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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-3 Adverse eventsAEs Reported in PALOMA-3 (Safety Population)1
Adapted from Cristofanilli M, et al. 2016.1
Grading according to CTCAE 4.0 and MedDRA 18.0. Clustered preferred terms were used for some adverse events. Anaemia was defined as any event having a preferred term that equals to anaemia or haematocrit decreased or haemoglobin decreased. Hyperglycaemia is any event having a preferred term that equals blood glucose increased or diabetes mellitus or diabetes mellitus inadequate control or glycosylated haemoglobin increased or hyperglycaemia or type 1 diabetes mellitus or type 2 diabetes mellitus. Infection is defined as any event having a preferred term of the system organ class infections and infestations. Leukopenia is any event having a preferred term that equals leukopenia or white blood cell count decreased. Lymphopenia is any event having a preferred term that equals lymphocyte count decreased or lymphopenia. Neutropenia is any event having a preferred term that equals neutropenia or neutrophil count decreased. Rash is any event having a preferred term that equals dermatitis or dermatitis acneiform or rash or rash erythematous or rash maculopapular or rash papular or rash pruritic. Pulmonary embolism is any event having a preferred term that equals pulmonary artery thrombosis or pulmonary embolism. Thrombocytopenia is any event having a preferred term that equals platelet count decreased or thrombocytopenia. Data cut-off date: March 16, 2015. Data are n (%) unless otherwise specified.1 
One other case of pleural effusion that was not graded also occurred in the IBRANCE + FUL group. 
Reported causes of death were neutropenic sepsis, multiple organ failure, and disease progression based on latest site follow-up information.  One other case of pleural effusion that was not graded also occurred in the IBRANCE + FUL group. 
Reported causes of death were neutropenic sepsis, multiple organ failure, and disease progression based on latest site follow-up information.  Download table Explore More PALOMA-2 AEs

Well-characterised safety profile

 See AE tables
AE = adverse event; AR = adverse reaction; CTCAE = Common Terminology Criteria for Adverse Events; LET = letrozole; MedDRA = Medical Dictionary for Regulatory Activities; n = number of patients; PLA = placebo.References:Cristofanilli M, et al. Lancet Oncol. 2016;17(4):425-439. 
SafetySelected safety features​​​​​​​ Consistent safety profile Find out more ​​​​​​​Dose modification

Effect on efficacy

 Find out more
IBRANCE Summary of Product Characteristics Product Characteristics Loading

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