chufangao/CTO huggingface dataset:
Clinical trial NCT06400264: Testing Nivolumab and BMS-986016 (Relatlimab) as Potentially Targeting Treatment in Cancers That Are LAG-3+ and Have Mismatch Repair Deficiency (MATCH - Subprotocol Z1M)
Official title: MATCH Treatment Subprotocol Z1M: Phase 2 Study of Nivolumab and BMS-986016 (Relatlimab) in Patients With LAG-3+ Tumors With Mismatch Repair Deficiency (MMR-d) After Progression on Anti-PD-1/PD-L1 Therapy
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: No result will be reported- no patient accrued. Status Withdrawn: Study halted prematurely, prior to enrollment of first participant.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-02-22
Primary completion date: 2023-01-17
Completion date: 2023-01-17
Plan to share individual participant data: YES
IPD sharing description: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Clinical trial NCT01904136: Natural Killer Cells Before and After Donor Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia
Official title: A Phase I/II Clinical Trial of NK Cells Administration to Prevent Disease Relapse for Patient With High-Risk Myeloid Malignancies Undergoing Haploidentical Stem-Cell Transplantation
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 54.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-04-22
Primary completion date: 2022-02-28
Completion date: 2022-02-28
Baseline population: Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
Clinical trial NCT03944902: CB-839 in Combination With Niraparib in Platinum Resistant BRCA -Wild-type Ovarian Cancer Patients
Official title: Phase 1 Trial of CB-839 in Combination With Niraparib in Platinum Resistant BRCA-wild-type Ovarian Cancer Patients
Acronym: BRCA
Sponsor: University of Alabama at Birmingham (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: will not resume. company choosing not to continue with drug. one participant now off study.
Enrollment: 1.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-09-01
Primary completion date: 2022-01-05
Completion date: 2022-01-05
Plan to share individual participant data: YES
IPD sharing description: To be determined.
IPD time frame: The above documents will be posted on CT.gov and available as long as study record is posted.
IPD access criteria: To be determined.
Clinical trial NCT02965443: Dapagliflozin + Saxagliptin in a Basal-bolus Insulin Treatment
Official title: Effectiveness of Dapagliflozin + Saxagliptin to Revert From a Basal-bolus Insulin Treatment (BBIT) Regimen to a Basal Supported Oral Therapy (BOT) in Patients With Type 2 Diabetes
Acronym: DapaSaxaBBIT
Sponsor: University Hospital Tuebingen (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Low patient recruitment
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-02-02
Primary completion date: 2020-02-03
Completion date: 2020-02-03
Plan to share individual participant data: NO
Clinical trial NCT02915744: A Study of Etirinotecan Pegol (NKTR-102) Versus Treatment of Physician's Choice (TPC) in Patients With Metastatic Breast Cancer Who Have Stable Brain Metastases and Have Been Previously Treated With an Anthracycline, a Taxane, and Capecitabine
Official title: A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 Versus Treatment of Physician's Choice (TPC) in Patients With Metastatic Breast Cancer Who Have Stable Brain Metastases and Have Been Previously Treated With an Anthracycline, a Taxane, and Capecitabine
Acronym: ATTAIN
Sponsor: Nektar Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 178.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-11-30
Primary completion date: 2020-07-31
Completion date: 2020-07-31
Clinical trial NCT05491603: A Trial to Evaluate the Safety and Efficacy of DBI-001 Gel, DBI-002 Gel, and Aqueous Gel in Subjects With Onychomycosis
Official title: An Observer-Blinded, Randomized, Aqueous Gel-Controlled Trial of the Safety and Efficacy of DBI-001 Gel, DBI-002 Gel, and Aqueous Gel in Subjects With Onychomycosis
Sponsor: DermBiont, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: SUSPENDED 
Why stopped: Suspended: Study halted prematurely but potentially will resume. Sponsor suspension, and not due to safety or site-related matters.
Enrollment: 60.0 (ESTIMATED)
Number of arms: 3.0
Start date: 2023-11-30
Primary completion date: 2023-11-30
Completion date: 2023-11-30
Clinical trial NCT01313429: Tumor Cell Vaccine for Patients Undergoing Surgery for Sarcomas, Melanomas, Germ Cell Tumors, or Malignancies That Have Metastasized to the Lungs, Pleura, or Mediastinum
Official title: Adjuvant Allogeneic Tumor Cell Vaccine With Metronomic Oral Cyclophosphamide and Celecoxib in Patients Undergoing Resection of Sarcomas, Melanomas, Germ Cell Tumors, or Epithelial Malignancies Metastatic to Lungs, Pleura, or Mediastinum
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Per stopping rule if 12 patients underwent immune response analysis after 6 vaccinations and none developed a response, the protocol would stop accrual.
Enrollment: 19.0 (ACTUAL)
Number of arms: 1.0
Start date: 2011-03-04
Primary completion date: 2020-02-26
Completion date: 2020-02-26
Clinical trial NCT02412631: Addressing Post Cessation Weight Gain
Official title: Varenicline and Lorcaserin for Smoking Cessation and Weight Gain Prevention
Sponsor: Mayo Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Lorcaserin removed from market
Enrollment: 84.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-06-15
Primary completion date: 2020-04-17
Completion date: 2020-04-17
Plan to share individual participant data: NO
Clinical trial NCT04500548: Testing the Combination of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) in Children, Adolescent, and Young Adult Patients With Relapsed/Refractory Cancers That Have an Increased Number of Genetic Changes, The 3CI Study
Official title: 3CI Study: Childhood Cancer Combination Immunotherapy. Phase Ib and Expansion Study of Nivolumab Combination Immunotherapy in Children, Adolescent and Young Adult (CAYA) Patients With Relapsed/Refractory Hypermutant Cancers
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Inadequate accrual rate
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-28
Primary completion date: 2022-06-21
Completion date: 2022-06-21
Plan to share individual participant data: YES
IPD sharing description: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Clinical trial NCT04178447: Pharmacokinetic Profile of Glepaglutide After a Single Injection in Subjects With Varying Degrees of Renal Function
Official title: An Open-label, Multi-center Trial to Evaluate the Pharmacokinetic Profile of Glepaglutide After a Single Subcutaneous Injection in Subjects With Varying Degrees of Renal Function
Sponsor: Zealand Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 16.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-12-10
Primary completion date: 2020-07-14
Completion date: 2020-07-14
Plan to share individual participant data: NO
Clinical trial NCT02891226: A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's Disease
Official title: A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo-Controlled Study of LY3074828 in Subjects With Active Crohn's Disease (SERENITY)
Acronym: SERENITY
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 191.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-12-14
Primary completion date: 2018-12-11
Completion date: 2021-02-05
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 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.
Clinical trial NCT05409235: Nesvategrast (OTT166) in Diabetic Retinopathy (DR)
Official title: OTT166-201 A Phase 2 Randomized, Double-Masked, Vehicle-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of OTT166 Ophthalmic Solution in the Treatment of Diabetic Retinopathy (DR)
Sponsor: OcuTerra Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 225.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-07-29
Primary completion date: 2023-12-29
Completion date: 2023-12-29
Limitations and caveats: \[Not specified\]
Plan to share individual participant data: NO
Clinical trial NCT03935347: Adoptive Cell Therapy With (LN-145) in Combination With Pembrolizumab in Treating Patients With Unresectable or Metastatic Transitional Cell Cancer Who Have Failed Cisplatin-Based Chemotherapy
Official title: Phase 2 Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) With Pembrolizumab, in Subjects Who Have Failed Cisplatin-Based Chemotherapy With Locally Advanced (Unresectable) or Metastatic Transitional Cell Cancer (TCC) of the Urothelium
Sponsor: Roswell Park Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: no accrual
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-06-20
Primary completion date: 2022-05-01
Completion date: 2023-05-01
Plan to share individual participant data: NO
Clinical trial NCT04272203: A Study to Determine Safety, Tolerability, Pharmacokinetics, and Recommended Phase 2 Dose (RP2D) of Intravenous ABBV-184 in Adult Participants With Previously Treated Cancers
Official title: A Phase 1 First in Human, Multicenter, Open-Label Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics, and RP2D of ABBV-184 in Subjects With Previously Treated Cancers
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Strategic considerations
Enrollment: 14.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-05-05
Primary completion date: 2022-06-27
Completion date: 2022-06-27
Plan to share individual participant data: NO
Clinical trial NCT03519984: EphB4-HSA Fusion Protein and Cytarabine /or Liposomal Vincristine in Patients With Recurrent or Refractory Acute Leukemia
Official title: A Phase I Dose Escalation Study With Expansion to Evaluate the Safety of SEPHB4-HSA in Combination With Cytarabine or Liposomal Vincristine in Patients With Relapsed or Refractory Acute Leukemia
Sponsor: University of Southern California (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study drug supply issue
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-05-09
Primary completion date: 2020-11-24
Completion date: 2020-11-24
Clinical trial NCT04451187: A Study of Oral Seltorexant as an add-on Medication to an Antidepressant on On-road Driving Performance in Participants With Major Depressive Disorder
Official title: A Multicentric, Randomized, Double-Blind, Placebo- and Positive-Controlled 4-way Crossover Study to Evaluate the Effects of Single and Repeated Administration of Oral Seltorexant as an add-on Medication to an Antidepressant on On-Road Driving Performance in Participants With Major Depressive Disorder
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 63.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-07-16
Primary completion date: 2023-03-16
Completion date: 2023-03-16
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 NCT03130348: Ibrutinib With or Without Bortezomib and Dexamethasone in Treating Patients With Relapsed or Refractory Immunoglobulin Light Chain Amyloidosis
Official title: Phase II Study of Ibrutinib With or Without Bortezomib and Dexamethasone for the Treatment of Patients With Relapsed/Refractory Immunoglobulin Light Chain Amyloidosis
Sponsor: Mayo Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study was dropped at site before participation
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-03-15
Primary completion date: 2022-04-30
Completion date: 2022-04-30
Clinical trial NCT01898793: Cytokine-induced Memory-like NK Cells in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Official title: A Phase 1/2 Study of Cytokine-Induced Memory-Like NK Cells in Patients With AML or MDS
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Insufficient funding/staff
Enrollment: 89.0 (ACTUAL)
Number of arms: 7.0
Start date: 2014-08-11
Primary completion date: 2021-12-28
Completion date: 2022-04-04
Plan to share individual participant data: NO
Clinical trial NCT03200093: Oral Vancomycin for Preventing Clostridium Difficile Recurrence
Official title: Secondary Prophylaxis With Oral Vancomycin for Clostridium Difficile Recurrence: A Randomized Control Study
Sponsor: Rochester General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Low recruitment due to few eligible participants.
Enrollment: 65.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-06-08
Primary completion date: 2021-04-22
Completion date: 2021-04-22
Plan to share individual participant data: NO
Clinical trial NCT04769869: A Clinical Trial in Healthy Volunteers and Patients With Mild Asthma to Investigate a New Medicine (AZD4604) for the Treatment of Asthma
Official title: A Single-blind, Randomized, Placebo-controlled 3 Part Study in Healthy Volunteers and Patients With Mild Asthma to Investigate the Safety, Tolerability, and Pharmacokinetics of Inhaled AZD4604 Following Single and Multiple Ascending Doses and to Investigate the Anti-inflammatory Effect of Inhaled AZD4604
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 110.0 (ACTUAL)
Number of arms: 19.0
Start date: 2022-07-08
Primary completion date: 2023-01-24
Completion date: 2023-01-24
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please re-refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Clinical trial NCT05368558: Study to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With Schizophrenia
Official title: A 6-Week, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Cariprazine in the Acute Exacerbation of Schizophrenia, With an Additional 18-Week Blinded Extension Period
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Business Decision
Enrollment: 34.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-08-18
Primary completion date: 2024-09-20
Completion date: 2024-09-20
Plan to share individual participant data: YES
IPD sharing description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Clinical trial NCT02554383: Efficacy of Antibiotics in Children With Acute Sinusitis: Which Subgroups Benefit?
Official title: Efficacy of Antibiotics in Children With Acute Sinusitis: Which Subgroups Benefit?
Sponsor: University of Pittsburgh (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 515.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-02-29
Primary completion date: 2022-03-31
Completion date: 2023-03-09
Baseline population: 515 children underwent randomization; 257 were randomized to the amoxicillin-clavulanate group and 258 to the placebo group. 3 and 2, respectively, were found ineligible after randomization. The remaining 254 and 256 participants, respectively, were the basis for analysis.
Plan to share individual participant data: YES
Clinical trial NCT03931551: Olaparib+Trastuzumab in HER2[+],Breast Cancer Susceptibility Gene (BRCA) Mutated Advanced Breast Cancer
Official title: Effectiveness of Olaparib Plus Trastuzumab in HER2-positive BRCA-mutated Advanced Breast Cancer Patients (The OPHELIA Study)
Acronym: OPHELIA
Sponsor: MedSIR (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Very slow recruitment due to subject profile
Enrollment: 5.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-04-30
Primary completion date: 2022-03-02
Completion date: 2022-03-02
Plan to share individual participant data: NO
IPD sharing description: It is not planned
Clinical trial NCT04031885: A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer
Official title: A Multicenter, Open-Label, Randomized-Controlled Study of Abemaciclib, a CDK4 and 6 Inhibitor, in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer With Visceral Metastases
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Business decision based on the inability to enroll subjects into the trial
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-14
Primary completion date: 2020-08-11
Completion date: 2020-08-11
Baseline population: All randomized participants.
Limitations and caveats: This study was terminated early as a business decision based on the inability to enroll subjects into the trial.
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 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.
Clinical trial NCT04129398: MK-8228 (Letermovir) in the Prevention of Human Cytomegalovirus (CMV) Infection and Disease in Adult Japanese Kidney Transplant Recipients (MK-8228-042)
Official title: A Phase 3, Open-Label, Single-Arm Clinical Study to Evaluate the Safety, Efficacy and Pharmacokinetics of MK-8228 (Letermovir) for the Prevention of Human Cytomegalovirus (CMV) Infection and Disease in Adult Japanese Kidney Transplant Recipients
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 22.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-12-27
Primary completion date: 2022-10-06
Completion date: 2022-10-06
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT04709575: Study to Assess the Efficacy of Anti-Bet v 1 Monoclonal Antibodies in Adults to Reduce Symptoms of Seasonal Allergic Rhinitis
Official title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy of Anti-Bet v 1 Monoclonal Antibodies to Reduce Symptoms of Seasonal Allergic Rhinitis
Sponsor: Regeneron Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 353.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-14
Primary completion date: 2021-08-24
Completion date: 2021-08-24
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., 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).