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Among the 67 patients 60 years of age receiving xeloda in combination with docetaxel, the incidence of grade 3 or 4 treatment-related adverse reactions, treatment-related serious adverse reactions, withdrawals due to adverse reactions, treatment discontinuations due to adverse reactions and treatment discontinuations within the first two treatment cycles was higher than in the 60 years of age patient group.

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Antitumor responses for patients with disease resistant to both paclitaxel and an anthracycline are shown in Table 19.

In both trialsoverall survivaltime to progression and response ratecomplete plus partial responseswere assessedResponses were defined by the World Health Organization criteria and submitted to a blinded independent review committeeIRCDifferences in assessments between the investigator and IRC were reconciled by the sponsorblinded to treatment armaccording to a specified algorithmSurvival was assessed based on a non-inferiority analysis.

Table 5 shows grade 3/4 laboratory abnormalities occurring in1of patients from one phase 3 trial in patients with DukesC colon cancer who received at least one dose of study medication and had at least one safety assessment.

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