{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T04:37:37Z","timestamp":1787027857670,"version":"build-2736575974"},"reference-count":61,"publisher":"MDPI AG","issue":"17","license":[{"start":{"date-parts":[[2025,8,23]],"date-time":"2025-08-23T00:00:00Z","timestamp":1755907200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Cancer Center Support Grant NIH NCI","award":["5P30CA056036"],"award-info":[{"award-number":["5P30CA056036"]}]},{"name":"Cancer Center Support Grant NIH NCI","award":["DOD W81XWH-22-10581"],"award-info":[{"award-number":["DOD W81XWH-22-10581"]}]},{"name":"Cancer Center Support Grant NIH NCI","award":["NIH NCI 1L30CA284329-01"],"award-info":[{"award-number":["NIH NCI 1L30CA284329-01"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancers"],"abstract":"<jats:p>Background\/objectives: Multiple systemic treatments are available for metastatic castration-resistant prostate cancer (mCRPC), with unclear safety profiles. This study seeks to describe the safety determined in randomized clinical trials of a systemic treatment for mCRPC and whether safety differs by age. Methods: We utilized individual patient data from industry-funded phase 2\/3 trials in mCRPC on abiraterone acetate (AA). Vivli, a clinical trial repository site, was used. One investigator independently performed screening. Relative effects of treatment were assessed with frequencies and odds of serious adverse events (SAEs). The Preferred Reporting Items for Systematic Reviews and Meta-analyses guideline was used. Subgroup analysis measured odds of SAEs as modified by age. Results: We identified 14 trials with 4296 patients. The median age of participants was 69 years. Nearly all participants experienced at least one adverse event (98.4% abiraterone, 97.3% standard of care [SOC]). More serious adverse events (grade 3 or 4) and deaths (grade 5) occurred in those receiving SOC (71.8%) compared to abiraterone (64.1%). The most frequent adverse event category was \u201cMusculoskeletal and Connective Tissue Disorders\u201d. The most frequent event types included anemia, back pain, hypertension, fatigue, hypokalemia, and bone pain. The odds of all events were lower in those receiving abiraterone compared to SOC. Odds of a serious musculoskeletal event were lower in older subjects by 22% (OR 0.78; 95% CI 0.63, 0.96). Conclusions: In this IPD meta-analysis, abiraterone acetate provides no greater risk of SAE in those receiving abiraterone than those receiving SOCs. Patients in the RCTs are younger and healthier than those in the general population; consequently, the results of RCTS might not be applied to the general population, especially those under-represented in the RCTs. There is a need to further evaluate abiraterone-related fractures and neuromuscular toxicities (NMTs) as key outcomes to gain insight into risk factors related to these adverse events. A real-world prospective study is warranted to examine the overall risks and benefits associated with treatment.<\/jats:p>","DOI":"10.3390\/cancers17172747","type":"journal-article","created":{"date-parts":[[2025,8,25]],"date-time":"2025-08-25T00:09:32Z","timestamp":1756080572000},"page":"2747","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["The Safety of Abiraterone Acetate in Patients with Metastatic Castration-Resistant Prostate Cancer: An Individual-Participant Data Meta-Analysis Based on 14 Randomized Clinical Trials"],"prefix":"10.3390","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0263-8708","authenticated-orcid":false,"given":"Amy L.","family":"Shaver","sequence":"first","affiliation":[{"name":"Department of Medical Oncology, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA 19107, USA"},{"name":"Sidney Kimmel Comprehensive Cancer Center, Thomas Jefferson University, Philadelphia, PA 19107, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nikita","family":"Nikita","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA 19107, USA"},{"name":"Sidney Kimmel Comprehensive Cancer Center, Thomas Jefferson University, Philadelphia, PA 19107, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8138-6184","authenticated-orcid":false,"given":"Swapnil","family":"Sharma","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA 19107, USA"},{"name":"Sidney Kimmel Comprehensive Cancer Center, Thomas Jefferson University, Philadelphia, PA 19107, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9428-1151","authenticated-orcid":false,"given":"Scott W.","family":"Keith","sequence":"additional","affiliation":[{"name":"Sidney Kimmel Comprehensive Cancer Center, Thomas Jefferson University, Philadelphia, PA 19107, USA"},{"name":"Division of Biostatistics and Bioinformatics, Department of Pharmacology, Physiology, and Cancer Biology, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA 19107, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9351-2317","authenticated-orcid":false,"given":"Kevin K.","family":"Zarrabi","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA 19107, USA"},{"name":"Sidney Kimmel Comprehensive Cancer Center, Thomas Jefferson University, Philadelphia, PA 19107, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2629-672X","authenticated-orcid":false,"given":"Wm. Kevin","family":"Kelly","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA 19107, USA"},{"name":"Sidney Kimmel Comprehensive Cancer Center, Thomas Jefferson University, Philadelphia, PA 19107, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2925-7737","authenticated-orcid":false,"given":"Grace","family":"Lu-Yao","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA 19107, USA"},{"name":"Sidney Kimmel Comprehensive Cancer Center, Thomas Jefferson University, Philadelphia, PA 19107, USA"},{"name":"College of Population Health, Thomas Jefferson University, Philadelphia, PA 19107, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,8,23]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"993","DOI":"10.1016\/j.euo.2024.01.016","article-title":"Risk of Fractures and Falls in Men with Advanced or Metastatic Prostate Cancer Receiving Androgen Deprivation Therapy and Treated with Novel Androgen Receptor Signalling Inhibitors: A Systematic Review and Meta-analysis of Randomised Controlled Trials","volume":"7","author":"Jones","year":"2024","journal-title":"Eur. Urol. Oncol."},{"key":"ref_2","doi-asserted-by":"crossref","unstructured":"Wu, C.C., Chen, P.Y., Wang, S.W., Tsai, M.H., Wang, Y.C.L., Tai, C.L., Luo, H.L., Wang, H.-J., and Chen, C.Y. (2021). Risk of Fracture During Androgen Deprivation Therapy Among Patients With Prostate Cancer: A Systematic Review and Meta-Analysis of Cohort Studies. Front. Pharmacol., 12.","DOI":"10.3389\/fphar.2021.652979"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"204","DOI":"10.1038\/aja.2011.104","article-title":"Muscle function, physical performance and body composition changes in men with prostate cancer undergoing androgen deprivation therapy","volume":"14","author":"Storer","year":"2012","journal-title":"Asian J. Androl."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"109306","DOI":"10.1016\/j.steroids.2023.109306","article-title":"An overview on androgen-mediated actions in skeletal muscle and adipose tissue","volume":"199","author":"Rizk","year":"2023","journal-title":"Steroids"},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"192","DOI":"10.1038\/pcan.2014.8","article-title":"Androgen dynamics and serum PSA in patients treated with abiraterone acetate","volume":"17","author":"yan","year":"2014","journal-title":"Prostate Cancer Prostatic Dis."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"20","DOI":"10.1038\/pcan.2009.50","article-title":"Bone health and prostate cancer","volume":"13","author":"Saylor","year":"2010","journal-title":"Prostate Cancer Prostatic Dis."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"100311","DOI":"10.1016\/j.jbo.2020.100311","article-title":"Guidance for the assessment and management of prostate cancer treatment-induced bone loss. A consensus position statement from an expert group","volume":"25","author":"Brown","year":"2020","journal-title":"J. Bone Oncol."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"737","DOI":"10.1016\/j.jaccao.2021.09.014","article-title":"How to Treat Prostate Cancer With Androgen Deprivation and Minimize Cardiovascular Risk: A Therapeutic Tightrope","volume":"3","author":"Narayan","year":"2021","journal-title":"JACC CardioOncol"},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"325","DOI":"10.1038\/bjc.2013.340","article-title":"Sarcopenia and change in body composition following maximal androgen suppression with abiraterone in men with castration-resistant prostate cancer","volume":"109","author":"Pezaro","year":"2013","journal-title":"Br. J. Cancer"},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"181","DOI":"10.1016\/S0022-5347(05)68000-7","article-title":"Progressive osteoporosis during androgen deprivation therapy for prostate cancer","volume":"163","author":"Daniell","year":"2000","journal-title":"J. Urol."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"1019","DOI":"10.1016\/j.jaci.2013.08.040","article-title":"Glucocorticoid-induced osteoporosis: An update on effects and management","volume":"132","author":"Buehring","year":"2013","journal-title":"J. Allergy Clin. Immunol."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"1231","DOI":"10.1634\/theoncologist.2014-0167","article-title":"Use of Prednisone With Abiraterone Acetate in Metastatic Castration-Resistant Prostate Cancer","volume":"19","author":"Auchus","year":"2014","journal-title":"Oncol."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"184","DOI":"10.1016\/j.jns.2016.06.002","article-title":"Neuromuscular complications in cancer","volume":"367","author":"Grisold","year":"2016","journal-title":"J. Neurol. Sci."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"658","DOI":"10.1097\/WCO.0000000000000969","article-title":"Neuromuscular complications of cancer therapy","volume":"34","author":"Argyriou","year":"2021","journal-title":"Curr. Opin. Neurol."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"138","DOI":"10.1056\/NEJMoa1209096","article-title":"Abiraterone in Metastatic Prostate Cancer without Previous Chemotherapy","volume":"368","author":"Ryan","year":"2013","journal-title":"N. Engl. J. Med."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"387","DOI":"10.4103\/1008-682X.129133","article-title":"Androgen synthesis inhibitors in the treatment of castration-resistant prostate cancer","volume":"16","author":"Stein","year":"2014","journal-title":"Asian J. Androl."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"507","DOI":"10.1210\/jc.2011-2189","article-title":"Clinical and Biochemical Consequences of CYP17A1 Inhibition with Abiraterone Given with and without Exogenous Glucocorticoids in Castrate Men with Advanced Prostate Cancer","volume":"97","author":"Attard","year":"2012","journal-title":"J. Clin. Endocrinol. Metab."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"1995","DOI":"10.1056\/NEJMoa1014618","article-title":"Abiraterone and Increased Survival in Metastatic Prostate Cancer","volume":"364","author":"Logothetis","year":"2011","journal-title":"N. Engl. J. Med."},{"key":"ref_19","unstructured":"Castro, D., and Sharma, S. (2025). Hypokalemia, StatPearls Publishing."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"101763","DOI":"10.1016\/j.jgo.2024.101763","article-title":"Outcomes in studies regarding older patients with prostate cancer: A systematic review","volume":"15","author":"Jochems","year":"2024","journal-title":"J. Geriatr. Oncol."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"1769","DOI":"10.1001\/jamaoncol.2019.2055","article-title":"Factors Associated With Age Disparities Among Cancer Clinical Trial Participants","volume":"5","author":"Ludmir","year":"2019","journal-title":"JAMA Oncol."},{"key":"ref_22","first-page":"210","article-title":"Efficacy and toxicity outcomes of elderly castrate-resistant prostate cancer patients treated with docetaxel\u2014A pooled analysis of 3 randomized studies","volume":"38","year":"2019","journal-title":"Urol. Oncol. Semin. Orig. Investig."},{"key":"ref_23","first-page":"903","article-title":"Two-stage or not two-stage?","volume":"14","author":"Riley","year":"2023","journal-title":"That is the question for IPD meta-analysis projects. Res. Synth. Methods"},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"1","DOI":"10.18637\/jss.v036.i03","article-title":"Conducting meta-analyses in R with the metafor package","volume":"36","author":"Viechtbauer","year":"2010","journal-title":"J. Stat. Softw."},{"key":"ref_25","doi-asserted-by":"crossref","unstructured":"Egger, M., Higgins, J.P.T., and Smith, G.D. (2022). Meta-Analysis in R. Systematic Reviews in Health Research: Meta-Analysis in Context, John Wiley & Sons, Ltd.. [3rd ed].","DOI":"10.1002\/9781119099369"},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"2537","DOI":"10.1002\/(SICI)1097-0258(19981130)17:22<2537::AID-SIM953>3.0.CO;2-C","article-title":"Meta-analysis of multiple outcomes by regression with random effects","volume":"17","author":"Berkey","year":"1998","journal-title":"Stat. Med."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"e073725","DOI":"10.1136\/bmj-2022-073725","article-title":"CONSORT Harms 2022 statement, explanation, and elaboration: Updated guideline for the reporting of harms in randomised trials","volume":"381","author":"Junqueira","year":"2023","journal-title":"BMJ"},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"43","DOI":"10.1097\/00001648-199001000-00010","article-title":"No adjustments are needed for multiple comparisons","volume":"1","author":"Rothman","year":"1990","journal-title":"Epidemiology"},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"637","DOI":"10.1200\/JCO.2010.33.7675","article-title":"Effects of Abiraterone Acetate on Androgen Signaling in Castrate-Resistant Prostate Cancer in Bone","volume":"30","author":"Efstathiou","year":"2012","journal-title":"J. Clin. Oncol."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"1496","DOI":"10.1200\/JCO.2009.25.9259","article-title":"Phase II Multicenter Study of Abiraterone Acetate Plus Prednisone Therapy in Patients With Docetaxel-Treated Castration-Resistant Prostate Cancer","volume":"28","author":"Danila","year":"2010","journal-title":"J. Clin. Oncol."},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"897","DOI":"10.1016\/j.eururo.2011.07.011","article-title":"TMPRSS2-ERG Status in Circulating Tumor Cells as a Predictive Biomarker of Sensitivity in Castration-Resistant Prostate Cancer Patients Treated With Abiraterone Acetate","volume":"60","author":"Danila","year":"2011","journal-title":"Eur. Urol."},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"152","DOI":"10.1016\/S1470-2045(14)71205-7","article-title":"Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer (COU-AA-302): Final overall survival analysis of a randomised, double-blind, placebo-controlled phase 3 study","volume":"16","author":"Ryan","year":"2015","journal-title":"Lancet Oncol."},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"e167","DOI":"10.1016\/j.clgc.2014.03.010","article-title":"Response to Subsequent Docetaxel in a Patient Cohort With Metastatic Castration-Resistant Prostate Cancer After Abiraterone Acetate Treatment","volume":"12","author":"Aggarwal","year":"2014","journal-title":"Clin. Genitourin. Cancer"},{"key":"ref_34","first-page":"1206","article-title":"A phase 2 study of abiraterone acetate in Japanese men with metastatic castration-resistant prostate cancer who had received docetaxel-based chemotherapy","volume":"44","author":"Satoh","year":"2014","journal-title":"Ultrasound Med. Biol."},{"key":"ref_35","unstructured":"Janssen-Ortho Inc Canada (2025, January 20). A Study to Determine the Short-Term Safety of Continuous Dosing of Abiraterone Acetate and Prednisone in Modified Fasting and Fed States to Patients With Metastatic Castration-Resistant Prostate Cancer, Available online: https:\/\/www.clinicaltrials.gov\/study\/NCT01424930."},{"key":"ref_36","unstructured":"Janssen Research & Development LLC (2024, June 15). A Phase 2 Open Label Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients with Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy. Available online: https:\/\/yoda.yale.edu\/clinical-trial\/nct01685983-a-phase-2-open-label-study-of-abiraterone-acetate-jnj-212082-and-prednisolone-in-patients-with-advanced-prostate-cancer-who-have-failed-androgen-deprivation-and-docetaxel-based-chemoth\/."},{"key":"ref_37","doi-asserted-by":"crossref","first-page":"404","DOI":"10.1111\/iju.13051","article-title":"Abiraterone acetate for metastatic castration-resistant prostate cancer after docetaxel failure: A randomized, double-blind, placebo-controlled phase 3 bridging study","volume":"23","author":"Sun","year":"2016","journal-title":"Int. J. Urol."},{"key":"ref_38","doi-asserted-by":"crossref","first-page":"75","DOI":"10.1016\/j.ajur.2017.01.002","article-title":"A phase 3, double-blind, randomized placebo-controlled efficacy and safety study of abiraterone acetate in chemotherapy-na\u00efve patients with mCRPC in China, Malaysia, Thailand and Russia","volume":"4","author":"Ye","year":"2017","journal-title":"Asian J. Urol."},{"key":"ref_39","doi-asserted-by":"crossref","first-page":"1159","DOI":"10.1001\/jamaoncol.2019.1011","article-title":"Assessment of the Safety of Glucocorticoid Regimens in Combination With Abiraterone Acetate for Metastatic Castration-Resistant Prostate Cancer: A Randomized, Open-label Phase 2 Study","volume":"5","author":"Attard","year":"2019","journal-title":"JAMA Oncol."},{"key":"ref_40","doi-asserted-by":"crossref","first-page":"1541","DOI":"10.1016\/S1470-2045(21)00402-2","article-title":"Apalutamide plus abiraterone acetate and prednisone versus placebo plus abiraterone and prednisone in metastatic, castration-resistant prostate cancer (ACIS): A randomised, placebo-controlled, double-blind, multinational, phase 3 study","volume":"22","author":"Saad","year":"2021","journal-title":"Lancet Oncol."},{"key":"ref_41","doi-asserted-by":"crossref","first-page":"2506","DOI":"10.1056\/NEJMoa1911206","article-title":"Cabazitaxel versus Abiraterone or Enzalutamide in Metastatic Prostate Cancer","volume":"381","author":"Sternberg","year":"2019","journal-title":"N. Engl. J. Med."},{"key":"ref_42","doi-asserted-by":"crossref","first-page":"102345","DOI":"10.1016\/j.clgc.2025.102345","article-title":"Treatment patterns and outcomes for younger patients with metastatic castration-resistant prostate cancer (mCRPC); An Australian prospective registry study","volume":"23","author":"Williams","year":"2025","journal-title":"Clin. Genitourin. Cancer"},{"key":"ref_43","doi-asserted-by":"crossref","first-page":"1691","DOI":"10.21037\/tau-20-1058","article-title":"The efficacy and safety of abiraterone acetate in patients with high-risk prostate cancer: A meta-analysis based on six randomized control trials","volume":"9","author":"Tan","year":"2020","journal-title":"Transl. Androl. Urol."},{"key":"ref_44","doi-asserted-by":"crossref","first-page":"1210","DOI":"10.1016\/S1470-2045(12)70473-4","article-title":"Effect of abiraterone acetate and prednisone compared with placebo and prednisone on pain control and skeletal-related events in patients with metastatic castration-resistant prostate cancer: Exploratory analysis of data from the COU-AA-301 randomised trial","volume":"13","author":"Logothetis","year":"2012","journal-title":"Lancet Oncol."},{"key":"ref_45","doi-asserted-by":"crossref","first-page":"12","DOI":"10.1186\/s40885-019-0116-x","article-title":"Risk of hypertension in cancer patients treated with abiraterone: A meta-analysis","volume":"25","author":"Zhu","year":"2019","journal-title":"Clin. Hypertens."},{"key":"ref_46","doi-asserted-by":"crossref","first-page":"1017","DOI":"10.1093\/annonc\/mds585","article-title":"Effect of abiraterone acetate on fatigue in patients with metastatic castration-resistant prostate cancer after docetaxel chemotherapy","volume":"24","author":"Sternberg","year":"2012","journal-title":"Ann. Oncol."},{"key":"ref_47","doi-asserted-by":"crossref","first-page":"20","DOI":"10.1200\/JCO.2025.43.5_suppl.20","article-title":"Which patients with metastatic hormone-sensitive prostate cancer (mHSPC) benefit more from androgen receptor pathway inhibitors (ARPIs)? STOPCAP meta-analyses of individual participant data (IPD)","volume":"43","author":"Fisher","year":"2025","journal-title":"J. Clin. Oncol."},{"key":"ref_48","doi-asserted-by":"crossref","first-page":"45","DOI":"10.1200\/OP.21.00206","article-title":"Recent Advances in the Management of Metastatic Prostate Cancer","volume":"18","author":"Sayegh","year":"2022","journal-title":"JCO Oncol. Pract."},{"key":"ref_49","unstructured":"Agarwal, N. (2025). Episode 5: Management and Monitoring of Adverse Events in mCRPC, in Evolving Treatment Landscape in Metastatic Castration Resistant Prostate Cancer (mCRPC). Target. Oncol."},{"key":"ref_50","doi-asserted-by":"crossref","first-page":"102388","DOI":"10.1016\/j.clgc.2025.102388","article-title":"Evaluation of the Effects of Enzalutamide and Abiraterone Acetate on Sarcopenia in Metastatic Castration-Sensitive Prostate Cancer","volume":"23","author":"Kapar","year":"2025","journal-title":"Clin. Genitourin. Cancer"},{"key":"ref_51","doi-asserted-by":"crossref","first-page":"e361","DOI":"10.1016\/j.ijrobp.2024.07.796","article-title":"Skeletal Muscle Loss after Short ADT Duration in Prostate Cancer Patients Treated with Radiation Therapy","volume":"120","author":"Gadam","year":"2024","journal-title":"Int. J. Radiat. Oncol."},{"key":"ref_52","doi-asserted-by":"crossref","unstructured":"Shaver, A.L., Platek, M.E., Singh, A.K., Ma, S.J., Farrugia, M., Wilding, G., Ray, A.D., Ochs-Balcom, H.M., and Noyes, K. (2022). Effect of musculature on mortality, a retrospective cohort study. BMC Cancer, 22.","DOI":"10.1186\/s12885-022-09751-6"},{"key":"ref_53","first-page":"3401","article-title":"Cross-sectional analysis of myosteatosis and physical function in pretreatment head and neck cancer patients","volume":"30","author":"Shaver","year":"2022","journal-title":"Support. Care Cancer"},{"key":"ref_54","doi-asserted-by":"crossref","unstructured":"Shaver, A.L., Noyes, K., Ochs-Balcom, H.M., Wilding, G., Ray, A.D., Ma, S.J., Farrugia, M., Singh, A.K., and Platek, M.E. (2021). A Retrospective Cohort Study of Myosteatosis and Quality of Life in Head and Neck Cancer Patients. Cancers, 13.","DOI":"10.3390\/cancers13174283"},{"key":"ref_55","doi-asserted-by":"crossref","unstructured":"Nunes, L.d.A., Hooper, R., McGettigan, P., and Phillips, R. (2024). Statistical methods leveraging the hierarchical structure of adverse events for signal detection in clinical trials: A scoping review of the methodological literature. BMC Med. Res. Methodol., 24.","DOI":"10.1186\/s12874-024-02369-1"},{"key":"ref_56","doi-asserted-by":"crossref","first-page":"185","DOI":"10.1016\/j.jclinepi.2021.12.023","article-title":"Improving the analysis of adverse event data in randomized controlled trials","volume":"144","author":"Cornelius","year":"2022","journal-title":"J. Clin. Epidemiology"},{"key":"ref_57","first-page":"1161","article-title":"Prostate cancer patients\u2019 self-reported participation in research: An examination of racial\/ethnic disparities","volume":"32","author":"Palmer","year":"2021","journal-title":"Cancer Causes Control"},{"key":"ref_58","doi-asserted-by":"crossref","first-page":"e000352","DOI":"10.1136\/bmjmed-2022-000352","article-title":"Quality of reporting of adverse events in clinical trials of covid-19 drugs: Systematic review","volume":"2","author":"Karima","year":"2023","journal-title":"BMJ Med."},{"key":"ref_59","doi-asserted-by":"crossref","unstructured":"Wang, Y., Chen, C., Du, W., Zhou, Y., He, L., Hong, S., and Zhang, L. (2022). Adverse Event Reporting Quality in Cancer Clinical Trials Evaluating Immune Checkpoint Inhibitor Therapy: A Systematic Review. Front. Immunol., 13.","DOI":"10.3389\/fimmu.2022.874829"},{"key":"ref_60","doi-asserted-by":"crossref","first-page":"369","DOI":"10.1016\/j.jgo.2019.12.007","article-title":"The underreporting of phase III chemo-therapeutic clinical trial data of older patients with cancer: A systematic review","volume":"11","author":"BrintzenhofeSzoc","year":"2020","journal-title":"J. Geriatr. Oncol."},{"key":"ref_61","doi-asserted-by":"crossref","first-page":"101480","DOI":"10.1016\/j.jgo.2023.101480","article-title":"Older adults with advanced cancer report pain not captured by clinician-graded Common Terminology Criteria for Adverse Events (CTCAE)","volume":"14","author":"Culakova","year":"2023","journal-title":"J. Geriatr. Oncol."}],"container-title":["Cancers"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2072-6694\/17\/17\/2747\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T18:34:40Z","timestamp":1760034880000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2072-6694\/17\/17\/2747"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,8,23]]},"references-count":61,"journal-issue":{"issue":"17","published-online":{"date-parts":[[2025,9]]}},"alternative-id":["cancers17172747"],"URL":"https:\/\/doi.org\/10.3390\/cancers17172747","relation":{},"ISSN":["2072-6694"],"issn-type":[{"value":"2072-6694","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,8,23]]}}}