CV Events in Emetogenic Chemotherapy

Vomiting Clinical Trial

Official title:

Cardiovascular Events in Cancer Patients Receiving Highly Emetogenic or Moderately Emetogenic Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01366599
• Other study ID #: 115777
• Secondary ID: WEUKSTV4114
• Status: Completed
• Phase: N/A
• First received: June 2, 2011
• Last updated: May 23, 2017
• Start date: May 2009
• Est. completion date: July 2009

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12058
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.)

Related Conditions & MeSH terms

• Arterial Thromboembolic Event
• Cardiovascular Event
• Thromboembolism
• Vomiting

Intervention

Drug:
• HEC or MEC
Any HEC or MEC, including aprepitant

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calculate the frequency and percent of patients with selected cardiovascular and arterial thromboembolic events in the analysis period, stratifying by any use of aprepitant (Emend) during the analysis period.		First day of first HEC/MEC cycle to 30 days past first day of last cycle