ID
4411
Descripción
ODM derived from http://clinicaltrials.gov/show/NCT00844064
Link
http://clinicaltrials.gov/show/NCT00844064
Palabras clave
Versiones (3)
- 9/12/13 9/12/13 - Martin Dugas
- 16/4/14 16/4/14 - Julian Varghese
- 20/9/21 20/9/21 -
Subido en
9 de diciembre de 2013
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00844064 Pancreatic Neoplasms, Melanoma, Colorectal Neoplasms
Eligibility
- StudyEvent: Eligibility
Descripción
Exclusion Criteria
Alias
- UMLS CUI 2011AA
- CL425201
Descripción
Patient unable to comply with the protocol regulations.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1299582
- SNOMED CT 2011_0131
- 371151008
- UMLS CUI 2011AA
- C0525058
Descripción
Pregnant or lactating female.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2011AA
- C2828358
- UMLS CUI 2011AA
- C0015780
- SNOMED CT 2011_0131
- 248152002
- HL7 V3 2006_05
- F
Descripción
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 datos
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
Descripción
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 datos
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
Descripción
Patient's participation in another clinical trial with investigational medication within 30 days prior to study entry.
Tipo de datos
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
Descripción
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 datos
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
Descripción
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 datos
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
Descripción
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 datos
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
Descripción
An active infection with HIV, HBV, or HCV.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C0021311
- 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
Descripción
Clinically significant acute viral, bacterial, or fungal infection.
Tipo de datos
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
Descripción
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 datos
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
Descripción
History of allergies to reagents used in this study.
Tipo de datos
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
Descripción
Drug abuse or extensive use of alcohol.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0013146
- SNOMED CT 2011_0131
- 26416006
- MedDRA 14.1
- 10013654
- LOINC Version 232
- LP36310-8
- ICD-9-CM Version 2011
- 305.90
- UMLS CUI 2011AA
- C0560219
- SNOMED CT 2011_0131
- 160592001
Descripción
Significant psychiatric disorders/ legal incapacity or limited legal capacity.
Tipo de datos
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
Descripción
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 datos
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
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