CV Events in Emetogenic Chemotherapy

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Vomiting; Arterial Thromboembolic Event; Cardiovascular Event

Treatments: Drug: HEC or MEC

Study type: Observational

Funder types: Industry

Identifiers

NCT01366599

115777

WEUKSTV4114 (Other Identifier)

Details and patient eligibility

About

Describe cardiovascular events in a cancer population receiving highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC).

Full description

Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymised and used to develop a patient cohort. All diagnoses and treatment are recorded in the course of routine medical practice.

Enrollment: 12,058 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Enrollment in IHCIS in 2006
• At least one HEC or MEC claim in 2006

Exclusion criteria

• HEC or MEC claim three months before first HEC/MEC claim - "wash-in" period (i.e. must be enrolled for three months prior to first HEC/MEC claim. For patients whose first HEC/MEC event is between January 1,2006 and March 31, 2006, enrollment criteria for inclusion in the study may extend as far back as October 1, 2005)
• HEC or MEC claims prior to 45 days after last HEC or MEC claim - "wash-out" period. (For patients whose last claim in 2006 was seen after December 1, 2006 enrollment into 2007 to look for further treatment and the 45 day "wash-out" period will be required.)

Trial design

12,058 participants in 1 patient group

Patients enrolled in IHCIS in 2006

Description:

Patients enrolled in IHCIS in 2006

Treatment:

Drug: HEC or MEC