Skip to main content
. 2018 Jan 17;13(1):e0189978. doi: 10.1371/journal.pone.0189978

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%) -