Table 2.
Adverse event | Flexyn2a (n = 34) Number (%) |
Placebo (n = 33) Number (%) |
||||
---|---|---|---|---|---|---|
mild | mod | any | mild | mod | any | |
Any AEs | 14 (41.2) | 3 (8.8) | 17 (50.0) | 8 (24.2) | 4 (12.1) | 12 (36.4) |
Pain/Tenderness at injection site | 8 (23.5) | 1 (2.9) | 9 (26.5) | 5 (15.2) | 1 (3.0) | 6 (18.2) |
Erythema/redness at injection site | 2 (5.9) | 0 (0.0) | 2 (5.9) | 3 (9.1) | 0 (0.0) | 3 (9.1) |
Induration/swelling at injection site | 2 (5.9) | 0 (0.0) | 2 (5.9) | 2 (6.1) | 0 (0.0) | 2 (6.1) |
Headache | 4 (11.8) | 1 (2.9) | 5 (14.7) | 6 (18.2) | 4 (12.1) | 10 (30.3) |
Vomiting | 1 (2.9) | 0 (0.0) | 1 (2.9) | 2 (6.1) | 1 (3.0) | 3 (9.1) |
Myalgia | 2 (5.9) | 1 (2.9) | 3 (8.8) | 0 (0.0) | 3 (9.1) | 3 (9.1) |
Arthralgia | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (3.0) | 1 (3.0) | 2 (6.1) |
Nausea | 3 (8.8) | 0 (0.0) | 3 (8.8) | 0 (0.0) | 1 (3.0) | 1 (3.0) |
Abdominal pain | 1 (2.9) | 1 (2.9) | 2 (5.9) | 1 (3.0) | 1 (3.0) | 2 (6.1) |
Chills | 2 (5.9) | 0 (0.0) | 2 (5.9) | 1 (3.0) | 3 (9.1) | 4 (12.1) |
Sweats | 1 (2.9) | 0 (0.0) | 1 (2.9) | 0 (0.0) | 3 (9.1) | 3 (9.1) |
AE= Adverse event; mod= moderate;%= percent.