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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-2 adverse events

No new safety signals observed across safety analyses at all efficacy assessment timepoints (median follow-ups: 23 months, 30 months, 90 months)1-3

Adverse reactions/adverse events reported in ≥10% of patients1,2Adapted from Finn RS, et al. 2016.1
Rugo H, et al. 2019,3 and Pfizer Data on File.2All causality; selected based on their designation as ARs in the EMA Summary of Product Characteristics. Data cut off date: February 26, 2016. Data cut off date: 31 May, 2017. Data cut off date: November 15, 2021.  Grade 1 events: 30%; Grade 2 events:3%. Grade 1 events: 15%; Grade 2 events:1%.Explore More PALOMA-3

Well-characterised safety profile

 See AE tables
AE = adverse event; AR = adverse reaction; N/A = not applicable.References:Finn RS, et al. N Engl J Med. 2016;375(20):1925-1936.Rugo H, et al. Breast Cancer Res Treat. 2019;174(3):719-729.Finn RS, et al. ASCO 2022; oral presentation LBA1003.
Safety PALOMA-3

Well-characterised safety profile

 See AE tables Loading
IBRANCE Summary of Product Characteristics Product Characteristics Loading

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