Table 5.
Adverse drug reactions (ADRs) and serious ADRs (n = 106)
| Preferred term | Number of events, n (%) | |
|---|---|---|
| Serious | Non-serious | |
| Total (patients/patients) | 12 (11.3) | |
| Total (case/patients) | 16 (15.1) | |
| Total serious ADRs (patients/patients) | 4 (3.8) | |
| Hepatobiliary disorders | 0 (0.0) | 3 (2.8) |
| Alcoholic liver disease | 0 (0.0) | 1 (0.9) |
| Hepatic function abnormal | 0 (0.0) | 2 (1.9) |
| Skin and subcutaneous tissue disorders | 0 (0.0) | 2 (1.9) |
| Eczema | 0 (0.0) | 1 (0.9) |
| Pruritus generalised | 0 (0.0) | 1 (0.9) |
| Nervous system disorders | 2 (1.9) | 2 (1.9) |
| MS relapse | 2 (1.9) | 0 (0.0) |
| Tremor | 0 (0.0) | 1 (0.9) |
| Resting tremor | 0 (0.0) | 1 (0.9) |
| Psychiatric disorders | 2 (1.9) | 0 (0.0) |
| Neurosis | 1 (0.9) | 0 (0.0) |
| Suicide attempta | 1 (0.9) | 0 (0.0) |
| General disorders and administration site conditions | 0 (0.0) | 3 (2.8) |
| Pyrexia | 0 (0.0) | 2 (1.9) |
| Chills | 0 (0.0) | 1 (0.9) |
| Infections and infestations | 0 (0.0) | 1 (0.9) |
| Herpes zoster | 0 (0.0) | 1 (0.9) |
| Musculoskeletal and connective tissue disorders | 0 (0.0) | 1 (0.9) |
| Back pain | 0 (0.0) | 1 (0.9) |
MS multiple sclerosis
aWe received additional information that was unlocked as of February 7, as follows: completed suicide (outcome: death)