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

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

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