chufangao/CTO huggingface dataset:
Clinical trial NCT03841448: A Study of Cemdisiran in Adults With Immunoglobulin A Nephropathy (IgAN)
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Cemdisiran in Adult Patients With IgA Nephropathy
Sponsor: Alnylam Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study was terminated early having identified clinically meaningful magnitude of proteinuria reduction due to cemdisiran (study goal). Participants completed DBT period\&were in OLE period. Sponsor had no concerns with safety\&integrity of participants.
Enrollment: 31.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-09-30
Primary completion date: 2022-03-17
Completion date: 2023-06-27
Baseline population: Safety Analysis Set included all participants who received any amount of study drug.
Plan to share individual participant data: NO
Clinical trial NCT05456165: Study of an Individualized Vaccine Targeting Neoantigens in Combination With Immune Checkpoint Blockade for Patients With Colon Cancer
Official title: A Randomized, Open-Label, Phase 2 Study of a Patient-Specific Vaccine Targeting Neoantigens in Combination With Immune Checkpoint Blockade for Patients With Colon Cancer With Minimal Residual Disease Following Surgical Resection and Standard Adjuvant Chemotherapy
Sponsor: Gritstone bio, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: terminated due to reprioritization
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-05-19
Primary completion date: 2022-09-01
Completion date: 2022-09-01
Clinical trial NCT04985136: A Study of Camrelizumab Combined With Rivoceranib Mesylate Versus Investigator's Choice of Regimen in Treatment of Patients With Advanced Hepatocellular Carcinoma (HCC)
Official title: A Randomized, Open-Label, Controlled, International Multi-Center Phase III Clinical Study of Camrelizumab Combined With Rivoceranib (Apatinib) Mesylate Versus Investigator's Choice of Regimen in Treatment of Patients With Hepatocellular Carcinoma (HCC) Who Have Been Treated With Immune Checkpoint Inhibitors (ICIs)
Sponsor: Jiangsu HengRui Medicine Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Sponsor R \& D Strategy Adjustment
Enrollment: 1.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-09-26
Primary completion date: 2021-12-29
Completion date: 2021-12-29
Clinical trial NCT03439085: DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine INO-3112 and Durvalumab in Treating Patients With Recurrent or Metastatic Human Papillomavirus Associated Cancers
Official title: A Phase 2, Open-Label Study to Evaluate Efficacy of Combination Treatment With MEDI0457 (INO-3112) and Durvalumab (MEDI4736) in Patients With Recurrent/Metastatic Human Papilloma Virus Associated Cancers
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Project delays
Enrollment: 41.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-11-14
Primary completion date: 2022-09-20
Completion date: 2022-09-20
Clinical trial NCT01160211: A Study to Compare the Safety and Efficacy of an Aromatase Inhibitor in Combination With Lapatinib, Trastuzumab or Both for the Treatment of Hormone Receptor Positive, HER2+ Metastatic Breast Cancer
Official title: A Phase III Trial to Compare the Safety and Efficacy of Lapatinib Plus Trastuzumab Plus an Aromatase Inhibitor (AI) vs. Trastuzumab Plus an AI vs. Lapatinib Plus an AI as 1st- or 2nd- Line Therapy in Postmenopausal Subjects With Hormone Receptor+, HER2-positive Metastatic Breast Cancer (MBC) Who Received Prior Trastuzumab and Endocrine Therapies
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 369.0 (ACTUAL)
Number of arms: 3.0
Start date: 2011-05-05
Primary completion date: 2016-03-11
Completion date: 2022-06-06
Baseline population: Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not treatment was administered. ITT was based on the treatment to which the subject was randomized and was the primary population for the analysis of efficacy data. Any subject who received a treatment randomization # was considered to have been randomized.
Plan to share individual participant data: YES
IPD sharing description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Clinical trial NCT03267836: Neoadjuvant Avelumab and Hypofractionated Proton Radiation Therapy Followed by Surgery for Recurrent Radiation-refractory Meningioma
Official title: A Phase Ib Study of Neoadjuvant Avelumab and Hypofractionated Proton Radiation Therapy Followed by Surgery for Recurrent Radiation-refractory Meningioma
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study sponsor wanted to terminate enrollment.
Enrollment: 9.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-01-10
Primary completion date: 2023-04-06
Completion date: 2023-04-06
Plan to share individual participant data: NO
Clinical trial NCT02451111: Rituximab With or Without Ibrutinib for Patients With Advanced Follicular Lymphoma
Official title: Rituximab With or Without Ibrutinib for Untreated Patients With Advanced Follicular Lymphoma in Need of Therapy. A Randomized, Double-blinded, SAKK and NLG Collaborative Phase II Trial.
Sponsor: Swiss Group for Clinical Cancer Research (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The premature termination is based on the decision by the SAKK board on November 14, 2020 due to the lack of further financial support for the follow up period.
Enrollment: 190.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-11-06
Primary completion date: 2022-12-01
Completion date: 2023-07-15
Plan to share individual participant data: NO
Clinical trial NCT04015492: Study to Compare How the Body Distributes and Excretes the Drugs Jivi (BAY 94-9027) and Adynovi in Patients With Severe Hemophilia A (Bleeding Disorder Resulting From a Lack of Blood Clotting Factor VIII)
Official title: Single Dose, Open Label, Randomized, Cross-over Study in Participants With Severe Hemophilia A Comparing Pharmacokinetic Parameters of BAY 94-9027 and Adynovi
Sponsor: Bayer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 18.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-08
Primary completion date: 2019-10-25
Completion date: 2020-01-29
Plan to share individual participant data: UNDECIDED
IPD sharing 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.
Clinical trial NCT01557244: A Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With Bladder Overactivity Caused By A Neurological Condition
Official title: A 24-WEEK RANDOMIZED, OPEN-LABEL, STUDY TO EVALUATE THE SAFETY AND EFFICACY OF FESOTERODINE IN SUBJECTS AGED 6 TO 17 YEARS WITH SYMPTOMS OF DETRUSOR OVERACTIVITY ASSOCIATED WITH A NEUROLOGICAL CONDITION (NEUROGENIC DETRUSOR OVERACTIVITY)
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 181.0 (ACTUAL)
Number of arms: 5.0
Start date: 2012-07-02
Primary completion date: 2019-11-07
Completion date: 2020-02-13
Baseline population: Analysis population included all randomized participants.
Plan to share individual participant data: YES
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 NCT02876094: Effect of Low-Dose Celecoxib on SMN2 in Patients With Spinal Muscular Atrophy
Official title: A Pilot, Open-Label, Dose Response Study Investigating the Effect of Low-Dose Celecoxib on SMN2 in Patients With Spinal Muscular Atrophy (SMA)
Acronym: SMA
Sponsor: Children's Hospital of Eastern Ontario (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Terminated: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-01-29
Primary completion date: 2020-08-06
Completion date: 2020-08-06
Plan to share individual participant data: YES
IPD sharing description: Results will be submitted for presentation at an international meeting and subsequently submitted for publication in a major international peer-reviewed medical journal.
Clinical trial NCT03959553: GV1001 Subcutaneous(SC) for the Treatment of Moderate Alzheimer's Disease (AD)
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Prospective, Phase IIa Clinical Trial to Evaluate the Safety and Efficacy of GV1001 Administered Subcutaneously for the Treatment of Moderate Alzheimer's Disease
Sponsor: GemVax & Kael (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: The study was stopped due to protocol amendment and project name change.
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-09-01
Primary completion date: 2021-08-31
Completion date: 2022-02-28
Plan to share individual participant data: NO
Clinical trial NCT04425629: Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Adult and Pediatric Patients With COVID-19
Official title: A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Patients With COVID-19
Sponsor: Regeneron Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Emerging SARS-CoV-2 variants impacting susceptibility to study drug
Enrollment: 10078.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-06-16
Primary completion date: 2022-01-21
Completion date: 2022-06-09
Limitations and caveats: Nasal and saliva sample collection was discontinued early in the study because nasopharyngeal samples were determined to be more reliable for quantitative analysis, as such endpoints related to nasal or saliva samples were not analyzed. The Phase 1/2 SAP does not specify any analyses related to nasal and saliva samples collections
Plan to share individual participant data: YES
IPD sharing description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
IPD time frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification
IPD access criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
Clinical trial NCT04056611: Effects of JNJ-53718678 in Adult and Adolescent Participants Who Had a Hematopoietic Stem Cell Transplantation and Who Are Infected With Respiratory Syncytial Virus (RSV)
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Clinical Outcomes, Antiviral Activity, Safety, Tolerability, Pharmacokinetics, and Pharmacokinetics/Pharmacodynamics of JNJ-53718678 in Adult and Adolescent Hematopoietic Stem Cell Transplant Recipients With Respiratory Syncytial Virus Infection of the Upper Respiratory Tract
Acronym: FREESIA
Sponsor: Janssen Sciences Ireland UC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: A strategic decision was made to discontinue the study. The decision was not based on a safety concern.
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-12-26
Primary completion date: 2022-02-04
Completion date: 2022-02-04
Limitations and caveats: As the study was terminated early due to low number of participants enrolled, some efficacy analyses were not performed as per change in the planned analysis. Hence, data were collected and analyzed for safety and selected efficacy parameters only.
Plan to share individual participant data: YES
IPD sharing description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu
Clinical trial NCT03988023: Study of Ampion for the Treatment of Pain and Function in Patients With Severe Osteoarthritis of the Knee.
Official title: A Randomized, Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of an Intra-Articular Injection of Ampion in Adults With Pain Due to Severe Osteoarthritis of the Knee.
Sponsor: Ampio Pharmaceuticals. Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The AP-013 study was prematurely terminated by the sponsor after Data Safety Monitoring Board (DSMB) guidance.
Enrollment: 1043.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-24
Primary completion date: 2021-07-13
Completion date: 2021-07-13
Limitations and caveats: The AP-013 study was prematurely terminated by the sponsor after Data Safety Monitoring Board (DSMB) guidance.
Plan to share individual participant data: NO
Clinical trial NCT03629210: Combination OZURDEX® & EyLea® vs. OZURDEX® Monotherapy in IncompLete-Responders wIth Diabetic Macular Edema
Official title: Combination OZURDEX® & EyLea® vs. OZURDEX® Monotherapy in IncompLete-Responders wIth Diabetic Macular Edema (COLLIDE)
Acronym: COLLIDE
Sponsor: North Toronto Eye Care Laser and Eye Specialists (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study funding discontinued
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-30
Primary completion date: 2021-02-28
Completion date: 2021-05-31
Plan to share individual participant data: NO
Clinical trial NCT04882072: A Study of Ustekinumab in Participants With Takayasu Arteritis (TAK)
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Participants With Takayasu Arteritis
Sponsor: Janssen Pharmaceutical K.K. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Due to difficulties in enrollment and ongoing feasibility issues
Enrollment: 14.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-15
Primary completion date: 2023-05-25
Completion date: 2023-05-25
Plan to share individual participant data: YES
IPD sharing description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Clinical trial NCT03090880: Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer (PROVE)
Official title: Long-term Prophylaxis of Venous Thromboembolism With Low-molecular-weight Heparin in Patients With Metastatic Lung Cancer
Acronym: PROVE
Sponsor: Assistance Publique - Hôpitaux de Paris (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The rate of inclusion is too low to hope to reach the target of 800 patients. 59 patients were included, and their data will not meet the research objectives.~The sponsor has decided to prematurely stop inclusions on January 13, 2022.
Enrollment: 59.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-09-14
Primary completion date: 2021-08-18
Completion date: 2021-08-18
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04185311: Ipilimumab, Nivolumab, and Talimogene Laherparepvec Before Surgery in Treating Participants With Localized, Triple-Negative or Estrogen Receptor Positive, HER2 Negative Breast Cancer-deleted
Official title: A Phase 1 Study of Ipilumumab, Nivolumab and Talimogene Laherparepvec Preoperative Treatment of Localized Breast Cancer-deleted
Sponsor: Jonsson Comprehensive Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: enrollment
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-07-10
Primary completion date: 2023-05-17
Completion date: 2023-05-17
Clinical trial NCT03001882: An Exploratory Study of the Effects of Nivolumab Combined With Ipilimumab in Patients With Treatment-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)
Official title: An Exploratory Study of the Biologic Effects and Biomarkers of Nivolumab in Combination With Ipilimumab in Subjects With Treatment-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)
Acronym: CheckMate 592
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 230.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-03-29
Primary completion date: 2022-02-17
Completion date: 2023-04-24
Clinical trial NCT04901676: Leronlimab in Moderately Ill Patients With COVID-19 Pneumonia
Official title: A Phase 3, Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Leronlimab in Combination With Standard of Care for Moderately Ill Patients With Coronavirus Disease 2019 (COVID-19) Pneumonia
Sponsor: Hospital Israelita Albert Einstein (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: SUSPENDED 
Why stopped: Pending DSMB evaluation
Enrollment: 612.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2021-09-09
Primary completion date: 2023-01-31
Completion date: 2023-02-28
Plan to share individual participant data: NO
Clinical trial NCT05092646: Evaluating Intra-articular Injection of Axolotl Ambient Compared to Saline in Subjects With Ankle Osteoarthritis
Official title: A Double-blind, Multi-Center, Prospective, Randomized Placebo-controlled Pilot Study Evaluating Intra-articular Injection of Axolotl Ambient Compared to Saline in Subjects With Ankle Osteoarthritis
Acronym: Phoenix
Sponsor: Axolotl Biologix (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Study stopped due to lack of enrollment
Enrollment: 12.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-12-01
Primary completion date: 2023-11-10
Completion date: 2023-11-10
Plan to share individual participant data: NO
Clinical trial NCT03861364: Hemodynamics During Induction of General Anesthesia With High and Low Propofol Dose.
Official title: Haemodynamic Stability During Induction of General Anesthesia With Propofol and Remifentanil: A Randomized, Controlled, Double-blind Study Comparing Low vs High Propofol Doses.
Acronym: PH
Sponsor: Helse Fonna (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 68.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-03
Primary completion date: 2020-05-19
Completion date: 2020-05-31
Plan to share individual participant data: YES
IPD sharing description: LiDCO-csv raw data and processed data will be made public at the publishers site, and the supporting information by request to the Principal Investigator. Statistical Data Plan is included in Study Protocol.
IPD time frame: The data will be stored for 15 years after end of study, and may be shared during this time frame.
IPD access criteria: The data may be shared by contacting the Principal Investigator.
Clinical trial NCT03510715: An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia
Official title: An Open-Label Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 18.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-08-31
Primary completion date: 2020-02-17
Completion date: 2020-02-17
Baseline population: Analysis was performed on all enrolled participants.
Plan to share individual participant data: NO
Clinical trial NCT04354103: Atomoxetine in Patients With Tourette's Syndrome
Official title: A Pilot Study to Evaluate the Effects of Atomoxetine on Impulsivity in Patients With Tourette's Syndrome
Acronym: ATO-TS
Sponsor: Poitiers University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: experimental treatment (Atomoxetine) not available
Enrollment: 5.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-05-31
Primary completion date: 2024-01-19
Completion date: 2024-01-19
Plan to share individual participant data: NO
Clinical trial NCT05127486: A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine
Official title: A Phase 4, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Galcanezumab Versus Rimegepant in Adult Participants With Episodic Migraine
Acronym: CHALLENGE-MIG
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 580.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-12-06
Primary completion date: 2023-05-23
Completion date: 2023-05-23
Baseline population: All randomized participants.
Plan to share individual participant data: YES
IPD sharing description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
IPD access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.