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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 (%).