Table 3 Safety profile according to treatment groups
Adverse events | Intervention arm SPAZ (N = 496) n (%) | Control arm SP (N = 496) n (%) | p-valuea |
|---|---|---|---|
Total events reported | 152 (30.6) | 176 (35.5) | 0.12 |
Serious AEs | 67 (13.5) | 83 (16.7) | 0.18 |
Non-serious AEs | 85 (17.1) | 93 (18.8) | 0.56 |
Detailed AEs | |||
Serious events | |||
Eclampsia | 2 (0.4) | 1 (0.2) | 0.47 |
Severe malaria | 10 (2.0) | 14 (2.8) | 0.41 |
Preterm birth | 23 (4.6) | 20 (4.0) | 0.75 |
Stillbirth | 7 (1.4) | 11 (2.2) | 0.75 |
Miscarriage | 3 (0.6) | 4 (0.8) | 0.70 |
Emergency cesarean section | 7 (2.2) | 10 (3.6) | 0.26 |
Severe anemia | 0 (0.0) | 2 (0.4) | 0.16 |
Fetal distress | 5 (1.0) | 4 (0.8) | 0.81 |
Neonatal death | 5 (1.0) | 4 (0.8) | 0.73 |
Premature rupture of membrane | 3 (0.6) | 6 (1.6) | 0.13 |
Neonatal resuscitation | 1 (0.2) | 3 (0.6) | 0.31 |
Neonatal distress | 1 (0.2) | 3 (0.6) | 0.31 |
Laparoschisis | 0 (0.0) | 1 (0.2) | 0.32 |
Non-serious AEs | |||
Threat preterm birth | 1 (0.2) | 2 (0.2) | 0.56 |
Abdominal pain | 10 (2.0) | 5 (1.0) | 0.20 |
Cervix infection | 0 (0.0) | 3 (0.6) | 0.08 |
Endometritis | 0 (0.0) | 2 (0.4) | 0.16 |
False labor | 4 (0.8) | 6 (1.2) | 0.52 |
Gastroenteritis | 5 (1.0) | 8 (1.6) | 0.40 |
Headache | 3 (0.6) | 5 (1.0) | 0.47 |
Uncomplicated malaria | 7 (1.4) | 9 (1.8) | 0.61 |
Neonatal infection | 4 (0.8) | 6 (1.2) | 0.52 |
Oligo-amnios | 2 (0.4) | 3 (0.2) | 0.56 |
Pelvic pain | 5 (1.0) | 3 (0.6) | 0.48 |
Pelvic spasm | 5 (1.0) | 9 (1.8) | 0.42 |
Pneumonia | 5 (1.0) | 7 (1.4) | 0.56 |
Preeclampsia | 5 (1.0) | 6 (1.2) | 0.76 |
Urinary infection | 1 (0.2) | 3 (0.6) | 0.18 |
Others | 17 (3.4) | 11 (2.2) | 0.34 |