<p>Summary of the safety profile: Nintedanib has been studied in clinical trials of 1,529 patients suffering from IPF. The safety data provided in the following are based on the two Phase III, randomized, double-blind, placebo-controlled studies in 1,061 patients comparing treatment with Nintedanib 150 mg twice daily to placebo for 52 weeks (INPULSIS-1 and INPULSIS-2) and based on data observed during the post-marketing period.<br />
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The most frequently reported adverse reactions associated with the use of Nintedanib included diarrhea, nausea and vomiting, abdominal pain, decreased appetite, weight decreased and hepatic enzyme increased.<br />
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Tabulated list of adverse reactions: The below table provides a summary of the adverse reactions by MedDRA System Organ Class (SOC) and frequency category.<br />
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Below table summarizes the frequencies of adverse drug reactions (ADRs) that were reported in the Nintedanib group (638 patients) pooled from the two placebo-controlled Phase III clinical trials of 52 weeks duration or from the post-marketing period.<br />
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Frequency categories are defined using the following convention: Very common (&ge; 1/10), common (&ge; 1/100 to &lt; 1/10), uncommon (&ge; 1/1,000 to &lt; 1/100), rare (&ge; 1/10,000 to &lt; 1/1,000), very rare (&lt; 1/10,000), not known (cannot be estimated from the available data).</p>