Table 3 Summary of the adverse events (AEs) by treatment allocation
Variable | Placebo | PGX | P-value | |
|---|---|---|---|---|
Number of participants | 38 | 42 | ||
Participants reporting adverse events | 13 (34.2%) | 12 (28.6%) | 0.7 | |
Total adverse events | 25 | 28 | ||
Participants reporting treatment-related events | 8 (21.1%) | 11 (26.2%) | 0.34 | |
Total treatment-related Events | 19 | 24 | ||
Total adverse events (by severity) | Unknown severity | 0 | 0 | |
Mild | 5 | 2 | ||
Moderate | 13 | 21 | ||
Severe | 7 | 5 | ||
Total treatment-related events (by severity) | Unknown Severity | 0 | 0 | |
Mild | 4 | 2 | ||
Moderate | 9 | 18 | ||
Severe | 6 | 4 | ||
Participants reporting AEs by type of AE | Constipation | 3 (7.9%) | 1 (2.4%) | 0.15 |
Diarrhea | 0 (0.0%) | 3 (7.1%) | NA | |
Bloating | 4 (10.5%) | 8 (19%) | 0.07 | |
Flatulence | 0 (0.0%) | 2 (4.8%) | NA | |
Headache | 4 (10.5%) | 1 (2.4%) | 0.17 | |
Cramping | 3 (7.9%) | 3 (7.1%) | 0.59 | |
Sick/unwell | 4 (10.5%) | 1 (2.4%) | 0.08 | |
Other | 3 (7.9%) | 7 (16.7%) | 0.06 |
