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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
PALOMA pooled analysis: Adverse reactionsARs Based on Pooled Dataset from 3 Randomised Studies (N=872)1
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The median duration of IBRANCE treatment across the pooled dataset at the time of the final overall survival analysis was 14.8 months.1
Adapted from IBRANCE Summary of Product Characteristics.1
Preferred Terms (PTs) are listed according to MedDRA 17.1. Infections includes all PTs that are part of the System Organ Class Infections and infestations. Neutropenia includes the following PTs: Neutropenia, Neutrophil count decreased. Leukopenia includes the following PTs: Leukopenia, White blood cell count decreased. Anaemia includes the following PTs: Anaemia, Haemoglobin decreased, Haematocrit decreased. Thrombocytopenia includes the following PTs: Thrombocytopenia, Platelet count decreased. Adverse Drug Reaction (ADR) identified post-marketing. ILD/pneumonitis includes any reported PTs that are part of the Standardised MedDRA Query Interstitial Lung Disease (narrow). Stomatitis includes the following PTs: Aphthous stomatitis, Cheilitis, Glossitis, Glossodynia, Mouth ulceration, Mucosal inflammation, Oral pain, Oropharyngeal discomfort, Oropharyngeal pain, Stomatitis. Rash includes the following PTs: Rash, Rash maculo-papular, Rash pruritic, Rash erythematous, Rash papular, Dermatitis, Dermatitis acneiform, Toxic skin eruption.
Adverse drug reaction identified post-marketing.
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Well-characterised safety profile

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Well-characterised safety profile

See AE tables
AE = adverse event; AR = adverse reactions; ALT = alanine aminotransferase; AST = aspartate aminotransferase; ILD = interstitial lung disease; MedDRA = Medical Dictionary for Regulatory Activities; N/n = number of patients; N/A = not applicable.References:IBRANCE Summary of Product Characteristics.
Safety Selected safety features

Consistent safety profile

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Dose modification

Effect on efficacy

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IBRANCE Summary of Product Characteristics Product Characteristics Loading

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