Toxicity
Toxicity is summarised in table 4. At least 1 treatment emergent adverse
event (TEAE) was reported in 38 (95%) Safety Analysis Set subjects.
More subjects reported TEAEs during oPac+E treatment (36 [92%]
subjects) than during IV paclitaxel treatment (29 [76%]). Grade 3
TEAEs were reported in 8 (20%) subjects, inclusive of 7 (18%) subjects
during oPac+E treatment and 2 (5%) subjects during IV paclitaxel
treatment. Serious TEAEs were reported in 6 (15%) subjects and were
judged treatment‑related by the Investigator in 2 (5%) subjects, both
of whom were during oPac+E treatment. Three (8%) subjects had at least
1 TEAE resulting in discontinuation of study drug (1 [3%] during
oPac+E treatment and 2 [5%] during IV paclitaxel treatment) and
2 (5%) subjects discontinued from the study due to a TEAE (both during
IV paclitaxel treatment). One subject died 26 days after her last dose
of on‑study IV paclitaxel.