9 n (%) a Fatigue b Bone fracture Falls (including accident) Weight decreased (any event) c Asthenic conditions d Rash Seizure f Mental impairment disorders f Depressed mood disorders Hypertension Hot ush f,g,h Cardiac arrhythmias i Coronary artery disordersf, f,j Heart failure Grade 3-4 4 (0.4) 10 (1.0) 9 (0.9) 0 2 (0.2) 2 (0.2) 0 3 (0.3) 1 (0.1) 33 (3.5) 0 17 (1.8) 19 (2.0) 4 (0.4) Any grade 126 (13.2) 52 (5.5) 50 (5.2) 40 (4.2) 38 (4.0) 30 (3.1) 2 (0.2)e 19 (2.0) 21 (2.2) 74 (7.8) 57 (6.0) 70 (7.3) 38 (4.0) 18 (1.9) EAIR (per 100 subject years) 8.9 3.4 3.3 2.6 2.5 2.0 0.1 1.3 1.4 4.9 3.8 4.6 2.5 1.2 Any grade 46 (8.3) 20 (3.6) 27 (4.9) 14 (2.5) 17 (3.1) 6 (1.1) 1 (0.2) 10 (1.8) 10 (1.8) 36 (6.5) 25 (4.5) 24 (4.3) 15 (2.7) 5 (0.9) Grade 3-4 5 (0.9) 5 (0.9) 4 (0.7) 0 2 (0.4) 1 (0.2) 0 0 0 13 (2.3) 0 4 (0.7) 2 (0.4) 0 EAIR (per 100 subject years) 7.4 3.2 4.3 2.2 2.7 1.0 0.2 1.6 1.6 5.8 4.0 3.8 2.4 0.8 2,3 Table 6. Incidence and Exposure-Adjusted Incidence of Treatment-Emergent Adverse Events of Interest Placebo + ADT (double blind) N=554 Darolutamide + ADT (double blind) N=954 EAIR, exposure-adjusted incidence rate; TEAE, treatment-emergent adverse event. a. In the primary analysis, this category combined the following MedDRA, version 20.0 terms: asthenic conditions, disturbances in consciousness, decreased strength and energy, malaise, lethargy, asthenia, and fatigue. In the nal analysis, this only included fatigue. b. Combined term comprising MedDRA terms of any fractures and dislocations, limb fractures and dislocations, skull fractures, facial bone fractures and dislocations, spinal fractures and dislocations, and thoracic cage fractures and dislocations c. Combined term comprising MedDRA terms of asthenic conditions, disturbances in consciousness, decreased strength and energy, malaise, lethargy, and asthenia d. MedDRA labeling grouping, including preferred terms of rash, rash macular, rash maculo-papular, rash papular and rash pustular e. One additional incidence of seizure occurred in the darolutamide group during the open-label period, in a patient with a history of epilepsy f. MedDRA High Level Group term g. Grade 5 events occurred in 2 patients receiving darolutamide in the double-blind period and 3 patients receiving placebo in the double-blind period h. An imbalance in the incidence of cardiac arrhythmias between the darolutamide and placebo groups was observed at baseline i. Grade 5 events occurred in 3 patients receiving darolutamide in the double-blind period, 1 patient receiving placebo during the double-blind period and 1 patient in the crossover group j. Grade 5 events occurred in 7 patients receiving darolutamide in the combined double-blind and open-label periods, and 3 patients receiving placebo during the double-blind period. At baseline, 3% (31/955) of patients in the darolutamide group and 6% (32/554) of patients in the placebo group used concomitant bone-sparing agents (i.e., drugs affecting bone structure and mineralization [such as bisphosphonate and denosumab], vitamin D and analogues, calcium and calcium combinations, uorides and 3,4 calcitonins). CPD Accreditation ® For any further information on Nubeqa (darolutimide) please contact your Bayer representative or Lynda Woods Customer Sales and Marketing Manager: Oncology South Eastern West Africa lynda.woods@bayer.com +27 82 651-2639 References/Enclosure(s): 1. Darolutamide [Prescribing Information]. Darolutamide PI. SAHPRA approval 15 March 2022 2. Fizazi K, Shore N, Tammela TL, et al. Darolutamide and overall survival in nonmetastatic castration- resistant prostate cancer. N Engl J Med. 2020; 38 (11): 1040-1049 3. Fizazi K, Shore N, Tammela TL, et al. Darolutamide in nonmetastatic, castration-resistant prostate cancer. N Engl J Med. 2019;380(13):1235-1246. 4. Data on le. Bayer HealthCare Pharmaceuticals, Whippany, NJ. Approval number MA-M_DAR-ZA-0015-1 UROLOGY, URO-ONCOLOGY AND SEXOLOGY UPDATE
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