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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