Posted by SLS on November 12, 2005, at 7:15:40
In reply to Campral and Sudden Death ???!!!???, posted by Reggie BoStar on November 10, 2005, at 23:20:57
ALL treatment-emergent adverse events must be reported during the clinical trials of drugs when the data is submitted to the FDA for approval.
Note that "treatment-emergent adverse events" is not the same as a "side-effect". It just means that the event coincided in time with the taking of the drug and could be unrelated to the drug. If someone with an occult thrombosis that existed for years were to have the lesion suddenly let loose during a drug trial, it must be reported as a sudden death.
I would not worry about it.
- Scott
poster:SLS
thread:577628
URL: http://www.dr-bob.org/babble/subs/20051106/msgs/577981.html