This study is a retrospective observational study that evaluates the rate of cardiovascular adverse events leading to hospitalization in metastatic colorectal cancer in the French county Calvados by drug exposure.
This study investigates the characteristics of cardiovascular adverse events leading to hospitalization in metastatic colorectal cancer. Descriptive analysis will include incidence, type of cardiovascular adverse events. We will explore the incidence of cardiovascular adverse events with regard of the antineoplastic drug exposures. This will provide information about the individual drug safety profiles.
Study Type
OBSERVATIONAL
Enrollment
2,000
Exposure measurement to any anticancer drug in its therapeutic use for the metastatic colorectal cancer with its posology and duration (the list provided is non-limitative). Exposure to anticancer drugs for another indication than the colorectal cancer will also be collected.
CHU Caen
Caen, Normandy, France
Difference in rates of cardiovascular adverse events leading to hospitalization between chemotherapy treated patients and chemotherapy-free patients.
Any cardiovascular adverse event (e.g. the non limitative list: ischaemic heart disease, heart failure, hypertension, ischaemic stroke, embolic or thrombotic events, arrhythmias, conductive disorders) that was the primary diagnosis of a hospital admission. Any anticancer drug (chemotherapy) intake will be considered for the primary analysis. We will use a competing risk statistical model.
Time frame: Between 2004 and 2017
Risk of cardiovascular adverse events (any) for each individual anticancer drug.
Drug exposure will be defined as a binary variable for each drug. (intakes/no intakes). A competing risk model will be used.
Time frame: Between 2004 and 2017
Risk of cardiovascular adverse events (any) for each anticancer drugs combination/protocol
Drugs combination will be defined as a binary variable for each protocol. (intakes/no intakes).
Time frame: Between 2004 and 2017
Risk of individual cardiovascular adverse events of chemotherapy treated patients versus chemotherapy-free patients
Several individual cardiovascular adverse events will be assessed in separate analyses: ischaemic heart disease, heart failure, hypertension, ischaemic stroke, embolic or thrombotic events, arrhythmias, conductive disorders). A competing risk model will be used
Time frame: Between 2004 and 2017
Dose-effect relation ship between individual anticancer drugs and cardiovascular adverse events
Dose will be approached by the number of cycles of the anticancer drug and by the cumulative dose (in milligram) received.
Time frame: Between 2004 and 2017
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Dose-effect relation ship between individual anticancer drugs combination/protocol and cardiovascular adverse events
Dose will be approached by the number of cycles of the anticancer drugs combination/protocol.
Time frame: Between 2004 and 2017