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.
Thirty (75%) subjects preferred oPac+E treatment over IV paclitaxel, while IV paclitaxel was preferred over oPac+E in 6 (15%) subjects. No treatment preference was reported in the remaining 4 subjects.