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Clinical Efficacy & SafetyPALOMA-2Trial Design OverviewPatient Baseline CharacteristicsPFS (Primary Endpoint)OS (Secondary Endpoint)Tumour Control (Secondary Endpoint)PALOMA-3Trial Design OverviewPatient Baseline CharacteristicsPFS (Primary Endpoint)OS (Secondary Endpoint)Tumour Control (Secondary Endpoint)SafetySafety OverviewPooled ARsPooled Laboratory AbnormalitiesPALOMA-2 AEsPALOMA-3 AEsSelected Safety FeaturesPALBACE® Long-term SafetyGI and Liver ToxicitiesEffect of PALBACE®  on QTc IntervalElderly PatientsVisceral Disease PatientsDose Reduction Effect on EfficacyReal-world EvidenceWhat are RWD and RWE?PALBACE® Development and RWDHow Does RWE Differ From RCT Evidence?What Is Meant by RWD and RWE?What Is the Value of RWE?Multiple Ongoing Real-world Studies at Varied Geographic LocationsEffectivenessWhat is the Flatiron Database?What Were the Key Features of P-REALITY?What Are the Characteristics of Patients in P-REALITY?P-REALITY Real-world Progression-free SurvivalP-REALITY Overall SurvivallP-REALITY StrengthsP-REALITY SummaryP-REALITY X OverviewP-REALITY X OS and rwPFSP-REALITY X Subgroup analysis OverviewP-REALITY X:OS and rwPFS in Subgroup(Lung & Liver metastasisTolerability/QoLWhat is the MADELINE Study?What Were the Key Features of the MADELINE Study?What Are the Characteristics Of Patients In MADELINE?MADELINE Physician-reported AEsMADELINE Patient-reported OutcomesMADELINE Study LimitationsMADELINE SummaryMADELINE ASIA OverviewMADELINE ASIA Patient Reported OutcomesMADELINE ASIA SafetyMADELINE ASIA Study LimitationsDosingDosingRecommended Dosing ScheduleRecommended Dose Modifications For AEsMonitoring

Monitoring

One Scheduled Monitoring Provision
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What is the Value of RWE?

RWE complements RCTS, together providing more robust evidence-based research.The combination of data from both RCTs and RWE offers complementary information1

   

Why is RWE important?

   

RWE can be used to gather data in patients excluded from or unable to be evaluated in RCTs3,6,7

   

   

RCT, randomised clinical trial; RWD, real-world data; RWE, real-world evidence.

   

References:

Kim HS, Lee S, Kim JH. Real-world evidence versus randomized controlled trial: clinical research based on electronic medical records. J Korean Med Sci. 2018;33(34):e213. Maissenhaelter BE, Woolmore AL, Schlag PM. Real-world evidence research based on big data: motivation-challenges-success factors. Onkologe (Berl). 2018;24(suppl 2):91-98.Webster J, Smith BD. The case for real-world evidence in the future of clinical research on chronic myeloid leukemia. Clin Ther. 2019;41(2):336-349.Seyfert-Margolis V. The evidence gap. Nat Biotechnol. 2018;36(3):228-232.Zuidgeest MGP, Goetz I, Groenwold RHH, et al. Series: pragmatic trials and real world evidence: paper 1. Introduction. J Clin Epidemiol. 2017;88:7-13.
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Blonde L, Khunti K, Harris SB, Meizinger C, Skolnik NS. Interpretation and impact of real-world clinical data for the practicing clinician. Adv Ther. 2018;35(11):1763-1774.Beaulieu-Jones BK, Finlayson SG, Yuan W, et al. Examining the use of real-world evidence in the regulatory process. Clin Pharmacol Ther. 2020;107(4):843-852. 

   

Please click the Prescribing Information link to view the safety and adverse events information of PALBACE®.
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PP-IBR-IND-0626  September 2023

What Are RWD and RWE?

   

Clinical Efficacy & Safety

PALOMA was the first clinical trial programme to explore how a CDK4/6 inhibitor could benefit women with HR+/HER2- mBC

Learn more

   

Dosing

Recommended dosing schedule and dose modifications for AEs

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Monitoring One scheduled monitoring provision Learn more
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