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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
Visit 7 (Day 15 Induction I)
- 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
Similar models
Visit 7 (Day 15 Induction I)
- 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
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Randomization number
Item
Randomization number
integer
C2348585 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
C0034656 (UMLS CUI [1,2])
Visit date
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Lost to follow up
Item
Visit 7 not done
boolean
C1302313 (UMLS CUI [1])
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])
Leukocytes
Item
Leukocytes Value
integer
C0023508 (UMLS CUI [1])
CL Item
Gpt/l (=10^9/l = /nl) (1)
CL Item
/μl (2)
CL Item
10^3/μ (3)
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Hemoglobin
Item
Haemoglobin value
integer
C0518015 (UMLS CUI [1])
CL Item
mmol/l (1)
CL Item
g/dl (2)
CL Item
g/l (3)
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Platelets
Item
Platelets value
integer
C0032181 (UMLS CUI [1])
CL Item
Gpt/l (=10^9/l = /nl) (1)
CL Item
/μl (2)
CL Item
10^3/μ (3)
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Neutrophiles
Item
Neutrophiles value
integer
C0200633 (UMLS CUI [1])
CL Item
Gpt/l (=10^9/l = /nl) (1)
CL Item
/μl (2)
CL Item
10^3/μ (3)
CL Item
% (4)
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Lymphocytes
Item
Lymphocytes value
integer
C0200635 (UMLS CUI [1])
CL Item
Gpt/l (=10^9/l = /nl) (1)
CL Item
/μl (2)
CL Item
10^3/μ (3)
CL Item
% (4)
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Monocytes
Item
Monocytes value
integer
C0200637 (UMLS CUI [1])
CL Item
Gpt/l (=10^9/l = /nl) (1)
CL Item
/μl (2)
CL Item
10^3/μ (3)
CL Item
% (4)
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Basophiles
Item
Basophiles value
integer
C0200641 (UMLS CUI [1])
CL Item
Gpt/l (=10^9/l = /nl) (1)
CL Item
/μl (2)
CL Item
10^3/μ (3)
CL Item
% (4)
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Eosinophiles
Item
Eosinophiles value
integer
C0750879 (UMLS CUI [1])
CL Item
Gpt/l (=10^9/l = /nl) (1)
CL Item
/μl (2)
CL Item
10^3/μ (3)
CL Item
% (4)
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Blast percentage
Item
Percentage of blasts in pB
integer
C0587348 (UMLS CUI [1,1])
C0229664 (UMLS CUI [1,2])
C0229664 (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])
AST (GOT)
Item
AST (GOT) value
float
C0201899 (UMLS CUI [1])
CL Item
U/l (1)
CL Item
μmol/s*l (μkat/l) (2)
CL Item
nkat/ (3)
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
ALT (GPT)
Item
ALT (GPT) value
float
C0201836 (UMLS CUI [1])
CL Item
U/l (1)
CL Item
μmol/s*l (μkat/l) (2)
CL Item
nkat/ (3)
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (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)
Sodium
Item
Sodium value
float
C0337443 (UMLS CUI [1])
CL Item
mmol/l (1)
CL Item
mEq/l (mval/l) (2)
CL Item
mg/dl (3)
CL Item
g/l (4)
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Potassium
Item
Potassium value
float
C0202194 (UMLS CUI [1])
CL Item
mmol/l (1)
CL Item
mEq/l (mval/l) (2)
CL Item
mg/dl (3)
CL Item
mg/l (4)
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])
PTT
Item
PTT (partial thromboplastin time) value
integer
C0030605 (UMLS CUI [1])
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
INR
Item
INR Value
float
C0525032 (UMLS CUI [1])
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
Fibrinogen
Item
Fibrinogen value
float
C0337428 (UMLS CUI [1])
CL Item
g/l (1)
CL Item
mg/dl (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
μg/l (1)
CL Item
pg/ml (2)
CL Item
ng/ml (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
μg/l (1)
CL Item
pg/ml (2)
CL Item
ng/ml (3)
CL Item
ng/dl (4)
CL Item
ng/l (5)
CL Item
Of clinical significance (1)
CL Item
Not of clinical significance (2)
CL Item
Not done (1)
CL Item
Failed (2)
CL Item
Done (3)
Bone Marrow biopsy date
Item
Date of aspiration or biopsy
date
C0011008 (UMLS CUI [1,1])
C0005954 (UMLS CUI [1,2])
C0005954 (UMLS CUI [1,2])
Percentage of blasts
Item
Percentage of blasts (Local)
float
C0587348 (UMLS CUI [1])
CL Item
assessed by cytology (1)
CL Item
assessed by histology (2)
Percentage of blasts
Item
Percentage of blasts (central, assessed by cytology)
float
C0587348 (UMLS CUI [1,1])
C1305671 (UMLS CUI [1,2])
C1305671 (UMLS CUI [1,2])
CL Item
Good Response (blast count < 5%, aspirate with marrow spicules) (1)
CL Item
Moderate Response (blast count >= 5%, reduction in blast count and/or bone marrow cellularity) (2)
CL Item
Refractory Disease ( increase in bone marrow blast count compared to baseline or no change in bone marrow cellularity with unchanged blast count.) (3)
Molecular genetics
Item
Molecular genetics not done or failed
boolean
C0086345 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C0086345 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C1272696 (UMLS CUI [1,2])
C0086345 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not done/failed (3)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not done/failed (3)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not done/failed (3)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not done/failed (3)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not done/failed (3)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not done/failed (3)
FLT3-ITD/wt ratio
Item
FLT3-ITD/wt ratio
text
C2348499 (UMLS CUI [1,1])
C0216388 (UMLS CUI [1,2])
C0456603 (UMLS CUI [1,3])
C0216388 (UMLS CUI [1,2])
C0456603 (UMLS CUI [1,3])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Other
Item
If other, please specify
text
C0026882 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Item
According to study protocol the treatment was
text
C1516048 (UMLS CUI [1,1])
C0679864 (UMLS CUI [1,2])
C0679864 (UMLS CUI [1,2])
CL Item
a success (blast count (local assessment) < 5%) (1)
CL Item
5 %, no assessment of extracted bone marrow possible, neither aspiration nor biopsy of bone marrow done, drop out be-fore bone marrow assessment at visit 7 including death) (a failure (failure: blast count >)