Post Marketing Active Surveillance to Evaluate the Safety and Efficacy of Aprepitant (EMEND®) for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated with High Emetogenic Cancer Chemotherapy in China (MK-0869-804)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Single-arm, prospective, post-marketing surveillance study

Study drug and medical condition

• Name of medicine:
  EMEND
• Anatomical Therapeutic Chemical (ATC) code:
  (A04AD12) aprepitant

  aprepitant
• Medical condition to be studied:
  Nausea

  Vomiting

Population studied

• Short description of the study population:
  Chinese patients, 18 years of age or above, both males and females, with a solid malignancy, who are treated with HEC regimens. To participate in this surveillance, patients are those who received at least one dose of Aprepitant, prior to HEC regimen. ; ; Inclusion Criteria ; All inclusion and exclusion criteria will be reviewed by the investigator or qualified designee to ensure the patient is qualified for the survey. ; 1. Adult male or female, 18 years Of age Or Older. ; 2. Patient must be willing to give written infonned consent. ; 3. Patient is scheduled to receive his/her highly emetogenie chemotherapy. ; 4. Patient who is treated with Aprepitant for the first time. ; 5. Patient is able to read, understand and complete the patient diaries. ; ; Exclusion Criteria ; 1. Patient having any medical condition or concurrent use Of medications, which may be contraindication to the approved local prescribing information as per the investigator's opinion. Contraindication to Aprepitant. ; The patient who has one or more of the following conditions: ; i) Aprepitant is a moderate cytoehrome P450 isoenzyme 3A4 (CYP3A4) inhibitor. Aprepitant should not be used concurrently with pimozide, terfenadine, astemizole, or eisapride. Inhibition Of CYP3A4 by Aprepitant could result in elevated plasma concentrations of these drugs, potentially causing serious or life-threatening reactions. ; ii) Aprepitant is contraindicated in patients who are hypersensitive to any component of the product. ; 2. Patient has received a non-approved (investigational) drug within the last 4 weeks. ; 3. Any condition which, in the opinion of the investigator may confound the results of the survey or pose unwarranted risk in administering study drug to the patient.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Solid malignancy patients
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  This was a non-interventional surveillance study to assess the safety and efficacy of aprepitant in the prevention of chemotherapy-induced nausea and vomiting (CINV) in Chinese participants with solid malignancies who were treated with a highly emetogenic chemotherapy (HEC) regimen.
• Outcomes:
  The primary outcome was related to safety and included the proportion of one or more of the following: adverse event(s), drug-related adverse event(s), serious adverse event(s), and discontinuations due to an adverse event(s). The secondary outcome was related to efficacy and included complete response at 0 to 120, 0 to 24, and 25 to 120 hours, no vomiting at 0 to 24, 25 to 120, and 0 to 120 hours, no significant nausea at 0 to 120 hours, no nausea at 0 to 120 hours, and no impact on daily life at 0 to 120 hours.
• Data analysis plan:
  The primary outcomes were summarized by number of events, observed incidence, and corresponding 95% CI (Clopper-Pearson) by descriptive statistics. The primary outcome was further analyzed by: age (<55, >=55 years), gender, and clinical characteristics derived by medical history including chemotherapy regimen(s), cancer diagnosis, clinically significant prior/concomitant medications (including Traditional Chinese Medicines), and the timing of aprepitant administration.The secondary outcomes were summarized by count, point estimate and corresponding 95% confidence interval (Clopper-Pearson), and analyzed by: age (<55, >=55 years), gender, and clinical characteristics derived by medical history including chemotherapy regimen(s), cancer diagnosis, clinically significant prior/concomitant medications (including Traditional Chinese Medicines), and the timing of aprepitant administration.