Adverse events (> 5% incidence in either the entacapone or placebo group) in fluctuating and non-fluctuating patients
| Fluctuating patients (n=172) | Non-fluctuating patients (n=128) | |||||||
|---|---|---|---|---|---|---|---|---|
| Entacapone (n=115) | Placebo (n=57) | Entacapone (n=88) | Placebo (n=40) | |||||
| Adverse event | n | % | n | % | n | % | n | % |
| Adverse events were classified according to the International Monitoring of Adverse Reactions to Drugs, Adverse Reaction Terminology, the Uppsala Monitoring Centre, Uppsala, Sweden, 1999. | ||||||||
| *Aggravation of parkinsonism, worsening of parkinsonian symptoms. | ||||||||
| AE, adverse event. | ||||||||
| Dyskinesia | 35 | 30.4 | 7 | 12.3 | 9 | 10.2 | 3 | 7.5 |
| Parkinsonism aggravated* | 21 | 18.3 | 15 | 26.3 | 8 | 9.1 | 2 | 5.0 |
| Urine abnormal | 20 | 17.4 | 0 | 0 | 10 | 11.4 | 0 | 0 |
| Nausea | 17 | 14.8 | 5 | 8.8 | 15 | 17.0 | 2 | 5.0 |
| Constipation | 14 | 12.2 | 1 | 1.8 | 7 | 8.0 | 3 | 7.5 |
| Dizziness | 13 | 11.3 | 3 | 5.3 | 7 | 8.0 | 1 | 2.5 |
| Diarrhoea | 13 | 11.3 | 2 | 3.5 | 12 | 13.6 | 1 | 2.5 |
| Depression | 8 | 7.0 | 4 | 7.0 | 3 | 3.4 | 2 | 5.0 |
| Pain | 8 | 7.0 | 2 | 3.5 | 3 | 3.4 | 3 | 7.5 |
| Fall | 8 | 7.0 | 7 | 12.3 | 2 | 2.3 | 0 | 0 |
| Hallucination | 6 | 5.2 | 3 | 5.3 | 6 | 6.8 | 1 | 2.5 |
| Abdominal pain | 6 | 5.2 | 3 | 5.3 | 4 | 4.5 | 0 | 0 |
| Fatigue | 5 | 4.3 | 4 | 7.0 | 8 | 9.1 | 1 | 2.5 |
| Patients with any AE | 105 | 91.3 | 48 | 84.2 | 79 | 89.9 | 28 | 70.0 |