Information:
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ID
42900
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: 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
Keywords
Versions (2)
- 3/7/18 3/7/18 -
- 9/17/21 9/17/21 -
Copyright Holder
Technische Universität Dresden,Dr. Röllig
Uploaded on
September 17, 2021
DOI
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License
Creative Commons BY-NC 3.0
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26496_Daunorubicin Acute Myeloid Leukemia NCT02140242
Visit 1 Baseline
- 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 1 Baseline
- 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
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])
Local trial center number
Item
Local trial center number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Visit date
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body surface
Item
Body surface
float
C0005902 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
CL Item
Not done (1)
CL Item
unknown (2)
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
4 (5)
CL Item
Not done (1)
CL Item
unknown (2)
CL Item
Done and no significant findings (1)
CL Item
Done and significant findings (2)
CL Item
Not Done (3)
General Appearance findings
Item
General Appearance: In case of significant findings, please specify
text
C1148438 (UMLS CUI [1,1])
C2607943 (UMLS CUI [1,2])
C2607943 (UMLS CUI [1,2])
CL Item
Done and no significant findings (1)
CL Item
Done and significant findings (2)
CL Item
Not Done (3)
Nervous system findings
Item
Nervous system: In case of significant findings, please specify
text
C0027763 (UMLS CUI [1,1])
C2607943 (UMLS CUI [1,2])
C2607943 (UMLS CUI [1,2])
CL Item
Done and no significant findings (1)
CL Item
Done and significant findings (2)
CL Item
Not Done (3)
Examination of Lungs findings
Item
Lungs: In case of significant findings, please specify
text
C2228454 (UMLS CUI [1,1])
C2607943 (UMLS CUI [1,2])
C2607943 (UMLS CUI [1,2])
CL Item
Done and no significant findings (1)
CL Item
Done and significant findings (2)
CL Item
Not Done (3)
Heart findings
Item
Heart: In case of significant findings, please specify
text
C0562319 (UMLS CUI [1,1])
C2607943 (UMLS CUI [1,2])
C2607943 (UMLS CUI [1,2])
CL Item
Done and no significant findings (1)
CL Item
Done and significant findings (2)
CL Item
Not Done (3)
Abdominal findings
Item
Abdomen: In case of significant findings, please specify
text
C0562238 (UMLS CUI [1,1])
C2607943 (UMLS CUI [1,2])
C2607943 (UMLS CUI [1,2])
CL Item
Done and no significant findings (1)
CL Item
Done and significant findings (2)
CL Item
Not Done (3)
Head examination findings
Item
Head: In case of significant findings, please specify
text
C2239107 (UMLS CUI [1,1])
C2607943 (UMLS CUI [1,2])
C2607943 (UMLS CUI [1,2])
CL Item
Done and no significant findings (1)
CL Item
Done and significant findings (2)
CL Item
Not Done (3)
Neck and thyroid examination findings
Item
Neck including Thyroid: In case of significant findings, please specify
text
C2228463 (UMLS CUI [1,1])
C2607943 (UMLS CUI [1,2])
C2228489 (UMLS CUI [2,1])
C2607943 (UMLS CUI [2,2])
C2607943 (UMLS CUI [1,2])
C2228489 (UMLS CUI [2,1])
C2607943 (UMLS CUI [2,2])
CL Item
Done and no significant findings (1)
CL Item
Done and significant findings (2)
CL Item
Not Done (3)
Skin examination findings
Item
Skin: In case of significant findings, please specify
text
C0436149 (UMLS CUI [1,1])
C2607943 (UMLS CUI [1,2])
C2607943 (UMLS CUI [1,2])
CL Item
Done and no significant findings (1)
CL Item
Done and significant findings (2)
CL Item
Not Done (3)
Extremities examination findings
Item
Extremities: In case of significant findings, please specify
text
C0436150 (UMLS CUI [1,1])
C2607943 (UMLS CUI [1,2])
C2607943 (UMLS CUI [1,2])
Item
Signs of bleeding
integer
C3251812 (UMLS CUI [1,1])
C0037088 (UMLS CUI [1,2])
C0037088 (UMLS CUI [1,2])
CL Item
Done and no significant findings (1)
CL Item
Done and significant findings (2)
CL Item
Not Done (3)
Signs of bleeding findings
Item
Signs of bleeding: In case of significant findings, please specify
text
C3251812 (UMLS CUI [1,1])
C2607943 (UMLS CUI [1,2])
C2607943 (UMLS CUI [1,2])
CL Item
Done and no lymphadenopathy palpable (1)
CL Item
Done and lymphadenopathy palpable (2)
CL Item
Not Done (3)
Lymph nodes examination findings
Item
Lymph nodes: Description of manifestations
text
C0562297 (UMLS CUI [1,1])
C2607943 (UMLS CUI [1,2])
C2607943 (UMLS CUI [1,2])
Lymph node size
Item
Length of largest lymph node
integer
C1285847 (UMLS CUI [1,1])
C0443228 (UMLS CUI [1,2])
C1444754 (UMLS CUI [1,3])
C0443228 (UMLS CUI [1,2])
C1444754 (UMLS CUI [1,3])
Lymph node size
Item
Width of largest lymph node
integer
C1285847 (UMLS CUI [1,1])
C0443228 (UMLS CUI [1,2])
C0487742 (UMLS CUI [1,3])
C0443228 (UMLS CUI [1,2])
C0487742 (UMLS CUI [1,3])
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)
Haemoglobin
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 assessment
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
CL Item
no pathological findings (1)
(Comment:en)
CL Item
new pathological findings (2)
(Comment:en)
CL Item
clinically NOT significant findings (1)
CL Item
clinically significant findings (2)
Significant ECG findings
Item
Significant ECG findings
text
C0438154 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,2])
CL Item
Not done (1)
CL Item
Failed (2)
Date of assessment
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
LVEF
Item
LV ejection fraction
integer
C0428772 (UMLS CUI [1])
valvular defects
Item
Any valvular defects?
boolean
C2748945 (UMLS CUI [1])
Tricuspid valve defect
Item
Tricuspid valve defect
boolean
C0264882 (UMLS CUI [1])
CL Item
Insufficiency (1)
CL Item
Stenosis (2)
Item
Degree of Tricuspid valve defect
integer
C0457451 (UMLS CUI [1,1])
C0264882 (UMLS CUI [1,2])
C0264882 (UMLS CUI [1,2])
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Pulmonary valve defect
Item
Pulmonary valve defect
boolean
C0034087 (UMLS CUI [1])
CL Item
Insufficiency (1)
CL Item
Stenosis (2)
Item
Degree of pulmonary valve defect
integer
C0457451 (UMLS CUI [1,1])
C0034087 (UMLS CUI [1,2])
C0034087 (UMLS CUI [1,2])
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Mitral valve defect
Item
Mitral valve defect
boolean
C0026265 (UMLS CUI [1])
CL Item
Insufficiency (1)
CL Item
Stenosis (2)
Item
Degree of Mitral valve defect
integer
C0457451 (UMLS CUI [1,1])
C0026265 (UMLS CUI [1,2])
C0026265 (UMLS CUI [1,2])
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Aortic valve defect
Item
Aortic valve defect
boolean
C1260873 (UMLS CUI [1])
CL Item
Insufficiency (1)
CL Item
Stenosis (2)
Item
Degree of aortic valve defect
integer
C0457451 (UMLS CUI [1,1])
C1260873 (UMLS CUI [1,2])
C1260873 (UMLS CUI [1,2])
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
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)
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