ID

44592

Description

ODM derived from http://clinicaltrials.gov/show/NCT01018069

Link

http://clinicaltrials.gov/show/NCT01018069

Keywords

Versions (3)
  1. 12/7/13 12/7/13 - Martin Dugas
  2. 4/17/14 4/17/14 - Julian Varghese
  3. 9/27/21 9/27/21 -
Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01018069 Leukemia

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Patients with AML, except those with APL (acute promyelocytic leukemia), failing a single standard dose cytarabine based frontline induction regimen. The diagnosis of refractory AML is based on the presence of either > 10% blasts in marrow or blood or 5-10% blasts in either site together with cytopenia (Hb < 10 g/dL, or platelets < 100 x 109/L, or neutrophil count < 1.0 x 109/L).
Description

Patients with AML, except those with APL (acute promyelocytic leukemia), failing a single standard dose cytarabine based frontline induction regimen. The diagnosis of refractory AML is based on the presence of either > 10% blasts in marrow or blood or 5-10% blasts in either site together with cytopenia (Hb < 10 g/dL, or platelets < 100 x 109/L, or neutrophil count < 1.0 x 109/L).

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
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0023487
SNOMED CT 2011_0131
110004001
MedDRA 14.1
10001019
ICD-10-CM Version 2010
C92.4
UMLS CUI 2011AA
C0231175
UMLS CUI 2011AA
C0205171
SNOMED CT 2011_0131
50607009
UMLS CUI 2011AA
C2828392
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0010711
SNOMED CT 2011_0131
89265009
UMLS CUI 2011AA
C0600558
UMLS CUI 2011AA
C0205269
SNOMED CT 2011_0131
20646008
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
C0010828
SNOMED CT 2011_0131
50820005
MedDRA 14.1
10066274
UMLS CUI 2011AA
C0019046
SNOMED CT 2011_0131
38082009
MedDRA 14.1
10019481
LOINC Version 232
LP14449-0
UMLS CUI 2011AA
C0005821
SNOMED CT 2011_0131
16378004
LOINC Version 232
MTHU002432
UMLS CUI 2011AA
C0200633
SNOMED CT 2011_0131
30630007
MedDRA 14.1
10029363
ECOG performance status finding <=2
Description

Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of <=2.

Data type

boolean

Alias
UMLS CUI 2011AA
C1520224
SNOMED CT 2011_0131
424122007
Male, or female patients who are post-menopausal (amenorrheic for at least 12 months), or surgically or biologically sterile.
Description

Male, or female patients who are post-menopausal (amenorrheic for at least 12 months), or surgically or biologically sterile.

Data type

boolean

Alias
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0232970
SNOMED CT 2011_0131
76498008
UMLS CUI 2011AA
C0002453
SNOMED CT 2011_0131
14302001
MedDRA 14.1
10001928
ICD-10-CM Version 2010
N91.2
ICD-9-CM Version 2011
626.0
UMLS CUI 2011AA
C0543467
SNOMED CT 2011_0131
83578000
MedDRA 14.1
10051332
LOINC Version 232
MTHU000079
UMLS CUI 2011AA
C0205460
SNOMED CT 2011_0131
12893009
UMLS CUI 2011AA
C0021359
SNOMED CT 2011_0131
8619003
MedDRA 14.1
10021926
Patients must have adequate organ and immune function as indicated by the following laboratory values:
Description

Patients must have adequate organ and immune function as indicated by the following laboratory values:

Data type

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0678852
UMLS CUI 2011AA
C1817756
SNOMED CT 2011_0131
106183005
UMLS CUI 2011AA
C1444656
SNOMED CT 2011_0131
410535002
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C0022877
SNOMED CT 2011_0131
261904005
LOINC Version 232
MTHU029808
UMLS CUI 2011AA
C1522609
Parameter Laboratory Values Serum creatinine; ≤2.0 mg/dL (≤ 177 μmol/L Total Bilirubin ≤2.0 mg/dL (≤ 34 μmol/L) AST (SGOT) and ALT (SGPT) ≤3 X ULN
Description

Parameter Laboratory Values Serum creatinine; ≤2.0 mg/dL (≤ 177 μmol/L Total Bilirubin ≤2.0 mg/dL (≤ 34 μmol/L) AST (SGOT) and ALT (SGPT) ≤3 X ULN

Data type

boolean

Alias
UMLS CUI 2011AA
C0201976
SNOMED CT 2011_0131
113075003
MedDRA 14.1
10040230
UMLS CUI 2011AA
C0201913
SNOMED CT 2011_0131
359986008
MedDRA 14.1
10004696
UMLS CUI 2011AA
C0004002
SNOMED CT 2011_0131
26091008
LOINC Version 232
MTHU004883
UMLS CUI 2011AA
C0001899
SNOMED CT 2011_0131
56935002
LOINC Version 232
MTHU006766
UMLS CUI 2011AA
C1519815
The patient must understand, be able and willing and likely to fully comply with study procedures, including scheduled follow-up, and restrictions.
Description

The patient must understand, be able and willing and likely to fully comply with study procedures, including scheduled follow-up, and restrictions.

Data type

boolean

Alias
UMLS CUI 2011AA
C1273101
SNOMED CT 2011_0131
395659009
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
405078008
UMLS CUI 2011AA
C0680734
UMLS CUI 2011AA
C1522577
UMLS CUI 2011AA
CL357089
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Clinical evidence of ongoing grade 3 or 4 non-hematological toxicities from the initial standard dose cytarabine-based induction chemotherapy
Description

Clinical evidence of ongoing grade 3 or 4 non-hematological toxicities from the initial standard dose cytarabine-based induction chemotherapy

Data type

boolean

Alias
UMLS CUI 2011AA
C0549178
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0205488
SNOMED CT 2011_0131
57407000
UMLS CUI 2011AA
C2826262
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0205450
SNOMED CT 2011_0131
9362000
UMLS CUI 2011AA
C0010711
SNOMED CT 2011_0131
89265009
UMLS CUI 2011AA
C0205263
SNOMED CT 2011_0131
16404004
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
Patients with a prior history of peripheral neuropathy of grade >= 2.
Description

Patients with a prior history of peripheral neuropathy of grade >= 2.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0031117
MedDRA 14.1
10029331
ICD-10-CM Version 2010
G64
ICD-9-CM Version 2011
350-359.99
UMLS CUI 2011AA
C0441800
SNOMED CT 2011_0131
258349007
LOINC Version 232
MTHU003112
Clinical evidence of active CNS leukemic involvement.
Description

Clinical evidence of active CNS leukemic involvement.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C1332884
SNOMED CT 2011_0131
10067299
UMLS CUI 2011AA
C1314939
SNOMED CT 2011_0131
248448006
Active and uncontrolled infection. Patients with an infection who are under active treatment with antibiotics and whose infections are controlled may be entered to the study.
Description

Active and uncontrolled infection. Patients with an infection who are under active treatment with antibiotics and whose infections are controlled may be entered to the study.

Data type

boolean

Alias
UMLS CUI 2011AA
C0009450
Current evidence of invasive fungal infection (blood or tissue culture).
Description

Current evidence of invasive fungal infection (blood or tissue culture).

Data type

boolean

Alias
UMLS CUI 2011AA
C0205281
SNOMED CT 2011_0131
10179008
UMLS CUI 2011AA
C0026946
SNOMED CT 2011_0131
3218000
MedDRA 14.1
10017533
ICD-10-CM Version 2010
B35-B49
ICD-9-CM Version 2011
110-118.99
UMLS CUI 2011AA
C0200949
SNOMED CT 2011_0131
30088009
MedDRA 14.1
10005485
ICD-9-CM Version 2011
90.52
UMLS CUI 2011AA
C0040284
SNOMED CT 2011_0131
77601007
Current evidence of an active second malignancy except for non-melanoma skin cancer.
Description

Current evidence of an active second malignancy except for non-melanoma skin cancer.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0085183
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0699893
MedDRA 14.1
10040810
Uncontrolled medical problems, unrelated to the malignancy, or of sufficient severity that in the opinion of the investigator, impair a patient's ability to give informed consent or unacceptably reduce the safety of the proposed treatment.
Description

Uncontrolled medical problems, unrelated to the malignancy, or of sufficient severity that in the opinion of the investigator, impair a patient's ability to give informed consent or unacceptably reduce the safety of the proposed treatment.

Data type

boolean

Alias
UMLS CUI 2011AA
C1522577
Neurological or psychiatric disorders that would interfere with consent or study follow-up.
Description

Neurological or psychiatric disorders that would interfere with consent or study follow-up.

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Known or suspected intolerance or hypersensitivity to the study drugs [or closely related compounds] or any of their stated ingredients. Study drugs being the antisense, cytarabine and idarubicin.
Description

Known or suspected intolerance or hypersensitivity to the study drugs [or closely related compounds] or any of their stated ingredients. Study drugs being the antisense, cytarabine and idarubicin.

Data type

boolean

Alias
UMLS CUI 2011AA
C1744706
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
UMLS CUI 2011AA
CL414967
UMLS CUI 2011AA
C0079925
UMLS CUI 2011AA
C0010711
SNOMED CT 2011_0131
89265009
UMLS CUI 2011AA
C0020789
SNOMED CT 2011_0131
372539000
History of alcohol or other substance abuse within the last year.
Description

History of alcohol or other substance abuse within the last year.

Data type

boolean

Alias
UMLS CUI 2011AA
C0085762
Use of another investigational agent within the last 14 days prior to enrolment. Patients who have received a previous antisense agent in the last 90 days will be excluded.
Description

Use of another investigational agent within the last 14 days prior to enrolment. Patients who have received a previous antisense agent in the last 90 days will be excluded.

Data type

boolean

Alias
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1516879
Female patients who are pregnant, lactating, or with a positive pregnancy test at screening must be excluded.
Description

Female patients who are pregnant, lactating, or with a positive pregnancy test at screening must be excluded.

Data type

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C2828358
UMLS CUI 2011AA
C0240802
SNOMED CT 2011_0131
250423000
MedDRA 14.1
10036575
UMLS CUI 2011AA
C1409616
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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 at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Patients with AML, except those with APL (acute promyelocytic leukemia), failing a single standard dose cytarabine based frontline induction regimen. The diagnosis of refractory AML is based on the presence of either > 10% blasts in marrow or blood or 5-10% blasts in either site together with cytopenia (Hb < 10 g/dL, or platelets < 100 x 109/L, or neutrophil count < 1.0 x 109/L).
Item
Patients with AML, except those with APL (acute promyelocytic leukemia), failing a single standard dose cytarabine based frontline induction regimen. The diagnosis of refractory AML is based on the presence of either > 10% blasts in marrow or blood or 5-10% blasts in either site together with cytopenia (Hb < 10 g/dL, or platelets < 100 x 109/L, or neutrophil count < 1.0 x 109/L).
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)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0023487 (UMLS CUI 2011AA)
110004001 (SNOMED CT 2011_0131)
10001019 (MedDRA 14.1)
C92.4 (ICD-10-CM Version 2010)
C0231175 (UMLS CUI 2011AA)
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C2828392 (UMLS CUI 2011AA)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0010711 (UMLS CUI 2011AA)
89265009 (SNOMED CT 2011_0131)
C0600558 (UMLS CUI 2011AA)
C0205269 (UMLS CUI 2011AA)
20646008 (SNOMED CT 2011_0131)
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)
C0010828 (UMLS CUI 2011AA)
50820005 (SNOMED CT 2011_0131)
10066274 (MedDRA 14.1)
C0019046 (UMLS CUI 2011AA)
38082009 (SNOMED CT 2011_0131)
10019481 (MedDRA 14.1)
LP14449-0 (LOINC Version 232)
C0005821 (UMLS CUI 2011AA)
16378004 (SNOMED CT 2011_0131)
MTHU002432 (LOINC Version 232)
C0200633 (UMLS CUI 2011AA)
30630007 (SNOMED CT 2011_0131)
10029363 (MedDRA 14.1)
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of <=2.
Item
ECOG performance status finding <=2
boolean
C1520224 (UMLS CUI 2011AA)
424122007 (SNOMED CT 2011_0131)
Male, or female patients who are post-menopausal (amenorrheic for at least 12 months), or surgically or biologically sterile.
Item
Male, or female patients who are post-menopausal (amenorrheic for at least 12 months), or surgically or biologically sterile.
boolean
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0232970 (UMLS CUI 2011AA)
76498008 (SNOMED CT 2011_0131)
C0002453 (UMLS CUI 2011AA)
14302001 (SNOMED CT 2011_0131)
10001928 (MedDRA 14.1)
N91.2 (ICD-10-CM Version 2010)
626.0 (ICD-9-CM Version 2011)
C0543467 (UMLS CUI 2011AA)
83578000 (SNOMED CT 2011_0131)
10051332 (MedDRA 14.1)
MTHU000079 (LOINC Version 232)
C0205460 (UMLS CUI 2011AA)
12893009 (SNOMED CT 2011_0131)
C0021359 (UMLS CUI 2011AA)
8619003 (SNOMED CT 2011_0131)
10021926 (MedDRA 14.1)
Patients must have adequate organ and immune function as indicated by the following laboratory values:
Item
Patients must have adequate organ and immune function as indicated by the following laboratory values:
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0678852 (UMLS CUI 2011AA)
C1817756 (UMLS CUI 2011AA)
106183005 (SNOMED CT 2011_0131)
C1444656 (UMLS CUI 2011AA)
410535002 (SNOMED CT 2011_0131)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
C1522609 (UMLS CUI 2011AA)
Parameter Laboratory Values Serum creatinine; ≤2.0 mg/dL (≤ 177 μmol/L Total Bilirubin ≤2.0 mg/dL (≤ 34 μmol/L) AST (SGOT) and ALT (SGPT) ≤3 X ULN
Item
Parameter Laboratory Values Serum creatinine; ≤2.0 mg/dL (≤ 177 μmol/L Total Bilirubin ≤2.0 mg/dL (≤ 34 μmol/L) AST (SGOT) and ALT (SGPT) ≤3 X ULN
boolean
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C0201913 (UMLS CUI 2011AA)
359986008 (SNOMED CT 2011_0131)
10004696 (MedDRA 14.1)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
The patient must understand, be able and willing and likely to fully comply with study procedures, including scheduled follow-up, and restrictions.
Item
The patient must understand, be able and willing and likely to fully comply with study procedures, including scheduled follow-up, and restrictions.
boolean
C1273101 (UMLS CUI 2011AA)
395659009 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0680734 (UMLS CUI 2011AA)
C1522577 (UMLS CUI 2011AA)
CL357089 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Clinical evidence of ongoing grade 3 or 4 non-hematological toxicities from the initial standard dose cytarabine-based induction chemotherapy
Item
Clinical evidence of ongoing grade 3 or 4 non-hematological toxicities from the initial standard dose cytarabine-based induction chemotherapy
boolean
C0549178 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0205488 (UMLS CUI 2011AA)
57407000 (SNOMED CT 2011_0131)
C2826262 (UMLS CUI 2011AA)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0010711 (UMLS CUI 2011AA)
89265009 (SNOMED CT 2011_0131)
C0205263 (UMLS CUI 2011AA)
16404004 (SNOMED CT 2011_0131)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
Patients with a prior history of peripheral neuropathy of grade >= 2.
Item
Patients with a prior history of peripheral neuropathy of grade >= 2.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0031117 (UMLS CUI 2011AA)
10029331 (MedDRA 14.1)
G64 (ICD-10-CM Version 2010)
350-359.99 (ICD-9-CM Version 2011)
C0441800 (UMLS CUI 2011AA)
258349007 (SNOMED CT 2011_0131)
MTHU003112 (LOINC Version 232)
Clinical evidence of active CNS leukemic involvement.
Item
Clinical evidence of active CNS leukemic involvement.
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C1332884 (UMLS CUI 2011AA)
10067299 (SNOMED CT 2011_0131)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
Active and uncontrolled infection. Patients with an infection who are under active treatment with antibiotics and whose infections are controlled may be entered to the study.
Item
Active and uncontrolled infection. Patients with an infection who are under active treatment with antibiotics and whose infections are controlled may be entered to the study.
boolean
C0009450 (UMLS CUI 2011AA)
Current evidence of invasive fungal infection (blood or tissue culture).
Item
Current evidence of invasive fungal infection (blood or tissue culture).
boolean
C0205281 (UMLS CUI 2011AA)
10179008 (SNOMED CT 2011_0131)
C0026946 (UMLS CUI 2011AA)
3218000 (SNOMED CT 2011_0131)
10017533 (MedDRA 14.1)
B35-B49 (ICD-10-CM Version 2010)
110-118.99 (ICD-9-CM Version 2011)
C0200949 (UMLS CUI 2011AA)
30088009 (SNOMED CT 2011_0131)
10005485 (MedDRA 14.1)
90.52 (ICD-9-CM Version 2011)
C0040284 (UMLS CUI 2011AA)
77601007 (SNOMED CT 2011_0131)
Current evidence of an active second malignancy except for non-melanoma skin cancer.
Item
Current evidence of an active second malignancy except for non-melanoma skin cancer.
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0085183 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0699893 (UMLS CUI 2011AA)
10040810 (MedDRA 14.1)
Uncontrolled medical problems, unrelated to the malignancy, or of sufficient severity that in the opinion of the investigator, impair a patient's ability to give informed consent or unacceptably reduce the safety of the proposed treatment.
Item
Uncontrolled medical problems, unrelated to the malignancy, or of sufficient severity that in the opinion of the investigator, impair a patient's ability to give informed consent or unacceptably reduce the safety of the proposed treatment.
boolean
C1522577 (UMLS CUI 2011AA)
Neurological or psychiatric disorders that would interfere with consent or study follow-up.
Item
Neurological or psychiatric disorders that would interfere with consent or study follow-up.
boolean
C0021430 (UMLS CUI 2011AA)
Known or suspected intolerance or hypersensitivity to the study drugs [or closely related compounds] or any of their stated ingredients. Study drugs being the antisense, cytarabine and idarubicin.
Item
Known or suspected intolerance or hypersensitivity to the study drugs [or closely related compounds] or any of their stated ingredients. Study drugs being the antisense, cytarabine and idarubicin.
boolean
C1744706 (UMLS CUI 2011AA)
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
CL414967 (UMLS CUI 2011AA)
C0079925 (UMLS CUI 2011AA)
C0010711 (UMLS CUI 2011AA)
89265009 (SNOMED CT 2011_0131)
C0020789 (UMLS CUI 2011AA)
372539000 (SNOMED CT 2011_0131)
History of alcohol or other substance abuse within the last year.
Item
History of alcohol or other substance abuse within the last year.
boolean
C0085762 (UMLS CUI 2011AA)
Use of another investigational agent within the last 14 days prior to enrolment. Patients who have received a previous antisense agent in the last 90 days will be excluded.
Item
Use of another investigational agent within the last 14 days prior to enrolment. Patients who have received a previous antisense agent in the last 90 days will be excluded.
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
Female patients who are pregnant, lactating, or with a positive pregnancy test at screening must be excluded.
Item
Female patients who are pregnant, lactating, or with a positive pregnancy test at screening must be excluded.
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C2828358 (UMLS CUI 2011AA)
C0240802 (UMLS CUI 2011AA)
250423000 (SNOMED CT 2011_0131)
10036575 (MedDRA 14.1)
C1409616 (UMLS CUI 2011AA)
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