Table 5.
Patients with select AEs and ADRs of special interest.
| Phase III program | Patients, n (%) | ||
|---|---|---|---|
| Levodopa <2000 mg/day (n = 340) | Levodopa ≥2000 mg/day (n = 72) | Overall (N = 412) | |
| Abuse liability AEs | |||
| Intentional overdose | 1 (0.3) | — | 1 (0.2) |
| Psychomotor hyperactivity | — | 1 (1.4) | 1 (0.2) |
| Sleep/sleep attack-related AEs | |||
| Sleep attacks | 30 (8.8) | 9 (12.5) | 39 (9.5) |
| Somnolence | 8 (2.4) | 4 (5.6) | 12 (2.9) |
| Hallucination/psychosis-related AEs | |||
| Hallucination | 25 (7.4) | 13 (18.1) | 38 (9.2) |
| Hallucination, auditory | 4 (1.2) | — | 4 (1.0) |
| Hallucination, tactile | 2 (0.6) | — | 2 (0.5) |
| Hallucination, visual | 11 (3.2) | 1 (1.4) | 12 (2.9) |
| Hallucination, mixed | 1 (0.3) | — | 1 (0.2) |
| Psychotic disorder | 3 (0.9) | 3 (4.2) | 6 (1.5) |
| Polyneuropathy-related AEsa | 32 (9.4) | 17 (23.6) | 49 (11.9) |
| Polyneuropathy-related AEs reported in >1% of patients overallb | |||
| Polyneuropathy | 15 (4.4) | 10 (13.9) | 25 (6.1) |
| Peripheral neuropathy | 5 (1.5) | 1 (1.4) | 6 (1.5) |
| Peripheral sensory neuropathy | 5 (1.5) | 1 (1.4) | 6 (1.5) |
|
| |||
| GLORIA registry | Levodopa <2000 mg/day (n = 309) | Levodopa ≥2000 mg/day (n = 47) | Overall (N = 356) |
|
| |||
| Somnolence | 2 (0.6) | 1 (2.1) | 3 (0.8) |
| Hallucination/psychosis-related ADRsb | |||
| Hallucination | 9 (2.9) | 3 (6.4) | 12 (3.4) |
| Hallucination, visual | 1 (0.3) | 1 (2.1) | 2 (0.6) |
| Psychotic disorder | 6 (1.9) | 1 (2.1) | 7 (2.0) |
| Polyneuropathy-related ADRsb reported in >1% of patients overall | |||
| Polyneuropathy | 12 (3.9) | 4 (8.5) | 16 (4.5) |
| Peripheral neuropathy | 4 (1.3) | 1 (2.1) | 5 (1.4) |
| Peripheral sensory neuropathy | 1 (0.3) | 3 (6.4) | 4 (1.1) |
aBased on the Standard MedDRA Query narrow search of Guillain–Barré syndrome and peripheral neuropathy. bPolyneuropathy AEs not listed in the table include Guillain–Barré syndrome, which occurred in two patients (n/N = 2/72, 2.8%) who required ≥2000 mg dose for PD symptom control. bADRs were AEs deemed by the investigator to have at least a reasonable possibility of a causal relationship to the treatment drug/device. ADR: adverse drug reaction; AE: adverse event; PD: Parkinson's disease.