Table 2.
Summary of treatment-emergent adverse events
| TEAE | Phase III safety population [n = 1340] | Subset of older patientsa [n = 42] |
|---|---|---|
| Any serious TEAEs | 238 (17.8) | 12 (28.6) |
| Serious TEAEs occurring in > 4 patients | ||
| Appendicitis | 7 (0.5) | 0 |
| Pneumonia | 6 (0.4) | 0 |
| Fall | 6 (0.4) | 1 (2.4) |
| Hyponatremia | 6 (0.4) | 0 |
| Seizure | 29 (2.2) | 0 |
| Epilepsy | 8 (0.6) | 0 |
| Ataxia | 7 (0.5) | 1 (2.4) |
| Status epilepticus | 7 (0.5) | 0 |
| Postictal paralysis | 6 (0.4) | 0 |
| Dizziness | 5 (0.4) | 0 |
| Suicidal ideation | 5 (0.4) | 0 |
| Suicide attempt | 5 (0.4) | 0 |
| Pulmonary embolism | 6 (0.4) | 1 (2.4) |
| Any TEAE | 1215 (90.7) | 41 (97.6) |
| TEAEs occurring in ≥ 10% of patients | ||
| Dizziness | 387 (28.9) | 18 (42.9) |
| Somnolence | 419 (31.3) | 16 (38.1) |
| Fall | 79 (5.9) | 12 (29.3)b |
| Fatigue | 260 (19.4) | 12 (28.6) |
| Balance disorder | 96 (7.2) | 9 (21.4) |
| Upper respiratory tract infection | 117 (8.7) | 9 (21.4) |
| Constipation | 84 (6.3) | 6 (14.3) |
| Urinary tract infection | 82 (6.1) | 5 (11.9) |
| Gait disturbance | 72 (5.4) | 5 (11.9) |
| Arthralgia | 37 (2.8) | 5 (11.9) |
| Cough | 36 (2.7) | 5 (11.9) |
Data are expressed as n (%)
TEAEs treatment-emergent adverse events
aTEAEs reported through 36 months
bOne patient with a history of ataxia was removed from the analysis for falls because their falls were likely related to prior history. Percentage is based on n = 41