ID
43483
Descrição
ODM derived from http://clinicaltrials.gov/show/NCT00844064
Link
http://clinicaltrials.gov/show/NCT00844064
Palavras-chave
Versões (3)
- 09/12/2013 09/12/2013 - Martin Dugas
- 16/04/2014 16/04/2014 - Julian Varghese
- 20/09/2021 20/09/2021 -
Transferido a
20 de setembro de 2021
DOI
Para um pedido faça login.
Licença
Creative Commons BY 4.0
Comentários do modelo :
Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.
Comentários do grupo de itens para :
Comentários do item para :
Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.
Eligibility NCT00844064 Pancreatic Neoplasms, Melanoma, Colorectal Neoplasms
Eligibility
- StudyEvent: Eligibility
Descrição
Ausschlusskriterien
Alias
- UMLS CUI 2011AA
- CL425201
Descrição
Patient unable to comply with the protocol regulations.
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C1321605
Descrição
Pregnant or lactating female.
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2011AA
- C2828358
- UMLS CUI 2011AA
- C0086287
- SNOMED CT 2011_0131
- 248152002
- HL7 V3 2006_05
- F
Descrição
Antitumor radiation therapy within 12 weeks, tumor surgery within 4 weeks or any other therapy with established antitumor effects within 2 weeks prior to study entry.
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C0597025
- UMLS CUI 2011AA
- C0597029
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C0920425
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C2348558
Descrição
The patient takes or is likely to need other prohibited concomitant medication. Administration of corticosteroids should be strictly avoided during the course of the study.
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C0683610
- UMLS CUI 2011AA
- C2347852
- UMLS CUI 2011AA
- C1533734
- SNOMED CT 2011_0131
- 416118004
- UMLS CUI 2011AA
- C0001617
- SNOMED CT 2011_0131
- 79440004
Descrição
Patient's participation in another clinical trial with investigational medication within 30 days prior to study entry.
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C0679823
- HL7 V3 2006_05
- PART
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0013230
Descrição
History of brain metastases. In the case of suspected brain metastases a CT scan of the skull will be performed (not mandatory in asymptomatic patients).
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0220650
- MedDRA 14.1
- 10006128
- UMLS CUI 2011AA
- C0750557
- UMLS CUI 2011AA
- C0750491
- SNOMED CT 2011_0131
- 415684004
- UMLS CUI 2011AA
- C0220650
- MedDRA 14.1
- 10006128
- UMLS CUI 2011AA
- C0040405
- MedDRA 14.1
- 10011603
- UMLS CUI 2011AA
- C0037303
- SNOMED CT 2011_0131
- 89546000
- LOINC Version 232
- MTHU003024
Descrição
Clinically significant cardiovascular abnormalities such as refractory hypertension, congestive heart failure, unstable angina, or poorly controlled arrhythmia, or a myocardial infarction within 6 months prior to treatment.
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C0243050
- SNOMED CT 2011_0131
- 9904008
- MedDRA 14.1
- 10061054
- UMLS CUI 2011AA
- C0860493
- MedDRA 14.1
- 10038274
- UMLS CUI 2011AA
- C0018802
- SNOMED CT 2011_0131
- 42343007
- MedDRA 14.1
- 10007559
- LOINC Version 232
- MTHU020787
- ICD-10-CM Version 2010
- I50.9
- ICD-9-CM Version 2011
- 428.0
- 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
- C0205169
- SNOMED CT 2011_0131
- 556001
- UMLS CUI 2011AA
- C2587213
- SNOMED CT 2011_0131
- 31509003
- UMLS CUI 2011AA
- C0003811
- SNOMED CT 2011_0131
- 44808001
- MedDRA 14.1
- 10003119
- ICD-9-CM Version 2011
- 427.9
- UMLS CUI 2011AA
- C0027051
- SNOMED CT 2011_0131
- 22298006
- MedDRA 14.1
- 10028596
- LOINC Version 232
- MTHU035551
- ICD-10-CM Version 2010
- I21-I22
- ICD-9-CM Version 2011
- 410
- CTCAE 1105E
- E10152
Descrição
Gastric or duodenal ulcers within 6 months before study entry or is at risk of gastrointestinal ulceration due to high consumption of NSAIDs.
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C0038358
- SNOMED CT 2011_0131
- 397825006
- MedDRA 14.1
- 10017822
- ICD-10-CM Version 2010
- K25
- ICD-9-CM Version 2011
- 531
- CTCAE 1105E
- E10727
- UMLS CUI 2011AA
- C0013295
- SNOMED CT 2011_0131
- 367474008
- MedDRA 14.1
- 10013836
- ICD-10-CM Version 2010
- K26
- ICD-9-CM Version 2011
- 532
- CTCAE 1105E
- E10611
- UMLS CUI 2011AA
- C0035647
- SNOMED CT 2011_0131
- 30207005
- HL7 V3 2006_05
- RSK
- UMLS CUI 2011AA
- C1963975
- MedDRA 14.1
- 20000106
- UMLS CUI 2011AA
- CL420107
- UMLS CUI 2011AA
- C0003211
- SNOMED CT 2011_0131
- 16403005, 372665008
Descrição
An active infection with HIV, HBV, or HCV.
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C0009450
- SNOMED CT 2011_0131
- 257551009
- MedDRA 14.1
- 10021789
- UMLS CUI 2011AA
- C0019682
- SNOMED CT 2011_0131
- 19030005
- UMLS CUI 2011AA
- C0019169
- SNOMED CT 2011_0131
- 81665004
- UMLS CUI 2011AA
- C0220847
- SNOMED CT 2011_0131
- 62944002
- MedDRA 14.1
- 10019752
Descrição
Clinically significant acute viral, bacterial, or fungal infection.
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C0205178
- SNOMED CT 2011_0131
- 272118002
- UMLS CUI 2011AA
- C0042769
- SNOMED CT 2011_0131
- 34014006
- MedDRA 14.1
- 10047461
- ICD-10-CM Version 2010
- B34.9
- UMLS CUI 2011AA
- C0004623
- SNOMED CT 2011_0131
- 87628006
- MedDRA 14.1
- 10060945
- ICD-10-CM Version 2010
- A49.9
- UMLS CUI 2011AA
- C0026946
- SNOMED CT 2011_0131
- 3218000
- MedDRA 14.1
- 10017533
- ICD-10-CM Version 2010
- B35-B49
- ICD-9-CM Version 2011
- 110-118.99
Descrição
Acute medical problems that may be considered to become an unacceptable risk, or any conditions that might be contraindications for starting study treatment.
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C0205178
- SNOMED CT 2011_0131
- 272118002
- UMLS CUI 2011AA
- C1715372
- LOINC Version 232
- 44100-6
- UMLS CUI 2011AA
- C0678227
- SNOMED CT 2011_0131
- 23981006
- UMLS CUI 2011AA
- C1883420
- UMLS CUI 2011AA
- C0035647
- SNOMED CT 2011_0131
- 30207005
- HL7 V3 2006_05
- RSK
- UMLS CUI 2011AA
- C0348080
- SNOMED CT 2011_0131
- 260905004
- HL7 V3 2006_05
- COND
- UMLS CUI 2011AA
- C1301624
- SNOMED CT 2011_0131
- 397745006
Descrição
History of allergies to reagents used in this study.
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C0489531
- LOINC Version 232
- MTHU001065
- UMLS CUI 2011AA
- C0034760
- LOINC Version 232
- MTHU019417
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
Descrição
Drug abuse or extensive use of alcohol.
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- C0237123
Descrição
Significant psychiatric disorders/ legal incapacity or limited legal capacity.
Tipo de dados
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
- C0332197
- SNOMED CT 2011_0131
- 2667000
- UMLS CUI 2011AA
- C0683673
- UMLS CUI 2011AA
- C0439801
- SNOMED CT 2011_0131
- 255469002
- UMLS CUI 2011AA
- C0683673
Descrição
History of Long QT Syndrome or QTc time ≥ 480 msec in screening/baseline ECGs. The average QTc time is to be calculated from three separate ECGs performed prior to start of infusion: two ECGs performed at Screening/Baseline (with a minimum 1-hour interval in between) and one performed within 1 hour prior to start of infusion.
Tipo de dados
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- 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
- C0860814
- MedDRA 14.1
- 10037707
- UMLS CUI 2011AA
- C1409616
- UMLS CUI 2011AA
- C1442488
- UMLS CUI 2011AA
- C1623258
- SNOMED CT 2011_0131
- 46825001
- MedDRA 14.1
- 10014084
Similar models
Eligibility
- StudyEvent: Eligibility
397669002 (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)
C0232973 (UMLS CUI 2011AA)
60001007 (SNOMED CT 2011_0131)
C2826207 (UMLS CUI 2011AA)
363418001 (SNOMED CT 2011_0131)
10033604 (MedDRA 14.1)
C25 (ICD-10-CM Version 2010)
157 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0205471 (UMLS CUI 2011AA)
40413002 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
C0854775 (UMLS CUI 2011AA)
10059326 (MedDRA 14.1)
CL108563 (UMLS CUI 2011AA)
2092003 (SNOMED CT 2011_0131)
10025650 (MedDRA 14.1)
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0205471 (UMLS CUI 2011AA)
40413002 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0855027 (UMLS CUI 2011AA)
10025670 (MedDRA 14.1)
C0854698 (UMLS CUI 2011AA)
10025671 (MedDRA 14.1)
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0205471 (UMLS CUI 2011AA)
40413002 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0677949 (UMLS CUI 2011AA)
10010034 (MedDRA 14.1)
C0677950 (UMLS CUI 2011AA)
10010035 (MedDRA 14.1)
C0438286 (UMLS CUI 2011AA)
266721009 (SNOMED CT 2011_0131)
10063670 (MedDRA 14.1)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C1513040 (UMLS CUI 2011AA)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C0040539 (UMLS CUI 2011AA)
C1314792 (UMLS CUI 2011AA)
134198009 (SNOMED CT 2011_0131)
C1514463 (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)
C1516048 (UMLS CUI 2011AA)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
C1522609 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C0856666 (UMLS CUI 2011AA)
10040426 (MedDRA 14.1)
C1519815 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
C0494165 (UMLS CUI 2011AA)
94381002 (SNOMED CT 2011_0131)
10027457 (MedDRA 14.1)
C78.7 (ICD-10-CM Version 2010)
197.7 (ICD-9-CM Version 2011)
C0002059 (UMLS CUI 2011AA)
57056007 (SNOMED CT 2011_0131)
MTHU005195 (LOINC Version 232)
C0011221 (UMLS CUI 2011AA)
79706000 (SNOMED CT 2011_0131)
1975-2 (LOINC Version 232)
CL415281 (UMLS CUI 2011AA)
C0030605 (UMLS CUI 2011AA)
42525009 (SNOMED CT 2011_0131)
10000630 (MedDRA 14.1)
C1519815 (UMLS CUI 2011AA)
38082009 (SNOMED CT 2011_0131)
10019481 (MedDRA 14.1)
LP14449-0 (LOINC Version 232)
767002 (SNOMED CT 2011_0131)
10047939 (MedDRA 14.1)
10052033 (MedDRA 14.1)
10036586 (MedDRA 14.1)
C2828358 (UMLS CUI 2011AA)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0597029 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0920425 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0683610 (UMLS CUI 2011AA)
C2347852 (UMLS CUI 2011AA)
C1533734 (UMLS CUI 2011AA)
416118004 (SNOMED CT 2011_0131)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
PART (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0220650 (UMLS CUI 2011AA)
10006128 (MedDRA 14.1)
C0750557 (UMLS CUI 2011AA)
C0750491 (UMLS CUI 2011AA)
415684004 (SNOMED CT 2011_0131)
C0220650 (UMLS CUI 2011AA)
10006128 (MedDRA 14.1)
C0040405 (UMLS CUI 2011AA)
10011603 (MedDRA 14.1)
C0037303 (UMLS CUI 2011AA)
89546000 (SNOMED CT 2011_0131)
MTHU003024 (LOINC Version 232)
9904008 (SNOMED CT 2011_0131)
10061054 (MedDRA 14.1)
C0860493 (UMLS CUI 2011AA)
10038274 (MedDRA 14.1)
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)
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)
C0205169 (UMLS CUI 2011AA)
556001 (SNOMED CT 2011_0131)
C2587213 (UMLS CUI 2011AA)
31509003 (SNOMED CT 2011_0131)
C0003811 (UMLS CUI 2011AA)
44808001 (SNOMED CT 2011_0131)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)
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)
397825006 (SNOMED CT 2011_0131)
10017822 (MedDRA 14.1)
K25 (ICD-10-CM Version 2010)
531 (ICD-9-CM Version 2011)
E10727 (CTCAE 1105E)
C0013295 (UMLS CUI 2011AA)
367474008 (SNOMED CT 2011_0131)
10013836 (MedDRA 14.1)
K26 (ICD-10-CM Version 2010)
532 (ICD-9-CM Version 2011)
E10611 (CTCAE 1105E)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C1963975 (UMLS CUI 2011AA)
20000106 (MedDRA 14.1)
CL420107 (UMLS CUI 2011AA)
C0003211 (UMLS CUI 2011AA)
16403005, 372665008 (SNOMED CT 2011_0131)
55561003 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0019682 (UMLS CUI 2011AA)
19030005 (SNOMED CT 2011_0131)
C0019169 (UMLS CUI 2011AA)
81665004 (SNOMED CT 2011_0131)
C0220847 (UMLS CUI 2011AA)
62944002 (SNOMED CT 2011_0131)
10019752 (MedDRA 14.1)
272118002 (SNOMED CT 2011_0131)
C0042769 (UMLS CUI 2011AA)
34014006 (SNOMED CT 2011_0131)
10047461 (MedDRA 14.1)
B34.9 (ICD-10-CM Version 2010)
C0004623 (UMLS CUI 2011AA)
87628006 (SNOMED CT 2011_0131)
10060945 (MedDRA 14.1)
A49.9 (ICD-10-CM Version 2010)
C0026946 (UMLS CUI 2011AA)
3218000 (SNOMED CT 2011_0131)
10017533 (MedDRA 14.1)
B35-B49 (ICD-10-CM Version 2010)
110-118.99 (ICD-9-CM Version 2011)
272118002 (SNOMED CT 2011_0131)
C1715372 (UMLS CUI 2011AA)
44100-6 (LOINC Version 232)
C0678227 (UMLS CUI 2011AA)
23981006 (SNOMED CT 2011_0131)
C1883420 (UMLS CUI 2011AA)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
MTHU001065 (LOINC Version 232)
C0034760 (UMLS CUI 2011AA)
MTHU019417 (LOINC Version 232)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0683673 (UMLS CUI 2011AA)
C0439801 (UMLS CUI 2011AA)
255469002 (SNOMED CT 2011_0131)
C0683673 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
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)
C0860814 (UMLS CUI 2011AA)
10037707 (MedDRA 14.1)
C1409616 (UMLS CUI 2011AA)
C1442488 (UMLS CUI 2011AA)
C1623258 (UMLS CUI 2011AA)
46825001 (SNOMED CT 2011_0131)
10014084 (MedDRA 14.1)