Time course profile of adverse events of interest and serious adverse events with darolutamide in the ARAMIS trial

C. J. Gratzke (Coresponding Author), K. Fizazi, N. D. Shore, M. R. Smith, S. Feyerabend, M. Grabbert, J. Carles, T. Lebret, E. Vjaters, P. Werbrouck, M. Miskic, J. Ortiz, A. Schmall, M. A. Le Berre, F. Verholen

Research output: Contribution to journalMeeting Abstractpeer-review


Background: Men with nonmetastatic castration-resistant prostate cancer (nmCRPC) are generally asymptomatic and may receive prolonged treatment with androgen receptor inhibitors (ARIs). Understanding the burden and time course of adverse events (AEs) commonly associated with ARIs that may impact patients' daily life will help inform optimal treatment selection for men with nmCRPC. We present analyses of time to AEs of interest associated with some ARIs (fatigue, falls, fracture, hypertension, mental impairment, and rash) and the cumulative incidence of these AEs, grade 3/4 AEs, and serious AEs from ARAMIS. Method(s): Men with nmCRPC were randomized 2:1 to darolutamide (DARO; n=955) or placebo (PBO; n=554) while continuing androgen deprivation therapy. The cumulative incidence of AEs was analyzed using Kaplan-Meier estimates for the first 24 months of the double-blind (DB) period to ensure >10% of the population in each treatment cohort. Time interval-specific analysis determined new event rates at each scheduled study visit. Result(s): During the first 24 months of the DB period, the incidence of AEs of interest in the DARO group was low and
Original languageEnglish
Article number630P
Pages (from-to)S664-S664
JournalAnnals of Oncology
Issue numberSupplement 5
Publication statusPublished - 2021
Externally publishedYes
EventEuropean Society of Medical Oncology (ESMO) Congress - virtual, Lugano, Switzerland
Duration: 17 Sept 202121 Sept 2021

Field of Science*

  • 3.2 Clinical medicine
  • 3.1 Basic medicine

Publication Type*

  • 3.3. Publications in conference proceedings indexed in Web of Science and/or Scopus database


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