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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
What is real-world evidence?

Real-world evidence (RWE) is clinical evidence regarding the use of a medical product derived from analyzing data relating to the patient’s health status and/or the delivery of healthcare collected outside of randomized clinical trials (RCTs).¹,²

RWE complements data from RCTs by attempting to address knowledge gaps in the data.

Features of RCTs and RW (real-world) studies Strengths and limitations of RCTs and RW Studies Observational retrospective analyses are not intended for direct comparison with clinical trials due to differences in study design and settings.Data collected from routine clinical practice can complement data from RCTs⁸

Combination of data derived from RCTs and RWE provides a more complete picture of a therapeutic intervention, which can in turn improve clinical practice, healthcare decisions, patient management and patient outcomes.⁸ 

Explore More Value of RWE Explore more Loading

References:

Khozin S, et al. J Natl Cancer Inst. 2017;109(11). doi:10.1093/jnci/djx187.Singal AG, et al. Clin Transl Gastroenterol. 2014;5.e45. doi:10.1038/ctg.2013.13.Akobeng AK. Arch Dis Child. 2005;90:840-844.Sanson-Fisher RW, et al. Am J Prev Med. 2007;33:155-161.Schmidt AF, et al. J Clin Epidemiol. 2013;66:599-607.Booth CM, Tannock IF. BJC 2014;110:551-555.Valentgas P, et al. https://www.npcnow.org/system/files/research/download/experimental_nonexperimental_study_final.pdf.
Accessed January 2023.
Kim HS, et al. J Korea Med Sci. 2018;33(34):e213.
Value of RWE
IBRANCE Summary of Product Characteristics Product Characteristics Loading

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