Table 2.

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.