Autopsy report · NCT02519842

Efficacy and Safety Study of Fosaprepitant (MK-0517) Plus Ondansetron Versus Ondansetron Alone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Participants (MK-0517-044)

“Further data are no longer required to support an application for use in pediatric patients. The decision to terminate was not based on any new safety findings”

The sponsor’s own words in the registry.

Life of this trial

• Registered 1 month before it started.
• Ran for about 1 year 5 months before it stopped.
• 75 participants enrolled.
• Results were posted on the registry 1 year after it ended.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Merck Sharp & Dohme LLC

Sponsor type

Industry

Conditions

Chemotherapy-induced Nausea and Vomiting

Interventions

Fosaprepitant; Placebo for fosaprepitant; Ondansetron; Dexamethasone; 5-HT3 antagonist

Participants

75

Trials that died the same way

• Ultrafiltration Therapy Registry Using Aquadex (ULTRA-Peds)
  “The study was stopped early only due to a business decision to pursue development of a pediatric dedicated device. This decision was not based on any efficacy or safety concerns."” (73% match in meaning)
• Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies
  “The study was terminated due to program discontinuation, based on mixed efficacy results in the parent studies. There were no safety concerns.” (69% match in meaning)
• Efficacy and Safety of Clevudine Compared With Adefovir in Patients With Chronic Hepatitis Due to Hepatitis B Virus
  “The study was terminated in the interest of patient safety.” (68% match in meaning)
• Study to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of Coronavirus Disease 2019 (COVID-19) in an Outpatient Setting
  “The study was terminated due to study enrollment feasibility and changing needs of non-hospitalized participants. This decision is not based on efficacy or safety concerns.” (68% match in meaning)
• A Study of TCD601 (Siplizumab) in New Onset Type 1 Diabetes Patients
  “The study has been early terminated due to business reasons. This decision is not related to any safety, efficacy, or regulatory concerns.” (67% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.