Last updated: 11/07/2018 09:51:20
CV Events in Emetogenic Chemotherapy
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Cardiovascular Events in Cancer Patients Receiving Highly Emetogenic or Moderately Emetogenic Chemotherapy
Trial description: Describe cardiovascular events in a cancer population receiving highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
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.
Timeframe: First day of first HEC/MEC cycle to 30 days past first day of last cycle
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
12058
Primary completion date:
Not applicable
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Thao T. Vo and Jeanenne J. Nelson. Cardiovascular Events in Cancer Patients Treated with Highly orModerately Emetogenic Chemotherapy: Results from a Population-Based Study. [J Cancer Epidemiol]. 2012;
Medical condition
Vomiting, cardiovascular event
Product
aprepitant, casopitant, ondansetron
Collaborators
Not applicable
Study date(s)
May 2009 to June 2009
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable+ years
Accepts healthy volunteers
No
- Enrollment in IHCIS in 2006
- At least one HEC or MEC claim in 2006
- 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.)
Inclusion and exclusion criteria
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 location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2009-30-06
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website