Table 2.
Adverse events by treatment cycle (safety population)
| Adverse events, n (%) | Cycle 1 (n = 187) | Cycle 2 (n = 177) | Cycle 3 (n = 50) | Cycle 4 (n = 24) | All sessions (N = 187) |
|---|---|---|---|---|---|
| Any AE | 77 (41.2) | 70 (39.5) | 20 (40.0) | 7 (29.2) | 109 (58.3) |
| Any treatment-related AE | 42 (22.5) | 26 (14.7) | 4 (8.0) | 2 (8.3) | 55 (29.4) |
| Any severe AE | 5 (2.7) | 8 (4.5) | 2 (4.0) | 2 (8.3) | 15 (8.0) |
| Any AE leading to discontinuation | 4 (2.1) | 6 (3.4) | 2 (4.0) | 1 (4.2) | 13 (7.0) |
| Any serious AE | 7 (3.7) | 14 (7.9) | 3 (6.0) | 2 (8.3) | 25 (13.4) |
| Death | 1 (0.5) | 4 (2.3) | 2 (4.0) | 1 (4.2) | 8 (4.3) |
| Most common AEs (≥ 2% overall) | |||||
| Dry mouth | 29 (15.5) | 10 (5.6) | 1 (2.0) | NA | 32 (17.1) |
| Dental caries | 13 (7.0) | 17 (9.6) | 6 (12.0) | 2 (8.3) | 28 (15.0) |
| Amyotrophic lateral sclerosisa | 2 (1.1) | 8 (4.5) | 1 (2.0) | 2 (8.3) | 10 (5.3) |
| Fall | 6 (3.2) | 3 (1.7) | 1 (2.0) | NA | 9 (4.8) |
| Nasopharyngitis | 6 (3.2) | NA | NA | 1 (4.2) | 7 (3.7) |
| Urinary tract infection | 1 (0.5) | 3 (1.7) | 1 (2.0) | NA | 5 (2.7) |
| Dysphagia | 4 (2.1) | NA | NA | NA | 4 (2.1) |
| Oral candidiasis | 3 (1.6) | 2 (1.1) | NA | NA | 4 (2.1) |
| Tooth fracture | 1 (0.5) | 2 (1.1) | 1 (2.0) | NA | 4 (2.1) |
AE Adverse event, NA not applicable
aProgression of amyotrophic lateral sclerosis