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Table 3 Summary of treatment-emergent adverse events (TEAEs)

From: Safety, tolerability and efficacy of intra-articular Progenza in knee osteoarthritis: a randomized double-blind placebo-controlled single ascending dose study

 

Placebo

(n = 4)

PRG 3.9M

(n = 8)

PRG 6.7M

(n = 8)

Patient summary

 TEAEs

4 (100.0)

8 (100.0)

8 (100.0)

 Most common TEAEsa

  Arthralgia

4 (100.0)

6 (75.0)

8 (100.0)

  Joint effusion

3 (75.0)

6 (75.0)

3 (37.5)

  Upper respiratory tract infection

1 (25.0)

2 (25.0)

3 (37.5)

  Joint stiffness

3 (75.0)

2 (25.0)

1 (12.5)

  Joint lock

1 (25.0)

2 (25.0)

1 (12.5)

 IP-related TEAEs

3 (75.0)

7 (87.5)

6 (75.0)

  Arthralgia

3 (75.0)

4 (50.0)

5 (62.5)

  Joint effusion

1 (25.0)

3 (37.5)

2 (25.0)

  Joint stiffness

1 (25.0)

2 (25.0)

1 (12.5)

  Bursitis

–

1 (12.5)

1 (12.5)

  Joint swelling

–

1 (12.5)

1 (12.5)

  Injection site pain

–

–

1 (12.5)

  Joint lock

–

1 (12.5)

–

  Joint warmth

–

1 (12.5)

–

  Malaise

–

1 (12.5)

–

  Paraesthesia

–

1 (12.5)

–

Event summary

 TEAEs

43

55

71

  Mild

35 (81.4)

45 (81.8)

63 (88.7)

  Moderate

8 (18.6)

9 (16.4)

8 (11.3)

  Severe

0 (0.0)

1 (1.8)

0 (0.0)

  SAEs

0 (0.0)

0 (0.0)

0 (0.0)

 IP-related TEAEs

5 (11.6)

16 (29.1)

13 (18.3)

  1. Data are presented as n (%) where n represents the number of patients or events
  2. TEAE, treatment emergent adverse event; SAE, serious adverse event. IP-related events were AEs deemed by a blinded study investigator to be possibly, probably or definitely related to the study drug
  3. aTEAEs occurring in > 4 patients across the trial