CV Events in Emetogenic Chemotherapy

NCT01366599 | Completed

• 2 other identifiers: 115777WEUKSTV4114
• Study Type: observational
• Target: 12,058
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Vomiting; Cardiovascular Event; Arterial Thromboembolic Event

Keywords

highly emetogenic chemotherapy; HEC; moderately emetogenic chemotherapy; MEC

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients enrolled in IHCIS in 2006

Patients enrolled in IHCIS in 2006

Drug: HEC or MEC

Interventions

HEC or MEC DRUG

Any HEC or MEC, including aprepitant

Patients enrolled in IHCIS in 2006

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Enrollment in IHCIS in 2006
• At least one HEC or MEC claim in 2006

You may not qualify if:

• 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.)

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Vomiting

Interventions

NDC80 protein, human

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2011
• First Posted: June 6, 2011
• Study Start: May 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: May 24, 2017

Record last verified: 2017-05