Adverse events in both study groups
| Doxycycline | Placebo | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse event | Total study population (n=232), n (%)* | Doxycycline (n=116), n (%) | Placebo (n=116), n (%) | p Value | Led to temporarily discontinuation, n† | Led to permanent discontinuation, n | Led to temporarily discontinuation, n | Led to permanent discontinuation, n |
| Sun sensitivity | 38 (16) | 35 (30) | 3 (3) | <0.001 | 6 | 9 | 0 | 1 |
| Diarrhoea | 25 (11) | 15 (13) | 10 (9) | 0.40 | 1 | 5 | 0 | 1 |
| Abdominal discomfort | 16 (7) | 6 (5) | 10 (9) | 0.44 | 0 | 4 | 0 | 1 |
| Erythema | 12 (5) | 8 (7) | 4 (3) | 0.38 | 1 | 2 | 0 | 1 |
| Nausea | 10 (4) | 5 (4) | 5 (4) | 1.0 | 0 | 1 | 0 | 1 |
| Upper respiratory tract infection | 9 (4) | 2 (2) | 7 (6) | 0.17 | 1 | 0 | 1 | 0 |
| Arthralgia/myalgia | 8 (3) | 4 (3) | 4 (3) | 1.0 | 0 | 2 | 0 | 0 |
| Headache | 7 (3) | 4 (3) | 3 (3) | 1.0 | 0 | 0 | 1 | 0 |
| Oedema | 6 (3) | 3 (3) | 3 (3) | 1.0 | 0 | 0 | 0 | 0 |
| Constipation | 6 (3) | 4 (3) | 2 (2) | 0.68 | 1 | 1 | 0 | 0 |
| Mycosis | 5 (2) | 4 (3) | 1 (1) | 0.37 | 1 | 1 | 0 | 0 |
| Other | 26 (11) | 10 (9) | 16 (14) | 0.30 | 2 | 2 | 1 | 2 |