Patient | Treatment | Clinical course and safety events (onseta) |
---|---|---|
Continuous fingolimod | ||
1 | Fingolimod 0.5 mg | Bradycardia (day 2); chest discomfort (day 2); enlargement of a pre-existing spinal cord lesion, LESCL, pons and midbrain lesions (day 9); myelitis and LESCL (day 145); diplopia, right upper limb paresis, multiple lesions in the cervical and thoracic cord, brainstem, cerebellum and cerebrum (day 235) |
2b | Fingolimod 1.25 mg | Decreased heart rate (day 1); myelitis relapse (day 5); decreased heart rate (day 5; day 1 after drug interruption); abnormal liver function test result (day 85); asymptomatic multiple enhancing lesions in the bilateral cerebral white matter and an asymptomatic enhancing spinal cord lesion at C6 (6 days after fingolimod discontinuation); conduction and amnestic aphasia (3 weeks after fingolimod discontinuation) |
Switched from placebo to fingolimod | ||
3 | Placebo/fingolimod 0.5 mg | Recurrence of right optic neuritis and myelitis (day 29 of extension phase); dysarthria, right ataxia and weakness, right frontal lobe lesion (3 months); right upper limb weakness (4 months); left parietal lobe lesion, left paresthesia, dizziness and eye movement disturbance (1 month after fingolimod discontinuation) |
4 | Placebo/fingolimod 1.25 mg | Relapse showing left hemispheric symptoms and exacerbation of cerebral and cerebellar white matter lesions (day 9 in the extension phase)c |