ID
43462
Beskrivning
ODM derived from http://clinicaltrials.gov/show/NCT00804856
Länk
http://clinicaltrials.gov/show/NCT00804856
Nyckelord
Versioner (3)
- 2013-12-09 2013-12-09 - Martin Dugas
- 2014-04-16 2014-04-16 - Julian Varghese
- 2021-09-20 2021-09-20 -
Uppladdad den
20 september 2021
DOI
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Licens
Creative Commons BY 4.0
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Eligibility DRKS00003750 NCT00812799 Allergic Rhinoconjunctivitis
Eligibility
- StudyEvent: Eligibility
Beskrivning
Ausschlusskriterien
Alias
- UMLS CUI 2011AA
- CL425201
Beskrivning
Previously untreated AML (phase I part only)
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0205156
Beskrivning
Relapsed or treatment refractory AML (phase IIa part only)
Datatyp
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
Beskrivning
Patient with APL (AML subtype M3 according to the French-American-British (FAB) classification)
Datatyp
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
Beskrivning
Hypersensitivity to one of the trial drugs or the excipients
Datatyp
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
Beskrivning
Other malignancy requiring treatment
Datatyp
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
Beskrivning
Symptomatic central nervous system involvement
Datatyp
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
Beskrivning
Clinically relevant QT prolongation (e.g. long QT syndrome, QTcF>470 ms)
Datatyp
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
Beskrivning
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
Datatyp
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
Beskrivning
Prothrombin time (PT) > 1.5 x ULN for subjects not on therapeutic vitamin K antagonists (phenprocoumon, warfarin)
Datatyp
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
Beskrivning
Bilirubin > 1.5 mg/dl (> 26 mcmol/L)
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0011221
- SNOMED CT 2011_0131
- 79706000
- LOINC Version 232
- 1975-2
Beskrivning
Serum creatinine > 2.0 mg/dl
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0201976
- SNOMED CT 2011_0131
- 113075003
- MedDRA 14.1
- 10040230
Beskrivning
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.
Datatyp
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
Beskrivning
Psychiatric illness or social situation that would limit compliance with trial requirements
Datatyp
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
Beskrivning
Concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C1707479
- UMLS CUI 2011AA
- C2347946
- UMLS CUI 2011AA
- C0013175
- SNOMED CT 2011_0131
- 185922005
Beskrivning
Contraindications for cytarabine treatment according to the SPC
Datatyp
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
Beskrivning
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.).
Datatyp
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
Beskrivning
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
Datatyp
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
Beskrivning
Pregnant or nursing female patients
Datatyp
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
Beskrivning
Patient unable to comply with the protocol
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C1321605
Similar models
Eligibility
- StudyEvent: Eligibility
397669002 (SNOMED CT 2011_0131)
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)
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)
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)
ELG (HL7 V3 2006_05)
C1708745 (UMLS CUI 2011AA)
C0010711 (UMLS CUI 2011AA)
89265009 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
424122007 (SNOMED CT 2011_0131)
C1409616 (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)
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)
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)
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)
264931009 (SNOMED CT 2011_0131)
C1269563 (UMLS CUI 2011AA)
278199004 (SNOMED CT 2011_0131)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
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)
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)
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)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
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)
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)
C2347946 (UMLS CUI 2011AA)
C0013175 (UMLS CUI 2011AA)
185922005 (SNOMED CT 2011_0131)
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)
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)
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)
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)
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