Table 4.
Maternal Adverse Events of Grade 3 or Higher Regardless of Relatedness to the Trial Regimen.
| Event | Immediate Group (N = 477) |
Deferred Group (N = 479) |
Total (N = 956) |
|---|---|---|---|
| number of participants (percent) | |||
| Any grade ≥3 adverse event | 144 (30) | 136 (28) | 280 (29) |
| Any grade ≥3 serious adverse event* | 69 (14) | 66 (14) | 135 (14) |
| Grade ≥3 abnormal laboratory findings | 63 (13) | 59 (12) | 122 (13) |
| Abnormal laboratory chemical values | 34 (7) | 40 (8) | 74 (8) |
| Elevated liver-enzyme levels | 29 (6) | 34 (7) | 63 (7) |
| Abnormal hematologic values | 35 (7) | 24 (5) | 59 (6) |
| Grade ≥3 clinical adverse event | 106 (22) | 98 (20) | 204 (21) |
| Gastrointestinal event | 8 (2) | 7 (1) | 15 (2) |
| Hepatitis | 5 (1) | 6 (1) | 11 (1) |
| Infection | 17 (4) | 14 (3) | 31 (3) |
| Nervous system disorder | 4 (1) | 5 (1) | 9 (1) |
| Peripheral neuropathy | 1 (<1) | 0 | 1 (<1) |
| Event related to pregnancy, the puerperium, or the perinatal period | 41 (9) | 39 (8) | 80 (8) |
| Eclampsia or preeclampsia | 8 (2) | 4 (1) | 12 (1) |
| Gestational hypertension | 4 (1) | 5 (1) | 9 (1) |
| Hemorrhage | 5 (1) | 7 (1) | 12 (1) |
| Stillbirth or spontaneous abortion† | 18 (4) | 9 (2) | 27 (3) |
| Weight loss | 31 (6) | 27 (6) | 58 (6) |
| Other clinical adverse event | 36 (8) | 31 (6) | 67 (7) |
*
A serious adverse event was defined as any adverse event that resulted in death, a life-threatening condition, inpatient hospitalization, prolongation of an existing hospitalization, or a persistent or clinically significant disability or incapacity.
†
One event in the immediate group was from a subsequent pregnancy.