Informações:
Falhas:
ID
44274
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 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
Palavras-chave
Versões (3)
- 24/10/2017 24/10/2017 - Julian Varghese
- 23/04/2019 23/04/2019 - Sarah Riepenhausen
- 20/09/2021 20/09/2021 -
Titular dos direitos
PD Dr. med. Christoph Röllig, MSc
Transferido a
20 de setembro de 2021
DOI
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Licença
Creative Commons BY-NC 3.0
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Daunorubicin Acute Myeloid Leukemia NCT02140242
Visit 1 - Medical History
- 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 1 - Medical History
- 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
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Randomization number
Item
Randomization number
integer
C2986235 (UMLS CUI [1])
Date of first diagnosis
Item
Date of first diagnosis
date
C2316983 (UMLS CUI [1])
CL Item
De novo (1)
C1515568 (UMLS CUI-1)
C0023467 (UMLS CUI-2)
(Comment:en)
C0023467 (UMLS CUI-2)
(Comment:en)
CL Item
AML after MDS (2)
C0280449 (UMLS CUI-1)
C3463824 (UMLS CUI-2)
(Comment:en)
C3463824 (UMLS CUI-2)
(Comment:en)
CL Item
AML after MPN-/OMF (3)
C0280449 (UMLS CUI-1)
C0027022 (UMLS CUI-2)
C0948968 (UMLS CUI-3)
(Comment:en)
C0027022 (UMLS CUI-2)
C0948968 (UMLS CUI-3)
(Comment:en)
History of malignancy
Item
History of malignancy
boolean
C2735088 (UMLS CUI [1])
History of Chemotherapy
Item
Chemotherapy in anamnesis
boolean
C0392920 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
History of therapeutic radiology procedure
Item
Radiation in anamnesis
boolean
C1522449 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
FAB Classification (local) not done or failed
Item
FAB Classification: (local) not done or failed
boolean
C2984084 (UMLS CUI [1])
CL Item
M0 (1)
CL Item
M1 (2)
CL Item
M2 (3)
CL Item
M4 (4)
CL Item
M4Eo (5)
CL Item
M5 (6)
CL Item
M6 (7)
CL Item
M7 (8)
CL Item
RAEB-t (9)
Item
If FAB Classification is M5a or M5b, please mark M5 first.
integer
C2984084 (UMLS CUI [1])
CL Item
M5a (1)
CL Item
M5b (2)
Item
In case of RAEB-t mark the corresponding WHO subtype group for AML not otherwise specified: (local)
integer
C1301142 (UMLS CUI [1])
Code List
In case of RAEB-t mark the corresponding WHO subtype group for AML not otherwise specified: (local)
CL Item
AML with minimal differentiation (1)
CL Item
AML without maturation (2)
CL Item
AML with maturation (3)
CL Item
AML myelomonocytic leukemia (4)
CL Item
AML monocytic leukemia (5)
CL Item
AML erythroid leukemia (6)
CL Item
AML megakaryoblastic leukemia (7)
CL Item
AML basophilic leukemia (8)
CL Item
AML panmyelosis with fibrosis (9)
FAB Classification (central) not done or failed
Item
FAB Classification: (central) not done or failed
boolean
C2984084 (UMLS CUI [1])
CL Item
M0 (1)
CL Item
M1 (2)
CL Item
M2 (3)
CL Item
M4 (4)
CL Item
M4Eo (5)
CL Item
M5 (6)
CL Item
M6 (7)
CL Item
M7 (8)
CL Item
RAEB-t (9)
Item
If FAB Classification is M5a or M5b, please mark M5 first.
integer
C2984084 (UMLS CUI [1])
CL Item
M5a (1)
CL Item
M5b (2)
Item
In case of RAEB-t mark the corresponding WHO subtype group for AML not otherwise specified: (central)
integer
C1301142 (UMLS CUI [1])
Code List
In case of RAEB-t mark the corresponding WHO subtype group for AML not otherwise specified: (central)
CL Item
AML with minimal differentiation (1)
CL Item
AML without maturation (2)
CL Item
AML with maturation (3)
CL Item
AML myelomonocytic leukemia (4)
CL Item
AML monocytic leukemia (5)
CL Item
AML erythroid leukemia (6)
CL Item
AML megakaryoblastic leukemia (7)
CL Item
AML basophilic leukemia (8)
CL Item
AML panmyelosis with fibrosis (9)
Item Group
Medical History of neoplastic diseases
C2735088 (UMLS CUI-1)
Type of malignancy
Item
Which type of malignancy?
text
C0006826 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
year of diagnosis
Item
Year of diagnosis
partialDate
C2316983 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C0439234 (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])
Year of chemotherapy
Item
Year of chemotherapy
partialDate
C0392920 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C0439234 (UMLS CUI [1,2])
Chemotherapy regimen
Item
Scheme
text
C0392920 (UMLS CUI [1])
Further entry?
Item
Further entry?
boolean
C1705654 (UMLS CUI [1,1])
C1517331 (UMLS CUI [1,2])
C1517331 (UMLS CUI [1,2])
Year of therapeutic radiology procedure
Item
Year of radiation
partialDate
C1522449 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C0439234 (UMLS CUI [1,2])
Radiation dose
Item
Dose
integer
C2919490 (UMLS CUI [1])
CL Item
Gy (1)
CL Item
GBq (2)
Further entry?
Item
Further entry?
boolean
C1705654 (UMLS CUI [1,1])
C1517331 (UMLS CUI [1,2])
C1517331 (UMLS CUI [1,2])
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
C0205394 (UMLS CUI [1])
CL Item
Not done (1)
CL Item
No signs (2)
CL Item
Yes, histologically proven (3)
CL Item
Suspected (4)
Extramedullary Manifestations
Item
Extramedullary Manifestations If yes or suspected, location
text
C1868812 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,2])
Item Group
Relevant Pre-existing Illnesses and Comorbidities
C0521987 (UMLS CUI-1)
C0009488 (UMLS CUI-3)
C0009488 (UMLS CUI-3)
pre-existing illnesses and comorbidities
Item
Any relevant pre-existing illnesses and comorbidities?
boolean
C0521987 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
C0009488 (UMLS CUI [2])
Item Group
Pre-existing illnesses and comorbidities
C0521987 (UMLS CUI-1)
C0009488 (UMLS CUI-3)
C0009488 (UMLS CUI-3)
Illness
Item
Illness
text
C0012634 (UMLS CUI [1])
Date of onset
Item
Onset (month/year)
partialDate
C0574845 (UMLS CUI [1])
Ongoing
Item
Ongoing
boolean
C0549178 (UMLS CUI [1])
CL Item
CTCAE grade 1(mild) (1)
CL Item
CTCAE grade 2(moderate) (2)
CL Item
CTCAE grade 3(severe) (3)
CL Item
CTCAE grade 4(life threatening or disabeling) (4)
CL Item
not assessable (0)
further row
Item
further row?
boolean
C1705654 (UMLS CUI [1,1])
C1517331 (UMLS CUI [1,2])
C1517331 (UMLS CUI [1,2])
CL Item
Done (1)
CL Item
Not done, sufficient amount of blasts in peripheral blood (2)
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])