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)
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)