Table 6. Summary of adverse events and adverse reactions.
| Categories | Efficacy population (n = 23) | ||
|---|---|---|---|
| n | % | 95% CI | |
| Any adverse event (AE) | 20 | 87.0 | 66.4, 97.2 |
| Grade 1 | 14 | 60.9 | 38.5, 80.3 |
| Grade 2 | 7 | 30.4 | 13.2, 52.9 |
| Grade 3 | 7 | 30.4 | 13.2, 52.9 |
| Serious AE | 4 | 17.4 | 5.0, 38.8 |
| Any adverse reaction (AR) | 13 | 56.5 | 34.5, 76.8 |
| Grade 1 | 8 | 34.8 | 16.4, 57.3 |
| Grade 2 | 6 | 26.1 | 10.2, 48.4 |
| Grade 3 | 2 | 8.7 | 1.1, 28.0 |
| Serious AR* | 1 | 4.3 | 0.1, 21.9 |
| AE leading to treatment discontinuation (HLGT/PT) | 4 | 17.4 | 5.0, 38.8 |
| Fatal outcomes | 2 | 8.7 | 1.1, 28.0 |
| Death | 2 | 8.7 | 1.1, 28.0 |
| General system disorders NEC | 1 | 4.3 | 0.1, 21.9 |
| Condition aggravated | 1 | 4.3 | 0.1, 21.9 |
| Hepatic and hepatobiliary disorders | 2 | 8.7 | 1.1, 28.0 |
| Hepatic function abnormal | 2 | 8.7 | 1.1, 28.0 |
| Renal disorders (excl. nephropathies) | 1 | 4.3 | 0.1, 21.9 |
| Acute kidney injury | 1 | 4.3 | 0.1, 21.9 |
| AE occurring in 20% or more (HLGT/PT) | |||
| Epidermal and dermal conditions | 6 | 26.1 | 10.2, 48.4 |
| Erythema | 2 | 8.7 | 1.1, 28.0 |
| Generalised erythema | 1 | 4.3 | 0.1, 21.9 |
| Pruritus | 1 | 4.3 | 0.1, 21.9 |
| Rash | 3 | 13 | 2.8, 33.6 |
| Hepatic and hepatobiliary disorders | 8 | 34.8 | 16.4, 57.3 |
| Hepatic function abnormal | 5 | 21.7 | 7.5, 43.7 |
| Hyperbilirubinemia | 2 | 8.7 | 1.1, 28.0 |
| Liver disorder | 1 | 4.3 | 0.1, 21.9 |
| Sleep disorders and disturbances | 5 | 21.7 | 7.5, 43.7 |
| Insomnia | 5 | 21.7 | 7.5, 43.7 |
* Preferred term, Seizure
** System Organ Class, Hepatobiliary disorders
n = number, CI = confidence interval, HLGT = High Level Group Term, PT = Preferred Term, NEC = Not Elsewhere Classified.