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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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