""The FDA agreed with Dendreon that Provenge was "generally well tolerated," with the most prominent side-effects being fever, chills and fatigue. However, the FDA said it was concerned about an increased number of strokes among patients treated with Provenge compared with patients who didn't get the drug.
The FDA said it would ask the panel whether a 3.9% stroke rate seen among Provenge patients - compared with a 2.6% rate among patients in the placebo groups - was a "potential safety signal" for Provenge.""
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