MOST COMMON ADVERSE REACTIONS1

MOST COMMON ADVERSE REACTIONS IN THE AFFIRM TRIAL1
Incidence ≥10% with TYSABRI and ≥2 difference with placebo TYSABRI
n=627
Placebo
n=312
Headache 38% 33%
Fatigue 27% 21%
Infusion reactionsa 24% 18%
Urinary tract infections 21% 17%
Arthralgia 19% 14%
Depression 19% 16%
Pain in extremity 16% 14%
Rash 12% 9%
Gastroenteritis 11% 9%
Vaginitisb 10% 6%
  • The most common serious adverse reactions with TYSABRI in AFFIRM were infections (3.2% vs 2.6% in placebo, including urinary tract infection [0.8% vs 0.3%] and pneumonia [0.6% vs 0%]), acute hypersensitivity reactions (1.1% vs 0.3%, including anaphylaxis/anaphylactoid reaction [0.8% vs 0%]), depression (1.0% vs 1.0%, including suicidal ideation or attempt [0.6% vs 0.3%]), and cholelithiasis (1.0% vs 0.3%)

aInfusion reactions were defined as any event that occurred within 2 hours after the start of the infusion.
bPercentage based on female patients only.