chufangao/CTO huggingface dataset:
Clinical trial NCT00195091: Phase II Study of Tetrathiomolybdate (TM) in Patients With Breast Cancer
Official title: A Phase II Study of Tetrathiomolybdate (TM) in Patients With Breast Cancer at Moderate to High Risk of Recurrence
Sponsor: Memorial Sloan Kettering Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: PI left MSKCC
Enrollment: 16.0 (ACTUAL)
Number of arms: 1.0
Start date: 2003-12-31
Primary completion date: 2023-03-02
Completion date: 2023-03-02
Plan to share individual participant data: YES
IPD sharing description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Clinical trial NCT03836716: Arimoclomol in Amyotropic Lateral Sclerosis - Open Label Extension Trial
Official title: Open Label, Non-randomized Extension Trial to Assess Long Term Safety and Efficacy of Arimoclomol in Subjects With Amyotropic Lateral Sclerosis Who Have Completed the ORARIALS-01 Trial
Sponsor: ZevraDenmark (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: As a consequence of the results of ORARIALS-01 which did not meet any of its efficacy endpoints. The planned duration was 152 weeks. After termination, the actual mean duration of treatment was approx. 28 weeks (range approx. 2 to 71 weeks).
Enrollment: 120.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-09-19
Primary completion date: 2021-07-02
Completion date: 2021-07-02
Limitations and caveats: Early termination led to data for a limited number of patients. No conclusions can be drawn from the laboratory results due to data for only a few patients.
Clinical trial NCT04322123: Safety and Efficacy of Hydroxychloroquine Associated With Azithromycin in SARS-Cov-2 Virus (COVID-19)
Official title: An Open-label, Randomized Controlled Trial of Hydroxychloroquine and Azithromycin for COVID-19 Infection on Hospitalized, Noncritical Patients
Acronym: Coalition-I
Sponsor: Hospital do Coracao (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 667.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-04-01
Primary completion date: 2020-06-02
Completion date: 2020-06-02
Plan to share individual participant data: NO
Clinical trial NCT05788328: A Drug-Drug Interaction Study to Estimate the Effect of PF-07081532 on the Pharmacokinetics of Dabigatran and Rosuvastatin in Overweight or Obese Adult Participants
Official title: A PHASE 1, OPEN-LABEL, FIXED-SEQUENCE STUDY TO ESTIMATE THE EFFECT OF PF-07081532 ADMINISTRATION ON THE SINGLE-DOSE PHARMACOKINETICS OF DABIGATRAN AND ROSUVASTATIN IN OVERWEIGHT OR OBESE ADULT PARTICIPANTS
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The decision to terminate clinical development of lotiglipron is based on pharmacokinetic data from Phase 1 drug-drug-interaction studies and laboratory measurements of elevated transaminases in these Phase 1 studies as well as a Phase 2 study.
Enrollment: 16.0 (ACTUAL)
Number of arms: 8.0
Start date: 2023-03-27
Primary completion date: 2023-09-11
Completion date: 2023-09-11
Plan to share individual participant data: NO
IPD sharing description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Clinical trial NCT04209725: A Study of CPX-351 (Vyxeos™) With Quizartinib for the Treatment of FLT3-ITD Mutation-Positive Acute Myeloid Leukemia
Official title: A Phase II Study Assessing CPX-351 (Vyxeos™) With Quizartinib for the Treatment of Relapsed or Refractory FLT3-ITD Mutation-Positive AML
Sponsor: SCRI Development Innovations, LLC (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Closed due to slow enrollment
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-06-03
Primary completion date: 2021-04-20
Completion date: 2021-04-20
Baseline population: Only 1 patient was enrolled and treated before study was terminated due to slow accrual
Clinical trial NCT04124926: Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Erosive Esophagitis
Official title: A Phase 3, Randomized, Double-Blind, Two Phase, Multicenter Study to Evaluate the Efficacy and Safety of Vonoprazan 20 mg Compared to Lansoprazole 30 mg for Healing in Patients With Erosive Esophagitis and to Evaluate the Efficacy and Safety of Vonoprazan (10 mg and 20 mg) Compared to Lansoprazole 15 mg for the Maintenance of Healing in Patients With Healed Erosive Esophagitis
Sponsor: Phathom Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1027.0 (ACTUAL)
Number of arms: 5.0
Start date: 2019-10-28
Primary completion date: 2021-07-29
Completion date: 2021-08-24
Baseline population: The Randomized Set included all participants randomly assigned to receive study drug regardless of whether or not they received a dose of study drug.
Plan to share individual participant data: UNDECIDED
IPD sharing description: Data from this study will be published; however, it is undecided if patient level data will be made available at this time.
Clinical trial NCT02929329: Registrational Study With Omecamtiv Mecarbil (AMG 423) to Treat Chronic Heart Failure With Reduced Ejection Fraction
Official title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection Fraction (GALACTIC-HF)
Acronym: GALACTIC-HF
Sponsor: Cytokinetics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 8256.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-01-06
Primary completion date: 2020-09-14
Completion date: 2020-09-14
Baseline population: The full analysis set included all the randomized participants except for 24 patients from a single site who were excluded on the basis of Good Clinical Practice violations.
Plan to share individual participant data: YES
IPD sharing description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
IPD time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Clinical trial NCT05056779: Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis With Inadequate Response to or for Whom Cyclosporine A is Not Medically Advisable
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis With Inadequate Response to or for Whom Cyclosporine A is Not Medically Advisable
Sponsor: Galderma R&D (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: The study data will not be utilized in the IND and is only being conducted in EU.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-01-31
Primary completion date: 2023-07-31
Completion date: 2023-07-31
Clinical trial NCT00424099: Methylphenidate and a Nursing Telephone Intervention for Fatigue
Official title: A Randomized Controlled Trial of Methylphenidate and a Nursing Telephone Intervention (NTI) for Fatigue in Advanced Cancer Patients
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 197.0 (ACTUAL)
Number of arms: 4.0
Start date: 2007-01-09
Primary completion date: 2021-11-22
Completion date: 2021-11-22
Baseline population: Analyses included all randomized participants
Clinical trial NCT03151681: The Trauma of Betrayal: Treating Adjustment Disorder With Reconsolidation Blockade Under Propranolol
Official title: Treating Adjustment Disorders Stemming From Romantic Betrayals: An Open-label Trial of Impairing Memory Reconsolidation Using Propranolol
Sponsor: Douglas Mental Health University Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 84.0 (ACTUAL)
Number of arms: 3.0
Start date: 2015-11-01
Primary completion date: 2020-09-30
Completion date: 2022-06-06
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03093974: Efficacy and Safety of Inhaled CMS in Bronchiectasis Subjects With Chronic P. Aeruginosa Infection. (PROMIS-I)
Official title: Double-blind, Placebo-controlled, Clinical Trial on Efficacy and Safety of 12-months Therapy With Inhaled Colistimethate Sodium in the Treatment of Subjects With Non-cystic Fibrosis Bronchiectasis Chronically Infected With P. Aeruginosa
Acronym: PROMIS-I
Sponsor: Zambon SpA (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 377.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-06-06
Primary completion date: 2021-04-09
Completion date: 2021-04-09
Baseline population: The Intention-To-Treat Population will include all subjects who provided informed consent and received a patient number (randomisation number) whether or not they receive IMP.
Plan to share individual participant data: NO
Clinical trial NCT04498182: A Phase 2b Study Evaluating the Safety and Efficacy of AR-15512 Ophthalmic Solution for the Treatment of Dry Eye Disease
Official title: A Phase 2b Study Evaluating the Safety and Efficacy of AR-15512 Ophthalmic Solution for the Treatment of Dry Eye Disease (COMET-1)
Acronym: COMET-1
Sponsor: Aerie Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 369.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-10-26
Primary completion date: 2021-07-17
Completion date: 2021-07-17
Baseline population: All randomized participants
Plan to share individual participant data: NO
Clinical trial NCT04349228: Assessment of the Efficacy and Safety of (HCQ) as a Prophylaxis for COVID19 for Health Professionals
Official title: Assessment of the Efficacy and Safety of Hydroxychloroquine (HCQ) Administered as a Prophylaxis for Health Professionals Exposed to COVID19 and Working in Medical Intensive Care Units, in Tunisia. Multicentric Randomized Comparative Study
Acronym: COVID_2Pro
Sponsor: Abderrahmane Mami Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: - Interest in the use of HCQ is controversial.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-28
Primary completion date: 2020-07-15
Completion date: 2020-07-15
Plan to share individual participant data: NO
Clinical trial NCT03469284: MOM's PAIN (Methylene Blue for Oral Mucositis' PAIN)
Official title: Randomized Controlled Trial Comparing 4 Intervention Arms, Including 3 Different Concentrations of Methylene Blue Oral Rinse Combined With Conventional Therapy and Conventional Therapy, in Patients With Intractable Pain Associated With Oral Mucositis
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 69.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-02-28
Primary completion date: 2022-02-03
Completion date: 2022-02-03
Clinical trial NCT03081052: Inhaled Selective Pulmonary Vasodilators for Advanced Heart Failure Therapies and Lung Transplantation Outcomes
Official title: Inhaled Selective Pulmonary Vasodilators for Advanced Heart Failure Therapies and Lung Transplantation Outcomes
Acronym: INSPIRE-FLO
Sponsor: Duke University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 519.0 (ACTUAL)
Number of arms: 4.0
Start date: 2017-05-04
Primary completion date: 2020-10-05
Completion date: 2021-09-05
Baseline population: Patients who were consented and randomized, but excluded or withdrawn prior to surgery and treatment are not included in this cohort description. No participant data was retained after patient exclusion or withdrawal prior to surgery and treatment.
Plan to share individual participant data: NO
Clinical trial NCT01464164: Safety and Efficacy Study of Sotatercept in Adults With Transfusion Dependent Diamond Blackfan Anemia
Official title: Phase I/II, Open-Label Study to Determine Safety and Efficacy of Sotatercept (ACE-011) in Adults With Red Blood Cell Transfusion- Dependent Diamond Blackfan Anemia
Acronym: ACE-011-DBA
Sponsor: Northwell Health (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Supporter terminated the study due to no active patients (secondary to travel restrictions due to COVID).
Enrollment: 19.0 (ACTUAL)
Number of arms: 2.0
Start date: 2012-01-31
Primary completion date: 2021-04-13
Completion date: 2021-04-13
Baseline population: There were no subjects in Cohort 5a at the time of the closure of the study.
Limitations and caveats: Early termination of 3 subjects lead to small numbers of subjects analyzed, as does the early closure of the study.~Time to response was unable to be evaluated as no subjects attained response. Response duration was also not evaluated as no subjects responded.
Plan to share individual participant data: NO
Clinical trial NCT03759587: Japan Phase 2 Study of Niraparib (Maintenance Therapy) in Participants With Relapsed Ovarian Cancer
Official title: A Phase 2, Multicenter, Open-label, Single-arm Study to Evaluate the Safety of Niraparib in Japanese Patients With Platinum-sensitive, Relapsed Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Achieved CR or PR in the Last Chemotherapy Containing Platinum-based Anticancer Agents
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 19.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-12-28
Primary completion date: 2019-03-17
Completion date: 2022-12-28
Baseline population: Safety Analysis Set included participants who received at least 1 dose of study drug.
Plan to share individual participant data: YES
IPD sharing description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Clinical trial NCT05342623: A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled 12-Week Study to Evaluate the Safety and Efficacy of Oral Difelikefalin in Advanced Chronic Kidney Disease Subjects With Moderate-to-Severe Pruritus With an up to 52-Week Long-term Extension
Sponsor: Cara Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Corporate decision to discontinue work in advanced chronic kidney disease.
Enrollment: 286.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-05-17
Primary completion date: 2024-02-29
Completion date: 2024-02-29
Plan to share individual participant data: NO
Clinical trial NCT04322604: A Study to Assess AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AK002 in Patients With Moderately to Severely Active Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)
Acronym: ENIGMA 2
Sponsor: Allakos Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 181.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-18
Primary completion date: 2021-11-29
Completion date: 2022-01-12
Plan to share individual participant data: NO
Clinical trial NCT02333344: The Efficacy Study of Aclasta on Prosthetic Fixation in Postmenopausal Women After THA
Official title: The Efficacy Study of Aclasta (Zoledronic Acid 5mg) on Prosthetic Fixation in Postmenopausal Women After Cementless Total Hip Arthroplasty (THA): a 24 Months, Single Center, Open- Label, Randomized, Parallel Controlled Study
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Study halted prematurely, prior to enrollment of first participant, for strategic reasons
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-07-30
Primary completion date: 2020-01-28
Completion date: 2020-01-28
Clinical trial NCT04751955: A Phase lb/ll, Open Label, Single Arm Study With Olinvacimab and Capecitabine in mCRC Patients (OLCAP)
Official title: A Phase lb/ll, Multicenter, Open Label, Single Arm Study to Assess the Safety and Efficacy of the Anti-VEGFR2 Monoclonal Antibody Olinvacimab and the Capecitabine in Patients With mCRC Who Failed Two Prior Chemotherapies
Sponsor: Korean Cancer Study Group (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: This clinical trial was not finally approved by the Korea FDA.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-01-01
Primary completion date: 2023-10-31
Completion date: 2024-08-31
Plan to share individual participant data: NO
Clinical trial NCT04349280: A Study to Evaluate the Efficacy and Safety of Bintrafusp Alfa (M7824) Monotherapy in Metastatic or Locally Advanced Urothelial Cancer
Official title: A Phase Ib Trial to Evaluate the Efficacy and Safety of Bintrafusp Alfa Monotherapy in Metastatic or Locally Advanced/Unresectable Urothelial Cancer With Disease Progression or Recurrence Following Treatment With a Platinum Agent
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Primary investigator withdrew the participant due to an SAE
Enrollment: 25.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-10-15
Primary completion date: 2022-08-15
Completion date: 2022-08-15
Plan to share individual participant data: YES
IPD sharing description: IPD for this study will be made available via the Clinical Study Data Request site.
IPD time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
IPD access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Clinical trial NCT02040857: Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive, HER2 Negative Invasive Breast Cancer
Official title: A Phase 2 Pilot Feasibility Study of Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive Invasive Breast Carcinoma
Sponsor: Dana-Farber Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 162.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-01-31
Primary completion date: 2018-05-31
Completion date: 2020-05-31
Plan to share individual participant data: NO
Clinical trial NCT03291886: Phase 2 Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer
Official title: Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer
Sponsor: Kyowa Kirin Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 133.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-09-22
Primary completion date: 2019-04-04
Completion date: 2021-03-26
Plan to share individual participant data: NO
Clinical trial NCT02639182: A Study of AGS-16C3F vs. Axitinib in Metastatic Renal Cell Carcinoma
Official title: A Multi-Center, Open Label, Randomized Phase 2 Study of AGS-16C3F vs. Axitinib in Metastatic Renal Cell Carcinoma
Sponsor: Astellas Pharma Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 133.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-05-03
Primary completion date: 2020-10-02
Completion date: 2020-10-02
Baseline population: Full Analysis Set (FAS): All participants who were randomized to study drug.
Plan to share individual participant data: YES
IPD sharing description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
IPD time frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
IPD access criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.