ID

5154

Description

ODM derived from http://clinicaltrials.gov/show/NCT01361334

Link

http://clinicaltrials.gov/show/NCT01361334

Keywords

Versions (6)
  1. 4/11/13 4/11/13 - Martin Dugas
  2. 7/26/13 7/26/13 - Martin Dugas
  3. 4/20/14 4/20/14 - Julian Varghese
  4. 8/18/15 8/18/15 - Martin Dugas
  5. 1/14/16 1/14/16 -
  6. 2/11/16 2/11/16 -
Uploaded on

April 20, 2014

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT01361334 Acute Myeloid Leukemia

German English

Eligibility

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

Inclusion Criteria

age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Subjects must provide written informed consent prior to performance of study-specific procedures or assessments which are not routinely performed for diagnosis or monitoring of acute myeloid leukemia (AML), and the subjects must be willing to comply with treatment and to follow up assessments and procedures
Description

Subjects must provide written informed consent prior to performance of study-specific procedures or assessments which are not routinely performed for diagnosis or monitoring of acute myeloid leukemia (AML), and the subjects must be willing to comply with treatment and to follow up assessments and procedures

Data type

boolean

Alias
UMLS CUI 2011AA
C0184704
SNOMED CT 2011_0131
55149002
UMLS CUI 2011AA
CL415337
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
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
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C0525058
Histologically or cytologically confirmed diagnosis of AML relapsed after or refractory to at least one induction regimen, or patients with AML at initial diagnosis who are not eligible for allogeneic transplant or intensive induction chemotherapy, except for AML M3 (acute promyelocytic leukemia)
Description

Histologically or cytologically confirmed diagnosis of AML relapsed after or refractory to at least one induction regimen, or patients with AML at initial diagnosis who are not eligible for allogeneic transplant or intensive induction chemotherapy, except for AML M3 (acute promyelocytic leukemia)

Data type

boolean

Alias
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0278780
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
C0600558
UMLS CUI 2011AA
C0205265
SNOMED CT 2011_0131
884001
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C1555471
HL7 V3 2006_05
NELG
UMLS CUI 2011AA
C0040739
SNOMED CT 2011_0131
50223000
UMLS CUI 2011AA
C3179010
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
ECOG performance status finding <= 3
Description

Eastern Cooperative Oncology Group (ECOG) performance status of ≤3

Data type

boolean

Alias
UMLS CUI 2011AA
C1520224
SNOMED CT 2011_0131
424122007
Measurable disease burden (blasts in BM and/or PB, extramedullary blasts [chloroma])
Description

Measurable disease burden (blasts in BM and/or PB, extramedullary blasts [chloroma])

Data type

boolean

Alias
UMLS CUI 2011AA
C1513041
UMLS CUI 2011AA
C2828008
UMLS CUI 2011AA
C0368761
SNOMED CT 2011_0131
312256009
LOINC Version 232
MTHU005201
UMLS CUI 2011AA
C0005953
SNOMED CT 2011_0131
14016003
LOINC Version 232
MTHU016536
UMLS CUI 2011AA
C0229664
SNOMED CT 2011_0131
119273009
LOINC Version 232
MTHU003709
UMLS CUI 2011AA
C1517060
UMLS CUI 2011AA
C0368761
SNOMED CT 2011_0131
312256009
LOINC Version 232
MTHU005201
UMLS CUI 2011AA
CL414320
SNOMED CT 2011_0131
188737002, 94719007
MedDRA 14.1
10008583
ICD-9-CM Version 2011
205.3
Able to swallow and retain oral medication
Description

Able to swallow and retain oral medication

Data type

boolean

Alias
UMLS CUI 2011AA
C0566356
SNOMED CT 2011_0131
288936000
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0333118
SNOMED CT 2011_0131
397909002
UMLS CUI 2011AA
CL436624
A life expectancy of at least 4 weeks
Description

A life expectancy of at least 4 weeks

Data type

boolean

Alias
UMLS CUI 2011AA
C0023671
LOINC Version 232
LP75025-4
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C0205450
SNOMED CT 2011_0131
9362000
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
Adequate contraception methods
Description

Adequate contraception methods

Data type

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
Adequate organ function as defined in the study protocol
Description

Adequate organ function as defined in the study protocol

Data type

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0178784
LOINC Version 232
MTHU020170
UMLS CUI 2011AA
C0542341
SNOMED CT 2011_0131
246464006
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
C2348563
Exclusion Criteria
Description

Exclusion Criteria

Patients with a valid option for intensive chemotherapy and/or stem cell transplantation (Patients after allogeneic stem cell transplant must be off immunosuppressive agents for at least 2 weeks prior to study entry and Graft-versus host disease must have resolved to Grade ≤2)
Description

Patients with a valid option for intensive chemotherapy and/or stem cell transplantation (Patients after allogeneic stem cell transplant must be off immunosuppressive agents for at least 2 weeks prior to study entry and Graft-versus host disease must have resolved to Grade ≤2)

Data type

boolean

Alias
UMLS CUI 2011AA
C2349099
UMLS CUI 2011AA
C0683525
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
UMLS CUI 2011AA
C1504389
MedDRA 14.1
10063581
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C0021081
SNOMED CT 2011_0131
372823004, 69431002
UMLS CUI 2011AA
C0018133
SNOMED CT 2011_0131
234646005
MedDRA 14.1
10018651
ICD-10-CM Version 2010
D89.813
ICD-9-CM Version 2011
279.50
UMLS CUI 2011AA
C1514893
UMLS CUI 2011AA
C0441800
SNOMED CT 2011_0131
258349007
LOINC Version 232
MTHU003112
History of cancer that according to the Investigator might confound the assessment of the endpoints of the study
Description

History of cancer that according to the Investigator might confound the assessment of the endpoints of the study

Data type

boolean

Alias
UMLS CUI 2011AA
C2735088
LOINC Version 232
MTHU034770
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C1516048
UMLS CUI 2011AA
C2349179
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Uncontrolled peptic ulcer disease or clinically significant gastrointestinal abnormalities which interfere with oral dosing or any unstable or serious concurrent condition (e.g., active uncontrolled infection)
Description

Uncontrolled peptic ulcer disease or clinically significant gastrointestinal abnormalities which interfere with oral dosing or any unstable or serious concurrent condition (e.g., active uncontrolled infection)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0030920
SNOMED CT 2011_0131
13200003
MedDRA 14.1
10034341
ICD-10-CM Version 2010
K27
ICD-9-CM Version 2011
533
UMLS CUI 2011AA
C0521362
LOINC Version 232
MTHU031867
UMLS CUI 2011AA
C1704258
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C1527415
SNOMED CT 2011_0131
26643006
HL7 V3 2006_05
_OralRoute
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0443343
SNOMED CT 2011_0131
263922001
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0021311
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
Poorly controlled hypertension [defined as systolic blood pressure (SBP) of >=140 mmHg or diastolic blood pressure (DBP) of >90 mmHg]. Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. BP must be re-assessed on two occasions that are separated by a minimum of 1 hour. on each of these occasions, the mean (of 3 readings) SBP / DBP values from each BP assessment must be <140/90 mmHg in order for a subject to be eligible for the study
Description

Poorly controlled hypertension [defined as systolic blood pressure (SBP) of >=140 mmHg or diastolic blood pressure (DBP) of >90 mmHg]. Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. BP must be re-assessed on two occasions that are separated by a minimum of 1 hour. on each of these occasions, the mean (of 3 readings) SBP / DBP values from each BP assessment must be <140/90 mmHg in order for a subject to be eligible for the study

Data type

boolean

Alias
UMLS CUI 2011AA
C0205169
SNOMED CT 2011_0131
556001
UMLS CUI 2011AA
C2587213
SNOMED CT 2011_0131
31509003
UMLS CUI 2011AA
C0020538
SNOMED CT 2011_0131
38341003
MedDRA 14.1
10020772
LOINC Version 232
MTHU020789
ICD-10-CM Version 2010
I10
ICD-9-CM Version 2011
997.91
CTCAE 1105E
E13785
UMLS CUI 2011AA
C1306620
MedDRA 14.1
10005756
UMLS CUI 2011AA
C0428883
SNOMED CT 2011_0131
271650006
Prolonged QTc interval
Description

Prolongation of corrected QT interval (QTc) >480 milliseconds

Data type

boolean

Alias
UMLS CUI 2011AA
C1560305
History of any one of more of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, symptomatic peripheral vascular disease, class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
Description

History of any one of more of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, symptomatic peripheral vascular disease, class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C1522601
UMLS CUI 2011AA
C0162577
SNOMED CT 2011_0131
418285008
MedDRA 14.1
10002475
LOINC Version 232
MTHU011020
UMLS CUI 2011AA
CL371838
UMLS CUI 2011AA
C0027051
SNOMED CT 2011_0131
22298006
MedDRA 14.1
10028596
LOINC Version 232
MTHU035551
ICD-10-CM Version 2010
I21-I22
ICD-9-CM Version 2011
410
CTCAE 1105E
E10152
UMLS CUI 2011AA
C0002965
SNOMED CT 2011_0131
4557003
MedDRA 14.1
10002388
ICD-10-CM Version 2010
I20.0
ICD-9-CM Version 2011
411.1
UMLS CUI 2011AA
C0085096
SNOMED CT 2011_0131
400047006
MedDRA 14.1
10034636
LOINC Version 232
MTHU020791
ICD-10-CM Version 2010
I73.9
ICD-9-CM Version 2011
443.9
UMLS CUI 2011AA
C0018802
SNOMED CT 2011_0131
42343007
MedDRA 14.1
10007559
LOINC Version 232
MTHU020787
ICD-10-CM Version 2010
I50.9
ICD-9-CM Version 2011
428.0
UMLS CUI 2011AA
C1319795
SNOMED CT 2011_0131
420913000
MedDRA 14.1
10064081
UMLS CUI 2011AA
C1319796
SNOMED CT 2011_0131
422293003
MedDRA 14.1
10064082
History of cerebrovascular infarction or bleeding, pulmonary embolism, or untreated deep venous thrombosis (DVT) within the past 6 months. Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulant agents for at least 6 weeks are eligible
Description

History of cerebrovascular infarction or bleeding, pulmonary embolism, or untreated deep venous thrombosis (DVT) within the past 6 months. Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulant agents for at least 6 weeks are eligible

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0007785
SNOMED CT 2011_0131
432504007
MedDRA 14.1
10060772
ICD-10-CM Version 2010
I63.9
UMLS CUI 2011AA
C1880018
UMLS CUI 2011AA
C0019080
SNOMED CT 2011_0131
50960005
MedDRA 14.1
10055798
ICD-10-CM Version 2010
R58
ICD-9-CM Version 2011
459.0
UMLS CUI 2011AA
C0034065
SNOMED CT 2011_0131
59282003
MedDRA 14.1
10037377
ICD-10-CM Version 2010
I26
ICD-9-CM Version 2011
415.1
UMLS CUI 2011AA
C0332155
SNOMED CT 2011_0131
25265005
UMLS CUI 2011AA
C0149871
SNOMED CT 2011_0131
128053003
MedDRA 14.1
10051055
ICD-10-CM Version 2010
I82.40
Evidence of serious active bleeding or bleeding diathesis (except for bleeding or petechiae due to AML-related thrombocytopenia which will be treated using platelet transfusions). Also, patients with known endobronchial lesions and/or lesions infiltrating major pulmonary vessels will be excluded from the study due to excess risk of bleeding.
Description

Evidence of serious active bleeding or bleeding diathesis (except for bleeding or petechiae due to AML-related thrombocytopenia which will be treated using platelet transfusions). Also, patients with known endobronchial lesions and/or lesions infiltrating major pulmonary vessels will be excluded from the study due to excess risk of bleeding.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205404
SNOMED CT 2011_0131
42745003
UMLS CUI 2011AA
C0019080
SNOMED CT 2011_0131
50960005
MedDRA 14.1
10055798
ICD-10-CM Version 2010
R58
ICD-9-CM Version 2011
459.0
UMLS CUI 2011AA
C1458140
SNOMED CT 2011_0131
248250000
MedDRA 14.1
10005134
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0019080
SNOMED CT 2011_0131
50960005
MedDRA 14.1
10055798
ICD-10-CM Version 2010
R58
ICD-9-CM Version 2011
459.0
UMLS CUI 2011AA
C0031256
SNOMED CT 2011_0131
50091001
MedDRA 14.1
10034754
ICD-10-CM Version 2010
R23.3
UMLS CUI 2011AA
CL420107
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
C0699792
SNOMED CT 2011_0131
263498003
UMLS CUI 2011AA
C0040034
SNOMED CT 2011_0131
302215000
MedDRA 14.1
10043554
ICD-10-CM Version 2010
D69.6
ICD-9-CM Version 2011
287.5
CTCAE 1105E
E12207
UMLS CUI 2011AA
CL425201
UMLS CUI 2011AA
C2985135
UMLS CUI 2011AA
C0273454
SNOMED CT 2011_0131
210790008
MedDRA 14.1
10022320
ICD-10-CM Version 2010
S25.4
ICD-9-CM Version 2011
901.40
Prior major surgery or trauma within 28 days prior to first dose of study drug
Description

Prior major surgery or trauma within 28 days prior to first dose of study drug

Data type

boolean

Alias
UMLS CUI 2011AA
C0679637
UMLS CUI 2011AA
C0175677
SNOMED CT 2011_0131
417746004
MedDRA 14.1
10022116
ICD-10-CM Version 2010
T14.9
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C2348558
Treatment with an investigational agent within 28 days or 5 half-lives, whichever is longer prior to the first dose of study drug (for bevacizumab 60 days).
Description

Treatment with an investigational agent within 28 days or 5 half-lives, whichever is longer prior to the first dose of study drug (for bevacizumab 60 days).

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C2348558
UMLS CUI 2011AA
C0796392
SNOMED CT 2011_0131
409406007
Concurrent cytoreductive chemotherapy (hydroxyurea must be discontinued at least one day before start of study medication)
Description

Concurrent cytoreductive chemotherapy (hydroxyurea must be discontinued at least one day before start of study medication)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205420
SNOMED CT 2011_0131
68405009
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
UMLS CUI 2011AA
C0864494
UMLS CUI 2011AA
C0020402
SNOMED CT 2011_0131
56602009
Known immediate or delayed hypersensitivity reaction or idiosyncrasy to pazopanib
Description

Known immediate or delayed hypersensitivity reaction or idiosyncrasy to pazopanib

Data type

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0231191
SNOMED CT 2011_0131
56840009
UMLS CUI 2011AA
C1831796
SNOMED CT 2011_0131
443763005
Patients with psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
Description

Patients with psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol

Data type

boolean

Alias
UMLS CUI 2011AA
C0205486
SNOMED CT 2011_0131
60224009
UMLS CUI 2011AA
C0241888
SNOMED CT 2011_0131
255401001
UMLS CUI 2011AA
C0037468
UMLS CUI 2011AA
C1517526
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
CL414898
UMLS CUI 2011AA
C0525058
Pregnant or lactating and actively breastfeeding patients
Description

Pregnant or lactating and actively breastfeeding patients

Data type

boolean

Alias
UMLS CUI 1
C0549206
MedDRA 1
10036586
UMLS CUI 2
C0006147
MedDRA 2
10006247
UMLS CUI 3
C2828358
SNOMED CT 2011_0131
116154003
Patients taking any of the following prohibited medication:
Description

Patients taking any of the following prohibited medication:

Data type

boolean

Alias
UMLS CUI 2011AA
C1512806
UMLS CUI 2011AA
CL407060
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C0683610
UMLS CUI 2011AA
C0013227
clarithromycin, telithromycin, troleandomycin (antibiotics)
Description

clarithromycin, telithromycin, troleandomycin (antibiotics)

Data type

boolean

Alias
UMLS CUI 2011AA
C0055856
SNOMED CT 2011_0131
83999008
LOINC Version 232
MTHU006897
UMLS CUI 2011AA
C1452484
SNOMED CT 2011_0131
395260006
LOINC Version 232
MTHU016681
UMLS CUI 2011AA
C0702222
SNOMED CT 2011_0131
371016002
LOINC Version 232
MTHU008495
UMLS CUI 2011AA
C0003232
SNOMED CT 2011_0131
255631004
ritonavir, indinavir, saquinavir, nelfinavir, amprenavir, lopinavir (HIV protease inhibitors)
Description

ritonavir, indinavir, saquinavir, nelfinavir, amprenavir, lopinavir (HIV protease inhibitors)

Data type

boolean

Alias
UMLS CUI 2011AA
C0292818
SNOMED CT 2011_0131
386896009
LOINC Version 232
MTHU013855
UMLS CUI 2011AA
C0376637
SNOMED CT 2011_0131
108695003
LOINC Version 232
MTHU013846
UMLS CUI 2011AA
C0286738
SNOMED CT 2011_0131
108700005
LOINC Version 232
MTHU008513
UMLS CUI 2011AA
C0525005
SNOMED CT 2011_0131
108706004
LOINC Version 232
MTHU013848
UMLS CUI 2011AA
C0754188
SNOMED CT 2011_0131
116088006
LOINC Version 232
MTHU013842
UMLS CUI 2011AA
C0674432
SNOMED CT 2011_0131
129475001
LOINC Version 232
MTHU014678
UMLS CUI 2011AA
C0162714
itraconazole, ketoconazole, voriconazole, fluconazole (antifungals)
Description

itraconazole, ketoconazole, voriconazole, fluconazole (antifungals)

Data type

boolean

Alias
UMLS CUI 2011AA
C0064113
SNOMED CT 2011_0131
387532006
LOINC Version 232
MTHU002298
UMLS CUI 2011AA
C0022625
SNOMED CT 2011_0131
387216007
LOINC Version 232
MTHU002299
UMLS CUI 2011AA
C0393080
SNOMED CT 2011_0131
385469007
LOINC Version 232
MTHU015011
UMLS CUI 2011AA
C0016277
SNOMED CT 2011_0131
31865003
LOINC Version 232
MTHU002296
UMLS CUI 2011AA
C0003308
SNOMED CT 2011_0131
373219008
nefazodone (antidepressant)
Description

nefazodone (antidepressant)

Data type

boolean

Alias
UMLS CUI 2011AA
C0068485
SNOMED CT 2011_0131
108435006
LOINC Version 232
MTHU003461
UMLS CUI 2011AA
C0003289
SNOMED CT 2011_0131
372720008
LOINC Version 232
MTHU006782
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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
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Subjects must provide written informed consent prior to performance of study-specific procedures or assessments which are not routinely performed for diagnosis or monitoring of acute myeloid leukemia (AML), and the subjects must be willing to comply with treatment and to follow up assessments and procedures
Item
Subjects must provide written informed consent prior to performance of study-specific procedures or assessments which are not routinely performed for diagnosis or monitoring of acute myeloid leukemia (AML), and the subjects must be willing to comply with treatment and to follow up assessments and procedures
boolean
C0184704 (UMLS CUI 2011AA)
55149002 (SNOMED CT 2011_0131)
CL415337 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
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)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C0525058 (UMLS CUI 2011AA)
Histologically or cytologically confirmed diagnosis of AML relapsed after or refractory to at least one induction regimen, or patients with AML at initial diagnosis who are not eligible for allogeneic transplant or intensive induction chemotherapy, except for AML M3 (acute promyelocytic leukemia)
Item
Histologically or cytologically confirmed diagnosis of AML relapsed after or refractory to at least one induction regimen, or patients with AML at initial diagnosis who are not eligible for allogeneic transplant or intensive induction chemotherapy, except for AML M3 (acute promyelocytic leukemia)
boolean
C0750484 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0278780 (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)
C0600558 (UMLS CUI 2011AA)
C0205265 (UMLS CUI 2011AA)
884001 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1555471 (UMLS CUI 2011AA)
NELG (HL7 V3 2006_05)
C0040739 (UMLS CUI 2011AA)
50223000 (SNOMED CT 2011_0131)
C3179010 (UMLS CUI 2011AA)
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)
Eastern Cooperative Oncology Group (ECOG) performance status of ≤3
Item
ECOG performance status finding <= 3
boolean
C1520224 (UMLS CUI 2011AA)
424122007 (SNOMED CT 2011_0131)
Measurable disease burden (blasts in BM and/or PB, extramedullary blasts [chloroma])
Item
Measurable disease burden (blasts in BM and/or PB, extramedullary blasts [chloroma])
boolean
C1513041 (UMLS CUI 2011AA)
C2828008 (UMLS CUI 2011AA)
C0368761 (UMLS CUI 2011AA)
312256009 (SNOMED CT 2011_0131)
MTHU005201 (LOINC Version 232)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
C0229664 (UMLS CUI 2011AA)
119273009 (SNOMED CT 2011_0131)
MTHU003709 (LOINC Version 232)
C1517060 (UMLS CUI 2011AA)
C0368761 (UMLS CUI 2011AA)
312256009 (SNOMED CT 2011_0131)
MTHU005201 (LOINC Version 232)
CL414320 (UMLS CUI 2011AA)
188737002, 94719007 (SNOMED CT 2011_0131)
10008583 (MedDRA 14.1)
205.3 (ICD-9-CM Version 2011)
Able to swallow and retain oral medication
Item
Able to swallow and retain oral medication
boolean
C0566356 (UMLS CUI 2011AA)
288936000 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0333118 (UMLS CUI 2011AA)
397909002 (SNOMED CT 2011_0131)
CL436624 (UMLS CUI 2011AA)
A life expectancy of at least 4 weeks
Item
A life expectancy of at least 4 weeks
boolean
C0023671 (UMLS CUI 2011AA)
LP75025-4 (LOINC Version 232)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
Adequate contraception methods
Item
Adequate contraception methods
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Adequate organ function as defined in the study protocol
Item
Adequate organ function as defined in the study protocol
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0178784 (UMLS CUI 2011AA)
MTHU020170 (LOINC Version 232)
C0542341 (UMLS CUI 2011AA)
246464006 (SNOMED CT 2011_0131)
C1704788 (UMLS CUI 2011AA)
C2348563 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
Patients with a valid option for intensive chemotherapy and/or stem cell transplantation (Patients after allogeneic stem cell transplant must be off immunosuppressive agents for at least 2 weeks prior to study entry and Graft-versus host disease must have resolved to Grade ≤2)
Item
Patients with a valid option for intensive chemotherapy and/or stem cell transplantation (Patients after allogeneic stem cell transplant must be off immunosuppressive agents for at least 2 weeks prior to study entry and Graft-versus host disease must have resolved to Grade ≤2)
boolean
C2349099 (UMLS CUI 2011AA)
C0683525 (UMLS CUI 2011AA)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C1504389 (UMLS CUI 2011AA)
10063581 (MedDRA 14.1)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0021081 (UMLS CUI 2011AA)
372823004, 69431002 (SNOMED CT 2011_0131)
C0018133 (UMLS CUI 2011AA)
234646005 (SNOMED CT 2011_0131)
10018651 (MedDRA 14.1)
D89.813 (ICD-10-CM Version 2010)
279.50 (ICD-9-CM Version 2011)
C1514893 (UMLS CUI 2011AA)
C0441800 (UMLS CUI 2011AA)
258349007 (SNOMED CT 2011_0131)
MTHU003112 (LOINC Version 232)
History of cancer that according to the Investigator might confound the assessment of the endpoints of the study
Item
History of cancer that according to the Investigator might confound the assessment of the endpoints of the study
boolean
C2735088 (UMLS CUI 2011AA)
MTHU034770 (LOINC Version 232)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C1516048 (UMLS CUI 2011AA)
C2349179 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Uncontrolled peptic ulcer disease or clinically significant gastrointestinal abnormalities which interfere with oral dosing or any unstable or serious concurrent condition (e.g., active uncontrolled infection)
Item
Uncontrolled peptic ulcer disease or clinically significant gastrointestinal abnormalities which interfere with oral dosing or any unstable or serious concurrent condition (e.g., active uncontrolled infection)
boolean
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0030920 (UMLS CUI 2011AA)
13200003 (SNOMED CT 2011_0131)
10034341 (MedDRA 14.1)
K27 (ICD-10-CM Version 2010)
533 (ICD-9-CM Version 2011)
C0521362 (UMLS CUI 2011AA)
MTHU031867 (LOINC Version 232)
C1704258 (UMLS CUI 2011AA)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0443343 (UMLS CUI 2011AA)
263922001 (SNOMED CT 2011_0131)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
Poorly controlled hypertension [defined as systolic blood pressure (SBP) of >=140 mmHg or diastolic blood pressure (DBP) of >90 mmHg]. Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. BP must be re-assessed on two occasions that are separated by a minimum of 1 hour. on each of these occasions, the mean (of 3 readings) SBP / DBP values from each BP assessment must be <140/90 mmHg in order for a subject to be eligible for the study
Item
Poorly controlled hypertension [defined as systolic blood pressure (SBP) of >=140 mmHg or diastolic blood pressure (DBP) of >90 mmHg]. Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. BP must be re-assessed on two occasions that are separated by a minimum of 1 hour. on each of these occasions, the mean (of 3 readings) SBP / DBP values from each BP assessment must be <140/90 mmHg in order for a subject to be eligible for the study
boolean
C0205169 (UMLS CUI 2011AA)
556001 (SNOMED CT 2011_0131)
C2587213 (UMLS CUI 2011AA)
31509003 (SNOMED CT 2011_0131)
C0020538 (UMLS CUI 2011AA)
38341003 (SNOMED CT 2011_0131)
10020772 (MedDRA 14.1)
MTHU020789 (LOINC Version 232)
I10 (ICD-10-CM Version 2010)
997.91 (ICD-9-CM Version 2011)
E13785 (CTCAE 1105E)
C1306620 (UMLS CUI 2011AA)
10005756 (MedDRA 14.1)
C0428883 (UMLS CUI 2011AA)
271650006 (SNOMED CT 2011_0131)
Prolongation of corrected QT interval (QTc) >480 milliseconds
Item
Prolonged QTc interval
boolean
C1560305 (UMLS CUI 2011AA)
History of any one of more of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, symptomatic peripheral vascular disease, class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
Item
History of any one of more of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, symptomatic peripheral vascular disease, class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C1522601 (UMLS CUI 2011AA)
C0162577 (UMLS CUI 2011AA)
418285008 (SNOMED CT 2011_0131)
10002475 (MedDRA 14.1)
MTHU011020 (LOINC Version 232)
CL371838 (UMLS CUI 2011AA)
C0027051 (UMLS CUI 2011AA)
22298006 (SNOMED CT 2011_0131)
10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE 1105E)
C0002965 (UMLS CUI 2011AA)
4557003 (SNOMED CT 2011_0131)
10002388 (MedDRA 14.1)
I20.0 (ICD-10-CM Version 2010)
411.1 (ICD-9-CM Version 2011)
C0085096 (UMLS CUI 2011AA)
400047006 (SNOMED CT 2011_0131)
10034636 (MedDRA 14.1)
MTHU020791 (LOINC Version 232)
I73.9 (ICD-10-CM Version 2010)
443.9 (ICD-9-CM Version 2011)
C0018802 (UMLS CUI 2011AA)
42343007 (SNOMED CT 2011_0131)
10007559 (MedDRA 14.1)
MTHU020787 (LOINC Version 232)
I50.9 (ICD-10-CM Version 2010)
428.0 (ICD-9-CM Version 2011)
C1319795 (UMLS CUI 2011AA)
420913000 (SNOMED CT 2011_0131)
10064081 (MedDRA 14.1)
C1319796 (UMLS CUI 2011AA)
422293003 (SNOMED CT 2011_0131)
10064082 (MedDRA 14.1)
History of cerebrovascular infarction or bleeding, pulmonary embolism, or untreated deep venous thrombosis (DVT) within the past 6 months. Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulant agents for at least 6 weeks are eligible
Item
History of cerebrovascular infarction or bleeding, pulmonary embolism, or untreated deep venous thrombosis (DVT) within the past 6 months. Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulant agents for at least 6 weeks are eligible
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0007785 (UMLS CUI 2011AA)
432504007 (SNOMED CT 2011_0131)
10060772 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
C1880018 (UMLS CUI 2011AA)
C0019080 (UMLS CUI 2011AA)
50960005 (SNOMED CT 2011_0131)
10055798 (MedDRA 14.1)
R58 (ICD-10-CM Version 2010)
459.0 (ICD-9-CM Version 2011)
C0034065 (UMLS CUI 2011AA)
59282003 (SNOMED CT 2011_0131)
10037377 (MedDRA 14.1)
I26 (ICD-10-CM Version 2010)
415.1 (ICD-9-CM Version 2011)
C0332155 (UMLS CUI 2011AA)
25265005 (SNOMED CT 2011_0131)
C0149871 (UMLS CUI 2011AA)
128053003 (SNOMED CT 2011_0131)
10051055 (MedDRA 14.1)
I82.40 (ICD-10-CM Version 2010)
Evidence of serious active bleeding or bleeding diathesis (except for bleeding or petechiae due to AML-related thrombocytopenia which will be treated using platelet transfusions). Also, patients with known endobronchial lesions and/or lesions infiltrating major pulmonary vessels will be excluded from the study due to excess risk of bleeding.
Item
Evidence of serious active bleeding or bleeding diathesis (except for bleeding or petechiae due to AML-related thrombocytopenia which will be treated using platelet transfusions). Also, patients with known endobronchial lesions and/or lesions infiltrating major pulmonary vessels will be excluded from the study due to excess risk of bleeding.
boolean
C0205404 (UMLS CUI 2011AA)
42745003 (SNOMED CT 2011_0131)
C0019080 (UMLS CUI 2011AA)
50960005 (SNOMED CT 2011_0131)
10055798 (MedDRA 14.1)
R58 (ICD-10-CM Version 2010)
459.0 (ICD-9-CM Version 2011)
C1458140 (UMLS CUI 2011AA)
248250000 (SNOMED CT 2011_0131)
10005134 (MedDRA 14.1)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0019080 (UMLS CUI 2011AA)
50960005 (SNOMED CT 2011_0131)
10055798 (MedDRA 14.1)
R58 (ICD-10-CM Version 2010)
459.0 (ICD-9-CM Version 2011)
C0031256 (UMLS CUI 2011AA)
50091001 (SNOMED CT 2011_0131)
10034754 (MedDRA 14.1)
R23.3 (ICD-10-CM Version 2010)
CL420107 (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)
C0699792 (UMLS CUI 2011AA)
263498003 (SNOMED CT 2011_0131)
C0040034 (UMLS CUI 2011AA)
302215000 (SNOMED CT 2011_0131)
10043554 (MedDRA 14.1)
D69.6 (ICD-10-CM Version 2010)
287.5 (ICD-9-CM Version 2011)
E12207 (CTCAE 1105E)
CL425201 (UMLS CUI 2011AA)
C2985135 (UMLS CUI 2011AA)
C0273454 (UMLS CUI 2011AA)
210790008 (SNOMED CT 2011_0131)
10022320 (MedDRA 14.1)
S25.4 (ICD-10-CM Version 2010)
901.40 (ICD-9-CM Version 2011)
Prior major surgery or trauma within 28 days prior to first dose of study drug
Item
Prior major surgery or trauma within 28 days prior to first dose of study drug
boolean
C0679637 (UMLS CUI 2011AA)
C0175677 (UMLS CUI 2011AA)
417746004 (SNOMED CT 2011_0131)
10022116 (MedDRA 14.1)
T14.9 (ICD-10-CM Version 2010)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
Treatment with an investigational agent within 28 days or 5 half-lives, whichever is longer prior to the first dose of study drug (for bevacizumab 60 days).
Item
Treatment with an investigational agent within 28 days or 5 half-lives, whichever is longer prior to the first dose of study drug (for bevacizumab 60 days).
boolean
C0039798 (UMLS CUI 2011AA)
C0013230 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
C0796392 (UMLS CUI 2011AA)
409406007 (SNOMED CT 2011_0131)
Concurrent cytoreductive chemotherapy (hydroxyurea must be discontinued at least one day before start of study medication)
Item
Concurrent cytoreductive chemotherapy (hydroxyurea must be discontinued at least one day before start of study medication)
boolean
C0205420 (UMLS CUI 2011AA)
68405009 (SNOMED CT 2011_0131)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C0864494 (UMLS CUI 2011AA)
C0020402 (UMLS CUI 2011AA)
56602009 (SNOMED CT 2011_0131)
Known immediate or delayed hypersensitivity reaction or idiosyncrasy to pazopanib
Item
Known immediate or delayed hypersensitivity reaction or idiosyncrasy to pazopanib
boolean
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0231191 (UMLS CUI 2011AA)
56840009 (SNOMED CT 2011_0131)
C1831796 (UMLS CUI 2011AA)
443763005 (SNOMED CT 2011_0131)
Patients with psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
Item
Patients with psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
boolean
C0205486 (UMLS CUI 2011AA)
60224009 (SNOMED CT 2011_0131)
C0241888 (UMLS CUI 2011AA)
255401001 (SNOMED CT 2011_0131)
C0037468 (UMLS CUI 2011AA)
C1517526 (UMLS CUI 2011AA)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
CL414898 (UMLS CUI 2011AA)
C0525058 (UMLS CUI 2011AA)
Pregnant or lactating and actively breastfeeding patients
Item
Pregnant or lactating and actively breastfeeding patients
boolean
C0549206 (UMLS CUI 1)
10036586 (MedDRA 1)
C0006147 (UMLS CUI 2)
10006247 (MedDRA 2)
C2828358 (UMLS CUI 3)
116154003 (SNOMED CT 2011_0131)
Patients taking any of the following prohibited medication:
Item
Patients taking any of the following prohibited medication:
boolean
C1512806 (UMLS CUI 2011AA)
CL407060 (UMLS CUI 2011AA)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0683610 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
clarithromycin, telithromycin, troleandomycin (antibiotics)
Item
clarithromycin, telithromycin, troleandomycin (antibiotics)
boolean
C0055856 (UMLS CUI 2011AA)
83999008 (SNOMED CT 2011_0131)
MTHU006897 (LOINC Version 232)
C1452484 (UMLS CUI 2011AA)
395260006 (SNOMED CT 2011_0131)
MTHU016681 (LOINC Version 232)
C0702222 (UMLS CUI 2011AA)
371016002 (SNOMED CT 2011_0131)
MTHU008495 (LOINC Version 232)
C0003232 (UMLS CUI 2011AA)
255631004 (SNOMED CT 2011_0131)
ritonavir, indinavir, saquinavir, nelfinavir, amprenavir, lopinavir (HIV protease inhibitors)
Item
ritonavir, indinavir, saquinavir, nelfinavir, amprenavir, lopinavir (HIV protease inhibitors)
boolean
C0292818 (UMLS CUI 2011AA)
386896009 (SNOMED CT 2011_0131)
MTHU013855 (LOINC Version 232)
C0376637 (UMLS CUI 2011AA)
108695003 (SNOMED CT 2011_0131)
MTHU013846 (LOINC Version 232)
C0286738 (UMLS CUI 2011AA)
108700005 (SNOMED CT 2011_0131)
MTHU008513 (LOINC Version 232)
C0525005 (UMLS CUI 2011AA)
108706004 (SNOMED CT 2011_0131)
MTHU013848 (LOINC Version 232)
C0754188 (UMLS CUI 2011AA)
116088006 (SNOMED CT 2011_0131)
MTHU013842 (LOINC Version 232)
C0674432 (UMLS CUI 2011AA)
129475001 (SNOMED CT 2011_0131)
MTHU014678 (LOINC Version 232)
C0162714 (UMLS CUI 2011AA)
itraconazole, ketoconazole, voriconazole, fluconazole (antifungals)
Item
itraconazole, ketoconazole, voriconazole, fluconazole (antifungals)
boolean
C0064113 (UMLS CUI 2011AA)
387532006 (SNOMED CT 2011_0131)
MTHU002298 (LOINC Version 232)
C0022625 (UMLS CUI 2011AA)
387216007 (SNOMED CT 2011_0131)
MTHU002299 (LOINC Version 232)
C0393080 (UMLS CUI 2011AA)
385469007 (SNOMED CT 2011_0131)
MTHU015011 (LOINC Version 232)
C0016277 (UMLS CUI 2011AA)
31865003 (SNOMED CT 2011_0131)
MTHU002296 (LOINC Version 232)
C0003308 (UMLS CUI 2011AA)
373219008 (SNOMED CT 2011_0131)
nefazodone (antidepressant)
Item
nefazodone (antidepressant)
boolean
C0068485 (UMLS CUI 2011AA)
108435006 (SNOMED CT 2011_0131)
MTHU003461 (LOINC Version 232)
C0003289 (UMLS CUI 2011AA)
372720008 (SNOMED CT 2011_0131)
MTHU006782 (LOINC Version 232)
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