Kadcyla Adverse Reactions

Clinical Trials: Early Breast Cancer: The safety of Kadcyla has been evaluated in 740 patients with EBC in Study BO27938 KATHERINE. Adverse drug reactions from KATHERINE (Table 5) are listed by MedDRA system organ class. The corresponding frequency category for each adverse drug reaction is based on the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000). (See Table 5.)

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Laboratory Abnormalities: The following table displays laboratory abnormalities observed in patients treated with Kadcyla in clinical trial BO27938 (KATHERINE). (See Table 6.)

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Metastatic Breast Cancer: The safety of Kadcyla has been evaluated in 1871 patients in clinical trials. Adverse drug reactions from clinical trials (Table 7) are listed by MedDRA system organ class. The corresponding frequency category for each adverse drug reaction is based on the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000). (See Table 7.)

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Laboratory Abnormalities: The following table displays laboratory abnormalities observed in patients treated with Kadcyla in clinical trial TDM4370g/BO21977. (See Table 8.)

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Postmarketing Experience: Not applicable.