TABLE 3.
Adverse events (defined as any incident leading to discontinuation of treatment or hospitalisation)
| Intervention | Control | OR (95% CI) | p-value | |
|---|---|---|---|---|
| Serious adverse events leading to hospitalisation | 0 | 0 | ||
| Adverse events | ||||
| DILI (ATS criteria)# | 0.7 (1/146) | 2.3 (3/130) | 0.29 (0.03–2.84) | 0.29 |
| DILI (local protocol)¶ | 0.7 (1/146) | 3.1 (4/130) | 0.22 (0.02–1.97) | 0.18 |
| Other adverse effects leading to discontinuation of treatment | 4.1 (6/146) | 6.2 (8/130) | 0.65 (0.22–1.94) | 0.44 |
| Specific symptoms reported in those discontinuing treatment+ | ||||
| Nausea | 1.4 (2/146) | 2.3 (3/130) | ||
| Vomiting | 0.0 (0/146) | 0.8 (1/130) | ||
| Itching | 2.7 (4/146) | 3.8 (5/130) | ||
| Rash | 1.4 (2/146) | 0.0 (0/130) | ||
| Paraesthesia | 0.0 (0/146) | 0.0 (0/130) | ||
| “Flu-like” illness | 0.0 (0/146) | 0.0 (0/130) | ||
| Abdominal pain/diarrhoea | 0.0 (0/146) | 0.0 (0/130) |
Data are presented as % or % (n/N), unless otherwise stated. DILI: drug-induced liver injury; ATS: American Thoracic Society; ALT: alanine transaminase; ULN: upper limit of normal. #: DILI (ATS criteria): ALT ≥3 times ULN with symptoms or ALT ≥5 times ULN without symptoms; ¶: DILI (local protocol): ALT ≥2 times ULN leading to cessation of treatment; +: excluding those who developed DILI.