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Clinical Efficacy & SafetyPALOMA-2Trial Design OverviewPatient Baseline CharacteristicsPFS (Primary Endpoint)OS (Secondary Endpoint)Tumour Control (Secondary Endpoint)PALOMA-3Trial Design OverviewPatient Baseline CharacteristicsPFS (Primary Endpoint)OS (Secondary Endpoint)Tumour Control (Secondary Endpoint)SafetySafety OverviewPooled ARsPooled Laboratory AbnormalitiesPALOMA-2 AEsPALOMA-3 AEsSelected Safety FeaturesPALBACE® Long-term SafetyGI and Liver ToxicitiesEffect of PALBACE®  on QTc IntervalElderly PatientsVisceral Disease PatientsDose Reduction Effect on EfficacyReal-world EvidenceWhat are RWD and RWE?PALBACE® Development and RWDHow Does RWE Differ From RCT Evidence?What Is Meant by RWD and RWE?What Is the Value of RWE?Multiple Ongoing Real-world Studies at Varied Geographic LocationsEffectivenessWhat is the Flatiron Database?What Were the Key Features of P-REALITY?What Are the Characteristics of Patients in P-REALITY?P-REALITY Real-world Progression-free SurvivalP-REALITY Overall SurvivallP-REALITY StrengthsP-REALITY SummaryP-REALITY X OverviewP-REALITY X OS and rwPFSP-REALITY X Subgroup analysis OverviewP-REALITY X:OS and rwPFS in Subgroup(Lung & Liver metastasisTolerability/QoLWhat is the MADELINE Study?What Were the Key Features of the MADELINE Study?What Are the Characteristics Of Patients In MADELINE?MADELINE Physician-reported AEsMADELINE Patient-reported OutcomesMADELINE Study LimitationsMADELINE SummaryMADELINE ASIA OverviewMADELINE ASIA Patient Reported OutcomesMADELINE ASIA SafetyMADELINE ASIA Study LimitationsDosingDosingRecommended Dosing ScheduleRecommended Dose Modifications For AEsMonitoring

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PALOMA-2 AEs

AEs (≥10%) From Any Cause Reported in PALOMA-2 (As-treated Population)1

    

Scroll left to view table

    

Adapted from Finn RS, et al. 2016.1
    
Grading according to CTCAE 4.0. Data cut-off date: 26 February 2016.​​​​​​​
    
    

*One death secondary to lower respiratory tract infection and pulmonary embolism occurred in the placebo + letrozole group and was believed to be treatment related. 
Grade 4 events that were reported in the PALBACE® + letrozole group but not shown in the table were increased ALT level, increased blood creatinine level, febrile neutropenia, pulmonary embolism, acute kidney injury, hyperuricaemia, acute pancreatitis, pathologic fracture, pericardial effusion, sepsis, increased amylase level, aortic valve stenosis, pulmonary oedema, staphylococcal bacteraemia, thrombotic cerebral infarction, urosepsis and increased lipase level; these Grade 4 events were reported in 1 patient each, except for increased lipase level, which was reported in 2 patients.
Categorised according to the MedDRA PTs. Neutropenia: neutropenia and neutrophil count decreased; Leukopenia: leukopenia and white blood cell count decreased; Anaemia: anaemia, haematocrit decreased and haemoglobin decreased. Rash: dermatitis, dermatitis acneiform, rash, rash erythematous, rash maculopapular, rash papular, rash pruritic and toxic skin eruption; Thrombocytopenia: platelet count decreased and thrombocytopenia.1 
§Febrile neutropenia was reported in 1.8% of patients in the PALBACE® + letrozole group and in no patients in the placebo + letrozole group.
||In the PALBACE® + letrozole group, 30.2% of patients had Grade 1 alopecia and 2.7% had Grade 2. In the placebo + letrozole group, 14.9% of patients had Grade 1 alopecia and 0.9% had Grade 2.¹

AE, adverse event; ALT, alanine transaminase; CTCAE, Common Terminology Criteria for Adverse Events; LET, letrozole; MedDRA, Medical Dictionary for Regulatory Activities; n, number of patients; PLA, placebo; PT, preferred term.

    
Reference:Finn RS, Martin M, Rugo HS, et al. Palbociclib and letrozole in advanced breast cancer. N Engl J Med. 2016;375(20):1925-1936.

   

Please click the Prescribing Information link to view the safety and adverse events information of PALBACE®.
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®)Trademark Proprietor: Pfizer Inc.USA Licensed User: Pfizer Products India Private Limited.India

    

PP-IBR-IND-0626  September 2023

Safety


Real-world Evidence

With RCT data, PALBACE® RWE can help improve the understanding of outcomes in patients with HR+/HER2- mBC

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Dosing

Recommended dosing schedule and dose modifications for AEs

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Monitoring One scheduled monitoring provision Learn more
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