Table 3.
Summary of participants with treatment-emergent adverse event (safety population; values expressed as n (%) subjects).
| Parameters | No Supplementation (n = 89) | MMS (n = 87) | Total (n = 176) |
|---|---|---|---|
| Number of TEAEs pertinent to the mother | 114 | 118 | 232 |
| Any TEAEs pertinent to the mother | 64 (71.9) | 61 (70.1) | 125 (71.0) |
| At least one suspected related a | NA | 3 (3.5) | 3 (1.7) |
| At least one serious TEAE | 11 (12.4) | 12 (13.8) | 23 (13.1) |
| At least one leading to temporary treatment interruption b | NA | 1 (1.2) | 1 (0.6) |
| At least one leading to permanent treatment discontinuation c | NA | 19 (21.8) | 19 (10.8) |
| Fatal outcome | 0 | 0 | 0 |
| Number of TEAEs pertinent to fetus/child | 4 | 9 | 13 |
| Any TEAEs pertinent to fetus/child | 3 (3.4) | 7 (8.1) | 10 (5.7) |
| At least one suspected related a | NA | 0 | 0 |
| At least one serious TEAE b | 2 (2.3) | 3 (3.5) | 5 (2.8) |
| At least one leading to temporary treatment interruption c | NA | 1 (1.2) | 1 (0.6) |
| At least one leading to permanent treatment discontinuation d | NA | 1 (1.2) | 1 (0.6) |
| Fatal outcome | 0 | 1 (1.2) | 1 (0.6) |
a Suspected related adverse events were those events with causal relationship equal to related; b No Supplementation group, the TEAEs pertinent to the fetus/child classified as severe were: fetal distress syndrome 1 (1.12%), fetal growth restriction 1 (1.12%); MMS group, the TEAEs pertinent to the fetus/child classified as severe were “Duodenal atresia” (1, 1.15%), “Fetal compartment fluid collection “(1, 1.15%), “Fetal growth restriction” (1, 1.15%) and “Polyhydramnios” (1, 1.15%). No TEAE pertinent to the fetus/child was suspected of being related to the study product; c adverse events leading to temporary treatment interruption were those events with action taken equal to drug interrupted; d adverse events leading to permanent treatment discontinuation were those events with action taken equal to drugs withdrawn. MMS, multiple micronutrients and docosahexaenoic acid supplementation; NA, not applicable; TEAEs, treatment-emergent adverse events.