Investigators evaluation of the PD symptoms on a rating scale of 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable).

A total of 26 patients were excluded from 1553 patients (Administration to patients who did not suffer from PD: 20, No efficacy data available: 6). As a result, 1527 patients included to the efficacy analysis set.

Motor examination is assessed by 27 questionnaire items in UPDRS Part III section. Each item is scored from 0 (best) to 4 (worst), and the total score of UPDRS Part III is from 0 (best) to 108 (worst). A decrease in the score means improvement.

The number of patients from the efficacy analysis set (1527) who had the assessment of UPDRS Part III total score at baseline and at or after 18 months of treatment or at the time of discontinuation (1356).

A severity of PD symptom are assessed by Modified Hoehn & Yahr rating scale. This scale consist of 10 levels including additional evaluation levels defined in Japan. Ten levels are described by 0 (best), 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5 (worst).

The number of patients from the efficacy analysis set (1527) who had the assessment of Modified Hoehn & Yahr rating scale at baseline and at or after 18 months of treatment or at the time of discontinuation (1430).

The aim of this Post Marketing Surveillance (PMS) was to obtain long-term safety data with treatment of pramipexole in Parkinson's disease (PD) patients. Therefore these items were considered as a safety evaluation.

Patients excluded from 1581 patients were: 15 who had no visit since the first prescription, 2 for no treatment, 10 patients who were irregularly enrolled patients (exclusion from analysis according to regulatory requirement) and 1 patient that had no safety data available. As a result, there were 1553 patients in the safety analysis set.