A Continuation Clinical Trial of Oral Vorinostat (MK-0683) in Advanced Cancers
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percent of Participants With a Serious Drug-related Adverse Event (AE)
A serious adverse event (SAE) was any AE occurring at any dose that resulted in death, was life-threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, or was an overdose. A drug-related SAE was one that was thought to be possibly, probably, or definitely related to the study drug.
From the first dose of study drug until the patient experiences disease progression, withdraws consent, or develops unacceptable toxicity (from Day 1 up to 4 years and 9 months)
United States: Food and Drug Administration