Palvored Adverse Reactions

Summary of the safety profile: The most common adverse reactions of any grade reported in patients receiving palbociclib were neutropenia, infections, leukopenia, fatigue, nausea, stomatitis, anaemia, diarrhoea, alopecia and thrombocytopenia. The most common Grade ≥3 adverse reactions of palbociclib were neutropenia, leukopenia, infections, anaemia, aspartate aminotransferase (AST) increased, fatigue, and alanine aminotransferase (ALT) increased.
Tabulated list of adverse reactions: Table 4 reports the adverse reactions. The median duration of palbociclib treatment across at the time of the final overall survival (OS) analysis was 14.8 months.
The adverse reactions are listed by system organ class and frequency category. Frequency categories are defined as: very common, common, and uncommon. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. (See Table 4.)

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Description of selected adverse reactions: Overall, neutropenia of any grade was reported in patients receiving PALVORED regardless of the combination, with Grade 3 neutropenia being reported, and Grade 4 neutropenia being reported. The median time to first episode of any grade neutropenia was 15 days and the median duration of Grade ≥3 neutropenia was 7 days.
Febrile neutropenia has been reported in patients receiving PALVORED in combination with fulvestrant and in patients receiving palbociclib in combination with letrozole.
Febrile neutropenia has been reported in patients exposed to PALVORED across the overall clinical programme.