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Table 9 Percent Incidence of Adverse Reactions Considered RemotelyPossibly or Probably Related to Treatment in5of Patients Participating in the Single Arm Trial in Stage IV Breast Cancer.

XELODA dosage may need to be individualized to optimize patient managementPatients should be carefully monitored for toxicity and doses of XELODA should be modified as necessary to accommodate individual patient tolerance to treatmentsee Clinical StudiesToxicity due to XELODA administration may be managed by symptomatic treatmentdose interruptions and adjustment of XELODA doseOnce the dose has been reducedit should not be increased at a later timeDoses of XELODA omitted for toxicity are not replaced or restoredinstead the patient should resume the planned treatment cycles.

Because clinical trials are conducted under widely varying conditionsadverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Table 7 Percent Incidence of Adverse Events Considered Related or Unrelated to Treatment in5of Patients Participating in the XELODA and Docetaxel Combination vs Docetaxel Monotherapy Study.

This treatment might harm a baby developing in the wombIt is important not to become pregnant or father a child while you are having treatment and for a few months afterwardsTalk to your doctor or nurse about effective contraception before starting treatment.

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