. 2019 Nov 12;10:141–146. doi: 10.2147/PHMT.S220817

Table 1.

Adverse Events In POMS Gilenya^® (Novartis International AG, Basel, Switzerland) (Fingolimod) Experience

Study	Study Design And Number Of Fingolimod-Treated Patients	All AE Incidence	Serious AE Incidence
PARADIGMS¹⁸	Phase 3 RCT, 107 patients	88.8%	Seizures (1.9%) Elevated ALT and ALT levels (3.7%) Leukopenia (1.9%) Agranulocytosis, arthralgia, autoimmune uveitis, bladder spasm, dyspepsia, dysuria, elevated ALT level, elevated GGT level, gastrointestinal necrosis (intussusception or necrotic bowel), head injury, humerus fracture, hypersensitivity vasculitis, migraine, migraine without aura, multiple sclerosis plaque, muscular weakness, rectal tenesmus, 2° atrioventricular block, and small-intestinal obstruction (0.9%)
Huppke et al¹⁹	Observational, 27 patients	25.9%	None
Fragoso et al²⁰	Observational, 17 patients	17.6%	None
Hamdy et al²¹	Observational, 8 patients	50%	None

Abbreviations: POMS, pediatric-onset multiple sclerosis; AE, adverse events; RCT, randomized controlled trial; ALT, alanine aminotransferase; GGT, gamma-glutamyltransferase.