Table 3.
New clinical and laboratory adverse events observed over 3 years
| Number of adverse events N (%) |
||
|---|---|---|
| Clinical adverse events grade ≥ 3 | 82 * | |
| Grade 3: severe | 45 | (54.9) |
| Grade 4: life threatening | 8 | (9.8) |
| Grade 5: death† | 7 | (8.5) |
| Obstetrical/postpartum medical condition | 22 | (26.8) |
| Laboratory event grade ≥ 2 | 149ǂ | |
| Low hemoglobin | 58 | (38.9) |
| Elevated alanine aminotransferase (ALT) | 37 | (24.8) |
| Low absolute neutrophil count | 18 | (12.1) |
| Low platelets | 13 | (8.7) |
| Elevated bilirubin (total) | 10 | (6.7) |
| Low Phosphate | 6 | (4.0) |
| Low white Blood Cells (WBC) | 4 | (2.7) |
| Low absolute lymphocyte count | 3 | (2.0) |
| Elevated creatinine | 0 | (0.0) |
* 82 new clinical events of grade ≥ 3 were recorded in 50 women
† Causes of death: 1 anemia, 1 jaundice, 1 miliary tuberculosis, 1 road accident, and 3 unknown
ǂ 149 new laboratory events of grade ≥ 3 were recorded in 109 women