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Table 5 Adverse events recorded < 10 and ≥ 10 days during follow-up.

From: Tumor necrosis factor-α blockade in recurrent and disabling chronic sciatica associated with post-operative peridural lumbar fibrosis: results of a double-blind, placebo randomized controlled study

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 -
  1. IFX: IFX group; PBO: placebo group.
  2. Data are absolute frequencies (%).