In the intention-to-treat analysis, any-cause grade 3 or greater maternal adverse events were seen in 30.5% of women in the immediate arm versus 28.4% in the delayed arm, with an incidence-rate difference of 4.2 per 100 person-years, which did not reach the noninferiority boundary.
The respective rates in the per-protocol analysis were 33% vs. 30.4%, for an incidence-rate difference of 4.3 per 100 person-years.
In both groups, elevated liver enzymes and weight loss were the most common maternal adverse events.
All cause hepatotoxicity occurred in 6% of participants in the immediate arm and 7% in the deferred. Rates of permanent discontinuation because of toxicity were 4% and 6%, respectively, along with the two women in the immediate IPT arm and four in the delayed arm who died during the study. There were no significant differences in these outcomes between the groups.