ID

4996

Description

ODM derived from http://clinicaltrials.gov/show/NCT00766779

Link

http://clinicaltrials.gov/show/NCT00766779

Keywords

Versions (2)
  1. 12/6/13 12/6/13 - Martin Dugas
  2. 4/16/14 4/16/14 - Julian Varghese
Uploaded on

April 16, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00766779 Acute Myeloid Leukemia

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 60 Years to 75 Years
Description

age 60 Years to 75 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
primary or secondary AML as defined by WHO or refractory anemia with excess of blasts (RAEB)
Description

primary or secondary AML as defined by WHO or refractory anemia with excess of blasts (RAEB)

Data type

boolean

Alias
UMLS CUI 2011AA
CL414904
UMLS CUI 2011AA
C0023467
SNOMED CT 2011_0131
91861009
MedDRA 14.1
10000880
ICD-10-CM Version 2010
C92.0
ICD-9-CM Version 2011
205.0
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0280449
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
C0451584
SNOMED CT 2011_0131
273931002
UMLS CUI 2011AA
C0002894
SNOMED CT 2011_0131
398623004
MedDRA 14.1
10038270
ICD-10-CM Version 2010
D46.20
First complete remission following one or two cycles of induction chemotherapy
Description

First complete remission following one or two cycles of induction chemotherapy

Data type

boolean

Alias
UMLS CUI 2011AA
C0205435
SNOMED CT 2011_0131
255216001
UMLS CUI 2011AA
C0677874
SNOMED CT 2011_0131
103338009
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C0439596
SNOMED CT 2011_0131
44180009
UMLS CUI 2011AA
C0600558
Chemotherapy was administered according to current participating cooperative group protocols
Description

Chemotherapy was administered according to current participating cooperative group protocols

Data type

boolean

Alias
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
UMLS CUI 2011AA
C1521801
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
CL415249
HL7 V3 2006_05
RGRP
UMLS CUI 2011AA
C2348563
Karnofsky performance status (assessment scale)
Description

Karnofsky score >= 70

Data type

boolean

Alias
UMLS CUI 2011AA
C0206065
SNOMED CT 2011_0131
273546003
Written informed consent
Description

Written informed consent

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
AML FAB M3
Description

AML FAB M3

Data type

boolean

Alias
UMLS CUI 2011AA
C0023467
SNOMED CT 2011_0131
91861009
MedDRA 14.1
10000880
ICD-10-CM Version 2010
C92.0
ICD-9-CM Version 2011
205.0
UMLS CUI 2011AA
C0457329
SNOMED CT 2011_0131
278165002
HIV Seropositivity
Description

HIV positivity

Data type

boolean

Alias
UMLS CUI 2011AA
C0019699
SNOMED CT 2011_0131
165816005
MedDRA 14.1
10020188
ICD-10-CM Version 2010
Z21
Participation in another clinical trial without prior consent of the coordinating investigator, patients may exceptionally take part in a further study only if
Description

Participation in another clinical trial without prior consent of the coordinating investigator, patients may exceptionally take part in a further study only if

Data type

boolean

Alias
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C1511481
LOINC Version 232
MTHU035862
UMLS CUI 2011AA
CL102947
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
The second study exclusively concerns induction therapy
Description

The second study exclusively concerns induction therapy

Data type

boolean

Alias
UMLS CUI 2011AA
C0205436
SNOMED CT 2011_0131
81170007
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0205171
SNOMED CT 2011_0131
50607009
UMLS CUI 2011AA
C2699424
UMLS CUI 2011AA
C0600558
Consolidation cycle one and two are given according to the accredited study group policy
Description

Consolidation cycle one and two are given according to the accredited study group policy

Data type

boolean

Alias
UMLS CUI 2011AA
C0702116
SNOMED CT 2011_0131
9656002
UMLS CUI 2011AA
C0439596
SNOMED CT 2011_0131
44180009
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
CL415249
HL7 V3 2006_05
RGRP
UMLS CUI 2011AA
C0242456
No investigational drugs are used post registration for the HCT vs CT in elderly AML study.
Description

No investigational drugs are used post registration for the HCT vs CT in elderly AML study.

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
C0472699
SNOMED CT 2011_0131
234336002
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
UMLS CUI 2011AA
C0001792
SNOMED CT 2011_0131
105436006
MedDRA 14.1
10014348
UMLS CUI 2011AA
C0023467
SNOMED CT 2011_0131
91861009
MedDRA 14.1
10000880
ICD-10-CM Version 2010
C92.0
ICD-9-CM Version 2011
205.0
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Documentation for the HCT vs CT in elderly AML study is not compromised. Second hand data from foreign study is not accepted
Description

Documentation for the HCT vs CT in elderly AML study is not compromised. Second hand data from foreign study is not accepted

Data type

boolean

Alias
UMLS CUI 2011AA
C0920316
UMLS CUI 2011AA
C0472699
SNOMED CT 2011_0131
234336002
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
UMLS CUI 2011AA
C0001792
SNOMED CT 2011_0131
105436006
MedDRA 14.1
10014348
UMLS CUI 2011AA
C0023467
SNOMED CT 2011_0131
91861009
MedDRA 14.1
10000880
ICD-10-CM Version 2010
C92.0
ICD-9-CM Version 2011
205.0
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0221099
SNOMED CT 2011_0131
260379002
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age 60 Years to 75 Years
Item
age 60 Years to 75 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
primary or secondary AML as defined by WHO or refractory anemia with excess of blasts (RAEB)
Item
primary or secondary AML as defined by WHO or refractory anemia with excess of blasts (RAEB)
boolean
CL414904 (UMLS CUI 2011AA)
C0023467 (UMLS CUI 2011AA)
91861009 (SNOMED CT 2011_0131)
10000880 (MedDRA 14.1)
C92.0 (ICD-10-CM Version 2010)
205.0 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0280449 (UMLS CUI 2011AA)
C1704788 (UMLS CUI 2011AA)
C0451584 (UMLS CUI 2011AA)
273931002 (SNOMED CT 2011_0131)
C0002894 (UMLS CUI 2011AA)
398623004 (SNOMED CT 2011_0131)
10038270 (MedDRA 14.1)
D46.20 (ICD-10-CM Version 2010)
First complete remission following one or two cycles of induction chemotherapy
Item
First complete remission following one or two cycles of induction chemotherapy
boolean
C0205435 (UMLS CUI 2011AA)
255216001 (SNOMED CT 2011_0131)
C0677874 (UMLS CUI 2011AA)
103338009 (SNOMED CT 2011_0131)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0439596 (UMLS CUI 2011AA)
44180009 (SNOMED CT 2011_0131)
C0600558 (UMLS CUI 2011AA)
Chemotherapy was administered according to current participating cooperative group protocols
Item
Chemotherapy was administered according to current participating cooperative group protocols
boolean
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C1521801 (UMLS CUI 2011AA)
C0680240 (UMLS CUI 2011AA)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
CL415249 (UMLS CUI 2011AA)
RGRP (HL7 V3 2006_05)
C2348563 (UMLS CUI 2011AA)
Karnofsky score >= 70
Item
Karnofsky performance status (assessment scale)
boolean
C0206065 (UMLS CUI 2011AA)
273546003 (SNOMED CT 2011_0131)
Written informed consent
Item
Written informed consent
boolean
C0021430 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
AML FAB M3
Item
AML FAB M3
boolean
C0023467 (UMLS CUI 2011AA)
91861009 (SNOMED CT 2011_0131)
10000880 (MedDRA 14.1)
C92.0 (ICD-10-CM Version 2010)
205.0 (ICD-9-CM Version 2011)
C0457329 (UMLS CUI 2011AA)
278165002 (SNOMED CT 2011_0131)
HIV positivity
Item
HIV Seropositivity
boolean
C0019699 (UMLS CUI 2011AA)
165816005 (SNOMED CT 2011_0131)
10020188 (MedDRA 14.1)
Z21 (ICD-10-CM Version 2010)
Participation in another clinical trial without prior consent of the coordinating investigator, patients may exceptionally take part in a further study only if
Item
Participation in another clinical trial without prior consent of the coordinating investigator, patients may exceptionally take part in a further study only if
boolean
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C1511481 (UMLS CUI 2011AA)
MTHU035862 (LOINC Version 232)
CL102947 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
The second study exclusively concerns induction therapy
Item
The second study exclusively concerns induction therapy
boolean
C0205436 (UMLS CUI 2011AA)
81170007 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C2699424 (UMLS CUI 2011AA)
C0600558 (UMLS CUI 2011AA)
Consolidation cycle one and two are given according to the accredited study group policy
Item
Consolidation cycle one and two are given according to the accredited study group policy
boolean
C0702116 (UMLS CUI 2011AA)
9656002 (SNOMED CT 2011_0131)
C0439596 (UMLS CUI 2011AA)
44180009 (SNOMED CT 2011_0131)
C0680240 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
CL415249 (UMLS CUI 2011AA)
RGRP (HL7 V3 2006_05)
C0242456 (UMLS CUI 2011AA)
No investigational drugs are used post registration for the HCT vs CT in elderly AML study.
Item
No investigational drugs are used post registration for the HCT vs CT in elderly AML study.
boolean
C1518422 (UMLS CUI 2011AA)
C0013230 (UMLS CUI 2011AA)
C0472699 (UMLS CUI 2011AA)
234336002 (SNOMED CT 2011_0131)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C0001792 (UMLS CUI 2011AA)
105436006 (SNOMED CT 2011_0131)
10014348 (MedDRA 14.1)
C0023467 (UMLS CUI 2011AA)
91861009 (SNOMED CT 2011_0131)
10000880 (MedDRA 14.1)
C92.0 (ICD-10-CM Version 2010)
205.0 (ICD-9-CM Version 2011)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Documentation for the HCT vs CT in elderly AML study is not compromised. Second hand data from foreign study is not accepted
Item
Documentation for the HCT vs CT in elderly AML study is not compromised. Second hand data from foreign study is not accepted
boolean
C0920316 (UMLS CUI 2011AA)
C0472699 (UMLS CUI 2011AA)
234336002 (SNOMED CT 2011_0131)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C0001792 (UMLS CUI 2011AA)
105436006 (SNOMED CT 2011_0131)
10014348 (MedDRA 14.1)
C0023467 (UMLS CUI 2011AA)
91861009 (SNOMED CT 2011_0131)
10000880 (MedDRA 14.1)
C92.0 (ICD-10-CM Version 2010)
205.0 (ICD-9-CM Version 2011)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0221099 (UMLS CUI 2011AA)
260379002 (SNOMED CT 2011_0131)
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