C0877248
Beskrivning
Adverse Event
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1521902
Beskrivning
Adverse Event
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1521902
Beskrivning
Adverse Event
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1521902
Beskrivning
Adverse Event
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1521902
Beskrivning
Adverse Event
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1521902
Beskrivning
Adverse Event
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1521902
Beskrivning
Adverse event Start date
Datatyp
date
Alias
- UMLS CUI [1]
- C2697888
Beskrivning
Adverse event End Date
Datatyp
date
Alias
- UMLS CUI [1]
- C2697886
Beskrivning
Adverse event seriousness
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1710056
Beskrivning
SAE reported?
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0684224
Beskrivning
Actions taken
Datatyp
integer
Alias
- UMLS CUI [1]
- C2826626
Beskrivning
Causality
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0015127
- UMLS CUI [1,2]
- C0304229
Beskrivning
CTCAE-Grade
Datatyp
integer
Alias
- UMLS CUI [1]
- C3888020
Beskrivning
Outcome
Datatyp
integer
Alias
- UMLS CUI [1]
- C1705586
Beskrivning
Death Sheet
Alias
- UMLS CUI-1
- C0011065
- UMLS CUI-2
- C0684224
Beskrivning
2DAUNO - xxx(local trial center number) - xxx(patient inclusion number) - xx(treatment arm part I) - x(treatment arm part II)
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2348585
- UMLS CUI [1,2]
- C0034656
Beskrivning
please document until day 60 after commencement final study induction
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0011065
Beskrivning
Date of death
Datatyp
date
Alias
- UMLS CUI [1]
- C1148348
Beskrivning
Cause of death
Datatyp
integer
Alias
- UMLS CUI [1]
- C0007465
Beskrivning
for death as a result of an AE
Datatyp
integer
Alias
- UMLS CUI [1]
- C2826275
Beskrivning
Cause of death description
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0007465
- UMLS CUI [1,2]
- C1521902
Beskrivning
Death in aplasia
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0243065
- UMLS CUI [1,2]
- C0011065
Beskrivning
bone marrow assessment
Datatyp
integer
Alias
- UMLS CUI [1]
- C0005957
Beskrivning
Please fill in date of most recent bone marrow examination.
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0005954
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C0349707
Beskrivning
Examination of Bone Marrow
Datatyp
integer
Alias
- UMLS CUI [1]
- C0005957
Beskrivning
Response
Datatyp
text
Alias
- UMLS CUI [1]
- C1704632
Beskrivning
Remission
Datatyp
text
Alias
- UMLS CUI [1]
- C0544452
Beskrivning
Investigators signature
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Date of completion
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0850287
Beskrivning
Comments
Alias
- UMLS CUI-1
- C0947611
Beskrivning
Comments
Datatyp
integer
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Comment
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Further comments
Datatyp
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])