Table 2.
Adverse events
| Adverse events | Non-serious adverse events | Serious adverse events | Total | ||||||
|---|---|---|---|---|---|---|---|---|---|
| N (%) | E | R | N (%) | E | R | N (%) | E | R | |
| Adverse events | 63 (34.1) | 133 | 99.9 | 6 (3.2) | 6 | 4.5 | 65 (35.1) | 139 | 104.4 |
| Mild | 35 (18.9) | 64 | 48.1 | 1 (0.5) | 1 | 0.8 | 36 (19.5) | 65 | 48.8 |
| Moderate | 28 (15.1) | 60 | 45.1 | 3 (1.6) | 3 | 2.3 | 31 (16.8) | 63 | 47.3 |
| Severe | 4 (2.2) | 9 | 6.8 | 2 (1.1) | 2 | 1.5 | 6 (3.2) | 11 | 8.3 |
| Action taken | |||||||||
| Drug interrupted | 14 (7.6) | 26 | 19.5 | 2 (1.1) | 2 | 1.5 | 15 (8.1) | 28 | 21.0 |
| Drug withdrawn | 19 (10.3) | 30 | 22.5 | 1 (0.5) | 1 | 0.8 | 20 (10.8) | 31 | 23.3 |
| Dose reduced | 14 (7.6) | 28 | 21.0 | 0 | 0 | 0 | 14 (7.6) | 28 | 21.0 |
| Gastrointestinal adverse events | 50 (27.0) | 89 | 66.9 | 0 | 0 | 0 | 50 (27.0) | 89 | 66.9 |
| Nausea | 27 (14.6) | 29 | 21.8 | 0 | 0 | 0 | 27 (14.6) | 29 | 21.8 |
| Vomiting | 15 (8.1) | 15 | 11.3 | 0 | 0 | 0 | 15 (8.1) | 15 | 11.3 |
| Diarrhoea | 9 (4.9) | 9 | 6.8 | 0 | 0 | 0 | 9 (4.9) | 9 | 6.8 |
In-study observation period
% Percentage of participants, E number of events, N number of participants, R event rate per 100 person-years