Table 4.

Summary of AAs across the treatment period and post-treatment follow-up period (safety analysis set)

	Placebo	Fasinumab
		6 mg SC Q4W	9 mg SC Q4W	9 mg IV Q8W	Combined
All patients, n	140	139	139	140	418
Patients with positive adjudications, n (%)	1 (0.7)	5 (3.6)	4 (2.9)	7 (5.0)	16 (3.8)
Total number of adjudications	46	80	89	110	279
Number of joints with positive adjudications, n (% of total adjudications) and JR outcome	1 (2.2)	7 (8.8)	4 (4.5)	8 (7.3)	19 (6.8)
RPOA1	1	5	3	6	14*
RPOA1, RPOA2†	0	1	0	0	1
RPOA1, SIF†	0	2	1	0	3
RPOA1 → JR	0	0	1	0	1
RPOA2 → JR	0	0	0	1	1
SIF	0	0	0	1	1
Patients with pOA, n	82	92	68	78	238
Patients with positive adjudications, n (%)‡	1 (1.2)	5 (5.4)	4 (5.9)	6 (7.7)	15 (6.3)
Total number of adjudications	41	60	56	88	204
Number of joints with positive adjudications (% of total adjudications) and JR outcome	1 (2.4)	7 (11.7)	4 (7.1)	7 (8.0)	18 (8.8)
RPOA1	1	5	3	5	13#
RPOA1, RPOA2†	0	1	0	0	1
RPOA1, SIF†	0	2	1	0	3
RPOA1 → JR*	0	0	1	0	1
RPOA2 → JR	0	0	0	1	1
SIF	0	0	0	1	1
Patients without pOA, n	58	47	71	62	180
Patients with positive adjudications, n (%)‡	0 (0.0)	0 (0.0)	0 (0.0)	1 (1.6)	1 (0.6)
Total number of adjudications	5	20	33	22	75
Number of joints with positive adjudications (% of total adjudications)	0	0	0	1 (4.5)	1 (1.3)
RPOA1	0	0	0	1	1

pOA defined by medical history and/or K-L score ≥2 in hip or ≥3 in knee.

*Two RPOA1 events (6 and 9 mg Q4W groups; both in patients with pOA) were reported two times (as a sole finding and as RPOA1, SIF).

†More than one adjudicated arthropathy category could have been reported simultaneously in a single joint.

‡Per cent values calculated using the number of patients in each subgroup as denominator.

IV, intravenous; JR, total joint replacement; K-L, Kellgren-Lawrence; pOA, peripheral osteoarthritis; Q4W, every 4 weeks; Q8W, every 8 weeks; RPOA1, rapid progressive OA type 1; RPOA2, rapid progressive OA type 2; SC, subcutaneous; SIF, subchondral insufficiency fracture.