Chemotherapy-induced Nausea and Vomiting
Conditions
Keywords
Nausea, Vomiting, Chemotherapy, Post-chemotherapy
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.
Interventions
DRUGEMEND
EMEND (Aprepitant,125 mg oral capsules) is administered 1 hour prior to chemotherapy on treatment Day 1. EMEND (80 mg) is administered on the morning of Days 2 and 3. EMEND is concomitantly administered with a regimen of a corticosteroid and a 5-HT3 antagonist.
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Global Assessment of Participants' Response to Therapy With EMEND (Aprepitant) for the Prevention of Acute and Delayed Nausea Following Chemotherapy | 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). |
Participant flow
Recruitment details
South Korean hospitals provided 3,546 participant's case report forms, 9/18/2006-1/22/2012. 407 participants were excluded: 201 violated dosage/administration, 173 lost to follow-up, 15 duplicated participants, 10 assessed before the contracted date, 3 previously received EMEND, 3 violated inclusion/exclusion criteria, and 2 didn't receive EMEND.
Participants by arm
| Arm | Count |
|---|---|
| Korean Participants Treated With EMEND (Aprepitant) EMEND (125 mg oral capsules) is administered 1 hour prior to chemotherapy on Treatment Day 1. EMEND (80 mg) is administered on the morning of Days 2 and 3. EMEND is concomitantly administered with a regimen of a corticosteroid and a 5-HT3 antagonist. | 3,139 |
| Total | 3,139 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not receive EMEND | 2 |
Baseline characteristics
| Characteristic | Korean Participants Treated With EMEND (Aprepitant) |
|---|---|
| Age, Customized 40 to 49 years | 635 Participants |
| Age, Customized <40 years | 296 Participants |
| Age, Customized 50 to 59 years | 898 Participants |
| Age, Customized 60 to 69 years | 957 Participants |
| Age, Customized ≥70 years | 353 Participants |
| Sex/Gender, Customized Female | 1410 Participants |
| Sex/Gender, Customized Male | 1729 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 399 / 3,139 |
| serious Total, serious adverse events | 89 / 3,139 |
Outcome results
Primary
Investigator Global Assessment of Participants' Response to Therapy With EMEND (Aprepitant) for the Prevention of Acute and Delayed Nausea Following Chemotherapy
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).
Time frame: Up to 14 days following the cessation of treatment
Population: The Efficacy Evaluable Population consisted of participants treated with EMEND for 3 days and assessed by an investigator for efficacy. Participants were excluded from efficacy analysis for having a EMEND administration period less than 3 days (143 participants) or unavailability of final efficacy evaluation (1 participant).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants Treated With EMEND | Investigator Global Assessment of Participants' Response to Therapy With EMEND (Aprepitant) for the Prevention of Acute and Delayed Nausea Following Chemotherapy | Excellent | 438 participants |
| Participants Treated With EMEND | Investigator Global Assessment of Participants' Response to Therapy With EMEND (Aprepitant) for the Prevention of Acute and Delayed Nausea Following Chemotherapy | Good | 2056 participants |
| Participants Treated With EMEND | Investigator Global Assessment of Participants' Response to Therapy With EMEND (Aprepitant) for the Prevention of Acute and Delayed Nausea Following Chemotherapy | Fair | 446 participants |
| Participants Treated With EMEND | Investigator Global Assessment of Participants' Response to Therapy With EMEND (Aprepitant) for the Prevention of Acute and Delayed Nausea Following Chemotherapy | Poor | 52 participants |
| Participants Treated With EMEND | Investigator Global Assessment of Participants' Response to Therapy With EMEND (Aprepitant) for the Prevention of Acute and Delayed Nausea Following Chemotherapy | None | 3 participants |