Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer (ARANOTE)

A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide in Addition to Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Men With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

The purpose of the study is to assess the efficacy and safety of darolutamide in combination with standard androgen deprivation therapy (ADT) in patients with metastatic hormone sensitive prostate cancer.

Study Overview

• Status: Completed
• Conditions: Prostatic Neoplasms
• Intervention / Treatment: Drug: Darolutamide (Nubeqa, BAY1841788); Other: Androgen deprivation therapy (ADT); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 669
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Kingswood, New South Wales, Australia, 2747
      • Nepean Hospital
    • St Leonards, New South Wales, Australia, 2065
      • Northern Cancer Institute
    • Sydney, New South Wales, Australia, 2109
      • Macquarie University Hospital - Oncology Department
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Cancer Research South Australia
  • Victoria
    • Frankston, Victoria, Australia, 3199
      • Peninsula Oncology Centre
    • Heidelberg, Victoria, Australia, 3084
      • Austin Health
• Brazil
  • Rio de Janeiro, Brazil, 22793-080
    • Instituto COI de Educação e Pesquisa
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 41950-640
      • Assistência Multidisciplinar em Oncologia (AMO)
  • Goiás
    • Goiânia, Goiás, Brazil, 74605-070
      • Hosp. Araujo Jorge da Associação de Combate ao Câncer
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30130-100
      • Hospital da Universidade Federal de Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30150-270
      • Cetus Oncologia Hospital Dia
  • Paraná
    • Curitiba, Paraná, Brazil, 81520-060
      • Liga Paranaense de Combate ao Cancer-Hosp Erasto Gaertner
  • Rio Grande do Norte
    • Natal, Rio Grande do Norte, Brazil, 59040-000
      • Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica
  • Rio Grande do Sul
    • Pelotas, Rio Grande do Sul, Brazil, 96020-080
      • Unidade de Pesquisas Clinicas em Oncologia
    • Porto Alegre, Rio Grande do Sul, Brazil, 90850-170
      • Hospital Mae de Deus
    • Porto Alegre, Rio Grande do Sul, Brazil, 91350-280
      • FZ Pesquisa e Servicos em Cardiologia | Porto Alegre, Brazil
    • Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
      • Santa Casa de Porto Alegre | Hospital Sao Francisco - Centro Medico Pesquisa Clinica Cardiologia
  • São Paulo
    • Barretos/SP, São Paulo, Brazil, 14784-400
      • Fundação Pio XII - Hospital de Câncer de Barretos
    • São José do Rio Preto, São Paulo, Brazil, 15090-000
      • Hospital de Base | Funfarme - Centro Integrado de Pesquisa - Cardiologia
    • São Paulo, São Paulo, Brazil, 03102-002
      • IBCC - Instituto Brasileiro de Controle do Cancer
    • São Paulo, São Paulo, Brazil, 01243-020
      • Urobrasil
    • São Paulo, São Paulo, Brazil, 04039-004
      • Inst. de Assistência Médica ao Sérvidor Público Estadual
• Canada
  • Ontario
    • Burlington, Ontario, Canada, L7N 3V2
      • G. Kenneth Jansz Medicine Professional Corporation
  • Quebec
    • Montreal, Quebec, Canada, H2X 0A9
      • Centre de Recherche du Centre Hospitalier de l'Université de Montreal (CRCHUM)
• Chile
  • Santiago, Chile, 7500921
    • Fundacion Arturo Lopez Perez
  • Santiago, Chile, 7510032
    • Oncovida
  • Santiago, Chile
    • UROMED
  • Santiago, Chile, TBC
    • Hospital Clínico de la Pontificia Univ. Católica de Chile
  • Región de Valparaíso
    • Viña del Mar, Región de Valparaíso, Chile, 2520598
      • Oncocentro
  • Región de la Araucanía
    • Temuco, Región de la Araucanía, Chile, 4781156
      • Centro de Investigacion Clinica del Sur
  • Santiago Metropolitan
    • Providencia, Santiago Metropolitan, Chile, 7500653
      • Centro de Estudios Clinicos SAGA Spa
• China
  • Beijing, China, 100142
    • Beijing Cancer Hospital
  • Beijing, China, 100083
    • Peking University Third Hospital
  • Beijing, China, 100000
    • Cancer hospital, Chinese Academy of Medical Sciences
  • Anhui
    • Hefei City, Anhui Province, Anhui, China, 230031
      • Anhui Provincial Hospital
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100730
      • Beijing Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Sun yat-sen University Cancer Center
    • Guangzhou, Guangdong, China, 510180
      • Guangzhou First People Hospital
    • Shenzhen, Guangdong, China, 518172
      • Cancer Hospital Chinese Academy of Medical Sciences, ShenZhen center
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.
    • Wuhan, Hubei, China, 430079
      • Hubei Cancer Hospital
    • Wuhan, Hubei, China, 430071
      • Zhongnan hospital ,Wuhan University
  • Hunan
    • Changsha, Hunan, China, 410013
      • Hunan Cancer Hospital - Oncology Department
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School
    • Nantong, Jiangsu, China, 226361
      • Nantong Tumor Hospital
    • Suzhou, Jiangsu, China, 215004
      • The 2nd Affiliated Hospital of Soochow University
  • Jilin
    • Changchun, Jilin, China, 130021
      • 1st Hospital of Jilin University
  • Liaoning
    • Shengyang, Liaoning, China, 110042
      • Liaoning Cancer Hospital and Institute
  • Shandong
    • Yantai, Shandong, China, 264000
      • Yantai Yuhuangding Hospital
  • Shanxi
    • Xi’an, Shanxi, China, 710061
      • The First Affiliated Hospital of Xi'an Jiaotong University
  • Sichuan
    • Chengdu, Sichuan, China, 610072
      • SichuanAcademyofMedicalSciences&SichuanProvincialPeople'sHos
    • Chengdu, Sichuan, China, MISSING
      • Sichuan University West China Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310014
      • Zhejiang Provincial People's Hospital
    • Hangzhou, Zhejiang, China, 310000
      • The 1st Affiliated Hospital of Zhejiang University
    • Ningbo, Zhejiang, China, 315010
      • Ningbo First Hospital
    • Wenzhou, Zhejiang, China, 325000
      • The First Affiliated Hospital of Wenzhou Medical University
• India
  • Chandigarh, India, 160012
    • Post Graduate Institute of Medical education and Research
  • Kolkata, India, 700156
    • Tata Medical Center
  • Nashik, India, 422009
    • Apex Wellness Hospital
  • New Delhi, India, 110 085
    • Rajiv Gandhi Cancer Institute & Research Centre
  • Andhra Pradesh
    • Visakhapatnam, Andhra Pradesh, India, 530017
      • Mahatma Gandhi Cancer Hospital & Research Institute
  • Gujarat
    • Ahmedabad, Gujarat, India, 380016
      • The Gujarat Cancer & Research Institute
    • Ahmedabad, Gujarat, India, 380060
      • HCG Cancer Centre - Ahmedabad
    • Vadodara, Gujarat, India, 390007
      • Cancer Care Clinic - Vadodara
  • Karnataka
    • Belagavi, Karnataka, India, 590010
      • K.L.E.S. Dr. Prabhakar Kore Hospital & Medical Research Centre
    • Bengaluru, Karnataka, India, 560027
      • Healthcare Global Enterprises Ltd
  • Kerala
    • Kochi, Kerala, India, 682 041
      • Amrita Institute of Medical Sciences
    • Thiruvananthapuram, Kerala, India, 695011
      • Regional Cancer Centre - Thiruvananthapuram
  • Maharashtra
    • Aurangabad, Maharashtra, India, 431001
      • Marathwada Regional Cancer Centre and Research Institute
    • Mumbai, Maharashtra, India, 400026
      • Jaslok Hospital and Research Centre
    • Nashik, Maharashtra, India, 422004
      • Curie Manavata Cancer Centre
    • Pune, Maharashtra, India, 411001
      • Jehangir Hospital
  • Odisha
    • Bhubaneswar, Odisha, India, 751019
      • All India Institute of Medical Sciences
    • Bhubaneswar, Odisha, India, 751007
      • Sparsh Hospital & Critical Care
  • Puducherry
    • Gorimedu, Puducherry, India, 605006
      • Jawaharlal Institute Of Postgraduate Medical Education and R
  • Punjab
    • Ludhiana, Punjab, India, 141008
      • Christian Medical Center & Hospital
  • Rajasthan
    • Jaipur, Rajasthan, India, 302017
      • Sawami Man Singh (SMS) Medical College & Attached Hospitals
  • Tamil Nadu
    • Madurai, Tamil Nadu, India, 625020
      • Apollo Speciality Hospitals
    • Madurai, Tamil Nadu, India, 625107
      • Meenakshi Mission Hospital & Research Centre
• Latvia
  • Daugavpils, Latvia, LV-5417
    • Daugavpils Regional Hospital
  • Riga, Latvia, LV-1002
    • P. Stradins Clinical University hospital
  • Riga, Latvia, 1038
    • RAKUS Hospital Gailezers
  • Riga, Latvia, LV-1001
    • URO Ltd.
  • Valmiera, Latvia, LV-4201
    • Vidzemes Hospital
• Lithuania
  • Kaunas, Lithuania, LT-50009
    • The Hospital of Lithuanian University of Health SciencesLUHS
  • Klaipėda, Lithuania, LT-92288
    • PI Klaipedos University Hospital
  • Vilnius, Lithuania, LT-08660
    • National Cancer Institute
  • Vilnius, Lithuania, LT-08661
    • Vilnius University Hospital Santaros Klinikos
• New Zealand
  • Bay of Plenty
    • Tauranga, Bay of Plenty, New Zealand, 3112
      • Tauranga Urology Research Limited
  • Canterbury
    • Christchurch, Canterbury, New Zealand, 8013
      • Canterbury Urology Research Trust
  • Waikato Region
    • Hamilton, Waikato Region, New Zealand, 3240
      • Waikato Hospital
• Peru
  • Lima, Peru, LIMA 11
    • Hospital Militar Luis Arias Schreiber
  • Lima, Peru, LIMA 27
    • Clinica El Golf
  • Lima region
    • San Isidro, Lima region, Peru, 15036
      • Aliada
    • Santiago de Surco, Lima region, Peru, 15033
      • Hospital Guillermo Almenara Irigoyen
• Russia
  • Arkhangelsk, Russia, 163045
    • Arkhangelsk Clinical Oncology Dispensary
  • Chelyabinsk, Russia, 454087
    • Chelyabinsk Regional Oncology Dispensary
  • Chelyabinsk, Russia, 454048
    • Ltd "EVIMED"
  • Ivanovo, Russia, 153040
    • Ivanovo regional oncology dispensary
  • Kazan', Russia, 420029
    • Republican Clinical Oncology Dispensary Kazan
  • Moscow, Russia, 117997
    • Research Centre of X-ray and Radiology
  • Nizhny Novgorod, Russia, 603109
    • Volga District Med Center FMBA
  • Novosibirsk, Russia, 630099
    • LLC Reafan
  • Novosibirsk, Russia, 630099
    • Medical Center "Avicenna"
  • Omsk, Russia, 644013
    • Clinical Oncological Dispensary of Omsk Region
  • Saint Petersburg, Russia, 196006
    • AV Medical Group
  • Saint Petersburg, Russia, 197758
    • Russian Scientific Radiology and Surgery Technologies Center
  • Saint Petersburg, Russia, 197758
    • Scientific Research Instutute of Oncology n.a. N.N. Petrov
  • Tyumen, Russia, 625041
    • Multi-Field Clinical Medical Center "Medical City"
  • Ufa, Russia, 450054
    • Republican Clinical Oncology Dispensary
  • Vologda, Russia, 160022
    • Vologda Regional Hospital
  • Yekaterinburg, Russia, 620102
    • Sverdlovsk Regional Clinical Hospital #1
• South Africa
  • Cape Town, South Africa, 7570
    • Cape Town Oncology Trials
  • Eastern Cape
    • Port Elizabeth, Eastern Cape, South Africa, 6045
      • Cancercare Langenhoven
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 1475
      • East Rand Medical Research Unit
    • Pretoria, Gauteng, South Africa, 2
      • University of Pretoria, Clinical Research Unit
• Spain
  • Barcelona, Spain, 08025
    • Fundacio Puigvert | Urologia
  • Barcelona, Spain, 08208
    • Parc Tauli Hospital Universitari | Oncologia
  • Cáceres, Spain, 10003
    • Hospital San Pedro De Alcantara | Oncologia
  • Málaga, Spain, 20910
    • Hospital Universitario Virgen De La Victoria | Urologia
  • Seville, Spain, 41013
    • Hospital Universitario Virgen Del Rocio S.L. | Urologia
  • Madrid
    • Alcorcón, Madrid, Spain, 28922
      • Hospital Universitario Fundacion Alcorcon | Urologia
• Taiwan
  • Changhua, Taiwan, 50006
    • Changhua Christian Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Kaohsiung
    • Kaohsiung City, Kaohsiung, Taiwan, 807377
      • Kaohsiung Medical University Chung-Ho Memorial Hospital
• Ukraine
  • Cherkasy, Ukraine, 18009
    • CNE "Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of the Cherkasy Regional Council"
  • Dnipro, Ukraine, 49102
    • City Dnipropetrovsk Multi- field Clinical Hosp. 4 DSMA
  • Kyiv, Ukraine, 4107
    • Kyiv Regional Oncological Dispensary
  • Kyiv, Ukraine, 02660
    • Kyiv City Hospital #3 - Department of Urology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of prostate
• Metastatic disease
• Started ADT (LHRH agonist/antagonist or orchiectomy) with or without first generation anti-androgen, but not earlier than 12 weeks before randomization
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2
• Adequate bone marrow, liver and renal function

Exclusion Criteria:

• Prior treatment with: LHRH agonist/antagonists except neoadjuvant and /or adjuvant therapy; Second-generation androgen receptor (AR) inhibitors such as enzalutamide, darolutamide, apalutamide or other investigational AR inhibitors; Cytochrome P17 enzyme inhibitor such as abiraterone acetate or oral ketoconazole as anti-cancer treatment for prostate cancer; Chemotherapy including docetaxel or immunotherapy for prostate cancer; Use of systemic corticosteroid with dose greater than the equivalent 10 mg of prednisone/day within 28 days prior to randomization; Radiopharmaceuticals; Any other anti-cancer treatment for prostate cancer, excluding local therapies and ADT.
• Treatment with radiotherapy within 2 weeks before randomization
• Contraindication to iodinated CT and gadolinium chelate MRI intravenous contrast agent(s)
• Had any of the following within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure (New York Heart Association Class III or IV)
• Uncontrolled hypertension as indicated by a resting systolic BP ≥ 160 mmHg or diastolic BP ≥ 100 mmHg despite medical management
• A gastrointestinal (GI) disorder or procedure which is expected to interfere significantly with absorption of study drug
• Any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years prior to randomization
• Inability to swallow oral medications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Darolutamide+ADT; Participants will receive darolutamide 600 mg (2 tablets of 300 mg) twice daily with food and ADT of investigator's choice as standard therapy	Drug: Darolutamide (Nubeqa, BAY1841788); Coated tablet, oral administration; Other: Androgen deprivation therapy (ADT); Luteinizing hormone-releasing hormone (LHRH) agonist/antagonists or orchiectomy
Placebo Comparator: Placebo+ADT; Participants will receive placebo twice daily with food and ADT of investigator's choice as standard therapy	Other: Androgen deprivation therapy (ADT); Luteinizing hormone-releasing hormone (LHRH) agonist/antagonists or orchiectomy; Drug: Placebo; Coated tablet matching Darolutamide in appearance, oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiological Progression-free Survival (rPFS) Assessed by Central Review	rPFS used conventional imaging method (99mTc-phosphonate bone scan, CT/MRI scan). rPFS was defined as the time from the date of randomization to the date of progressive disease in malignant soft tissue lesions, progressive disease in malignant bone lesions, or death due to any cause, whichever occurs first. Malignant soft tissue lesions were assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria and malignant bone lesions were assessed by Prostate Cancer Clinical Trials Working Group (PCWG3) criteria.	From randomization to the date when 222 rPFS events were observed, approximately 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Time from the date of randomization to the date of death from any cause.	From randomization to the date when 222 rPFS events were observed, approximately 36 months
Time to Castration-Resistant Prostate Cancer (CRPC)	Time from the date of randomization to the date of first castration resistant event (radiological progression, Prostate-specific antigen (PSA) progression or symptomatic skeletal events, whichever occurs first).	From randomization to the date when 222 rPFS events were observed, approximately 36 months
Time to Initiation of Subsequent Anti-cancer Therapy	Time from the date of randomization to initiation of first subsequent anti-cancer therapy for prostate cancer.	From randomization to the date when 222 rPFS events were observed, approximately 36 months
Time to PSA Progression	Time from the date of randomization to the date of first prostate-specific antigen (PSA) progression. PSA progression with serum testosterone being at castrate level <0.50 ng/mL, is defined as a ≥25% increase above the nadir (lowest at or after baseline) value and an increase in absolute value of ≥2 ng/mL above nadir, and is at least 12 weeks from randomization date, which is confirmed by a second value 3 or more weeks later. All PSA values between the initial assessment meeting the PSA progression criteria and confirmation assessment must be ≥2 ng/mL and ≥25% increase above nadir, serum testosterone at castrate levels <0.50 ng/mL is requested at initial assessment.	From randomization to the date when 222 rPFS events were observed, approximately 36 months
PSA Undetectable Rates (<0.2 ng/mL)	Percentage of subjects with detectable PSA values of ≥0.2 ng/mL at baseline which became undetectable with any PSA values <0.2 ng/mL during the period between randomization and 30 days after last dose of study drug or start of new anti-cancer therapy whichever occurred earliest, based on the subjects had detectable PSA value at baseline.	From randomization to the date when 222 rPFS events were observed, approximately 36 months
Time to Pain Progression	Pain progression was assessed by Question 3 (Q3) of the BPI-SF questionnaire related to the worst pain in the last 24 hours (worst pain subscale [WPS]) taken as an average for post baseline score, or initiation of short or long-acting opioids for malignant disease for ≥7 consecutive days after randomization. Pain progression was defined as: (1) for asymptomatic subjects with WPS=0 at baseline, an increase of 2 or more points in the WPS score from nadir observed at 2 consecutive evaluations ≥4 weeks apart, or initiation of short- or long-acting opioid use for malignant disease for ≥7 consecutive days after randomization; (2) for symptomatic subjects with WPS >0 at baseline, an increase of 2 or more points in the WPS score from nadir observed at 2 consecutive evaluations ≥4 weeks apart and a WPS ≥5, or initiation of short- or long-acting opioid use for malignant disease for ≥7 consecutive days after randomization.	From randomization to the date when 222 rPFS events were observed, approximately 36 months
Number of Participants With Adverse Events as a Measure of Safety	An AE is any untoward medical occurrence in a patient or clinical study participant, after providing written IC for participation in the study, may or may not be temporally associated with the use of study drug, whether or not considered related to the study drug. Treatment-emergent AE (TEAE) is defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug.	From start of study drug administration until 30 days after the last administration

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: Orion Corporation, Orion Pharma

Publications and helpful links

General Publications

• Saad F, Vjaters E, Shore N, Olmos D, Xing N, Pereira de Santana Gomes AJ, Cesar de Andrade Mota A, Salman P, Jievaltas M, Ulys A, Jakubovskis M, Kopyltsov E, Han W, Nevalaita L, Testa I, Le Berre MA, Kuss I, Haresh KP; ARANOTE Study Investigators. Darolutamide in Combination With Androgen-Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer From the Phase III ARANOTE Trial. J Clin Oncol. 2024 Dec 20;42(36):4271-4281. doi: 10.1200/JCO-24-01798. Epub 2024 Sep 16.

Helpful Links

• Click here to find further information and, after study completion, the study results according to Bayer's transparency standards

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2021
• Primary Completion (Actual): June 7, 2024
• Study Completion (Actual): January 23, 2026

Study Registration Dates

• First Submitted: January 29, 2021
• First Submitted That Met QC Criteria: January 29, 2021
• First Posted (Actual): February 3, 2021

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Metastatic hormone-sensitive prostate cancer
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Pharmacologic Actions; Chemical Actions and Uses; Androgen Antagonists; darolutamide
• Other Study ID Numbers: 21140; 2020-003093-48 (EudraCT Number); 2022-502244-12-00 (Other Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No