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
Finalized
Finalized
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:
Drug: HEC or MEC
Enrollment:
12058
Observational study model:
Cohort
Primary completion date:
Not applicable
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)
No location data available.
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
Finalized
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
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