ID
43462
Beschrijving
ODM derived from http://clinicaltrials.gov/show/NCT00804856
Link
http://clinicaltrials.gov/show/NCT00804856
Trefwoorden
Versies (3)
- 09-12-13 09-12-13 - Martin Dugas
- 16-04-14 16-04-14 - Julian Varghese
- 20-09-21 20-09-21 -
Geüploaded op
20 september 2021
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY 4.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Eligibility DRKS00003750 NCT00812799 Allergic Rhinoconjunctivitis
Eligibility
- StudyEvent: Eligibility
Beschrijving
Ausschlusskriterien
Alias
- UMLS CUI 2011AA
- CL425201
Beschrijving
Previously untreated AML (phase I part only)
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0205156
Beschrijving
Relapsed or treatment refractory AML (phase IIa part only)
Datatype
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
Beschrijving
Patient with APL (AML subtype M3 according to the French-American-British (FAB) classification)
Datatype
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
Beschrijving
Hypersensitivity to one of the trial drugs or the excipients
Datatype
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
Beschrijving
Other malignancy requiring treatment
Datatype
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
Beschrijving
Symptomatic central nervous system involvement
Datatype
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
Beschrijving
Clinically relevant QT prolongation (e.g. long QT syndrome, QTcF>470 ms)
Datatype
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
Beschrijving
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
Datatype
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
Beschrijving
Prothrombin time (PT) > 1.5 x ULN for subjects not on therapeutic vitamin K antagonists (phenprocoumon, warfarin)
Datatype
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
Beschrijving
Bilirubin > 1.5 mg/dl (> 26 mcmol/L)
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0011221
- SNOMED CT 2011_0131
- 79706000
- LOINC Version 232
- 1975-2
Beschrijving
Serum creatinine > 2.0 mg/dl
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0201976
- SNOMED CT 2011_0131
- 113075003
- MedDRA 14.1
- 10040230
Beschrijving
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.
Datatype
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
Beschrijving
Psychiatric illness or social situation that would limit compliance with trial requirements
Datatype
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
Beschrijving
Concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1707479
- UMLS CUI 2011AA
- C2347946
- UMLS CUI 2011AA
- C0013175
- SNOMED CT 2011_0131
- 185922005
Beschrijving
Contraindications for cytarabine treatment according to the SPC
Datatype
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
Beschrijving
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.).
Datatype
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
Beschrijving
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
Datatype
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
Beschrijving
Pregnant or nursing female patients
Datatype
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
Beschrijving
Patient unable to comply with the protocol
Datatype
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)
Geen commentaren