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Pivotal Trial Results
Post-Hoc Analysis Results
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The most common adverse reactions (≥1%) in patients taking CIBINQO in placebo-controlled trials for up to 16 weeks.
The most common adverse reactions (≥1%) in patients taking CIBINQO in placebo-controlled trials for up to 16 weeks.
Nausea was most frequent during the first week of CIBINQO therapy and generally resolved with continued therapy.
If patients experience nausea, it sometimes helps to take medicine with food.
Median time to resolution was 3.5 days for patients taking CIBINQO 100 mg and 5 days for patients taking CIBINQO 200 mg.
There were no events of headache that were categorized as serious or severe.
There was no clustering of acne events early or late in treatment.
Approximately one-third (33.0%) of the first events resolved by day 84.
There were no events of acne that were considered serious or severe or that led to discontinuation.
Nausea was most frequent during the first week of CIBINQO therapy and generally resolved with continued therapy.
If patients experience nausea, it sometimes helps to take medicine with food.
Median time to resolution was 3.5 days for patients taking CIBINQO 100 mg and 5 days for patients taking CIBINQO 200 mg.
There were no events of headache that were categorized as serious or severe.
There was no clustering of acne events early or late in treatment.
Approximately one-third (33.0%) of the first events resolved by day 84.
There were no events of acne that were considered serious or severe or that led to discontinuation.
Discontinuation rates due to adverse events for JADE MONO-1, MONO-2, and COMPARE, respectively
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