Eranfu Adverse Reactions

This section provides information based on all adverse reactions from clinical trials, post-marketing studies or spontaneous reports. The most frequently reported adverse reactions are injection site reactions, asthenia, nausea and increased hepatic enzymes (ALT, AST, ALP).
The following frequency categories for adverse drug reactions (ADRs) were calculated based on Fulvestrant 500 mg treatment group in pooled safety analyses of the CONFIRM (Study D6997C00002), FINDER 1 (Study D6997C00004), FINDER 2 (Study D6997C00006) and NEWEST (Study D6997C00003) studies that compared Fulvestrant 500 mg with Fulvestrant 250 mg. The frequencies in the following table were based on all reported events, regardless of the investigator assessment of causality.
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.)

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