Primary Endpoints. Primary safety endpoints include: · occurrence of all adverse events including but not limited to · all MIs · cardiovascular hospitalization · serious ventricular arrhythmias sustained · VT (symptomatic or sustained VT [duration longer than 30 seconds or 100 beats, or associated with hemodynamic collapse]) · VF · symptomatic bradycardia, pauses of longer than 3.0 seconds, complete atrioventricular block, Mobitz II atrioventricular block · symptomatic heart failure (NYHA criteria + physical examination OR hospitalization because of heart failure) · renal failure · stroke · death
Appears in 2 contracts
Sources: License and Commercialization Agreement (BioLineRx Ltd.), License and Commercialization Agreement (BioLineRx Ltd.)