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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
Safety in patients with visceral disease

In an analysis of PALOMA-2 and PALOMA-3, IBRANCE in combination with letrozole and IBRANCE in combination with fulvestrant in 1st line or later demonstrated a consistent safety profile in patients with visceral disease1,2

Regardless of presence or absence of visceral diseaseData cut-off dates: 23 October 2015 for PALOMA-3 and 26 February 2016 for PALOMA-2.1AEs reported using a cluster of preferred terms as follows: Anaemia is any event having a preferred term that equals to anaemia or haematocrit decreased or haemoglobin decreased; Infections is any event having a preferred term that is part of the system organ class infections and infestations; Leukopenia is any event having a preferred term that equals to leukopenia or white blood cell count decreased; Neutropenia is any event having a preferred term that equals to neutropenia or neutrophil count decreased.2
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; ET = endocrine therapy; FUL = fulvestrant; LET = letrozole; TEAE = treatment-emergent adverse event.References:Turner NC, et al. Ann Oncol. 2018;29(3):669-680.Turner NC, et al. Ann Oncol. 2018;29(3):669-680. Supplementary Appendix Table S3.Turner NC, et al. Ann Oncol. 2018;29(3):669 -680. Supplementary Appendix Table S2.
Selected safety features
IBRANCE Summary of Product Characteristics Product Characteristics Loading

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