Treatment-emergent adverse events reported by ≥1% of subjects from either treatment group, based on the pooled safety population (Trial 1 and Trial 2) are listed in Table 4. (See Table 4.)
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Uncommon (<1%) adverse reactions in subjects treated with STAQUIS included contact urticaria (see Precautions).
The safety profile from a completed STAQUIS open-label clinical trial (Trial 3) in which STAQUIS was applied intermittently in 28 day treatment courses for up to 48 weeks was consistent with that of Trial 1 and Trial 2 (see Pharmacology: Pharmacodynamics under Actions). (See Table 5.)
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Pediatric clinical trial: In a multicenter, open-label, uncontrolled trial, 137 pediatric subjects aged 3 months to less than 2 years were treated with STAQUIS twice daily for 4 weeks. Overall, the safety profile of STAQUIS in this age group was consistent with that of Trials 1 and 2 in subjects 2 years of age and older.
Post-market reported adverse reactions: The following adverse reactions have been identified during post-approval use of STAQUIS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Application site reactions.
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