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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
Elderly patients

In an exploratory, pooled analysis of patients aged ≥65 years in the PALOMA trials, the TEAEs reported were generally consistent with the known AE profile of IBRANCE1

PALOMA Pooled Analysis: TEAEs Occurring in ≥10% of Patients ≥65 years in Either Treatment Group1Adapted from Rugo HS, et al. 2018.1
Data cut-off dates: January 2, 2015 for PALOMA-1, February 26, 2016 for PALOMA-2 and October 23, 2015 for PALOMA-3.
Patients in PALOMA-1 and PALOMA-2 received IBRANCE + LET; patients in PALOMA-3 had endocrine-resistant mBC and received IBRANCE + FUL. 
Includes LET alone in PALOMA-1, LET + PLA in PALOMA-2, and FUL + PLA in PALOMA-3. 
All-causality AEs occurring in ≥10% of patients aged ≥65 years in the as-treated populations were graded in accordance with the maximum grade per CTCAE, version 3.0 (PALOMA-1) or 4.0 (PALOMA-2 and -3) and classified according to MedDRA, version 19.0. 
Clustered preferred terms defined as follows: anaemia includes the preferred terms anaemia, haematocrit decreased, and haemoglobin decreased; infections includes any reported preferred terms of the System Organ Class Infections and Infestations; leukopenia includes the preferred terms Leukopenia and White blood cell count decreased; neutropenia includes the preferred terms Neutropenia and Neutrophil count decreased; thrombocytopenia includes the preferred terms Platelet count decreased and Thrombocytopenia; stomatitis includes the preferred terms Aphthous stomatitis, Cheilitis, Glossitis, Glossodynia, Mouth ulceration, Mucosal inflammation, Oral pain, Oropharyngeal discomfort, Oropharyngeal pain, and Stomatitis.

Up to 6% of patients aged 65 to ≥75 years discontinued because of TEAEs1

Explore More PALOMA-2 AEs

Well-characterised safety profile

See AE tables

Well-characterised safety profile

See AE tables
AE = adverse event; CTCAE = Common Terminology Criteria for Adverse Events; ET= endocrine therapy; FUL = fulvestrant; Gr = grade; LET = letrozole; mBC = metastatic breast cancer; MedDRA = Medical Dictionary for Regulatory Activities; n = number of patients; PLA = placebo; TEAE = treatment-emergent adverse event.References:Rugo HS, et al. Eur J Cancer. 2018;101:123-133.
Selected safety features
IBRANCE Summary of Product Characteristics Product Characteristics Loading

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