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Table 3 Adverse events (safety population)

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

Dose group Low Medium High All
N = 25 N = 25 N = 25 N = 75
n P n E n P n E n P n E n P n E
Any SOC 23 79 24 71 22 112 69 262
Musculoskeletal and connective tissue disorders 18 41 24 44 22 48 64 133
 Joint effusion 17 20 22 27 20 27 59 74
 Arthralgia 6 10 4 4 6 8 16 22
 Joint swelling 3 4 2 3 1 2 6 9
 Joint crepitation 4 4 2 2 6 6
 Chondropathy 1 1 1 1 1 2 3 4
 Back pain 1 1 2 2 3 3
 Tendonitis 1 1 2 2 3 3
 Joint lock 2 2 2 2
 Muscular weakness 1 2 1 2
Nervous system disorders 5 16 2 2 1 30 8 48
Infections and infestations 5 7 8 10 4 7 17 24
Injury, poisoning and procedural complications 6 6 5 7 7 10 18 23
Gastrointestinal disorders 1 1 1 1 3 5 5 7
Metabolism and nutrition disorders 1 1 2 4 3 5
General disorders and admin. site conditions 1 1 1 2 1 1 3 4
Vascular disorders 1 1 1 1 2 2 4 4
Cardiac disorders 1 1 1 1 2 2
Ear and labyrinth disorders 1 1 1 1 2 2
Immune system disorders 1 1 1 1 2 2
Surgical and medical procedures 1 2 1 2
  1. MedDRA SOC and preferred terms are used. Numbers of patients (n P) and events (n E) are given. Inclusion for all n P (all) >1