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Table 7 Study drug discontinuations due to adverse events

From: Electrocardiographic assessments and cardiac events after fingolimod first dose – a comprehensive monitoring study

  Fingolimod 0.5 mg N = 38
Number of patients, n (%) Number of events, n
Adverse events leading to discontinuation of study drug (<4% in SOC/PT)
 Cardiac disorders 16 (42.1) 20
  AV block second-degree 9 (23.7) 10
  Bradycardia 3 (7.9) 3
 Gastrointestinal disorders 8 (21.1) 10
  Nausea 4 (10.5) 4
  Diarrhoea 3 (7.9) 3
 Nervous system disorders 8 (21.1) 8
  Dizziness 2 (5.3) 2
  Headache 2 (5.3) 2
 Vascular disorders 5 (13.2) 5
  Hypertension 4 (10.5) 4
 Investigations 5 (13.2) 5
  QT prolongation 2 (5.3) 2
 Skin and subcutaneous tissue disorders 5 (13.2) 5
 Psychiatric disorders 4 (10.5) 4
 General disorders and administration site conditions 3 (7.9) 4
  Asthenia 2 (5.3) 2
 Eye disorders 2 (5.3) 2
  Vision blurred 2 (5.3) 2
 Pregnancy, puerperium and perinatal conditions 2 (5.3) 2
  Pregnancy 2 (5.3) 2
  1. PT preferred term, SOC system organ class