Palbociclib Pfizer

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HomeAboutMode of actionEfficacyPALOMA-2Trial design overviewPatient baseline characteristicsProgression-free survival (primary endpoint)Overall survival (secondary endpoint)Tumour control (secondary endpoint)PALOMA-3Trial design overviewPatient baseline characteristicsProgression-free survival (primary endpoint)Overall survival (secondary endpoint)Tumour control (secondary endpoint)Real World EvidenceP-REALITY study designP-REALITY patients characteristicsP-REALITY real-world progression-free survivalP-REALITY overall survivalP-REALITY strengthsSafetyImportant Safety InformationSafetySafety overviewPooled ARsPooled laboratory abnormalitiesPALOMA-2 AEsPALOMA-3 AEsSelected safety featuresPalbociclib long-term safetyGI and liver toxicitiesEffect of Palbociclib on QTc intervalElderly patientsVisceral disease patientsDose reduction effect on efficacyDosingRecommended dosing scheduleRecommended dose modifications for AEsOne scheduled monitoring provisionMedical InformationVisit the Pfizer Medical Information Africa Website for Healthcare ProfessionalsSubmit a medical question to Pfizer

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Safety in patients with visceral disease

In an analysis of PALOMA-2 and -3, Palbociclib Pfizer in combination with letrozole and Palbociclib Pfizer in combination with fulvestrant in 1st line or later demonstrated a consistent safety profile in patients with visceral disease1,2

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Data cut-off dates: 23 October 2015 for PALOMA-3 and 26 February 2016 for PALOMA-2.1AEs reported using a cluster of preferred terms as follows: Anaemia is any event having a preferred term that equals to anaemia or haematocrit decreased or haemoglobin decreased; Infections is any event having a preferred term that is part of the system organ class infections and infestations; Leukopenia is any event having a preferred term that equals to leukopenia or white blood cell count decreased; Neutropenia is any event having a preferred term that equals to neutropenia or neutrophil count decreased.2  
Explore More PALOMA-2 AEs See AE tables PALOMA-3 AEs See AE tables
AE = adverse event; ET = endocrine therapy; FUL = fulvestrant; LET = letrozole; TEAE = treatment-emergent adverse event.References:Turner NC, et al. Ann Oncol. 2018;29(3):669-680.Turner NC, et al. Ann Oncol. 2018;29(3):669-680. Supplementary Appendix Table S3.Turner NC, et al. Ann Oncol. 2018;29(3):669-680. Supplementary Appendix Table S2.
Selected safety features

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