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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

Monitoring

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Pooled ARs

PALOMA Pooled Analysis: ARs

   

ARs based on pooled data set from 3 randomised studies (N=872)1

   

Scroll left to view table

   

The median duration of PALBACE® treatment across the pooled data set at the time of the final OS analysis was 14.8 months.1

   

Adapted from Palbace. Local product document. version 7. 2023.

   

   

*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. 
**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.

 jVenous thromboembolism includes the following PTs: pulmonary embolism, embolism, deep vein thrombosis, peripheral embolism, thrombosis.

 

AR, adverse reaction; ALT, alanine aminotransferase; AST, aspartate aminotransferase; ILD, interstitial lung disease; MedDRA, Medical Dictionary for Regulatory Activities; N/n, total number of patients/number of patients; NA, not applicable; OS, overall survival; PT, preferred term.

   

Reference:

LPD Palbace( Palbociclib) prescribing document, Pfizer Products India private Limited, version 7.0 LPDPAB062023

   

Please click the Prescribing Information link to view the safety and adverse events information of PALBACE®.
For the use only of Registered Medical Practitioners or a Hospital or a Laboratory.
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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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