Table 6.
AEs and ADRs that led to discontinuation.
| Phase III program | Patients, n (%) | ||
|---|---|---|---|
| Levodopa <2000 mg/day (n = 340) | Levodopa ≥2000 mg/day (n = 72) | Overall (N = 412) | |
| Incidence of AEs leading to discontinuation | 59 (17.4) | 18 (25.0) | 77 (18.7) |
| AEs leading to discontinuation in >2 patients overall | |||
| Death | 9 (2.6) | 1 (1.4) | 10 (2.4) |
| Pneumonia | 4 (1.2) | 1 (1.4) | 5 (1.2) |
| Myocardial infarction | 3 (0.9) | 1 (1.4) | 4 (1.0) |
| Cardiac arrest | 1 (0.3) | 2 (2.8) | 3 (0.7) |
| Fall | 2 (0.6) | 1 (1.4) | 3 (0.7) |
| Parkinson's diseasea | 3 (0.9) | — | 3 (0.7) |
|
| |||
| GLORIA registry | Levodopa <2000 mg/day (n = 309) | Levodopa ≥2000 mg/day (n = 47) | Overall (N = 356) |
|
| |||
| Patients with ≥1 ADRb leading to discontinuation | 24 (7.8) | — | 24 (6.7) |
| ADRs leading to discontinuation in 2 patientsc overall | ∗No ADRs met this criterion | ||
aRefers to the reemergence of Parkinson's disease symptoms, often due to a problem with drug delivery. bADRs were AEs deemed by the investigator to have at least a reasonable possibility of a causal relationship to the treatment drug/device. cExcluding those associated with the procedure/device. ADR: adverse drug reaction; AE: adverse event.