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Table 3 Summary of the most frequent adverse events that occurred during the study (frequency ≥ 10% of patients)

From: Interferon beta-1a for the maintenance of remission in patients with Crohn's disease: results of a phase II dose-finding study

 

Number of patients (%)

Adverse event (preferred term)

Placebo (n = 16)

IFN beta-1a 44 mcg biw (n = 17)

IFN beta-1a 44 mcg tiw (n = 16)

IFN beta-1a 66 mcg tiw (n = 18)

Total (n = 67)

Influenza-like symptoms

3 (18.8)

8 (47.1)

6 (37.5)

7 (38.9)

24 (35.8)

Headache

3 (18.8)

8 (47.1)

7 (43.8)

4 (22.2)

22 (32.8)

Injection-site reaction

2 (12.5)

5 (29.4)

6 (37.5)

5 (27.8)

18 (26.9)

Fever

2 (12.5)

3 (17.6)

5 (31.3)

6 (33.3)

16 (23.9)

Abdominal pain

4 (25.0)

2 (11.8)

5 (31.3)

5 (27.8)

16 (23.9)

Injection-site inflammation

2 (12.5)

3 (17.6)

5 (31.3)

5 (27.8)

15 (22.4)

Fatigue

3 (18.8)

3 (17.6)

4 (25.0)

2 (11.1)

12 (17.9)

Nausea

3 (18.8)

3 (17.6)

2 (12.5)

3 (16.7)

11 (16.4)

ESR increased

0

2 (11.8)

5 (31.3)

3 (16.7)

10 (14.9)

Arthralgia

2 (12.5)

4 (23.5)

3 (18.8)

1 (5.6)

10 (14.9)

Injection-site rash

0

3 (17.6)

3 (18.8)

2 (11.1)

8 (11.9)

Rhinitis

2 (12.5)

2 (11.8)

3 (18.8)

1 (5.6)_

8 (11.9)

Myalgia

1 (6.3)

4 (23.5)

2 (12.5)

1 (5.6)

8 (11.9)

Injection-site pain

0

2 (11.8)

1 (6.3)

4 (22.2)

7 (10.4)

Anaemia

0

4 (23.5)

2 (12.5)

1 (5.6)

7 (10.4)

  1. biw: twice weekly; ESR: erythrocyte sedimentation rate; IFN: interferon; tiw: three times weekly