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Table 3 Most frequent adverse events and serious adverse events during the extension phase (extension safety population)

From: Fingolimod (FTY720) therapy in Japanese patients with relapsing multiple sclerosis over 12 months: results of a phase 2 observational extension

Adverse event, n (%)

Placebo-fingolimod 0.5 mg (n = 27)

Placebo-fingolimod 1.25 mga(n = 23)

Continuous fingolimod 0.5 mg (n = 47)

Continuous fingolimod 1.25 mga(n = 46)

Any adverse event

22 (81.5)

23 (100)

35 (74.5)

41 (89.1)

Any serious adverse event

1 (3.7)

4 (17.4)

1 (2.1)

0 (0.0)

Any adverse event leading to discontinuation of study drug

5 (18.5)

3 (13.0)

2 (4.3)

0 (0.0)

Any infection or infestation adverse event

11 (40.7)

14 (60.9)

23 (48.9)

28 (60.9)

Most commonly reported adverse events b

 Nasopharyngitis

7 (25.9)

7 (30.4)

16 (34.0)

19 (41.3)

 Liver function test abnormal

4 (14.8)

9 (39.1)

3 (6.4)

4 (8.7)

 Leukopenia

4 (14.8)

1 (4.3)

0 (0.0)

3 (6.5)

 Bradycardia

0 (0.0)

3 (13.0)

0 (0.0)

0 (0.0)

 Influenza

0 (0.0)

3 (13.0)

0 (0.0)

2 (4.3)

 Second-degree atrioventricular block

0 (0.0)

3 (13.0)

0 (0.0)

0 (0.0)

 Headache

0 (0.0)

2 (8.7)

5 (10.6)

0 (0.0)

 Lymphocyte count decreased

1 (3.7)

2 (8.7)

1 (2.1)

2 (4.3)

 Lymphopenia

0 (0.0)

2 (8.7)

0 (0.0)

3 (6.5)

 γ-glutamyltransferase increased

1 (3.7)

2 (8.7)

1 (2.1)

0 (0.0)

 White blood cell count decreased

0 (0.0)

2 (8.7)

0 (0.0)

1 (2.2)

 Eczema

0 (0.0)

1 (4.3)

1 (2.1)

4 (8.7)

 Rash

2 (7.4)

1 (4.3)

1 (2.1)

0 (0.0)

 Alanine aminotransferase increased

2 (7.4)

0 (0.0)

0 (0.0)

0 (0.0)

 Blood triglycerides increased

2 (7.4)

0 (0.0)

0 (0.0)

0 (0.0)

 Dental caries

0 (0.0)

0 (0.0)

0 (0.0)

3 (6.5)

 Diarrhea

1 (3.7)

0 (0.0)

2 (4.3)

3 (6.5)

 Stomatitis

1 (3.7)

1 (4.3)

0 (0.0)

3 (6.5)

 Pharyngitis

0 (0.0)

1 (4.3)

1 (2.1)

3 (6.5)

 Tinea pedis

1 (3.7)

1 (4.3)

3 (6.4)

0 (0.0)

 Skin papilloma

0 (0.0)

0 (0.0)

3 (6.4)

0 (0.0)

Serious adverse events

    

 Bradycardia

0 (0.0)

2 (8.7)

0 (0.0)

0 (0.0)

 Leukoencephalopathyc

0 (0.0)

1 (4.3)

0 (0.0)

0 (0.0)

 Multiple sclerosis relapse

0 (0.0)

0 (0.0)

1 (2.1)

0 (0.0)

 Neuromyelitis optica

1 (3.7)

0 (0.0)

0 (0.0)

0 (0.0)

 Abortion induced

0 (0.0)

1 (4.3)

0 (0.0)

0 (0.0)

  1. aAll patients receiving fingolimod 1.25 mg/day were switched to fingolimod 0.5 mg/day after the fingolimod 1.25 mg/day dose was discontinued from all multiple sclerosis clinical studies.
  2. bAdverse events reported in 5% of patients or more in any treatment group during the extension phase.
  3. cThis single case of leukoencephalopathy was not of the type associated with progressive multifocal leukoencephalopathy.
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BMC Neurology

ISSN: 1471-2377

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