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 1 Patient accountability

	Placebo	25 mg	50 mg	100 mg	200 mg	Overall
	n(%)	n (%)	n (%)	n (%)	n (%)	n(%)
Patients randomly assigned	80	81	80	80	80	401
Patients who took at least onedose of study drug	77	80	79	80	79	395
Patients in per-protocol population^a	66	67	64	64	35	296
Patients completing 12 months of dosing	69 (90%)	65 (81%)	66 (84%)	64 (80%)	19 (24%)	283 (72%)
Patients who withdrew	8 (10%)	15 (19%)	13 (16%)	16 (20%)	60 (76%)	112 (28%)
Reason for withdrawal
Adverse event	4 (5%)	10 (13%)	6 (8%)	11 (14%)	34 (43%)	65 (16%)
Protocol violation	1 (1%)	1 (1%)	2 (3%)	2 (3%)	1 (1%)	7 (2%)
Voluntary withdrawal	3 (4%)	3 (4%)	4 (5%)	2 (3%)	3 (4%)	15 (4%)
Lost to follow-up	0 (0%)	1 (1%)	0 (0%)	1 (1%)	0 (0%)	2 (<1%)
Unable to meet protocol criteria	0 (0%)	0 (0%)	1 (1%)	0 (0%)	1 (1%)	2 (<1%)
IDMC recommendation	0 (0%)	0 (0%)	0 (0%)	0 (0%)	21 (27%)	21 (5%)

n (%) = number and percentage of patients. % = n/N × 100.
^aPer-protocol population refers to patients who completed the study as per protocol, including 75% compliance with randomized study drug during the course of the trial.
IDMC, Independent Data Monitoring Committee.

ISSN: 1478-6362