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*Includes adverse reactions occurring more frequently in the VOXZOGO arm and with a risk difference of \u22655% (ie, difference of >2 subjects) between treatment arms.<\/small>
\n\u2020<\/sup>Injection site reactions occurring more frequently in VOXZOGO-treated subjects than placebo.<\/small>
\n\u2021<\/sup>Includes the preferred terms: gastroenteritis and gastroenteritis, viral.<\/small>
\n\u00a7<\/sup>Includes the preferred terms: dizziness, presyncope, procedural dizziness, and vertigo.<\/small>
\n||<\/sup>Includes the preferred terms: fatigue, lethargy, and malaise.<\/small><\/p>\n <\/div>\n <\/div>\n <\/div>\n<\/div>\n\n\n
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97% of children given VOXZOGO (58\/60) remained on treatment during the phase 3 pivotal clinical trial1,3<\/sup><\/h2>\nOne patient discontinued due to pain and one discontinued due to anxiety with injections.<\/p>\n <\/div>\n <\/div>\n <\/div>\n<\/div>\n\n
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Overall safety profile in patients <5 years was similar to that seen in older pediatric patients1<\/sup><\/h2>\n\n- The safety of VOXZOGO in patients <5 years was evaluated in a 52-week randomized, placebo controlled, double-blind study1<\/sup><\/li>\n
- The most common adverse reactions (>10%) reported in pediatric patients <5 years were injection site reactions (86%) and rash (28%)1<\/sup><\/li>\n<\/ul>\n <\/div>\n <\/div>\n <\/div>\n<\/div>\n\n
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Transient decreases in blood pressure1<\/sup><\/h2>\nIn the phase 3 study of children aged 5 to 15 years, the median time to onset of events from injection was 31 minutes (range, 18-120 minutes)1<\/sup><\/p>\n <\/div>\n \n \n \n \n \n \n