Table 4.
Adverse events, safety population
| Amiloride (n=111) | Fluoxetine (n=111) | Riluzole (n=109) | Placebo (n=112) | ||
|---|---|---|---|---|---|
| Adverse events (n) | 609 | 738 | 634 | 582 | |
| Patients experiencing at least one adverse event | 100 (90%) | 105 (95%) | 101 (93%) | 103 (92%) | |
| Cardiac disorders | 1 (1%) | 3 (3%) | 8 (7%) | 2 (2%) | |
| Eye disorders | 13 (12%) | 8 (7%) | 9 (8%) | 8 (7%) | |
| Gastrointestinal disorders | 46 (41%) | 62 (56%) | 49 (45%) | 36 (32%) | |
| General disorders and administration | 26 (23%) | 28 (25%) | 27 (25%) | 32 (29%) | |
| Infections and infestations | 68 (61%) | 58 (52%) | 62 (57%) | 69 (62%) | |
| Injury, poisoning, and procedural complications | 26 (23%) | 43 (39%) | 29 (27%) | 28 (25%) | |
| Investigations* | 10 (9%) | 20 (18%) | 17 (16%) | 8 (7%) | |
| Metabolism and nutrition disorders | 2 (2%) | 9 (8%) | 7 (6%) | 4 (4%) | |
| Musculoskeletal and connective tissue disorders | 37 (33%) | 26 (23%) | 37 (34%) | 29 (26%) | |
| Nervous system disorders | 48 (43%) | 46 (41%) | 47 (43%) | 44 (39%) | |
| Psychiatric disorders | 21 (19%) | 30 (27%) | 22 (20%) | 22 (20%) | |
| Renal and urinary disorders | 9 (8%) | 13 (12%) | 10 (9%) | 5 (4%) | |
| Respiratory disorders | 15 (14%) | 23 (21%) | 13 (12%) | 16 (14%) | |
| Skin and subcutaneous tissue disorders | 16 (14%) | 11 (10%) | 13 (12%) | 17 (15%) | |
| Surgical and medical procedures | 6 (5%) | 3 (3%) | 8 (7%) | 7 (6%) | |
| Vascular disorders | 4 (4%) | 2 (2%) | 3 (3%) | 6 (5%) | |
| Patients experiencing at least one serious adverse event | 10 (9%) | 7 (6%) | 12 (11%) | 13 (12%) | |
| Infections and infestations | 4 (4%) | 1 (1%) | 4 (4%) | 4 (4%) | |
| Injury, poisoning, and procedural complications | 3 (3%) | 0 (0%) | 3 (3%) | 2 (2%) | |
| Patients experiencing at least one suspected unexplained serious adverse reaction | 0 (0%) | 0 (0%) | 1 (1%) | 0 (0%) | |
Data are number of patients experiencing each type of event (% of cohort). Adverse events occurring in at least 5% of patients in any study group are shown. Serious adverse events occurring in at least 3% of patients in any group are shown. Full data are provided in the appendix (pp 14–15). The safety population comprised all patients who underwent randomisation, excluding two patients allocated riluzole who were prescribed fluoxetine by their family doctor towards the end of the trial (protocol deviation); these patients had five adverse events and no serious adverse events; a few of the adverse events occurred after fluoxetine was prescribed and, therefore, might be attributable to fluoxetine rather than riluzole (or a combination of the two). Progressive change due to secondary progressive multiple sclerosis in motor, sensory, balance, sphincter (including urinary tract infections), vision, cognitive, and fatigue levels were not reported as adverse events, serious adverse events, or suspected unexplained serious adverse reactions. Relapses were not reported as adverse events, serious adverse events, or suspected unexplained serious adverse reactions but are collated separately.
For example, abnormal blood results or weight loss.