Breast cancer Tx Ibrance¡¯s AE rate at 86%...6yr PMS results
By Lee, Hye-Kyung | translator Kim, Jung-Ju
23.06.22 05:50:34
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Post-marketing surveillance conducted on 293 patients in Korea...8 report serious adverse drug reactions
MFDS prepared a labeling change plan...will collect opinions until the 5th of next month
The Ministry of Food and Drug Safety prepared a label change order (draft) items based on its reevaluation results and will be conducting an opinion inquiry until the 5th of next month.
The results of the post-marketing surveillance study conducted by Pfizer on 293 people for 6 years for its reevaluation showed that Ibrance¡¯s reported adverse event rate was 86.01% (252/293 people, 642 cases), regardless of a causal relationship.
Of these, 2.73% (8/293 patients, 11 cases) were serious adverse reactions (ADRs) whos
Lee, Hye-Kyung(hgrace7@dailypharm.com)
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