Table 4. Most frequently reported treatment emergent adverse events and serious adverse events, as reported in clinical study report.
doxylamine-pyridoxine (n = 133) | Placebo (n = 128) |
p-value | |
---|---|---|---|
Headache | 17 (12.8%) | 20 (15.6%) | 0.51 |
Somnolence | 19 (14.2%) | 15 (11.7%) | 0.58 |
Fatigue | 9 (6.8%) | 8 (6.3%) | 0.86 |
Dizziness | 8 (6.0%) | 8 (6.3%) | 0.94 |
Back pain | 7 (5.3%) | 4 (3.1%) | 0.39 |
Serious | |||
Bile duct stone | 0 | 1 (0.8%) | 0.49 |
Missed abortion | 1 (0.8%) | 1 (0.8%) | 1.0 |
Spontaneous abortion | 2 (1.5%) | 1 (0.8%) | 0.49 |
Fetal disorder | 0 | 1 (0.8%) | 0.49 |
Intrauterine death | 1 (0.8%) | 0 | 1.0 |
Premature rupture of membranes | 0 | 1 (0.8%) | 0.49 |
Withdrawals | |||
Withdrawals due to adverse events | 5 (3.8%) | 5 (3.9%) | - |