Adverse events expected profile

The expected adverse event profile will also determine the study design. A drug for which the prescription is to be initiated in a tertiary referral clinic by leading experts in the field, such as many oncological compounds, will have a... 

The EMEA filing for aliskiren contained safety information obtained from a large number of clinical studies in a total of 11,566 treated patients. Aliskiren showed a favorable overall adverse event profile (37.7%) compared to placebo (40.2%). Diarrhea was the most common adverse event and was more common in the aliskiren group (2.4%) versus placebo (1.2%). Relative to ACE inhibitors, which are associated with cough due to inhibition of ACE-dependent bradykinin cleavage, aliskiren demonstrated a significantly improved profile (1.0% vs 3.8% for ACE inhibitors), as expected based on the specificity of renin for angiotensinogen.9... 

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