CV Events in Emetogenic Chemotherapy
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Purpose
Describe cardiovascular events in a cancer population receiving highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC).
| Condition | Intervention |
|---|---|
|
Vomiting Cardiovascular Event Arterial Thromboembolic Event |
Drug: HEC or MEC |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Cardiovascular Events in Cancer Patients Receiving Highly Emetogenic or Moderately Emetogenic Chemotherapy |
- 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. [ Time Frame: First day of first HEC/MEC cycle to 30 days past first day of last cycle ] [ Designated as safety issue: Yes ]
| Enrollment: | 12058 |
| Study Start Date: | May 2009 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Patients enrolled in IHCIS in 2006
Patients enrolled in IHCIS in 2006
|
Drug: HEC or MEC
Any HEC or MEC, including aprepitant
|
Detailed 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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
IHCIS, 2005-2007. The Impact National Managed Care Benchmark Database™ (formally known as Integrated Healthcare Information Services - IHCIS - prior to its purchase by Ingenix, Inc and referred to as IHCIS within GSK) is a comprehensive, de-identified U.S. healthcare claims database that is representative of the non-elderly, insurance-carrying population in the U.S. The database contains inpatient/outpatient and pharmacy claims, lab results and enrollment information on over 82 million lives from 1997 to 2007. Over 75 percent of all patients in the database have both medical and pharmacy benefits and, on average, 23.4 months of enrollment/claims information; the annual attrition rate is roughly 15-25 percent. The data are collected from over 45 different healthcare plans serving members across nine census regions. The database is HIPAA compliant and features encrypted member and provider IDs.
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.)
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01366599 History of Changes |
| Other Study ID Numbers: | 115777, WEUKSTV4114 |
| Study First Received: | June 2, 2011 |
| Last Updated: | June 2, 2011 |
| Health Authority: | United States: No Health Authority |
Keywords provided by GlaxoSmithKline:
|
highly emetogenic chemotherapy HEC moderately emetogenic chemotherapy MEC |
Additional relevant MeSH terms:
|
Thromboembolism Embolism Vomiting Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Thrombosis Signs and Symptoms, Digestive Signs and Symptoms |
Emetics Physiological Effects of Drugs Pharmacologic Actions Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 19, 2013