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.