This site is intended only for healthcare professionals resident in the Republic of Ireland

Search

Menu

Close

Sign in or RegisterLog out Our medicinesTherapy areasExplore contentExplore contentMaterialsVideosPodcastsLet’s connectLet's connectContact usSign up

Menu

Close

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

Legal Category: S1A
Further information is available upon request

PP-IBR-IRL-0592. January 2023

Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
 

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

PfizerPro AccountPfizerPro Account

Please sign in or register to gain access to information relating to Pfizer medicines and vaccines, medical conditions, patient materials and services.

Sign in or RegisterRegisterAccountLog out

This site is intended only for healthcare professionals resident in the Republic of Ireland. If you are a member of the public wishing to access information on a specific medicine, please visit https://www.medicines.ie

 

This website is brought to you by Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland. Registered in the Republic of Ireland No. 127002.

 

Copyright © 2023 Pfizer Limited. All rights reserved.

PP-UNP-IRL-0176. January 2023
For Healthcare Professionals in the Republic of Ireland *

The information contained on this site is reserved exclusively for healthcare professionals resident in the Republic of Ireland.

I confirm that I am a healthcare professional resident in the Republic of Ireland.*

I accept and agree to the terms of use.*

If you select 'No', you will be redirected to Pfizer.ie, where you will be able to access information on Pfizer Healthcare Ireland.

PP-UNP-IRL-0176. January 2023

Yes No
You are now leaving PfizerPro
You are now leaving PfizerPro Ireland. Links to external websites are provided as a resource to the viewer. This website is neither owned nor controlled by Pfizer. Pfizer accepts no responsibility for the content or services of the linked site.