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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 provisionPrescribing Information ResourcesMaterials
What is the value of RWE?

RWE can be used to gather data not included in RCTs¹-³

Healthcare stakeholders are increasingly using RWE to address their key needs4-10 Explore More P-REALITY overview Explore more LoadingHTA = health technology assessment; QoL = quality of life; RCT = randomized controlled trial; RWE = real-world evidence.

References:

FDA. https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm513027.pdf. Accessed January 2023.EMA https://ec.europa.eu/health/sites/health/files/files/committee/stamp/201603_stamp4/4_real_world_evidence_ema_presentation.pdf. Accessed January 2023.Valentgas P, et al. https://effectivehealthcare.ahrq.gov/sites/default/files/ch_6-user-guide-to-ocer_130129.pdf. Accessed January 2023.  Berger M, et al. Value Health. 2017;20:1003-1008. Nordon C, et al. Value Health. 2016;19:75-81.Pietri G, Masoura P. Value Health 2014;17:450-451.Pobiruchin M, et al. J Biomed Inform 2016;60:385-394.Khozin S, et al. J Natl Cancer Inst. 2017;109:10.Shore C, et al. eds. Examining the Impact of Real-World Evidence on Medical Product Development: Proceedings of a Workshop Series. Washington (DC): National Academies Press (US); 2019. https://www.ncbi.nlm.nih.gov/books/NBK540105/. Accessed January 2023. Khosla S, et al. F1000Res. 2018;7:111.
Value of RWE
IBRANCE Summary of Product Characteristics Product Characteristics Loading

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