Table 4.
Maternal and infant serious adverse events and grade 3 or higher AEs by study arm and cohort
| Cohort 1 Maternal adverse events | Dapivirine arm (n=101) n (%) | TDF/FTC arm (n=49) n (%) | Both arms (n=150) n (%) |
|---|---|---|---|
| Participants with one or more composite AEs1 | 1 (1.0) | 4 (8.2) | 5 (3.3) |
| Nausea | 0 (0) | 1 (2.0) | 1 (0.7) |
| Urinary tract infection | 1 (1.0) | 0 (0) | 1 (0.7) |
| Perineal injury | 0 (0) | 1 (2.0) | 1 (0.7) |
| Fetal distress syndrome | 0 (0) | 1 (2.0) | 1 (0.7) |
| Hemorrhage in pregnancy | 0 (0) | 1 (2.0) | 1 (0.7) |
| Preeclampsia | 0 (0) | 1 (2) | 1 (0.7) |
| Cohort 1 Infant adverse events | Dapivirine arm (n=99)n (%) | TDF/FTC arm (n=48) n (%) | Both arms (n=147) n (%) |
| Participants with one or more composite AEs1 | 12 (12.1) | 6 (12.5) | 18 (12.2) |
| Trisomy 21 | 1 (1.0) | 0 (0) | 1 (0.7) |
| Pneumonia | 1 (1.0) | 1 (2.1) | 2 (1.4) |
| Underweight | 6 (6.1) | 3 (6.3) | 9 (6.1) |
| Rectus diastasis | 0 (0) | 1 (2.1) | 1 (0.7) |
| Hypoxic-ischemic encephalopathy | 0 (0) | 1 (2.1) | 1 (0.7) |
| Jaundice | 1 (1.0) | 0 (0) | 1 (0.7) |
| Acute kidney injury | 1 (1.0) | 0 (0) | 1 (0.7) |
| Meconium aspiration syndrome | 0 (0) | 1 (2.1) | 1 (0.7) |
| Neonatal asphyxia | 2 (2.0) | 0 (0) | 2 (1.4) |
| Neonatal respiratory distress syndrome | 1 (1.0) | 0 (0) | 1 (0.7) |
| Respiratory distress | 0 (0) | 1 (2.1) | 1 (0.7) |
| Transient tachypnoea of the newborn | 1 (1.0) | 0 (0) | 1 (0.7) |
| Cohort 2 Maternal adverse events | Dapivirine arm (n=106) n (%) | TDF/FTC arm (n=51) n (%) | Both arms (n=157) n (%) |
| Participants with one or more composite AEs1 | 14 (13.2) | 5 (9.8) | 19 (12.1) |
| Anemia | 0 (0) | 1 (2.0) | 1 (0.6) |
| Amniotic cavity infection | 1 (0.9) | 0 (0) | 1 (0.6) |
| COVID-19 | 1 (0.9) | 0 (0) | 1 (0.6) |
| Gastroenteritis | 0 (0) | 1 (2.0) | 1 (0.6) |
| Postoperative wound infection | 1 (0.9) | 0 (0) | 1 (0.6) |
| Gestational hypertension | 1 (0.9) | 0 (0) | 1 (0.6) |
| Hemorrhage in pregnancy | 1 (0.9) | 0 (0) | 1 (0.6) |
| Oligohydramnios | 1 (0.9) | 0 (0) | 1 (0.6) |
| Placenta previa hemorrhage | 0 (0) | 1 (2.0) | 1 (0.6) |
| Post-partum hemorrhage | 1 (0.9) | 0 (0) | 1 (0.6) |
| Preeclampsia | 2 (1.9) | 0 (0) | 2 (1.3) |
| Premature labor | 4 (3.8) | 2 (3.9) | 6 (3.8) |
| Preterm, premature rupture of membranes | 1 (0.9) | 0 (0) | 1 (0.6) |
| Proteinuria | 2 (1.9) | 0 (0) | 2 (1.3) |
| Cohort 2 Infant adverse events | Dapivirine arm (n=102) n (%) | TDF/FTC arm (n=51) n (%) | Both arms (n=153) n (%) |
| Participants with one or more composite AEs1 | 17 (16.7) | 7 (13.7) | 24 (15.7) |
| Dysmorphism | 1 (1.0) | 0 (0) | 1 (0.7) |
| Facial edema | 1 (1.0) | 0 (0) | 1 (0.7) |
| Multiple organ dysfunction syndrome | 1 (1.0) | 0 (0) | 1 (0.7) |
| Bronchiolitis | 2 (2.0) | 1 (2.0) | 3 (2.0) |
| Gastroenteritis | 1 (1.0) | 0 (0) | 1 (0.7) |
| Pneumonia | 1 (1.0) | 1 (2.0) | 2 (1.3) |
| Fetal distress syndrome | 2 (2.0) | 0 (0) | 2 (1.3) |
| Jaundice | 1 (1.0) | 0 (0) | 1 (0.7) |
| Small for dates | 9 (8.8) | 6 (11.8) | 15 (9.8) |
| Neonatal asphyxia | 2 (2.0) | 0 (0) | 2 (1.3) |
1
Composite safety for both mother and infant encompassed all serious adverse events (SAEs) and grade 3 or higher adverse events (AEs) as per Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events24,25.
Abbreviations: TDF/FTC= tenofovir disoproxil fumarate/emtricitabine