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Table 4 Summary of clinical course and safety events in patients positive for anti-AQP4 antibodies

From: Fingolimod (FTY720) therapy in Japanese patients with relapsing multiple sclerosis over 12 months: results of a phase 2 observational extension

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
  1. aDays after initiation of fingolimod in core study or extension phase.
  2. bThis patient discontinued from the study on day 78 during the core phase.
  3. cThis case was not diagnosed as progressive multifocal leukoencephalopathy.
  4. Abbreviations: AQP4 aquaporin 4; LESCL longitudinally extensive spinal cord lesion.