Parkinson’s Disease / 2020 / Article / Tab 4

Research Article

Safety of Levodopa-Carbidopa Intestinal Gel Treatment in Patients with Advanced Parkinson’s Disease Receiving ≥2000 mg Daily Dose of Levodopa

Table 4

Summary of serious AEs and serious ADRs.

Phase III programPatients, n (%)
Levodopa <2000 mg/day (n = 340)Levodopa ≥2000 mg/day (n = 72)Overall (N = 412)

Patients with any serious AE149 (43.8)46 (63.9)195 (47.3)
Any SAE occurring in ≥2% of patients overall
 Pneumonia21 (6.2)5 (6.9)26 (6.3)
Parkinson’s diseasea10 (2.9)5 (6.9)26 (6.3)
 Fall10 (2.9)4 (5.6)14 (3.4)
 Death10 (2.9)1 (1.4)11 (2.7)
Hip fracture7 (2.1)4 (5.6)11 (2.7)
Pneumonia aspiration7 (2.1)3 (4.2)10 (2.4)
Polyneuropathy6 (1.8)3 (4.2)9 (2.2)

GLORIA registryLevodopa <2000 mg/day (n = 309)Levodopa ≥2000 mg/day (n = 47)Overall (N = 356)

Patients with any serious ADRb89 (28.8)18 (38.3)107 (30.1)
Any serious ADRs occurring in ≥2% of patients overallc
 Parkinsonisma7 (2.3)7 (2.0)
 Parkinson’s diseasea6 (1.9)1 (2.1)7 (2.0)

AEs and ADRs in italics represent events reported in the ≥2000 mg dose group at twice the rate of that in the low-dose group. 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; SAE: serious adverse event.

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