Pooled Safety Analysis Of Adjudicated Serious Adverse Events With The Fixed-Dose Combination Of Tiotropium + Olodaterol

Rationale: The objective of this analysis was to obtain a comprehensive and objective safety assessment of the fixed-dose combination of tiotropium with olodaterol (T+O FDC) in patients (pts) with moderate to very severe COPD. Methods: Data from two 1-year pivotal trials investigating T+O FDC 5/5 µg and T+O FDC 2.5/5 µg versus tiotropium (T) 2.5 µg, 5 µg, and olodaterol (O) 5 µg were pooled; patient narratives and profiles of serious adverse-event (SAE) reports were reviewed by an independent Adjudication Committee. The committee members independently assessed all SAEs to determine if any of the deaths, hospital…