eactions Reported in Greater than or equal to 5% of Patients and More Commonly than in Patients Given Placebo, Regardless of Investigator Assessment of Causality+ ---------------------------------------------------------------------- Number of Patients (%) ---------------------------------------------------------------------- Monotherapy JANUVIA 100 mg Placebo ---------------------------------------------------------------------- N = 443 N = 363 ---------------------------------------------------------------------- Nasopharyngitis 23 (5.2) 12 (3.3) ---------------------------------------------------------------------- Combination with Pioglitazone JANUVIA 100 mg + Placebo + Pioglitazone Pioglitazone ---------------------------------------------------------------------- N = 175 N = 178 ---------------------------------------------------------------------- Upper Respiratory Tract Infection 11 (6.3) 6 (3.4) ---------------------------------------------------------------------- Headache 9 (5.1) 7 (3.9) ---------------------------------------------------------------------- + Intent to treat population In patients receiving JANUVIA in combination with metformin, there were no adverse reactions reported regardless of investigator assessment of causality in greater than or equal to 5% of patients and more commonly than in patients given placebo. The overall incidence of hypoglycemia in patients treated with JANUVIA 100 mg was similar to placebo (1.2% vs 0.9%). The incidence of selected gastrointestinal adverse reactions in patients treated with JANUVIA was as follows: abdominal pain (JANUVIA 10
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