| 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) |