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PRIME Reported TEAEs

PRIME reinforced the manageable safety profile demonstrated in PRIMA, with no new safety signals for ZEJULA (niraparib)1-3

For a full list of Adverse Events and Special Warnings and Precautions please click here to view the Summary of Product Characteristics for Zejula

TEAEs reported in ≥20% of patients treated with ZEJULA or placebo in the ITT population (N=384) after 27.5-month median follow-up:1

Graph showing AEs reported in patients in PRIME in overall population

Adapted from Li N, et al. 2023.

*Represent pooled terminology. “Neutropenia” also includes “neutrophil cell count decreased” and “febrile neutropenia”. “Leukopenia” also includes “white cell count decreased”. “Thrombocytopenia” also includes “platelet count decreased”

The most common any grade and grade ≥3 TEAEs were haematological and gastrointestinal1

In PRIME, all patients received an individualised starting dose, prospectively1

See Monitoring and AE Management

Find out more

PRIME study design

PRIME efficacy

ZEJULA QoL

ZEJULA (niraparib) is indicated4

  • as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
  • as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

Abbreviations

AE, adverse events; ALT, alanine transaminase; AST, aspartate transaminase; FIGO, Federation of Gynaecology and Obstetrics; GGT, γ-glutamyltransferase; ITT, Intention-to-treat; TEAE, treatment-emergent adverse event.

Reference

  1. Li N, et al. JAMA Oncol. 2023;9(9):1230–1237;
  2. Gonzàlez-Martín A, et al. N Engl J Med. 2019;381(25):2391–2402;
  3. Gonzàlez-Martín A, et al. Eur J Cancer. 2023;189:112908.
  4. ZEJULA (niraparib) Summary of Product Characteristics. (Last accessed May 2024).

Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk (UK) or search for MHRA Yellow Card in the Google Play or Apple App store. Adverse events should also be reported to GSK Limited on 0800 221 441 or by email at uksafety@gsk.com.

©2024 GSK Group of Companies or its licensor. Trademarks are the property of their respective owners.

May 2024 | PM-GB-NRP-WCNT-220021 (V2.0)