Table 6.
Incidence of adverse events reported by ≥5% and at least two patients in any primary-neurological-condition category (safety population).
| Preferred term, % (n) | AD/dementia (n = 17) | MS (n = 223) | Stroke/ CBVD (n = 51) | TBI (n = 23) | ALS/MND (n = 199) | PD/movement disorders (n = 23) | Other PBA (n = 17) | p Valuea | Total (N = 553) |
|---|---|---|---|---|---|---|---|---|---|
| Any AE | 70.6 (12) | 89.7 (200) | 90.2 (46) | 82.6 (19) | 98.0 (195) | 91.3 (21) | 88.2 (15) | 0.0004 | 91.9 (508) |
| Nausea | 11.8 (2) | 23.8 (53) | 19.6 (10) | 13.0 (3) | 31.7 (63) | 8.7 (2) | 23.5 (4) | 0.0544 | 24.8 (137) |
| Headache | 5.9 (1) | 25.1 (56) | 15.7 (8) | 26.1 (6) | 22.1 (44) | 26.1 (6) | 29.4 (5) | 0.4613 | 22.8 (126) |
| Dizziness | 5.9 (1) | 21.5 (48) | 19.6 (10) | 21.7 (5) | 17.1 (34) | 30.4 (7) | 17.6 (3) | 0.5201 | 19.5 (108) |
| Fall | 17.6 (3) | 13.5 (30) | 7.8 (4) | 13.0 (3) | 22.6 (45) | 21.7 (5) | 5.9 (1) | 0.0674 | 16.5 (91) |
| Diarrhea | 23.5 (4) | 15.7 (35) | 11.8 (6) | 13.0 (3) | 19.1 (38) | 0 (0) | 23.5 (4) | 0.2426 | 16.3 (90) |
| Fatigue | 17.6 (3) | 16.6 (37) | 7.8 (4) | 39.1 (9) | 11.1 (22) | 13.0 (3) | 17.6 (3) | 0.0141 | 14.6 (81) |
| Weakness | 0 (0) | 14.8 (33) | 3.9 (2) | 4.3 (1) | 18.6 (37) | 4.3 (1) | 11.8 (2) | 0.0245 | 13.7 (76) |
| Nasopharyngitis | 0 (0) | 16.1 (36) | 9.8 (5) | 13.0 (3) | 9.5 (19) | 4.3 (1) | 11.8 (2) | 0.1944 | 11.9 (66) |
| Somnolence | 5.9 (1) | 4.9 (11) | 15.7 (8) | 4.3 (1) | 15.6 (31) | 26.1 (6) | 11.8 (2) | 0.0019 | 10.8 (60) |
| Arthralgia | 0 (0) | 14.3 (32) | 5.9 (3) | 0 (0) | 10.1 (20) | 13.0 (3) | 5.9 (1) | 0.1334 | 10.7 (59) |
| Cough | 5.9 (1) | 10.3 (23) | 3.9 (2) | 13.0 (3) | 14.6 (29) | 4.3 (1) | 0 (0) | 0.1633 | 10.7 (59) |
| Ecchymosis | 5.9 (1) | 8.1 (18) | 5.9 (3) | 4.3 (1) | 12.6 (25) | 13.0 (3) | 17.6 (3) | 0.4343 | 9.8 (54) |
| Pain in limb | 0 (0) | 13.0 (29) | 11.8 (6) | 0 (0) | 8.5 (17) | 0 (0) | 5.9 (1) | 0.1056 | 9.6 (53) |
| Constipation | 11.8 (2) | 5.4 (12) | 5.9 (3) | 0 (0) | 15.1 (30) | 4.3 (1) | 11.8 (2) | 0.0124 | 9.0 (50) |
| Insomnia | 0 (0) | 6.7 (15) | 7.8 (4) | 8.7 (2) | 13.6 (27) | 0 (0) | 11.8 (2) | 0.1004 | 9.0 (50) |
| Back pain | 5.9 (1) | 9.9 (22) | 5.9 (3) | 0 (0) | 9.0 (18) | 4.3 (1) | 5.9 (1) | 0.6684 | 8.3 (46) |
| Dysphagia | 0 (0) | 1.8 (4) | 3.9 (2) | 0 (0) | 20.1 (40) | 0 (0) | 0 (0) | <0.0001 | 8.3 (46) |
| Dry mouth | 5.9 (1) | 5.8 (13) | 9.8 (5) | 0 (0) | 8.5 (17) | 13.0 (3) | 0 (0) | 0.4119 | 7.1 (39) |
| Edema lower limb | 5.9 (1) | 3.6 (8) | 7.8 (4) | 8.7 (2) | 9.5 (19) | 8.7 (2) | 11.8 (2) | 0.3244 | 6.9 (38) |
| Respiratory failure | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 19.1 (38) | 0 (0) | 0 (0) | <0.0001 | 6.9 (38) |
| Sore throat | 5.9 (1) | 9.0 (20) | 3.9 (2) | 4.3 (1) | 7.0 (14) | 0.4887 | 6.9 (38) | ||
| Urinary tract infection | 0 (0) | 9.9 (22) | 5.9 (3) | 4.3 (1) | 4.5 (9) | 4.3 (1) | 11.8 (2) | 0.2970 | 6.9 (38) |
| Dyspnea | 0 (0) | 3.6 (8) | 3.9 (2) | 8.7 (2) | 11.6 (23) | 4.3 (1) | 5.9 (1) | 0.0399 | 6.7 (37) |
| Fatigue aggravated | 0 (0) | 9.4 (21) | 3.9 (2) | 0 (0) | 5.0 (10) | 0 (0) | 5.9 (1) | 0.1663 | 6.1 (34) |
| Laceration | 0 (0) | 5.8 (13) | 5.9 (3) | 0 (0) | 8.0 (16) | 4.3 (1) | 5.9 (1) | 0.6724 | 6.1 (34) |
| MS aggravated | 0 (0) | 14.3 (32) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | <0.0001 | 5.8 (32) |
| Pyrexia | 5.9 (1) | 7.6 (17) | 3.9 (2) | 5.0 (10) | 4.3 (1) | 5.9 (1) | 0.7549 | 5.8 (32) | |
| Vomiting | 5.9 (1) | 7.6 (17) | 2.0 (1) | 8.7 (2) | 5.0 (10) | 4.3 (1) | 0 (0) | 0.6161 | 5.8 (32) |
| Muscle spasms | 0 (0) | 6.7 (15) | 0 (0) | 8.7 (2) | 6.0 (12) | 0 (0) | 5.9 (1) | 0.3610 | 5.4 (30) |
| Nasal congestion | 0 (0) | 6.3 (14) | 3.9 (2) | 4.3 (1) | 6.0 (12) | 0 (0) | 0 (0) | 0.6634 | 5.2 (29) |
| Anxiety | 0 (0) | 3.6 (8) | 0 (0) | 4.3 (1) | 7.5 (15) | 13.0 | 5.9 (1) | 0.1138 | 5.1 (28) |
| Joint stiffness | 0 (0) | 5.4 (12) | 2.0 (1) | 0 (0) | 6.5 (13) | 0 (0) | 11.8 (2) | 0.3292 | 5.1 (28) |
AD: Alzheimer’s disease; AE: adverse event; ALS: amyotrophic lateral sclerosis; CBVD: cerebrovascular disorders; MND: motor neuron disease; MS: multiple sclerosis; PBA: pseudobulbar affect; PD: Parkinson’s disease; TBI: traumatic brain injury.
aChi-square test.