Selected adverse drug reactions that were treatment related in the pooled analysis of clinical trials are listed in the table as follows by System Organ Class (SOC). The frequency of these terms has been based on all-causality adverse drug reactions in the clinical trial data set (very common (≥1/10), common (≥1/100, <1/100) and rare (<1/1,000)).
The adverse reactions listed may also be associated with the underlying and/or concomitant medications. (See Table 2.)
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The following adverse drug reactions were reported during POST-MARKETING SURVEILLANCE: See Table 3.
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