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Comparison of investigator-reported and mortality adjudication committee-adjudicated fatal events (myocardial infarction, sudden death, sudden cardiac death and death) in the tiotropium Respimat 5 µg and HandiHaler 18 µg treatment groups. IR: incidence rate per 100 patient-years; MACE: major cardiovascular event; SOC: system organ class; PV: pharmacovigilance term; PT: preferred term; #: standardised MedDRA query (SMQ) ischaemic heart disease, sub-SMQ myocardial infarction.
