Like the others in the clinical trial, Patient No. 11561004 already had tried one treatment for his advanced kidney cancer, but it didn’t work.
So the 69-year-old man volunteered to try an unproven drug that offered some hope he might live longer.
Less than four months after going on the drug known as Inlyta, the man — identified only by age and a number in an FDA review of the clinical trial— developed severe abdominal pain, was admitted to the hospital and died that day from gastrointestinal bleeding.