Skip to main content

Table 4 Adverse events considered probably or possibly treatment-related (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 17 34 24 41 22 38 63 113
Musculoskeletal and connective tissue disorders 17 30 24 37 22 34 63 101
 Joint effusion 17 20 22 27 19 25 58 72
 Arthralgia 3 4 2 2 3 4 8 10
 Joint swelling 2 3 2 2 4 5
 Joint crepitation 3 3 2 2 5 5
 Chondropathy 1 2 1 2
 Muscular weakness 1 2 1 2
 Joint lock 2 2 2 2
 Muscle atrophy 1 1 1 1
 Patellofemoral pain syndrome 1 1 1 1
 Tendonitis 1 1 1 1
Injury, poisoning and procedural complications 3 3 3 3 6 6
 Ligament sprain 3 3 3 3
 Fall 2 2 2 2
 Wound dehiscence 1 1 1 1
General disorders and admin. site conditions 1 1 1 1 2 2
 Pain 1 1 1 1 2 2
Vascular disorders 1 1 1 1 2 2
 Deep vein thrombosis 1 1 1 1
 Lymphoedema 1 1 1 1
Cardiac disorders 1 1 1 1
 Tachycardia 1 1 1 1
Ear and labyrinth disorders 1 1 1 1
 Sudden hearing loss 1 1 1 1
  1. Numbers of patients (n P) and events (n E) are given