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 program
Patients, n (%)
Levodopa <2000 mg/day (n = 340)
Levodopa ≥2000 mg/day (n = 72)
Overall (N = 412)
Patients with any serious AE
149 (43.8)
46 (63.9)
195 (47.3)
Any SAE occurring in ≥2% of patients overall
Pneumonia
21 (6.2)
5 (6.9)
26 (6.3)
Parkinson’s diseasea
10 (2.9)
5 (6.9)
26 (6.3)
Fall
10 (2.9)
4 (5.6)
14 (3.4)
Death
10 (2.9)
1 (1.4)
11 (2.7)
Hip fracture
7 (2.1)
4 (5.6)
11 (2.7)
Pneumonia aspiration
7 (2.1)
3 (4.2)
10 (2.4)
Polyneuropathy
6 (1.8)
3 (4.2)
9 (2.2)
GLORIA registry
Levodopa <2000 mg/day (n = 309)
Levodopa ≥2000 mg/day (n = 47)
Overall (N = 356)
Patients with any serious ADRb
89 (28.8)
18 (38.3)
107 (30.1)
Any serious ADRs occurring in ≥2% of patients overallc
Parkinsonisma
7 (2.3)
—
7 (2.0)
Parkinson’s diseasea
6 (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.
