Actually this is not entirely true. It’s anything that happened to any patient during any phase of testing. This is why so many “side effects” include death, because if you’re doing an n=1000 study or whatever, SOMEONE is going to die, statistically, and you can’t provably show that the drug you’re testing didn’t lead, at least in part, to that death. Good intentions with the reporting regulation, but not a good execution.
Actually this is not entirely true. It’s anything that happened to any patient during any phase of testing. This is why so many “side effects” include death, because if you’re doing an n=1000 study or whatever, SOMEONE is going to die, statistically, and you can’t provably show that the drug you’re testing didn’t lead, at least in part, to that death. Good intentions with the reporting regulation, but not a good execution.