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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PALOMA pooled analysis: Adverse reactionsARs Based on Pooled Dataset from 3 Randomised Studies (N=872)1
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The median duration of Palbociclib Pfizer treatment across the pooled dataset at the time of the final overall survival analysis was 14.8 months.1
Adapted from Palbociclib Pfizer Summary of Product Characteristics.1Preferred 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.Explore More PALOMA-2 AEs See AE tables PALOMA-3 AEs 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:Palbociclib Pfizer Summary of Product Characteristics.
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