2.3 Collection, recording and reporting of adverse events
All safety data were assessed by the treating physician. Standard
definitions were used for adverse event, seriousness, and outcome.
Relatedness was defined as either ‘’Possible”: a causal relationship is
conceivable and at least reasonably possible; or ‘’Unlikely”: the event
is most likely related to a different etiology than the medicinal
product. AEs with unclear causality were categorized as possibly
related. Safety data solicited were all serious adverse events (SAE),
all causal AEs, and AEs of special interest. Any unsolicited safety data
reported by physicians were also included. All AEs reported were
categorized by preferred term and system organ class (Medical Dictionary
for Regulatory Activities versions 23.0).