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Clinical efficacy & safetyPALOMA-2Trial design overviewPatient baseline characteristicsProgression-free survival (primary endpoint)Overall survival (secondary endpoint)Tumour control (secondary endpoint)PALOMA-2 summaryPALOMA-3Trial design overviewPatient baseline characteristicsProgression-free survival (primary endpoint)Overall survival (secondary endpoint)Tumour control (secondary endpoint)SafetySafety overviewPooled ARsPooled laboratory abnormalitiesPALOMA-2 AEsPALOMA-3 AEsSelected safety featuresIBRANCE long-term safetyGI and liver toxicitiesEffect of IBRANCE on QTc intervalElderly patientsVisceral disease patientsDose reduction effect on efficacyRW evidenceValue of RWEWhat is real-world evidence?What is the value of RWE?P-REALITY and P-REALITY XP-REALITY OverviewP-REALITY OS and rwPFSP-REALITY X OverviewP-REALITY X OS and rwPFSIRISIRIS OverviewIRIS PFS and OSPOLARIS POLARIS OverviewPOLARIS Patient-Reported OutcomesMADELINEMADELINE OverviewMADELINE Patient CharacteristicsMADELINE Patient-Reported OutcomesPalomAGEPalomAGE OverviewRWE in Older Patients with mBCPatient-reported outcomesPALOMA-2: FACT-B scoresPALOMA-3: EORTC QLQ-C30 scoresPALOMA-3: Time to deterioration in pain symptomsDosingRecommended dosing scheduleRecommended dose modifications for AEsMonitoringOne scheduled monitoring provision ResourcesMaterials
PALOMA pooled analysis: Laboratory abnormalitiesLaboratory Abnormalities* Observed in Pooled Dataset from 3 Randomised Studies (N=872)1
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The median duration of IBRANCE treatment across the pooled dataset at the time of the final overall survival analysis was 14.8 months.1

Adapted from IBRANCE Summary of Product Characteristics.1Note: Laboratory results are graded according to the NCI CTCAE version 4.0 severity grade. 
Letrozole or fulvestrant.Explore More PALOMA-2 AEs

Well-characterised safety profile

 See AE tables PALOMA-3 AEs

Well-characterised safety profile

 See AE tables
AE = adverse event; ALT = alanine aminotransferase; AST = aspartate aminotransferase; N = number of patients; N/A = not applicable; NCI CTCAE = National Cancer Institute Common Toxicity Criteria for adverse events; WBC = white blood cells.References:IBRANCE Summary of Product Characteristics.
Safety Dose modification

Effect on efficacy

 Find out more Selected safety features

Consistent safety profile

 Find out more
IBRANCE Summary of Product Characteristics Product Characteristics Loading

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