Adverse events | < 10 days | ≥ 10 days | Total | ||||
---|---|---|---|---|---|---|---|
IFX | PBO | IFX | PBO | IFX | PBO | p-value | |
Increased neuropathic pain | 0 (0) | 0 (0) | 0 (0) | 1 (5.9) | 0 (0) | 1 (5.9) | - |
Increased lumbar pain | 0 (0) | 1 (5.9) | 0 (0) | 2 (11.8) | 0 (0) | 4 (23.5) | - |
Increased radicular pain | 5 (27.8) | 4 (23.5) | 3 (16.7) | 2 (11.8) | 10 (55.6) | 8 (47.1) | 0.56 |
Headache | 3 (16.7) | 1 (5.9) | 2 (11.1) | 1 (5.9) | 5 (27.8) | 2 (11.8) | - |
Fatigue | 2 (11.1) | 0 (0) | 2 (11.1) | 1 (5.9) | 5 (27.8) | 1 (5.9) | - |
Hospitalization | 0 (0) | 0 (0) | 0 (0) | 2 (11.8) | 0 (0) | 2 (11.8) | - |
Hospitalization for lumbo-radicular pain | 0 (0) | 0 (0) | 3 (16.7) | 1 (5.9) | 3 (16.7) | 1 (5.9) | - |
Infections | 4 (22.2) | 1 (5.9) | 11 (56.0) | 13 (76.4) | 14 (77.8) | 14 (82.4) | 0.93 |
Cardiovascular symptoms | 0 (0) | 1 (5.9) | 0 (0) | 1 (5.9) | 0 (0) | 2 (11.8) | - |
Skin symptoms | 1 (5.6) | 1 (5.9) | 1 (5.6) | 2 (11.8) | 2 (11.1) | 3 (17.6) | - |
Gastrointestinal symptoms | 2 (11.1) | 2 (11.8) | 6 (33.3) | 4 (23.5) | 8 (44.4) | 6 (35.3) | 0.53 |
Gynecological symptoms | 0 (0) | 0 (0) | 0 (0) | 2 (11.8) | 0 (0) | 2 (11.8) | - |
Hormonal manifestations | 2 (11.1) | 2 (11.8) | 0 (0) | 0 (0) | 2 (11.1) | 2 (11.8) | - |
Joint pain | 2 (11.1) | 0 (0) | 4 (22.2) | 6 (35.3) | 6 (33.3) | 6 (35.3) | 0.95 |
Psychiatric disorder | 1 (5.6) | 0 (0) | 0 (0) | 1 (5.9) | 1 (5.6) | 1 (5.9) | - |
Respiratory symptoms | 0 (0) | 1 (5.9) | 2 (11.1) | 4 (23.5) | 2 (11.1) | 5 (29.4) | - |
Sleeping disorder | 0 (0) | 0 (0) | 1 (5.6) | 1 (5.9) | 1 (5.6) | 1 (5.9) | - |
Sexual disorder | 0 (0) | 1 (5.9) | 1 5.6) | 1 (5.9) | 1 (5.6) | 3 (17.6) | - |
Traumatism | 0 (0) | 1 (5.9) | 0 (0) | 0 (0) | 0 (0) | 1 (5.9) | - |
Vertigo | 0 (0) | 0 (0) | 3 (16.7) | 0 (0) | 3 (16.7) | 0 (0) | - |
Total | 22 | 17 | 38 | 44 | 63 | 65 | - |