Table 2.
Overall summary of tolerability/adverse events for ITT-S subjects
| Treatment group | |||
|---|---|---|---|
| Diclegis (N = 131) | Placebo (N = 127) | P-value 1 | |
| 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.