VomitingNCT01366599
CV Events in Emetogenic Chemotherapy
An observational study of Vomiting and Cardiovascular Event, run by GlaxoSmithKline.
Trial summary
Describe cardiovascular events in a cancer population receiving highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vomiting, Cardiovascular Event, Arterial Thromboembolic Event
- What is being tested?
- HEC or MEC
- How many people
- 12,058 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Jul 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older 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.
Who may be able to join
- Enrollment in IHCIS in 2006
- At least one HEC or MEC claim in 2006
Who cannot join
- 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.)
About this study
Official title: Cardiovascular Events in Cancer Patients Receiving Highly Emetogenic or Moderately Emetogenic Chemotherapy
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.
- Being tested
- HEC or MEC
- Keywords
- highly emetogenic chemotherapy, HEC, moderately emetogenic chemotherapy, MEC
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEC or MECDrug
Any HEC or MEC, including aprepitant
| Study group | Role | What they receive |
|---|---|---|
| Patients enrolled in IHCIS in 2006 | Patients enrolled in IHCIS in 2006 Receives: Drug: HEC or MEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First day of first HEC/MEC cycle to 30 days past first day of last cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2011 (estimated)
- Study startMay 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VomitingStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 12,058 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366599
- Sponsor's protocol ID
- 115777
- Other IDs
- WEUKSTV4114
- Status last verified
- May 2017
- First submitted
- 2 Jun 2011
- Last updated
- 24 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Events in Cancer Patients Receiving Highly Emetogenic or Moderately Emetogenic Chemotherapy
- ClinicalTrials.gov ID
- NCT01366599
- Acronym / sponsor ID
- 115777
- Keywords
- highly emetogenic chemotherapy, HEC, moderately emetogenic chemotherapy, MEC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,058 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 6 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients enrolled in IHCIS in 2006 | – | Drug: HEC or MECPatients enrolled in IHCIS in 2006 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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.
Key inclusion criteria (2 listed)
- Enrollment in IHCIS in 2006
- At least one HEC or MEC claim in 2006
Key exclusion criteria (2 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEC or MECAny HEC or MEC, including aprepitant | Drug | Patients enrolled in IHCIS in 2006 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
Related trials for Vomiting
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Not yet recruiting
Amisulpride Injection for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
PONV
Not yet recruiting
Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy
Not yet recruitingObservational study
Diagnostic and Psychometric Validation of the FRENCH HELP Scale in Hyperemesis Gravidarum
Hyperemesis Gravidarum, Nausea and Vomiting of Pregnancy
RecruitingPhase 2
Personalized Antiemetic Regimen According to Patients' Pharmacogenetic Profile
Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Vomiting and Cardiovascular Event, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2017.