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)
Male or female adult with previously untreated acute myeloid leukaemia (AML)
Item
Male or female adult with previously untreated acute myeloid leukaemia (AML)
boolean
C0024554 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0001675 (UMLS CUI 2011AA)
133936004 (SNOMED CT 2011_0131)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
CL415147 (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)
Confirmed diagnosis of AML according to the WHO definition (except for acute promyelocytic leukaemia, APL)
Item
Confirmed diagnosis of AML according to the WHO definition (except for acute promyelocytic leukaemia, APL)
boolean
C0750484 (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)
C0680240 (UMLS CUI 2011AA)
C0043237 (UMLS CUI 2011AA)
C1704788 (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)
Patient is considered ineligible for intensive treatment
Item
Patient is considered ineligible for intensive treatment
boolean
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C1548635 (UMLS CUI 2011AA)
ELG (HL7 V3 2006_05)
C0522510 (UMLS CUI 2011AA)
103370009 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
Patient is eligible for low-dose cytarabine (LD-Ara-C) treatment
Item
Patient is eligible for low-dose cytarabine (LD-Ara-C) treatment
boolean
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C1548635 (UMLS CUI 2011AA)
C1708745 (UMLS CUI 2011AA)
C0010711 (UMLS CUI 2011AA)
89265009 (SNOMED CT 2011_0131)
Life expectancy > 3 months
Item
Life expectancy > 3 months
boolean
C0023671 (UMLS CUI 2011AA)
LP75025-4 (LOINC Version 232)
C2825406 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
Eastern co-operative oncology group (ECOG, R01-0787) performance score <=2 at screening
Item
Eastern co-operative oncology group (ECOG, R01-0787) performance score <=2 at screening
boolean
C1828127 (UMLS CUI 2011AA)
424122007 (SNOMED CT 2011_0131)
C1520224 (UMLS CUI 2011AA)
423740007 (SNOMED CT 2011_0131)
10067961 (MedDRA 14.1)
C1409616 (UMLS CUI 2011AA)
Signed written informed consent consistent with international conference on harmonisation good clinical practice (ICH-GCP) and local legislation
Item
Signed written informed consent consistent with international conference on harmonisation good clinical practice (ICH-GCP) and local legislation
boolean
C1561610 (UMLS CUI 2011AA)
C0600657 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Patient with APL (AML subtype M3 according to the French-American-British (FAB) classification).
Item
Patient with APL (AML subtype M3 according to the French-American-British (FAB) classification).
boolean
C0023487 (UMLS CUI 2011AA)
110004001 (SNOMED CT 2011_0131)
10001019 (MedDRA 14.1)
C92.4 (ICD-10-CM Version 2010)
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)
C0449560 (UMLS CUI 2011AA)
260837004 (SNOMED CT 2011_0131)
C0680240 (UMLS CUI 2011AA)
CL421536 (UMLS CUI 2011AA)
Relapsed or treatment refractory AML.
Item
Relapsed or treatment refractory AML.
boolean
C0278780 (UMLS CUI 2011AA)
C0039798 (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)
Hypersensitivity to one of the trial drugs or the excipients.
Item
Hypersensitivity to one of the trial drugs or the excipients.
boolean
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0015237 (UMLS CUI 2011AA)
360215002 (SNOMED CT 2011_0131)
Other malignancy requiring treatment.
Item
Other malignancy requiring treatment.
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C1514873 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
Known central nervous system involvement.
Item
Known central nervous system involvement.
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0449389 (UMLS CUI 2011AA)
260766009 (SNOMED CT 2011_0131)
Aspartate amino transferase (AST) or alanine amino transferase (ALT) > 2.5 times the upper limit of normal (ULN).
Item
Aspartate amino transferase (AST) or alanine amino transferase (ALT) > 2.5 times the upper limit of normal (ULN).
boolean
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)
C1632851 (UMLS CUI 2011AA)
417929005 (SNOMED CT 2011_0131)
C1519815 (UMLS CUI 2011AA)
INR > 1.5 x ULN for subjects not on therapeutic vitamin K antagonists (phenprocoumon, warfarin).
Item
INR > 1.5 x ULN for subjects not on therapeutic vitamin K antagonists (phenprocoumon, warfarin).
boolean
C0525032 (UMLS CUI 2011AA)
165581004 (SNOMED CT 2011_0131)
10022400 (MedDRA 14.1)
C1519815 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C1611640 (UMLS CUI 2011AA)
5487002 (SNOMED CT 2011_0131)
THER (HL7 V3 2006_05)
C1096489 (UMLS CUI 2011AA)
10053755 (MedDRA 14.1)
C0031444 (UMLS CUI 2011AA)
59488002 (SNOMED CT 2011_0131)
MTHU016364 (LOINC Version 232)
C0043031 (UMLS CUI 2011AA)
48603004 (SNOMED CT 2011_0131)
MTHU003212 (LOINC Version 232)
Bilirubin > 1.5 mg/dl.
Item
Bilirubin
boolean
C1278039 (UMLS CUI 2011AA)
79706000 (SNOMED CT 2011_0131)
1975-2 (LOINC Version 232)
Serum creatinine > 2.0 mg/dl.
Item
Serum Creatinine Measurement
boolean
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
LVEF (Left ventricular ejection fraction) < 50% in echocardiography or clinical congestive heart failure New York Heart Association (NYHA) grade III or IV.
Item
LVEF (Left ventricular ejection fraction) < 50% in echocardiography or clinical congestive heart failure New York Heart Association (NYHA) grade III or IV.
boolean
C0428772 (UMLS CUI 2011AA)
250908004 (SNOMED CT 2011_0131)
10069170 (MedDRA 14.1)
C0013516 (UMLS CUI 2011AA)
40701008 (SNOMED CT 2011_0131)
10014116 (MedDRA 14.1)
88.72 (ICD-9-CM Version 2011)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
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)
Concomitant intercurrent illness, which would compromise the evaluation of efficacy or safety of the trial drug, e.g. active severe infection, unstable angina pectoris or cardiac arrhythmia.
Item
Concomitant intercurrent illness, which would compromise the evaluation of efficacy or safety of the trial drug, e.g. active severe infection, unstable angina pectoris or cardiac arrhythmia.
boolean
C0243087 (UMLS CUI 2011AA)
C0277557 (UMLS CUI 2011AA)
88472004 (SNOMED CT 2011_0131)
C0221099 (UMLS CUI 2011AA)
260379002 (SNOMED CT 2011_0131)
C0220825 (UMLS CUI 2011AA)
C1280519 (UMLS CUI 2011AA)
255403003 (SNOMED CT 2011_0131)
C0036043 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
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)
C0003811 (UMLS CUI 2011AA)
44808001 (SNOMED CT 2011_0131)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)
Psychiatric illness or social situation that would limit compliance with trial requirements.
Item
Psychiatric illness or social situation that would limit compliance with trial requirements.
boolean
C0004936 (UMLS CUI 2011AA)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
C0851364 (UMLS CUI 2011AA)
10041244 (MedDRA 14.1)
C0439801 (UMLS CUI 2011AA)
255469002 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1514873 (UMLS CUI 2011AA)
Concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug (i.e. other chemo- or immunotherapy, see also section 4.2.2).
Item
Concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug (i.e. other chemo- or immunotherapy, see also section 4.2.2).
boolean
C1707479 (UMLS CUI 2011AA)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
C2347946 (UMLS CUI 2011AA)
C0220825 (UMLS CUI 2011AA)
C1280519 (UMLS CUI 2011AA)
255403003 (SNOMED CT 2011_0131)
C0036043 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C0021083 (UMLS CUI 2011AA)
146638005 (SNOMED CT 2011_0131)
Contraindications for cytarabine treatment according to the summary of product characteristics (SPC).
Item
Contraindications for cytarabine treatment according to the summary of product characteristics (SPC).
boolean
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C0010711 (UMLS CUI 2011AA)
89265009 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0680240 (UMLS CUI 2011AA)
C1709515 (UMLS CUI 2011AA)
Patients who are sexually active and unwilling to use a medically acceptable method of contraception during the trial (hormonal contraception, intrauterine device, condom with spermicide, etc.).
Item
Patients who are sexually active and unwilling to use a medically acceptable method of contraception during the trial (hormonal contraception, intrauterine device, condom with spermicide, etc.).
boolean
C0241028 (UMLS CUI 2011AA)
228453005 (SNOMED CT 2011_0131)
10066098 (MedDRA 14.1)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
CL424941 (UMLS CUI 2011AA)
C0021900 (UMLS CUI 2011AA)
268460000 (SNOMED CT 2011_0131)
10022745 (MedDRA 14.1)
C0677582 (UMLS CUI 2011AA)
C0037862 (UMLS CUI 2011AA)
425484006 (SNOMED CT 2011_0131)
Pregnant or nursing female patients.
Item
Pregnant or nursing female patients.
boolean
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
Patient unable to comply with the protocol.
Item
Patient unable to comply with the protocol.
boolean
C1321605 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
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