Search results for " Safety Tolerability"

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Safety of the first dose of fingolimod for multiple sclerosis: results of an open-label clinical trial

2014

BACKGROUND: In patients with relapsing-remitting MS (RRMS) fingolimod prevents disease relapses and delays disability progression. First dose administration of fingolimod is associated with a transient, dose-dependent decrease in heart rate (HR) in the 6 hours after drug intake.The aim of the study is to to assess safety and tolerability of the first dose of fingolimod in a cohort of Italian patients with RRMS without alternative therapeutic options. METHODS: Open-label, single arm, multicentre study. After the first dose of fingolimod, patients were observed for 6 hours and had their vital signs monitored hourly. Extended on-site monitoring was provided when required. RESULTS: Of the 906 p…

OncologyMaleNeurologyfingolimod multiple sclerosis treatment first dose safetyadministration /&/ dosage/adverse effects/analogs /&/ derivatives/therapeutic useImmunosuppressive AgentSphingosineMultiple SclerosiAtrioventricular Blockadministration /&/ dosage/adverse effects/therapeutic useGeneral MedicineMiddle AgedTolerabilityPropylene GlycolFingolimoddrug therapyTolerabilityAnesthesiaCohortAdolescent Adult Atrioventricular Block; chemically induced/epidemiology Drug Therapy; Combination Female Humans Immunosuppressive Agents; administration /&/ dosage/adverse effects/therapeutic use Male Middle Aged Multiple Sclerosis; drug therapy Propylene Glycols; administration /&/ dosage/adverse effects/therapeutic use Sphingosine; administration /&/ dosage/adverse effects/analogs /&/ derivatives/therapeutic use Young AdultCombinationDrug Therapy CombinationSettore MED/26 - NeurologiaFemaleAtrioventricular block; Bradycardia; Fingolimod; Multiple sclerosis; Safety; Tolerability; Adolescent; Adult; Atrioventricular Block; Drug Therapy Combination; Female; Fingolimod Hydrochloride; Humans; Immunosuppressive Agents; Male; Middle Aged; Multiple Sclerosis; Propylene Glycols; Sphingosine; Young Adult; Neurology (clinical)SafetyAtrioventricular block Bradicardia Multiple sclerosis Fingolimod Safety TolerabilityImmunosuppressive AgentsResearch ArticleHumanmedicine.drugAdultmedicine.medical_specialtyMultiple SclerosisAdolescentClinical NeurologyYoung AdultFingolimod HydrochlorideInternal medicineBradycardiamedicineHumansNeurochemistryFingolimod Hydrochloridebusiness.industryMultiple sclerosisFingolimodmedicine.diseaseClinical trialPropylene GlycolsAtrioventricular block Bradycardia Multiple sclerosis Fingolimod Safety Tolerabilitychemically induced/epidemiologyNeurology (clinical)business
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