Established safety profile

 

AEs (≥10%) reported in PALOMA-3 (safety population)2

established-safety-profile-1

Adapted from Cristofanilli et al. 2016.2

Grading according to CTCAE 4.0 and MedDRA 18.0. Data cut-off date: March 16, 2015. Data are n (%) unless otherwise specified.2
*One other case of pleural effusion that was not graded also occurred in the IBRANCE® + FUL group. Reported causes of death were neutropenic sepsis, multiple organ failure, and disease progression based on latest site follow-up information.

AE = adverse event; CTCAE = Common Terminology Criteria for Adverse Events; FUL = fulvestrant; MedDRA = Medical Dictionary for Regulatory Activity; n = number of patients; PLA = placebo.

References
  1. IBRANCE® Summary of Product Characteristics.
  2. Cristofanilli M, et al. Lancet Oncol. 2016;17(4):425-439.

 

©2020 Pfizer. All rights reserved. PP-IBR-IRL-0501 Date of Preparation: March 2022 Legal Category: S1A