Biotech Values

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From post dasatinib poster:

Table 3. Arterial Thrombotic AEs (Treatment-Emergent)

Cardiovascular, cerebrovascular, and peripheral vascular categories are each comprised of multiple preferred terms

The arterial thrombotic events that were observed were acute myocardial infarction/myocardial
infarction (n=5), cerebral infarction (n=4), angina pectoris (n=3), intermittent claudication (n=3),
peripheral arterial occlusive disease (n=3), peripheral artery stenosis (n=3), peripheral ischemia (n=2),
coronary artery disease (n=2), carotid artery occlusion (n=1), cerebrovascular insufficiency (n=1),
extremity necrosis (n=1), cerebrovascular accident (n=1), monoparesis (n=1), splenic infarction (n=1),
hemorrhagic cerebral infarction (n=1), cerebral artery stenosis (n=1), coronary artery stenosis (n=1),
and transient ischemic attack (n=1)

5% of patients who received dasatinib as their most recent prior therapy experienced any venous
thromboembolic event; serious AEs were observed in 4% of patients
– Venous thromboembolic events were deep vein thrombosis (n=2), pulmonary embolism (n=2),
and venous thrombosis (n=1)

This is the first time I have seen ARIA listed all MedDRA preferred terms (PTs). Assume the AE management poster used same PTs, these numbers are starting to get very close to FDA vascular events numbers - FDA could have added/deleted some PTs to/from the list.

From AE management poster:

Table 2. Incidence and Timing of Select Adverse Events in CP-CML (N=270)

Arterial thrombotic events: any grade 20%, grade 3/4 12%;
Venous thromboembolic events: any grade 4%, grade 3/4 3%;
Cardiac failure events: any grade 7%, grade 3/4 4%.

Note: grade 3/4 AEs and SAEs are not necessarily the same.