What were the most serious adverse events reported in the registrational clinical trials of Kepivance®?
In patients with hematologic malignancies, the most common serious adverse reaction in clinical trials attributed to Kepivance® was skin rash reported in less than 1% of patients. Grade 3 skin rashes occurred in 3% of patients receiving Kepivance® and 2% of patients receiving placebo. In seven patients (5 Kepivance®, 2 placebo), study drug was discontinued due to skin rash.1 Other serious adverse reactions occurred at a similar rate in patients who received Kepivance® or placebo with the most frequent being fever, gastrointestinal events, and respiratory events.
Related Questions
- In patients with hematologic malignancies, what were the most frequently reported adverse events attributed to Kepivance® in the registrational clinical trials?
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