Table 2 Primary outcome: CGI item 4 † - Side effects interfering with patient’s functioning (score ≥3); FAS, LOCF
Treatment-related AE ‡ (CGI item 4 score) | Intensity of AE | Rotigotine dose (study phase) at AE onset | Action taken with rotigotine | Oral DA (actual dose [converted rotigotine dose]) | Total DA dose* | Levodopa dose mg/day | Severity of disease: Hoehn & Yahr Stage during “on”; duration of PD |
|---|---|---|---|---|---|---|---|
Patient 1: Hallucination (score 3) | Moderate | 8 mg/24 h (maintenance) | No change | Pramipexole ER (0.75 mg/day [3 mg/24 h]) | 11 mg/24 h | 600 | 2; 3 years |
Patient 2: Dyskinesia (score 4) | Severe | 4 mg/24 h (maintenance) | Discontinuation | Ropinirole IR (2 mg/day [2 mg/24 h]) | 6 mg/24 h | 1425 | 3; 21 years |
Patient 3: Nausea (score 3) | Severe | 2 mg/24 h (maintenance) | Discontinuation | Pramipexole IR (0.375 mg/day [1.5 mg/24 h]) | 3.5 mg/24 h | 675 | 3; 10 years |
Patient 4: Nausea, dizziness, insomnia, hyperhidrosis (score 4) | Severe | 2 mg/24 h (titration) | Discontinuation | Pramipexole IR (1 mg/day [4 mg/24 h]) | 6 mg/24 h | 525 | 3; 6 years |
Patient 5: Rash, dizziness postural (score 3) | Moderate, mild | 8 mg/24 h (maintenance) | No change | Pramipexole IR (0.25 mg/day [1 mg]) | 9 mg/24 h | 200 | 1; 9 years |
Patient 6: Worsening of PD (score 4) | Moderate | 2 mg/24 h (titration) | Discontinuation | Pramipexole ER (0.75 mg/day [3 mg/24 h]) | 5 mg/24 h | 250 | 3; 11 years |