Safety of three different product doses in autologous chondrocyte implantation: results of a prospective, randomised, controlled trial

Table 5 Adverse events in the SOC ‘musculoskeletal and connective tissue disorders’ (safety population)

Dose group	Low dose				Medium dose				High dose
Dose group	N = 25				N = 25				N = 25
Relationship	NR	Unl	Pos	Pro	NR	Unl	Pos	Pro	NR	Unl	Pos	Pro
Any adverse event	3	5	6	14	3	3	7	23	6	4	7	19
Joint effusion	–	–	4	13	–	–	2	21	1	1	2	17
Arthralgia	2	2	2	1	–	2	1	1	3	1	3	1
Joint swelling	–	1	–	2	1	–	–	2	1	1	–	–
Joint crepitation	–	–	–	–	1	–	2	1	–	–	1	1
Chondropathy	–	1	–	–	1	–	–	–	–	–	–	2
Back pain	–	1	–	–	–	–	–	–	2	–	–	–
Tendonitis	–	–	–	–	–	1	–	–	–	1	1	–
Joint lock	–	–	–	–	–	–	2	–	–	–	–	–
Muscular weakness	–	–	1	–	–	–	–	–	–	–	–	–
Bone cyst	1	–	–	–	–	–	–	–	–	–	–	–
Bone pain	–	1	–	–	–	–	–	–	1	–	–	–
Intervertebral disc prot.	–	–	–	–	1	–	–	–	–	–	–	–
Ligament disorder	–	1	–	–	–	–	–	–	–	–	–	–
Muscle atrophy	–	–	–	–	–	–	–	1	–	–	–	–
Myalgia	–	–	–	–	–	–	–	–	–	1	–	–
Osteoarthritis	–	–	–	–	–	–	–	–	1	–	–	–
Patellofemoral pain sy.	–	–	1	–	–	–	–	–	–	–	–	–

ISSN: 1749-799X