Tabulated list of adverse reactions: Adverse reactions listed as follows are classified according to frequency and System Organ Class (SOC). Frequency groupings are defined according to the following convention: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100). Within each frequency grouping adverse reactions are reported in order of decreasing seriousness. (See Table 1.)

Combination therapy with palbociclib: The most common (≥ 20%) adverse reactions of any grade reported in patients receiving fulvestrant in combination with palbociclib were neutropenia, leukopenia, infections, fatigue, nausea, anaemia, stomatitis, diarrhoea, and thrombocytopenia.
The most common (≥ 2%) Grade ≥ 3 adverse reactions were neutropenia, leukopenia, anaemia, infections, AST increased, thrombocytopenia and fatigue. (See Table 2.)

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