Re-examination Study For General Drug Use to Assess the Safety and Efficacy Profile of EMEND in Usual Practice
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 3,546
- Primary Endpoint
- Investigator Global Assessment of Participants' Response to Therapy With EMEND (Aprepitant) for the Prevention of Acute and Delayed Nausea Following Chemotherapy
Study Overview
Brief Summary
This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation. Its aim is to reconfirm the clinical usefulness of EMEMD (aprepitant) through collecting the safety information according to the Re-examination Regulation for New Drugs.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants who are treated with EMEND for the first time as per the EMEND label
Exclusion Criteria
- •Contraindication to EMEND
Arms & Interventions
Korean Participants Treated With EMEND (aprepitant)
Participants receiving EMEND on Treatment Days 1, 2, and 3 concomitantly with a corticosteroid and a 5-hydroxytryptamine 3 (5-HT3) antagonist.
Intervention: EMEND (Drug)
Outcomes
Primary Outcomes
Investigator Global Assessment of Participants' Response to Therapy With EMEND (Aprepitant) for the Prevention of Acute and Delayed Nausea Following Chemotherapy
Time Frame: Up to 14 days following the cessation of treatment
The investigators assessed a participant's response to therapy with EMEND to prevent acute and delayed nausea and vomiting associated with initial and repeat courses of chemotherapy when used concomitantly with other antiemetics. The response categories were: excellent (best possible anticipated response, considering the severity and stage of disease), good (good response, but less than the best possible anticipated response), fair (definite response, but could be better), poor (minimal response, unacceptable), or none (no response, absence of drug effect).
Secondary Outcomes
No secondary outcomes reported