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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
Male or female adult with relapsed/refractory AML ineligible for intensive treatment (phase I part only)
Description

Male or female adult with relapsed/refractory AML ineligible for intensive treatment (phase I part only)

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
C0001675
SNOMED CT 2011_0131
133936004
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
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1548635
HL7 V3 2006_05
ELG
UMLS CUI 2011AA
C0085559
MedDRA 14.1
10022519
UMLS CUI 2011AA
C0205390
SNOMED CT 2011_0131
21191007
UMLS CUI 2011AA
C0439068
SNOMED CT 2011_0131
257469003
Male or female adult with previously untreated AML ineligible for intensive treatment (phase IIa part only)
Description

Male or female adult with previously untreated AML ineligible for intensive treatment (phase IIa part only)

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
C0001675
SNOMED CT 2011_0131
133936004
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
CL415147
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
C1518422
UMLS CUI 2011AA
C1548635
HL7 V3 2006_05
ELG
UMLS CUI 2011AA
C0085559
MedDRA 14.1
10022519
UMLS CUI 2011AA
C1706446
Confirmed diagnosis of AML according to the WHO definition (except for acute promyelocytic leukaemia, APL)
Description

Confirmed diagnosis of AML according to the WHO definition (except for acute promyelocytic leukaemia, APL)

Data type

boolean

Alias
UMLS CUI 2011AA
C0750484
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
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C0451584
SNOMED CT 2011_0131
273931002
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
Patient is eligible for LD-Ara-C treatment
Description

Patient is eligible for LD-Ara-C treatment

Data type

boolean

Alias
UMLS CUI 2011AA
C1548635
HL7 V3 2006_05
ELG
UMLS CUI 2011AA
C1708745
UMLS CUI 2011AA
C0010711
SNOMED CT 2011_0131
89265009
UMLS CUI 2011AA
C0039798
Life expectancy > 3 months
Description

Life expectancy > 3 months

Data type

boolean

Alias
UMLS CUI 2011AA
C0023671
Eastern co-operative oncology group (ECOG, R01-0787) performance score <=2 at screening
Description

Eastern co-operative oncology group (ECOG, R01-0787) performance score <=2 at screening

Data type

boolean

Alias
UMLS CUI 2011AA
C1828127
SNOMED CT 2011_0131
424122007
UMLS CUI 2011AA
C1409616
Signed written informed consent consistent with international conference on harmonisation, good clinical practice (ICH-GCP) and local legislation
Description

Signed written informed consent consistent with international conference on harmonisation, good clinical practice (ICH-GCP) and local legislation

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Previously untreated AML (phase I part only)
Description

Previously untreated AML (phase I part only)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0205390
SNOMED CT 2011_0131
21191007
UMLS CUI 2011AA
C0439068
SNOMED CT 2011_0131
257469003
Relapsed or treatment refractory AML (phase IIa part only)
Description

Relapsed or treatment refractory AML (phase IIa part only)

Data type

boolean

Alias
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
C1706446
Patient with APL (AML subtype M3 according to the French-American-British (FAB) classification)
Description

Patient with APL (AML subtype M3 according to the French-American-British (FAB) classification)

Data type

boolean

Alias
UMLS CUI 2011AA
C0023487
SNOMED CT 2011_0131
110004001
MedDRA 14.1
10001019
ICD-10-CM Version 2010
C92.4
UMLS CUI 2011AA
C0023467
SNOMED CT 2011_0131
91861009
MedDRA 14.1
10000880
ICD-10-CM Version 2010
C92.0
ICD-9-CM Version 2011
205.0
UMLS CUI 2011AA
C0457329
SNOMED CT 2011_0131
278165002
Hypersensitivity to one of the trial drugs or the excipients
Description

Hypersensitivity to one of the trial drugs or the excipients

Data type

boolean

Alias
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
C0015237
SNOMED CT 2011_0131
360215002
Other malignancy requiring treatment
Description

Other malignancy requiring treatment

Data type

boolean

Alias
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0039798
Symptomatic central nervous system involvement
Description

Symptomatic central nervous system involvement

Data type

boolean

Alias
UMLS CUI 2011AA
C0231220
SNOMED CT 2011_0131
264931009
UMLS CUI 2011AA
C1269563
SNOMED CT 2011_0131
278199004
UMLS CUI 2011AA
C1314939
SNOMED CT 2011_0131
248448006
Clinically relevant QT prolongation (e.g. long QT syndrome, QTcF>470 ms)
Description

Clinically relevant QT prolongation (e.g. long QT syndrome, QTcF>470 ms)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C2347946
UMLS CUI 2011AA
C0151878
SNOMED CT 2011_0131
111975006
MedDRA 14.1
10014387
CTCAE 1105E
E12146
UMLS CUI 2011AA
C0023976
SNOMED CT 2011_0131
9651007
MedDRA 14.1
10024803
ICD-10-CM Version 2010
I45.81
ICD-9-CM Version 2011
426.82
UMLS CUI 2011AA
C1882513
Aspartate amino transferase (AST) or alanine amino transferase (ALT) > 2.5 times the upper limit of normal (ULN), or AST or ALT > 5 times the ULN in case of known leukaemia liver involvement
Description

Aspartate amino transferase (AST) or alanine amino transferase (ALT) > 2.5 times the upper limit of normal (ULN), or AST or ALT > 5 times the ULN in case of known leukaemia liver involvement

Data type

boolean

Alias
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
UMLS CUI 2011AA
C0023418
SNOMED CT 2011_0131
93143009
MedDRA 14.1
10024288
ICD-10-CM Version 2010
C95.9
ICD-9-CM Version 2011
208.9
UMLS CUI 2011AA
C0023884
SNOMED CT 2011_0131
10200004
LOINC Version 232
MTHU002039
UMLS CUI 2011AA
C1314939
SNOMED CT 2011_0131
248448006
Prothrombin time (PT) > 1.5 x ULN for subjects not on therapeutic vitamin K antagonists (phenprocoumon, warfarin)
Description

Prothrombin time (PT) > 1.5 x ULN for subjects not on therapeutic vitamin K antagonists (phenprocoumon, warfarin)

Data type

boolean

Alias
UMLS CUI 2011AA
CL434069
UMLS CUI 2011AA
C1519815
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1096489
MedDRA 14.1
10053755
UMLS CUI 2011AA
C0031444
SNOMED CT 2011_0131
59488002
LOINC Version 232
MTHU016364
UMLS CUI 2011AA
C0043031
SNOMED CT 2011_0131
48603004
LOINC Version 232
MTHU003212
Bilirubin
Description

Bilirubin > 1.5 mg/dl (> 26 mcmol/L)

Data type

boolean

Alias
UMLS CUI 2011AA
C0011221
SNOMED CT 2011_0131
79706000
LOINC Version 232
1975-2
Serum Creatinine Measurement
Description

Serum creatinine > 2.0 mg/dl

Data type

boolean

Alias
UMLS CUI 2011AA
C0201976
SNOMED CT 2011_0131
113075003
MedDRA 14.1
10040230
Concomitant intercurrent illness, which would compromise the evaluation of efficacy or safety of the trial drug, e.g. active severe infection, unstable angina pectoris, cardiac arrhythmia or severe heart failure/cardiac insufficiency.
Description

Concomitant intercurrent illness, which would compromise the evaluation of efficacy or safety of the trial drug, e.g. active severe infection, unstable angina pectoris, cardiac arrhythmia or severe heart failure/cardiac insufficiency.

Data type

boolean

Alias
UMLS CUI 2011AA
CL415222
UMLS CUI 2011AA
C0277557
SNOMED CT 2011_0131
88472004
UMLS CUI 2011AA
C0221099
SNOMED CT 2011_0131
260379002
UMLS CUI 2011AA
C0013175
SNOMED CT 2011_0131
185922005
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
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
C0003811
SNOMED CT 2011_0131
44808001
MedDRA 14.1
10003119
ICD-9-CM Version 2011
427.9
UMLS CUI 2011AA
C0018801
SNOMED CT 2011_0131
155374007
MedDRA 14.1
10019279
ICD-9-CM Version 2011
428
CTCAE 1105E
E10124
Psychiatric illness or social situation that would limit compliance with trial requirements
Description

Psychiatric illness or social situation that would limit compliance with trial requirements

Data type

boolean

Alias
UMLS CUI 2011AA
C0004936
SNOMED CT 2011_0131
74732009
MedDRA 14.1
10037174
ICD-10-CM Version 2010
F99
ICD-9-CM Version 2011
290-319.99
UMLS CUI 2011AA
C0851364
MedDRA 14.1
10041244
UMLS CUI 2011AA
C0449295
SNOMED CT 2011_0131
246175000
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
405078008
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1514873
Concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug
Description

Concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug

Data type

boolean

Alias
UMLS CUI 2011AA
C1707479
UMLS CUI 2011AA
C2347946
UMLS CUI 2011AA
C0013175
SNOMED CT 2011_0131
185922005
Contraindications for cytarabine treatment according to the SPC
Description

Contraindications for cytarabine treatment according to the SPC

Data type

boolean

Alias
UMLS CUI 2011AA
C1301624
SNOMED CT 2011_0131
397745006
UMLS CUI 2011AA
C0010711
SNOMED CT 2011_0131
89265009
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C1709515
Female patients of childbearing potential who are sexually active and unwilling to use a medically acceptable method of contraception during the trial, i.e. combination of two forms of effective contraception (hormonal contraception, intrauterine device, condom with spermicide, etc.).
Description

Female patients of childbearing potential who are sexually active and unwilling to use a medically acceptable method of contraception during the trial, i.e. combination of two forms of effective contraception (hormonal contraception, intrauterine device, condom with spermicide, etc.).

Data type

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0241028
SNOMED CT 2011_0131
228453005
MedDRA 14.1
10066098
UMLS CUI 2011AA
C0558080
SNOMED CT 2011_0131
225465005
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
CL424941
UMLS CUI 2011AA
C0021900
SNOMED CT 2011_0131
268460000
MedDRA 14.1
10022745
UMLS CUI 2011AA
C0677582
UMLS CUI 2011AA
C0037862
SNOMED CT 2011_0131
425484006
Male patients with partners of childbearing potential who are unwilling to use condoms in combination with a second medically acceptable method of contraception during the trial
Description

Male patients with partners of childbearing potential who are unwilling to use condoms in combination with a second medically acceptable method of contraception during the trial

Data type

boolean

Alias
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0682323
SNOMED CT 2011_0131
262043009
HL7 V3 2006_05
SIGOTHR
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0558080
SNOMED CT 2011_0131
225465005
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0677582
UMLS CUI 2011AA
C1947911
UMLS CUI 2011AA
C0205436
SNOMED CT 2011_0131
81170007
UMLS CUI 2011AA
C0025663
SNOMED CT 2011_0131
260686004
LOINC Version 232
MTHU024654
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
Pregnant or nursing female patients
Description

Pregnant or nursing female patients

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
Patient unable to comply with the protocol
Description

Patient unable to comply with the protocol

Data type

boolean

Alias
UMLS CUI 2011AA
C1321605
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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)
Male or female adult with relapsed/refractory AML ineligible for intensive treatment (phase I part only)
Item
Male or female adult with relapsed/refractory AML ineligible for intensive treatment (phase I part only)
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)
C0001675 (UMLS CUI 2011AA)
133936004 (SNOMED CT 2011_0131)
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)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1518422 (UMLS CUI 2011AA)
C1548635 (UMLS CUI 2011AA)
ELG (HL7 V3 2006_05)
C0085559 (UMLS CUI 2011AA)
10022519 (MedDRA 14.1)
C0205390 (UMLS CUI 2011AA)
21191007 (SNOMED CT 2011_0131)
C0439068 (UMLS CUI 2011AA)
257469003 (SNOMED CT 2011_0131)
Male or female adult with previously untreated AML ineligible for intensive treatment (phase IIa part only)
Item
Male or female adult with previously untreated AML ineligible for intensive treatment (phase IIa part only)
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)
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)
C1518422 (UMLS CUI 2011AA)
C1548635 (UMLS CUI 2011AA)
ELG (HL7 V3 2006_05)
C0085559 (UMLS CUI 2011AA)
10022519 (MedDRA 14.1)
C1706446 (UMLS CUI 2011AA)
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)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C0451584 (UMLS CUI 2011AA)
273931002 (SNOMED CT 2011_0131)
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 eligible for LD-Ara-C treatment
Item
Patient is eligible for LD-Ara-C treatment
boolean
C1548635 (UMLS CUI 2011AA)
ELG (HL7 V3 2006_05)
C1708745 (UMLS CUI 2011AA)
C0010711 (UMLS CUI 2011AA)
89265009 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
Life expectancy > 3 months
Item
Life expectancy > 3 months
boolean
C0023671 (UMLS CUI 2011AA)
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)
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
C0021430 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Previously untreated AML (phase I part only)
Item
Previously untreated AML (phase I part only)
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
CL415147 (UMLS CUI 2011AA)
C0205390 (UMLS CUI 2011AA)
21191007 (SNOMED CT 2011_0131)
C0439068 (UMLS CUI 2011AA)
257469003 (SNOMED CT 2011_0131)
Relapsed or treatment refractory AML (phase IIa part only)
Item
Relapsed or treatment refractory AML (phase IIa part only)
boolean
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)
C1706446 (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)
C0457329 (UMLS CUI 2011AA)
278165002 (SNOMED CT 2011_0131)
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)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
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)
Symptomatic central nervous system involvement
Item
Symptomatic central nervous system involvement
boolean
C0231220 (UMLS CUI 2011AA)
264931009 (SNOMED CT 2011_0131)
C1269563 (UMLS CUI 2011AA)
278199004 (SNOMED CT 2011_0131)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
Clinically relevant QT prolongation (e.g. long QT syndrome, QTcF>470 ms)
Item
Clinically relevant QT prolongation (e.g. long QT syndrome, QTcF>470 ms)
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C2347946 (UMLS CUI 2011AA)
C0151878 (UMLS CUI 2011AA)
111975006 (SNOMED CT 2011_0131)
10014387 (MedDRA 14.1)
E12146 (CTCAE 1105E)
C0023976 (UMLS CUI 2011AA)
9651007 (SNOMED CT 2011_0131)
10024803 (MedDRA 14.1)
I45.81 (ICD-10-CM Version 2010)
426.82 (ICD-9-CM Version 2011)
C1882513 (UMLS CUI 2011AA)
Aspartate amino transferase (AST) or alanine amino transferase (ALT) > 2.5 times the upper limit of normal (ULN), or AST or ALT > 5 times the ULN in case of known leukaemia liver involvement
Item
Aspartate amino transferase (AST) or alanine amino transferase (ALT) > 2.5 times the upper limit of normal (ULN), or AST or ALT > 5 times the ULN in case of known leukaemia liver involvement
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)
C1519815 (UMLS CUI 2011AA)
C0023418 (UMLS CUI 2011AA)
93143009 (SNOMED CT 2011_0131)
10024288 (MedDRA 14.1)
C95.9 (ICD-10-CM Version 2010)
208.9 (ICD-9-CM Version 2011)
C0023884 (UMLS CUI 2011AA)
10200004 (SNOMED CT 2011_0131)
MTHU002039 (LOINC Version 232)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
Prothrombin time (PT) > 1.5 x ULN for subjects not on therapeutic vitamin K antagonists (phenprocoumon, warfarin)
Item
Prothrombin time (PT) > 1.5 x ULN for subjects not on therapeutic vitamin K antagonists (phenprocoumon, warfarin)
boolean
CL434069 (UMLS CUI 2011AA)
C1519815 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
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 (> 26 mcmol/L)
Item
Bilirubin
boolean
C0011221 (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)
Concomitant intercurrent illness, which would compromise the evaluation of efficacy or safety of the trial drug, e.g. active severe infection, unstable angina pectoris, cardiac arrhythmia or severe heart failure/cardiac insufficiency.
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, cardiac arrhythmia or severe heart failure/cardiac insufficiency.
boolean
CL415222 (UMLS CUI 2011AA)
C0277557 (UMLS CUI 2011AA)
88472004 (SNOMED CT 2011_0131)
C0221099 (UMLS CUI 2011AA)
260379002 (SNOMED CT 2011_0131)
C0013175 (UMLS CUI 2011AA)
185922005 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0009450 (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)
C0018801 (UMLS CUI 2011AA)
155374007 (SNOMED CT 2011_0131)
10019279 (MedDRA 14.1)
428 (ICD-9-CM Version 2011)
E10124 (CTCAE 1105E)
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)
C0449295 (UMLS CUI 2011AA)
246175000 (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
Item
Concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug
boolean
C1707479 (UMLS CUI 2011AA)
C2347946 (UMLS CUI 2011AA)
C0013175 (UMLS CUI 2011AA)
185922005 (SNOMED CT 2011_0131)
Contraindications for cytarabine treatment according to the SPC
Item
Contraindications for cytarabine treatment according to the SPC
boolean
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C0010711 (UMLS CUI 2011AA)
89265009 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C1709515 (UMLS CUI 2011AA)
Female patients of childbearing potential who are sexually active and unwilling to use a medically acceptable method of contraception during the trial, i.e. combination of two forms of effective contraception (hormonal contraception, intrauterine device, condom with spermicide, etc.).
Item
Female patients of childbearing potential who are sexually active and unwilling to use a medically acceptable method of contraception during the trial, i.e. combination of two forms of effective contraception (hormonal contraception, intrauterine device, condom with spermicide, etc.).
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0241028 (UMLS CUI 2011AA)
228453005 (SNOMED CT 2011_0131)
10066098 (MedDRA 14.1)
C0558080 (UMLS CUI 2011AA)
225465005 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
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)
Male patients with partners of childbearing potential who are unwilling to use condoms in combination with a second medically acceptable method of contraception during the trial
Item
Male patients with partners of childbearing potential who are unwilling to use condoms in combination with a second medically acceptable method of contraception during the trial
boolean
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0682323 (UMLS CUI 2011AA)
262043009 (SNOMED CT 2011_0131)
SIGOTHR (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0558080 (UMLS CUI 2011AA)
225465005 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0677582 (UMLS CUI 2011AA)
C1947911 (UMLS CUI 2011AA)
C0205436 (UMLS CUI 2011AA)
81170007 (SNOMED CT 2011_0131)
C0025663 (UMLS CUI 2011AA)
260686004 (SNOMED CT 2011_0131)
MTHU024654 (LOINC Version 232)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Pregnant or nursing female patients
Item
Pregnant or nursing female patients
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
Patient unable to comply with the protocol
Item
Patient unable to comply with the protocol
boolean
C1321605 (UMLS CUI 2011AA)
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