Table 4.
Summary of adverse events (AEs) reported during part II by frequency
| Treatment A (n = 20) | Treatment B1 (n = 20) | Treatment B2 (n = 19) | Overall (n = 20) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Preferred term | AEs | n | % | AEs | n | % | AEs | n | % | AEs | n | % |
| Number of subjects with at least one AE | 8 | 40 | 4 | 20 | 6 | 31 | 12 | 60 | ||||
| Number of different AEs | 5 | 8 | 3 | 13 | ||||||||
| Total number of AEs | 16 | 8 | 9 | 33 | ||||||||
| Headache | 8 | 8 | 40 | 5 | 5 | 26.3 | 13 | 9 | 45 | |||
| Nausea | 2 | 2 | 10 | 2 | 2 | 10.5 | 4 | 4 | 20 | |||
| Vomiting | 3 | 1 | 5 | 2 | 1 | 5.3 | 5 | 2 | 10 | |||
| Limb discomfort | 2 | 2 | 10 | 2 | 2 | 10 | ||||||
| Hypoesthesia | 1 | 1 | 5 | 1 | 1 | 5 | ||||||
| Somnolence | 1 | 1 | 5 | 1 | 1 | 5 | ||||||
| Flatulence | 1 | 1 | 5 | 1 | 1 | 5 | ||||||
| Back pain | 1 | 1 | 5 | 1 | 1 | 5 | ||||||
| Pain in extremity | 1 | 1 | 5 | 1 | 1 | 5 | ||||||
| Fatigue | 1 | 1 | 5 | 1 | 1 | 5 | ||||||
| Peripheral oedema | 1 | 1 | 5 | 1 | 1 | 5 | ||||||
| Ear discomfort | 1 | 1 | 5 | 1 | 1 | 5 | ||||||
| Generalized pruritus | 1 | 1 | 5 | 1 | 1 | 5 | ||||||
Treatments: A = selexipag; B1 = rifampicin; B2 = rifampicin + selexipag. Data are expressed as AE (number of adverse events), n (number of subjects experiencing at least one AE) and % (percentage of subjects with at least one AE)