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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 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

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Selected safety features

Consistent safety profile

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IBRANCE Summary of Product Characteristics Product Characteristics Loading

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