Established safety profile


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


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.

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


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