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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/29953
• EU PAS number:
  EUPAS29952
• Study ID:
  29953
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  China
• Study description:
  This was a multi-center, prospective, 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. Participants received 125 mg of oral aprepitant one hour prior to HEC chemotherapy on Day 1 and 80 mg of oral aprepitant once daily on the mornings of Days 2 and 3. Participants who took at least one dose of aprepitant were surveyed using diaries that included the following: the Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT), Functional Living Index-Emesis (FLIE) questionnaire, and a medication questionnaire. In addition, participants were contacted by investigators to assess adverse event (AE) up to 14 days after the last dose of aprepitant.
• Study status:
  Finalised

Research institutions and networks

Institutions

Merck & Co.

The First Affiliated Hospital of Medical School of Zhejiang University Hangzhou, Zhejiang Province, People's Republic of China

Study timelines

Date when funding contract was signed

Actual: 30/01/2014

Study start date

Actual: 15/07/2014

Data analysis start date

Actual: 25/04/2016

Date of final study report

Actual: 20/10/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme Corp.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable