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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