Table 3. Summary of Adverse Eventsa.
| Variable | Treatment groupb | ||||
|---|---|---|---|---|---|
| Placebo (n = 114) | XEN1101, 10 mg (n = 46) | XEN1101, 20 mg (n = 51) | XEN1101, 25 mg (n = 114) | XEN1101, any dose (n = 211) | |
| Summary of all TEAEs in the double-blind period within the safety population | |||||
| At least 1 TEAE, No. (%) | 71 (62.3) | 31 (67.4) | 35 (68.6) | 97 (85.1) | 163 (77.3) |
| At least 1 serious TEAE, No. (%) | 3 (2.6) | 2 (4.3) | 2 (3.9) | 3 (2.6) | 7 (3.3) |
| At least 1 TEAE leading to permanent treatment discontinuation, No. (%) | 4 (3.5) | 1 (2.2) | 7 (13.7) | 18 (15.8) | 26 (12.3) |
| At least 1 serious TEAE leading to death, No. (%) | 0 | 0 | 0 | 0 | 0 |
| Most common TEAEs ≥5% in any arm | |||||
| Nervous system disorders | 35 (30.7) | 20 (43.5) | 28 (54.9) | 83 (72.8) | 131 (62.1) |
| Dizziness | 8 (7.0) | 3 (6.5) | 13 (25.5) | 36 (31.6) | 52 (24.6) |
| Somnolence | 8 (7.0) | 5 (10.9) | 11 (21.6) | 17 (14.9) | 33 (15.6) |
| Headache | 9 (7.9) | 6 (13.0) | 6 (11.8) | 9 (7.9) | 21 (10.0) |
| Balance disorder | 2 (1.8) | 2 (4.3) | 4 (7.8) | 13 (11.4) | 19 (9.0) |
| Tremor | 2 (1.8) | 3 (6.5) | 3 (5.9) | 12 (10.5) | 18 (8.5) |
| Aphasia | 1 (0.9) | 1 (2.2) | 1 (2.0) | 8 (7.0) | 10 (4.7) |
| Ataxia | 1 (0.9) | 3 (6.5) | 1 (2.0) | 5 (4.4) | 9 (4.3) |
| Dysarthria | 0 | 1 (2.2) | 0 | 8 (7.0) | 9 (4.3) |
| Memory impairment | 1 (0.9) | 1 (2.2) | 2 (3.9) | 6 (5.3) | 9 (4.3) |
| Disturbance in attention | 1 (0.9) | 0 | 3 (5.9) | 5 (4.4) | 8 (3.8) |
| Psychiatric disorders | 18 (15.8) | 7 (15.2) | 13 (25.5) | 31 (27.2) | 51 (24.4) |
| Confusional state | 1 (0.9) | 1 (2.2) | 3 (5.9) | 6 (5.3) | 10 (4.7) |
| Anxiety | 6 (5.3) | 0 | 5 (9.8) | 2 (1.8) | 7 (3.3) |
| Hallucination | 0 | 0 | 3 (5.9) | 0 | 3 (1.4) |
| General disorders and administration site conditions | 12 (10.5) | 10 (21.7) | 9 (17.6) | 30 (26.3) | 49 (23.2) |
| Fatigue | 6 (5.3) | 5 (10.9) | 4 (7.8) | 14 (12.3) | 23 (10.9) |
| Gait disturbance | 1 (0.9) | 2 (4.3) | 2 (3.9) | 8 (7.0) | 12 (5.7) |
| Gastrointestinal disorders | 10 (8.8) | 10 (21.7) | 5 (9.8) | 19 (16.7) | 34 (16.1) |
| Nausea | 3 (2.6) | 1 (2.2) | 1 (2.0) | 7 (6.1) | 9 (4.3) |
| Constipation | 1 (0.9) | 2 (4.3) | 3 (5.9) | 3 (2.6) | 8 (3.8) |
| Eye disorders | 6 (5.3) | 3 (6.5) | 5 (9.8) | 18 (15.8) | 26 (12.3) |
| Vision blurred | 1 (0.9) | 0 | 1 (2.0) | 7 (6.1) | 8 (3.8) |
| Infections and infestations | 13 (11.4) | 6 (13.0) | 6 (11.8) | 6 (5.3) | 18 (8.5) |
| Urinary tract infection | 4 (3.5) | 4 (8.7) | 3 (5.9) | 2 (1.8) | 9 (4.3) |
| Serious TEAEs in the double-blind period | |||||
| Overall | 3 (2.6) | 2 (4.3) | 2 (3.9) | 3 (2.6) | 7 (3.3) |
| Psychiatric disorders | 0 | 1 (2.2) | 2 (3.9) | 1 (0.9) | 4 (1.9) |
| Confusional state | 0 | 1 (2.2) | 0 | 0 | 1 (0.5) |
| Psychogenic seizure | 0 | 0 | 0 | 1 (0.9) | 1 (0.5) |
| Psychotic disorder | 0 | 0 | 1 (2.0) | 0 | 1 (0.5) |
| Somatic delusion | 0 | 0 | 1 (2.0) | 0 | 1 (0.5) |
| Nervous system disorders | 2 (1.8) | 1 (2.2) | 0 | 2 (1.8) | 3 (1.4) |
| Dizziness | 0 | 0 | 0 | 1 (0.9) | 1 (0.5) |
| Muscle spasticity | 0 | 0 | 0 | 1 (0.9) | 1 (0.5) |
| Seizure | 0 | 1 (2.2) | 0 | 0 | 1 (0.5) |
| Partial seizures | 1 (0.9) | 0 | 0 | 0 | 0 |
| Presyncope | 1 (0.9) | 0 | 0 | 0 | 0 |
| Metabolism and nutrition disorders | 0 | 1 (2.2) | 0 | 0 | 1 (0.5) |
| Hyponatremia | 0 | 1 (2.2) | 0 | 0 | 1 (0.5) |
| Infections and infestations | 1 (0.9) | 0 | 0 | 0 | 0 |
| Coronavirus infection | 1 (0.9) | 0 | 0 | 0 | 0 |
| Injury, poisoning and procedural complications | 1 (0.9) | 0 | 0 | 0 | 0 |
| Pneumothorax traumatic | 1 (0.9) | 0 | 0 | 0 | 0 |
| Rib fracture | 1 (0.9) | 0 | 0 | 0 | 0 |
Abbreviation: TEAEs, treatment-emergent adverse events.
a
The TEAEs listed here are only the most common ones (≥5% in any arm). Because not all TEAEs in each cohort occurred at this level, the sum may not equal the total.
b
All doses were administered with food.