Development of musculoskeletal toxicity without clear benefit after administration of PG-116800, a matrix metalloproteinase inhibitor, to patients with knee osteoarthritis: a randomized, 12-month, double-blind, placebo-controlled study

Table 6 Changes from baseline in shoulder range of motion (intent-to-treat population)

	Placebo	25 mg	50 mg	100 mg	200 mg
Patients with ≥30% decrease from baseline in ≥1 ROM measurement at any postbaseline visit for either shoulder, number (percentage)	12/77 (16%)	11/79 (14%)	18/78 (23%)	24/79 (30%)	25/78 (32%)
P value^a		0.824	0.310	0.036	0.023
Patients with ≥30% decrease from baseline in the same ROM measurement at 2 or more consecutive postbaseline visits for either shoulder, number (percentage)	4/74 (5%)	5/78 (6%)	8/74 (11%)	12/77 (16%)	11/73 (15%)
P value^a		1.000	0.367	0.062	0.061
Patients with ≥30% decrease from baseline in 2 or more ROM measurements at the same postbaseline visit for either shoulder, number (percentage)	2/77 (3%)	2/79 (3%)	5/78 (6%)	13/79 (16%)	12/78 (15%)
P value^a		1.000	0.442	0.005	0.009

^aTreatment groups were compared to placebo by means of the Fisher exact test. ROM, range of motion.

ISSN: 1478-6362