It's 2.6% vs. 24% if the treatment duration factor is taken into account.
The doctors' View (2-Year Follow-Up): "Serious cardiovascular, cerebrovascular, and peripheral vascular AEs occurred in 6%, 3%, and 2% of pts (drug-related: 2%, 1%, 1%)."
The FDA View (median treatment duration 1.3 years): "24% patients have experienced serious adverse vascular events."
There is an enormous gulf between these doctors' view of SAE's vs. the FDA's views, in one case 4% SAE's for the doctors, 24% for the FDA. Other disparities are even greater. How can the disparities be so great?
Who is right, the FDA or the 25 clinical trial doctors? I would rather believe the doctors are telling the truth.
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