CV Events in Emetogenic Chemotherapy | NCT01366599

Studies
CV Events in Emetogenic Chemotherapy

NCT01366599

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

May 24, 2017Actual

Enrollment

12,058Actual

Phase

Not provided

Conditions

Vomiting
Cardiovascular Event
Arterial Thromboembolic Event

Interventions

HEC or MEC

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
WEUKSTV4114	Other Identifier	GSK

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Jul 2009Actual

Completion Date

Jul 2009Actual

First Submitted Date

Jun 2, 2011

First Submission Date that Met QC Criteria

Jun 2, 2011

First Posted Date

Jun 6, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 23, 2017

Last Update Posted Date

May 24, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12,058Actual

Label	Type	Description	Intervention Names
Patients enrolled in IHCIS in 2006		Patients enrolled in IHCIS in 2006	Drug: HEC or MEC

Name	Type	Description	Arm Group Labels	Other Names
HEC or MEC	Drug	Any HEC or MEC, including aprepitant	Patients enrolled in IHCIS in 2006

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms