A prospective monitoring of fatal serious adverse events (SAEs) in a Dutch Colorectal Cancer Group (DCCG) phase III trial (CAIRO) in patients with advanced colorectal cancer

Annals of Oncology

Volumn 21, Issue 2, 2009, Pages 415-418

  Mol, L ^a   Koopman, M ^b   Ottevanger, P B ^b   Punt, C J A ^a,b  

^a Integraal Kankercentrum Oost   (Netherlands)

^b RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

Author keywords

Colorectal cancer; Data management; Monitoring; Protocol violations; Serious adverse events

Indexed keywords

CAPECITABINE; IRINOTECAN; OXALIPLATIN;

ADULT; AGED; ARTICLE; CANCER MORTALITY; CLINICAL PROTOCOL; CLINICAL TRIAL; COLORECTAL CANCER; CONTINUING EDUCATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE COURSE; DRUG FATALITY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FEBRILE NEUTROPENIA; HUMAN; INFORMATION PROCESSING; MAJOR CLINICAL STUDY; MEDICAL RECORD REVIEW; MEDICAL STAFF; MORTALITY; MULTICENTER STUDY; NETHERLANDS; NEUTROPENIA; OUTCOME ASSESSMENT; PATIENT EDUCATION; PATIENT MONITORING; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; QUALITY CONTROL; RANDOMIZED CONTROLLED TRIAL; SEPSIS; TREATMENT RESPONSE; VOMITING;

ADULT; ADVERSE DRUG REACTION REPORTING SYSTEMS; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; CAUSE OF DEATH; CLINICAL TRIALS, PHASE III AS TOPIC; COLORECTAL NEOPLASMS; DENMARK; DEOXYCYTIDINE; DISEASE PROGRESSION; DRUG MONITORING; FLUOROURACIL; HUMANS; MIDDLE AGED; MULTICENTER STUDIES AS TOPIC; ORGANOPLATINUM COMPOUNDS; RETROSPECTIVE STUDIES;

EID: 77949516835     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdp330     Document Type: Article

References (5)

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