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

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

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	-

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