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CompletedNCT01366599Updated May 24, 2017

CV Events in Emetogenic Chemotherapy

An observational study in Vomiting, Cardiovascular Event and Arterial Thromboembolic Event, sponsored by GlaxoSmithKline. Completed. Per ClinicalTrials.gov, last updated 2017-05-24.

Sponsored by GlaxoSmithKline · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
12,058
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Vomiting
  • Cardiovascular Event
  • Arterial Thromboembolic Event

Keywords

  • highly emetogenic chemotherapy
  • HEC
  • moderately emetogenic chemotherapy
  • MEC
03

In context

Thromboembolism

818 studies on the registry are indexed under Thromboembolism; 98 are open to participants now.

This study's enrollment of 12,058 is above the median of 500 across 344 observational studies indexed under Thromboembolism.

Browse Thromboembolism studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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.

Inclusion criteria

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

Exclusion criteria

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.)
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
12,058 participants (actual)

Groups and cohorts

  • Patients enrolled in IHCIS in 2006

    Patients enrolled in IHCIS in 2006

    Drug: HEC or MEC

Interventions

  • DrugHEC or MEC

    Any HEC or MEC, including aprepitant

06

What researchers measure

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.

    Time frame: First day of first HEC/MEC cycle to 30 days past first day of last cycle

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01366599
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Jun 6, 2011
Start date
May 2009
Primary completion
Jul 2009
Completion
Jul 2009
Last update
May 24, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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