Incidence of adverse events after first and second injections of study drug.
| 1st Injection — Blinded Study Drug (Placebo or rAAV2–TNFR:Fc) | 2nd Injection — Open-Label rAAV2-TNFR:Fc | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Placebo, N = 31 | 1 × 1011, N = 33 | 1 × 1012, N = 32 | 1 × 1013, N = 31 | All Active, N = 96 | 1 × 1011, N = 32 | 1 × 1012, N = 29 | 1 × 1013, N = 34 | All Active, N = 95 | |
| Any adverse event | 23 (74) | 28 (85) | 24 (75) | 25 (81) | 77 (80) | 27 (84) | 26 (90) | 29 (85) | 82 (86) |
| Gastrointestinal disorders | 1 (3) | 9 (27) | 4 (13) | 4 (13) | 17 (18) | 13 (41) | 6 (21) | 5 (15) | 24 (25) |
| General and administration site disorders | 4 (13) | 8 (24) | 6 (19) | 8 (26) | 22 (23) | 3 (9) | 9 (31) | 11 (32) | 23 (24) |
| Infections and infestations | 13 (42) | 15 (45) | 12 (38) | 7 (23) | 34 (35) | 13 (41) | 11 (38) | 15 (44) | 39 (41) |
| Injury, poisoning, procedural complications | 3 (10) | 3 (9) | 6 (19) | 5 (16) | 14 (15) | 6 (19) | 4 (14) | 4 (12) | 14 (15) |
| Investigations | 1 (3) | 2 (6) | 3 (9) | 3 (10) | 8 (8) | 2 (6) | 3 (10) | 1 (3) | 6 (0) |
| Metabolism and nutrition disorders | 2 (6) | 6 (18) | 1 (3) | 0 | 7 (7) | 2 (6) | 1 (3) | 0 | 3 (3) |
| Musculoskeletal and connective tissue disorders | 13 (42) | 14 (42) | 12 (38) | 9 (29) | 35 (36) | 15 (47) | 12 (41) | 14 (41) | 41 (43) |
| Nervous system disorders | 1 (3) | 6 (18) | 3 (9) | 3 (10) | 12 (13) | 5 (16) | 2 (7) | 5 (15) | 12 (13) |
| Respiratory, thoracic, mediastinal disorders | 7 (23) | 4 (12) | 4 (13) | 0 | 8 (8) | 4 (13) | 9 (31) | 1 (3) | 14 (15) |
| Skin and subcutaneous tissue disorders | 2 (6) | 4 (12) | 3 (9) | 1 (3) | 8 (8) | 5 (16) | 2 (7) | 2 (6) | 9 (9) |
| Serious adverse event | 1 (3) | 2 (6) | 1 (3) | 1 (3) | 4 (4) | 2 (6) | 3 (10) | 1 (3) | 6 (6) |
| Serious infections* | 0 | 1 (3) | 1 (3) | 0 | 2 (2) | 2 (6) | 1 (3) | 1 (3) | 4 (4) |
| Administration site reaction | 1 (3) | 3 (9) | 0 | 7 (23) | 10 (10) | 1 (3) | 6 (21) | 6 (18) | 13 (14) |
↵* Serious infection is an infection that was also considered a serious adverse event because it required hospitalization or resulted in death.