CV Events in Emetogenic Chemotherapy

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01366599
First received: June 2, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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
Study Population

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.

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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  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 August 21, 2014