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 |