Informações:
Falhas:
ID
42900
Descrição
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: https://www.clinicaltrials.gov/ct2/show/NCT02140242 Copyright Holder: PD Dr. med. Christoph Röllig, MSc Source:PD Dr. med. Christoph Röllig, MSc Universitätsklinikum Dresden
Link
https://www.clinicaltrials.gov/ct2/show/NCT02140242
Palavras-chave
Versões (2)
- 07/03/2018 07/03/2018 -
- 17/09/2021 17/09/2021 -
Titular dos direitos
Technische Universität Dresden,Dr. Röllig
Transferido a
17 de setembro de 2021
DOI
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Licença
Creative Commons BY-NC 3.0
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26496_Daunorubicin Acute Myeloid Leukemia NCT02140242
Visit 3/4/5/6 (Day 2, 3, 4, 5 Induction I)
- StudyEvent: ODM
- Visit Registration/Randomization I
- Visit 1 - Medical History
- Visit 1 Baseline
- Visit 2 (Day 1 Induction I)
- Visit 3/4/5/6 (Day 2, 3, 4, 5 Induction I)
- Visit 7 (Day 15 Induction I)
- Visit Randomization II
- 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
Similar models
Visit 3/4/5/6 (Day 2, 3, 4, 5 Induction I)
- StudyEvent: ODM
- Visit Registration/Randomization I
- Visit 1 - Medical History
- Visit 1 Baseline
- Visit 2 (Day 1 Induction I)
- Visit 3/4/5/6 (Day 2, 3, 4, 5 Induction I)
- Visit 7 (Day 15 Induction I)
- Visit Randomization II
- 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
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Randomization number
Item
Randomization number
integer
C2348585 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
C0034656 (UMLS CUI [1,2])
Item
Clinical Chemistry
integer
C0008000 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,2])
CL Item
Not done (1)
CL Item
Failed (2)
Date of sampling
Item
Date of sampling
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Bilirubin
Item
Bilirubin (total) value
float
C1278039 (UMLS CUI [1])
CL Item
mg/dl (1)
CL Item
g/l (2)
CL Item
μmol/l (3)
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Creatinine
Item
Creatinine value
float
C0201976 (UMLS CUI [1])
CL Item
mg/dl (1)
CL Item
μmol/l (2)
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
CL Item
Not done (1)
CL Item
Failed (2)
Date of sampling
Item
Date of sampling
date
C0178913 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
NT-proBNP
Item
NT-proBNP value
float
C3272900 (UMLS CUI [1])
CL Item
pg/ml (1)
CL Item
pmol/l (2)
CL Item
ng/ml (μg/l) (3)
CL Item
ng/dl (4)
CL Item
ng/l (5)
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
TnT
Item
Troponin T value
float
C0523953 (UMLS CUI [1])
CL Item
pg/ml (1)
CL Item
pmol/l (2)
CL Item
ng/ml (μg/l) (3)
CL Item
ng/dl (4)
CL Item
ng/l (5)
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
TnI
Item
Troponin I value
float
C0920210 (UMLS CUI [1])
CL Item
pg/ml (1)
CL Item
pmol/l (2)
CL Item
ng/ml (μg/l) (3)
CL Item
ng/dl (4)
CL Item
ng/l (5)
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Cytarabine Administration date
Item
Cytarabine Administration date
date
C0010711 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1533734 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Total dose
Item
Total dose administered
integer
C3174092 (UMLS CUI [1,1])
C0010711 (UMLS CUI [1,2])
C0010711 (UMLS CUI [1,2])
further entry?
Item
further entry?
boolean
C1705654 (UMLS CUI [1,1])
C1517331 (UMLS CUI [1,2])
C1517331 (UMLS CUI [1,2])
Daunorubicin Administration Date
Item
Daunorubicin Administration Date
date
C0011015 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1533734 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Total dose
Item
Total dose administered
integer
C3174092 (UMLS CUI [1,1])
C0010711 (UMLS CUI [1,2])
C0010711 (UMLS CUI [1,2])
further entry?
Item
further entry?
boolean
C1705654 (UMLS CUI [1,1])
C1517331 (UMLS CUI [1,2])
C1517331 (UMLS CUI [1,2])
dose modifications
Item
One or more dose modifications of Cytarabine?
boolean
C1707811 (UMLS CUI [1])
delay or suspension of administration
Item
Any delay or suspension of administration?
boolean
C1299700 (UMLS CUI [1])
dose modifications
Item
One or more dose modifications of Daunorubicin?
boolean
C1707811 (UMLS CUI [1])
delay or suspension of administration
Item
Any delay or suspension of administration?
boolean
C1299700 (UMLS CUI [1])