Subgroup analyses of primary end point data (tremor score): stratification of the intent to treat population according to the presence or absence of “off”periods at baseline, high or low tremor scores, and patients with and without fatigue, reported as adverse event
| Pramipexole | Placebo | Mean difference between groups (p value) | Interaction test (treatment×subgroup qualifier) | |
|---|---|---|---|---|
| *p=0.73 for pramipexole treated patients. | ||||
| NA; not applicable; change in tremor score from baseline to end of maintenance; difference in the mean change between treatment groups (p value for the difference between treatment groups); and interaction tests with factors treatment×subgroup qualifiers (“off” status, tremor score). Change in tremor score in patients with or without fatigue per treatment group. | ||||
| “Off” status (yes/no) | 22/22 patients | 23/16 patients | p=0.038 | |
| Patients with “off” | −8.1 (5.4) | −2.3 (3.6) | −5.8 (p=0.0001) | |
| Patients without “off” | −3.6 (3.3) | −0.4 (2.3) | −3.2 (p=0.006) | |
| Tremor score (high/low) | 24/20 patients | 18/21 patients | p=0.01 | |
| Tremor score ≥11 | −8.0 (5.4) | −1.9 (3.7) | −6.1 (p=0.0001) | |
| Tremor score <11 | −3.3 (2.6) | −1.1 (2.8) | −2.2 (p=0.03) | |
| Fatigue (yes/no) | 10/34 patients | 4/35 patients | NA | |
| Patients with fatigue | −5.4 (5.6)* | −0.8 (3.3) | NA | |
| Patients without fatigue | −6 (4.8)* | −1.6 (3.3) | NA | |