Ophthalmologic Baseline Characteristics and 2-Year Ophthalmologic Safety Profile of Pramipexole IR Compared with Ropinirole IR in Patients with Early Parkinson’s Disease
Table 6
Summary of adverse events (AEs; treatment-emergent irrespective of relationship to treatment, unless described specifically as treatment-related).
AEs
Pramipexole
Ropinirole
Any AE, n (%)
119 (98.3)
122 (97.6)
Severe AE, n (%)
24 (19.8)
35 (28.0)
Drug-related AE, n (%)
105 (86.8)
113 (90.4)
Other significant AEs, n (%)
62 (51.2)
64 (51.2)
AEs leading to discontinuation of study drug, n (%)
18 (14.9)
16 (12.8)
Serious AEs, n (%)
22 (18.2)
21 (16.8)
AEs occurring in ≥10% subjects in either group
Gastrointestinal disorders
64 (52.9)
87 (69.6)
Constipation
18 (14.9)
26 (20.8)
Nausea
31 (25.6)
59 (47.2)
General disorders/administrative-site conditions
60 (49.6)
51 (40.8)
Fatigue
27 (22.3)
25 (20.0)
Peripheral edema
22 (18.2)
18 (14.4)
Infections and infestations
48 (39.7)
52 (41.6)
Nasopharyngitis
17 (14.0)
16 (12.8)
Upper respiratory tract infection
12 (9.9)
13 (10.4)
Musculoskeletal and connective tissue disorders
52 (43.0)
57 (45.6)
Back pain
18 (14.9)
9 (7.2)
Pain in extremity
12 (9.9)
13 (10.4)
Nervous system disorders
86 (71.1)
101 (80.8)
Dizziness
27 (22.3)
35 (28.0)
Headache
15 (12.4)
27 (21.6)
Somnolence
53 (43.8)
71 (56.8)
Sudden onset of sleep
11 (9.1)
16 (12.8)
Psychiatric disorders
50 (41.3)
72 (57.6)
Anxiety
10 (8.3)
14 (11.2)
Depression
8 (6.6)
15 (12.0)
Insomnia
19 (15.7)
27 (21.6)
Vascular disorders
26 (21.5)
31 (24.8)
Orthostatic hypotension
10 (8.3)
14 (11.2)
Drug-related AEs affecting >15% of patients
Somnolence
50 (41.3)
69 (55.2)
Nausea
28 (23.1)
56 (44.8)
Fatigue
23 (19.0)
21 (16.8)
Dizziness
21 (17.4)
30 (24.0)
AEs of special interest
Sudden onset of sleep
19 (16%)
29 (23%)
On-treatment evidence of melanoma
0 (0%)
1 (0.8%) (1 more patient reported melanoma as an SAE between visits)
Clinically relevant AEs (impulse control disorders)
Binge eating
1 (0.8%)
0 (0%)
Dermatillomania
1 (0.8%)
0 (0%)
Eating disorder
1 (0.8%)
0 (0%)
Impulse control disorder
1 (0.8%)
0 (0%)
Impulsive behavior
1 (0.8%)
0 (0%)
Compulsions
0 (0%)
1 (0.8%)
Hypersexuality
0 (0%)
1 (0.8%)
Compulsive shopping
1 (0.8%)
1 (0.8%)
Pathologic gambling
1 (0.8%)
1 (0.8%)
Fatal SAE (nondrug related)
1 (0.8%): stab wound
0 (0%)
As defined by the investigator. Marked hematological and other laboratory abnormalities (other than those meeting the definition of serious) and any events that led to an intervention, including withdrawal of test drug/investigational product treatment, dose reduction, or significant additional concomitant therapy, other than those reported as serious adverse events (SAE).
