Safety Analyses
For treatment emergent adverse events (TEAEs), verbatim terms were
mapped to preferred terms (PTs) and system organ classes (SOCs) using
the Medical Dictionary for Regulatory Activities (MedDRA; version 20.0);
CTCAE v4.03 was used to grade severity. Incidences of TEAEs were
displayed by SOC and PT, and summarized by treatment, treatment period,
and treatment sequence. Treatment emergent AEs and SAEs were listed with
start and end dates (unless ongoing), severity, relationship to study
drug, study drug action taken, and outcome by subject. Laboratory
evaluations were summarized and evaluated for markedly abnormal values
based on the normal range; shift tables from baseline to posttreatment
were also provided for select parameters. Results from ECGs and ECOG
Performance Status were summarized. Vital signs, physical examination
findings, and treatment preference were listed by subject. Treatment
preference was summarized and listed.