Pooled ARs

PALOMA Pooled Analysis: ARs

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

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.

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