Intention-to-treat analysis of falling outcomes: 0–6 and 6–12 months
| Period | PDSAFE | Control | PDSAFE/Control* OR (95% CI) | P value* | |
| n (%) | |||||
| Repeat falling restricted to ≥50% diaries | Baseline | 127/231 (55) | 92/230 (40) | ||
| Baseline† | 112/203 (55) | 80/211 (38) | |||
| 0–6 months | 125/203 (62) | 116/211 (55) | 1.21 (0.74 to 1.98) | 0.447 | |
| Baseline† | 55/114 (48) | 47/132 (36) | |||
| 6–12 months | 57/114 (50) | 71/132 (54) | 0.86 (0.45 to 1.65) | 0.657 | |
| Falls/person/6 months‡ | FRR (95% CI) | ||||
| Fall rates | Baseline | 4.5 | 3.3 | ||
| 0–6 months | 3.4 | 2.7 | 0.98 (0.80 to 1.19) | 0.824 | |
| 6–12 months | 2.7 | 2.8 | 0.83 (0.62 to 1.11) | 0.200 | |
| Near falls/person/6 months‡ | NFRR (95% CI) | ||||
| Near fall rates | Baseline | 8.0 | 8.1 | ||
| 0–6 months | 4.7 | 5.6 | 0.67 (0.53 to 0.86) | 0.001 | |
| 6–12 months | 3.9 | 3.7 | 1.01 (0.67 to 1.52) | 0.968 | |
*Controlled for site, age, gender, repeat falling or not in the year prior to screening, log number of falls in the year prior to screening, log rate of falling in the prerandomisation falls collection period and Hoehn and Yahr (NFRR additionally controlled for log rate of near falling in the prerandomisation falls collection period).
†Baseline repeat falling restricted to participants including in the 0–6 and 6–12 month analyses.
‡Geometric mean of individual fall rates with 0.5 added to all numerators.
FRR, fall rate ratio; NFRR, near fall rate ratio.