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Patients with moderate renal impairment at baseline require dose reductionsee DOSAGE AND ADMINISTRATIONPatients with mild and moderate renal impairment at baseline should be carefully monitored for adverse reactionsPrompt interruption of therapy with subsequent dose adjustments is recommended if a patient develops a grade 2 to 4 adverse event as outlined in Table 2see DOSAGE AND ADMINISTRATIONUse in Specific Populationsand CLINICAL PHARMACOLOGY

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.

Figure 1 Kaplan-Meier Estimates of Disease-Free SurvivalAll Randomized Population)

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