Maternal safety of the delayed-release doxylamine and pyridoxine combination for nausea and vomiting of pregnancy; a randomized placebo controlled trial

Table 2 Overall summary of tolerability/adverse events for ITT-S subjects

	Treatment group
	Diclegis (N = 131)	Placebo (N = 127)	P-value¹
Measure of tolerability
Number of Subjects with at least one treatment-emergent AE	74 (56.5%)	65 (51.2%)	0.393
Number of Subjects with a serious treatment-emergent AE	4 (3.1%)	4 (3.1%)	1.000²
Number of Subjects with at least one Related AE	40 (30.5%)	32 (25.2%)	0.339
Number of Subjects discontinuing study drug due to AE	6 (4.6%)	4 (3.1%)	0.749²
Number of deaths	0	0	_
Overall treatment0emergent AEs
Number of Subjects with at least one Mild AE	62 (47.3%)	59 (46.5%)	0.221
Number of Subjects with at least one Moderate AE	5 (3.8%)	1 (0.8%)	0.215²
Number of Subjects with at least one Severe AE	7 (5.3%)	5 (3.9%)	0.711
Number of Subjects with Unrelated AE	34 (26.0%)	33 (26.0%)	0.570
Number of Subjects with at least one Possibly Related AE	24 (18.3%)	23 (18.1%)	0.714
Number of Subjects with at least one Probably Related AE	13 (9.9%)	8 (6.3%)	0.388
Number of Subjects with at least on Definitely Related AE	3 (2.3%	1 (0.8%)	0.623²

¹The p-value for comparing Treatment groups uses Chi-square test method.
²P-value is calculated using Fisher’s exact test method.
Related category includes Possible, Probable, and Definite relationships. Unrelated category includes unlikely and not related.
Subjects reporting more than one AE will only be counted under the strongest relationship and/or severity.
Mild: asymptomatic or mild symptoms, intervention not needed; Moderate: minimal, local or non invasive intervention indicated; Severe: medically significant.

ISSN: 1471-2393