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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
POLARIS patient-reported outcomesMean global health/QoL scores over time1

Mean (SD) global health status/QoL scores were similar over the first 6 months of IBRANCE treatment.¹

Mean functional scale score

Mean scores for the 5 functional scales remained stable during the first 6 months.¹

Among patients who completed the EORTC QLQ-C30 at baseline and at 6 months, mean changes from baseline generally were below the 10-point threshold regarded as clinically meaningful.4,5

Mean symptom scale score

Among patients who completed the EORTC QLQ-C30 at baseline and at 6 months, mean changes from baseline for each of the symptom scales generally were less than 5 points, with the notable exception of pain scores, which decreased by 7 points.¹

TitleObservational retrospective analyses are designed to evaluate associations among variables and cannot establish causality. Observational retrospective analyses are not intended for direct comparison with clinical trials.Explore More MADELINE overview Explore more Loading MADELINE PROs Explore more LoadingReferencesEORTC QLQ-C30 = EORTC Core Quality of Life questionnaire; QoL = quality of life; SD = standard deviation.References:Rocque G, et al. SABCS 2019; Poster P19-A-875.Nolte S, et al. Eur J Cancer. 2019;107:153-163.Fayers PM, et al. EORTC QLQ-C30 Scoring Manual. Brussels, Belgium: European Organisation for Research 
and Treatment of Cancer 2001.Snyder CF, et al. Qual Life Res. 2015;24:1207-1216.Osoba D, et al. J Clin Oncol. 1998;16:139-144.POLARIS
IBRANCE Summary of Product Characteristics Product Characteristics Loading

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