October 2012 Australian Public Assessment Report for Ivabradine Proprietary Product Name: Coralan Sponsor: Servier Laboratories
Download 3.74 Mb.
|
In its pre-ACPM response, the sponsor is requested to provide a short summary of the rates of the important TEAEs, including the 4 TEAEs mentioned above, in the patients aged 70 years or more in the RS BBdose compared with those in the patients aged less than 70 years in the RS BBdose population and also compared with the RS BBdose population itself.In the Safety Set (SS) BBdose population, patients aged 70 years at baseline (N=603) had a greater incidence of emergent adverse events on treatment (EAEs) (455 patients, 75.5%) compared to patients aged < 70 years (N = 2573; 1825 patients, 70.9%), and also compared to patients of the Safety Set (SS) BBdose population overall (N = 3176; 2280 patients, 71.8%). The incidence of all EAEs was slightly higher in the ivabradine group compared to the placebo group in both age sub-groups 70 years (78.0% versus 72.6%) and < 70 years (72.3% versus 69.6%). TEAEs reported more frequently with ivabradine than with placebo (ivabradine versus placebo) were: bradycardia asymptomatic: 70 years (6.9% versus 2.1%) and < 70 years (5.6% versus 1.4%), bradycardia symptomatic: 70 years (6.3% versus 2.5%) and < 70 years (4.5% versus 0.7%), atrial fibrillation: 70 years (10.7% versus 10.2%) and < 70 years (6.9% versus 5.6%), blood pressure inadequately controlled: 70 years (11.0% versus 6.7%). EAEs reported less frequently with ivabradine than with placebo (ivabradine versus placebo) were related to: cardiac failure: 70 years (21.4% vs 26.3%) and < 70 years (18.9% versus 21.2%), blood pressure inadequately controlled:< 70 years (7.6% versus 8.1%). See Table 35 below. Table 35 
Directory: sites -> default -> files files -> Answer True False 2 points Question 2 files -> Northern England’s set-jetting locations files -> Nstructions for Acquiring Excess Equipment online, through the 1033 Program files -> Occupational health and safety files -> The Black Panther Party’s Ten Point Program files -> International programs roel profile files -> Fermi Questions a guide for Teachers, Students, and Event Supervisors Lloyd Abrams, Ph. D. DuPont Company, cr&D/ccas experimental Station Wilmington, de 19880 files -> Personal Information Name: Maha Al-Ammari Nationality: Saudi Relationship Status Download 3.74 Mb. Share with your friends:
|