Commonly Observed (based on first year and second year data - XENICAL 120 mg three times a day versus placebo): Gastrointestinal (GI) symptoms were the most commonly observed treatment-emergent adverse events associated with the use of XENICAL in the seven double-blind , placebo-controlled clinical trials and are primarily a manifestation of the mechanism of action. (Commonly observed is defined as an incidence of ≥ 5% and an incidence in the XENICAL 120 mg group that is at least twice that of placebo.) Table 11: Commonly Observed Adverse Events Year 1 Year 2 Adverse Event XENICAL * % Patients (N=1913) Placebo * % Patients (N=1466) XENICAL * % Patients (N=613) Placebo * % Patients (N=524) Oily Spotting 26.6 1.3 4.4 0.2 Flatus with Discharge 23.9 1.4 2.1 0.2 Fecal Urgency 22.1 6.7 2.8 1.7 Fatty/Oily Stool 20.0 2.9 5.5 0.6 Oily Evacuation 11.9 0.8 2.3 0.2 Increased Defecation 10.8 4.1 2.6 0.8 Fecal Incontinence 7.7 0.9 1.8 0.2 *Treatment designates XENICAL three times a day plus diet or placebo plus diet These and other commonly observed adverse reactions were generally mild and transient, and they decreased during the second year of treatment. In general, the first occurrence of these events was within 3 months of starting therapy . Overall, approximately 50% of all episodes of GI adverse events associated with orlistat treatment lasted for less than 1 week, and a majority lasted for no more than 4 weeks. However, GI adverse events may occur in some individuals over a period
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