ID
43483
Beschrijving
ODM derived from http://clinicaltrials.gov/show/NCT00844064
Link
http://clinicaltrials.gov/show/NCT00844064
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
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Eligibility NCT00844064 Pancreatic Neoplasms, Melanoma, Colorectal Neoplasms
Eligibility
- StudyEvent: Eligibility
Beschrijving
Ausschlusskriterien
Alias
- UMLS CUI 2011AA
- CL425201
Beschrijving
Patient unable to comply with the protocol regulations.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1321605
Beschrijving
Pregnant or lactating female.
Datatype
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
Beschrijving
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.
Datatype
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
Beschrijving
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.
Datatype
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
Beschrijving
Patient's participation in another clinical trial with investigational medication within 30 days prior to study entry.
Datatype
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
Beschrijving
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).
Datatype
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
Beschrijving
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.
Datatype
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
Beschrijving
Gastric or duodenal ulcers within 6 months before study entry or is at risk of gastrointestinal ulceration due to high consumption of NSAIDs.
Datatype
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
Beschrijving
An active infection with HIV, HBV, or HCV.
Datatype
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
Beschrijving
Clinically significant acute viral, bacterial, or fungal infection.
Datatype
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
Beschrijving
Acute medical problems that may be considered to become an unacceptable risk, or any conditions that might be contraindications for starting study treatment.
Datatype
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
Beschrijving
History of allergies to reagents used in this study.
Datatype
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
Beschrijving
Drug abuse or extensive use of alcohol.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0237123
Beschrijving
Significant psychiatric disorders/ legal incapacity or limited legal capacity.
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
- C0332197
- SNOMED CT 2011_0131
- 2667000
- UMLS CUI 2011AA
- C0683673
- UMLS CUI 2011AA
- C0439801
- SNOMED CT 2011_0131
- 255469002
- UMLS CUI 2011AA
- C0683673
Beschrijving
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.
Datatype
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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