Outcome mARV iNVP p-value (n=1220) (n=1211) (K-M log rank test) Rate (95% CI) Rate (95% CI) Composite maternal safety endpoint 14.8 14.6 0.99 (Grade 3-4 sign/symptoms; Grade (12.7 – 17.3) (12.5 – 16.9) 2-4 lab events, maternal deaths) Composite severe maternal safety endpoint 5.1 5.6 0.61 (excludes Grade 2 lab events) (4.3 – 6.1) (4.8 – 6.6) Composite infant safety endpoint (Grade 3-4 sign/symptoms; Grade 44.1 43.5 0.95 2-4 lab events, infant deaths) (39.2 – 49.5) (38.7 – 48.8) [Safety outcome incidence rates (per 100 person years) by study arm]
Outcome mARV (n=1220) Rate (95% CI) iNVP (n=1211) Rate (95% CI) p-value (K-M log rank test) Composite maternal safety endpoint (Grade 3-4 sign/symptoms; Grade 2-4 lab events, maternal deaths) 14.8 (12.7 – 17.3) 14.6 (12.5 – 16.9) 0.99 Composite severe maternal safety endpoint (excludes Grade 2 lab events) 5.1 (4.3 – 6.1) 5.6 (4.8 – 6.6) 0.61 Composite infant safety endpoint (Grade 3-4 sign/symptoms; Grade 2-4 lab events, infant deaths) 44.1 (39.2 – 49.5) 43.5 (38.7 – 48.8) 0.95 [Safety outcome incidence rates (per 100 person years) by study arm]
Proceedings-2017.docx