Safety of @entity12698 and nonselective nonsteroidal anti-inflammatory drugs in XXXX : results of the phase 4 registry.

@entity1 @entity12698 @entity2852 @entity625 @entity4932 @entity1623 @entity281 @entity6470 @entity9213
BACKGROUND: This study aimed to assess long-term safety and developmental data on @entity4932 ( @entity4932 ) @entity1 treated in routine clinical practice with @entity12698 or nonselective nonsteroidal anti-inflammatory drugs (nsNSAIDs). METHODS: @entity1 aged >= 2 to <18  years with @entity6470 , persistent or extended @entity4932 , or systemic @entity625 were enrolled into this prospective, observational, multicenter standard-of-care registry. Eligible @entity1 were newly or recently prescribed ( <=6  months) an nsNSAID or @entity12698 . Enrolled @entity1 were followed to the end of the study, whether they remained on the original NSAID, switched, or discontinued therapy altogether. All adverse events (AEs) regardless of severity were captured in the database. RESULTS: A total of 274 @entity1 (nsNSAID, n   =   219; @entity12698 , n   =   55) were observed for 410 @entity1 -years of observation. @entity1623 , @entity9213 , and @entity2852 were the most frequently used nsNSAIDs. At baseline, the @entity12698 group was older, had a numerically longer median time since diagnosis, and a numerically higher proportion of @entity1 with a history of gastrointestinal-related NSAID intolerance. AEs reported were those frequently observed with NSAID treatment and were similar across groups (nsNSAIDs: 52.0%; @entity12698 : 52.9%). Twelve unique @entity1 experienced a total of 18 serious AEs; the most frequent were @entity281 , and none was attributed to NSAID use. CONCLUSIONS: The safety profile of @entity12698 and nsNSAIDs appears similar overall. The results from this registry, ongoing pharmacovigilance, and the phase 3 trial that led to the approval of @entity12698 for @entity1 with @entity4932 provide evidence that the benefit-risk for @entity12698 treatment in @entity4932 remains positive. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00688545.
