chufangao/CTO huggingface dataset:
Clinical trial NCT04377503: Tocilizumab Versus Methylprednisolone in the Cytokine Release Syndrome of Patients With COVID-19
Official title: Comparison of the Efficacy and Safety of Tocilizumab Versus Methylprednisolone in the Cytokine Release Syndrome of Patients With COVID-19. A Prospective Randomized Controlled Phase II Trial
Sponsor: Hospital Sao Domingos (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The number of critically ill patients wirh COVID-19 decrease abruptly
Enrollment: 30.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-01
Primary completion date: 2020-08-31
Completion date: 2020-11-30
Plan to share individual participant data: NO
Clinical trial NCT05156905: Study of Docetaxel Combined with Cirmtuzumab in Metastatic Castration Resistant Prostate Cancer
Official title: A Phase 1b Trial Investigating Docetaxel Combined with Cirmtuzumab in Patients with Metastatic Castration Resistant Prostate Cancer
Sponsor: University of California, San Diego (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Oncternal closing clinical trial operations.
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-06-16
Primary completion date: 2024-10-01
Completion date: 2024-10-01
Plan to share individual participant data: NO
Clinical trial NCT03249792: Study of MK-2118 Administered as Intratumoral Injection as Monotherapy and in Combination With Pembrolizumab (MK-3475) or by Subcutaneous Injection in Combination With Pembrolizumab in the Treatment of Adults With Advanced/Metastatic Solid Tumors or Lymphomas (MK-2118-001)
Official title: A Phase 1 Open-label, Multicenter Study of MK-2118 Administered by Intratumoral Injection as Monotherapy and in Combination With Pembrolizumab or by Subcutaneous Injection in Combination With Pembrolizumab for Patients With Advanced/Metastatic Solid Tumors or Lymphomas
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Business Reasons
Enrollment: 140.0 (ACTUAL)
Number of arms: 25.0
Start date: 2017-09-20
Primary completion date: 2023-02-22
Completion date: 2023-02-22
Baseline population: Baseline characteristics were analyzed in all participants allocated to Arms 1, 2, and 4. Arm 3 did not enroll any participants. Per protocol, baseline characteristics were not analyzed separately for the switch over period.
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT03472872: A Comparative Efficacy Trial of IV Acetaminophen Versus IV Ketorolac for Emergency Department Treatment of Generalized Headache
Official title: A Randomized Double-blind Comparative Efficacy Trial of IV Acetaminophen Versus IV Ketorolac for Emergency Department Treatment of Generalized Headache
Sponsor: Spectrum Health - Lakeland (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: no longer recruiting or studying
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-09-05
Primary completion date: 2020-06-14
Completion date: 2020-06-14
Plan to share individual participant data: NO
Clinical trial NCT03275064: Study of Safety, Tolerability, Preliminary Efficacy of Intra-articular LNA043 Injections in Patients With Articular Cartilage Lesions and Knee Osteoarthritis.
Official title: A Two-part, Randomized, Placebo-controlled, Patient and Investigator Blinded, Study Investigating the Safety, Tolerability and Preliminary Efficacy of Intra-articular LNA043 Injections in Regenerating the Articular Cartilage of the Knee in Patients With Articular Cartilage Lesions (Part A) and in Patients With Knee Osteoarthritis (Part B).
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 142.0 (ACTUAL)
Number of arms: 5.0
Start date: 2017-09-12
Primary completion date: 2022-09-06
Completion date: 2022-09-06
Limitations and caveats: For several outcomes there was a loss in samples size, which may limit the interpretability of results. For Part B, subgroup 1 was defined to address heterogeneity in MRI quality, and to ensure validity of the reported data. P-values for T2 relaxation time are omitted, as there was an error in the calculation. For Part A, the protocol sample size section refers to a ratio for the primary analysis, but data was reported as superficial and deep cartilage layers separately. Both will be updated.
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 NCT03610516: Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Lupus Nephritis.
Official title: A Randomized, Placebo-controlled, Patient and Investigator Blinded, Study Investigating the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Multiple Doses of CFZ533 in Patients With Moderately Active Proliferative Lupus Nephritis
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 57.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-09-12
Primary completion date: 2023-06-29
Completion date: 2023-06-29
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 NCT04762277: A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa
Official title: Randomized, Double-blind, Placebo-controlled, Study of Spesolimab in Patients With Moderate to Severe Hidradenitis Suppurativa
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 52.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-04-06
Primary completion date: 2022-01-19
Completion date: 2022-04-21
Baseline population: Safety Analysis Set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug.
Plan to share individual participant data: YES
IPD sharing description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement. Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.
IPD time frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
IPD access criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
Clinical trial NCT06048705: Study of GSK3901961 In Previously Treated Advanced (Metastatic OR Unresectable) Synovial Sarcoma/ Myxoid/Round Cell Liposarcoma, and Previously Treated Metastatic Non-Small Cell Lung Cancer
Official title: Assessment of Safety and Recommended Phase 2 Dose of Autologous T Cells Engineered With an Affinity-enhanced TCR Targeting NYESO1 and LAGE1a, and Co-expressing CD8α (GSK3901961) in Participants With NYESO1 and/or LAGE1a Positive Previously Treated Advanced (Metastatic or Unresectable) Synovial Sarcoma / Myxoid/Round Cell Liposarcoma; or NYESO1 and/or LAGE1a Positive Previously Treated Metastatic Non-Small Cell Lung Cancer
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The study was terminated due to a change in GSK's R\&D priorities.
Enrollment: 7.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-03-09
Primary completion date: 2023-06-08
Completion date: 2023-06-08
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
IPD time frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
IPD access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.
Clinical trial NCT04569760: Cannabinoids for the Treatment of Anxiety Disorders: An 8-Week Pilot Study
Official title: Cannabinoids for the Treatment of Anxiety Disorders: An 8-Week Pilot Study
Sponsor: McMaster University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Project cancelled prior to commencing recruitment
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-04-30
Primary completion date: 2023-04-30
Completion date: 2023-06-30
Plan to share individual participant data: NO
Clinical trial NCT03430544: Cariprazine Effects on Brain and Behavior in Cocaine Use Disorder
Official title: A Randomized, Single-blind, Placebo-controlled Phase II Study to Assess the Effects of Cariprazine on Brain and Behavior in Subjects With Cocaine Use Disorder
Sponsor: University of Pennsylvania (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Low recruitment in final grant year, halted on-site research due to COVID-19 during NCE year.
Enrollment: 14.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-04-04
Primary completion date: 2020-09-04
Completion date: 2020-09-04
Clinical trial NCT03490019: Treatment of Bardet-Biedl-Syndrome With Metformin for Evaluation of a Possible Visual Improvement
Official title: Treatment of Infantile and Juvenile Patients With Bardet-Biedl-Syndrome With Metformin. Evaluation of a Visual Improvement as a Side Effect of the Pediatric Treatment of Adipositas - a Prospective Pilot Study Without Control
Acronym: BBS
Sponsor: University Hospital Tuebingen (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: unrealizable wishes of national authorities
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-04-01
Primary completion date: 2019-10-31
Completion date: 2020-08-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04614467: A Placebo-Controlled Trial of CLBS16 in Subjects With Coronary Microvascular Dysfunction
Official title: A Double-Blind, Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of CLBS16 in Subjects With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease
Acronym: FREEDOM
Sponsor: Lisata Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 34.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-29
Primary completion date: 2022-09-28
Completion date: 2022-09-28
Clinical trial NCT02740699: CT COMPARE: CT Coronary Angiography to Measure Plaque Reduction
Official title: CT COMPARE: CT Coronary Angiography to Measure Plaque Reduction
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Principal Investigator resigned and closed program
Enrollment: 79.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-04-11
Primary completion date: 2022-01-27
Completion date: 2022-03-11
Limitations and caveats: Protocol was terminated early due to departure of Principal Investigator.
Clinical trial NCT03496610: Surgeon Infiltration QL Block Comparison
Official title: Intraoperative Surgical Wound Infiltration vs Quadratus Lumborum (QL) Block for Post-operative Pain Control After Nephrectomy in Living Donor Kidney Transplant Patients
Sponsor: Duke University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 44.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-25
Primary completion date: 2023-02-23
Completion date: 2023-02-23
Baseline population: The number of participants in the QL group excludes two subjects-- one subject who voluntarily withdrew and one who was withdrawn by the PI for a surgical site infection.
Plan to share individual participant data: NO
Clinical trial NCT04301011: Study of TBio-6517 Given Alone or in Combination With Pembrolizumab in Solid Tumors
Official title: A Phase 1/2a, Multicenter, Open-label Trial of TBio-6517, an Oncolytic Vaccinia Virus, Administered Alone and in Combination With Pembrolizumab, in Patients With Advanced Solid Tumors
Acronym: RAPTOR
Sponsor: Turnstone Biologics, Corp. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 27.0 (ACTUAL)
Number of arms: 8.0
Start date: 2020-06-02
Primary completion date: 2023-01-23
Completion date: 2023-01-23
Clinical trial NCT03515837: Study of Pemetrexed + Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With Tyrosine Kinase Inhibitor- (TKI)-Resistant Epidermal Growth Factor Receptor- (EGFR)-Mutated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-789/KEYNOTE-789)
Official title: A Randomized, Double-Blind, Phase 3 Study of Pemetrexed + Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in TKI-resistant EGFR-mutated Tumors in Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) Participants (KEYNOTE-789)
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 492.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-06-29
Primary completion date: 2023-01-17
Completion date: 2023-10-02
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT03142191: A Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis
Official title: A Phase 2, 24-Week, Randomized, Double-blind, Placebo-controlled, Multicenter Study, With an 80-Week Active Treatment Extension, to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis
Sponsor: Celgene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Business objectives have changed.
Enrollment: 138.0 (ACTUAL)
Number of arms: 5.0
Start date: 2017-07-26
Primary completion date: 2021-12-24
Completion date: 2021-12-24
Clinical trial NCT04123561: Extended and Controlled Release Liposomal Formulated Dexamethasone for Chronic Knee OA Pain
Official title: A Phase 3, Randomized, Double-blind, Placebo- and Active-controlled Study to Evaluate the Efficacy and Safety of TLC599 in Patients With Osteoarthritis of the Knee
Acronym: EXCELLENCE
Sponsor: Taiwan Liposome Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 504.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-11-26
Primary completion date: 2022-02-03
Completion date: 2022-02-03
Baseline population: The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline.
Plan to share individual participant data: NO
Clinical trial NCT03646123: Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma
Official title: Multiple Part Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma Subjects
Sponsor: Seagen Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study was prematurely discontinued as the sponsor believes the data collected is enough to show the safety and efficacy of the combinations studied in all cohorts. The decision was not based on any safety and/or efficacy concerns.
Enrollment: 255.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-01-28
Primary completion date: 2022-11-07
Completion date: 2024-08-23
Clinical trial NCT04507906: Nivolumab Combined With Anlotinib as Re-challenge Treatment in Advanced NSCLC
Official title: Safety and Efficacy of Nivolumab Combined With Anlotinib in Advanced Non-small Cell Lung Cancer Patients Previously Treated With Checkpoint Inhibitor-A Single Center and Exploratory Study
Sponsor: Shanghai Chest Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 21.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-11-02
Primary completion date: 2022-03-31
Completion date: 2022-03-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03767543: Study Comparing the Efficacy and Safety of Insulin Glargine (Basal Insulin)/Lixisenatide (GLP-1 Receptor Agonist) Combination (Soliqua™) in Patients With Type 2 Diabetes Mellitus (T2DM)
Official title: A Randomized, 26-week, Open-label, 2-treatment Arm, Parallel Group Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed-ratio Combination (Soliqua™) Titrated Using a Simple Titration Algorithm (One Unit Daily Adjustment) Compared With Insulin Glargine/Lixisenatide Fixed-ratio Combination (Soliqua™) Titrated by Weekly Adjustment in Patients With Type 2 Diabetes Mellitus (T2DM)
Acronym: LixilanOne CAN
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 265.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-03-11
Primary completion date: 2020-10-23
Completion date: 2020-10-23
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Clinical trial NCT04630158: Study of Efficacy and Safety of SAF312 Eye Drops in Subjects With Post-operative Corneal Induced Chronic Pain (CICP)
Official title: A 12-week Parallel Group, Randomized, Placebo-controlled, Double-blinded, Multi-center Study to Evaluate Efficacy and Safety of 2 Concentrations of SAF312 Eye Drops (5 mg/ml and 15 mg/ml) Used Twice-daily in the Treatment of Post-operative Corneal Induced Chronic Pain (CICP) Following Photorefractive Keratectomy (PRK) or Laser-assisted in Situ Keratomileusis (LASIK) Surgeries
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 153.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-04-21
Primary completion date: 2023-06-07
Completion date: 2023-06-08
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 https://www.clinicalstudydatarequest.com/.
Clinical trial NCT05199090: Study to Assess Safety, Tolerability and Efficacy of SC Administered MBL949 in Obese Participants With or Without T2DM
Official title: A Randomized, Placebo-controlled, Participant-and-investigator- Blinded, Sponsor Open-label Study to Evaluate the Safety, Tolerability, and Efficacy With Different Dosing Regimens of Subcutaneously Administered MBL949 in Obese Participants With or Without Type 2 Diabetes Mellitus
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The tolerability to benefit ratio based on maximum weight loss observed was not considered favorable at the doses studied and the study was terminated early
Enrollment: 126.0 (ACTUAL)
Number of arms: 6.0
Start date: 2022-02-10
Primary completion date: 2023-05-11
Completion date: 2023-05-11
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 NCT04371523: Hydroxychloroquine to Prevent COVID-19 Disease Amongst Healthcare Workers
Official title: Hydroxychloroquine to Prevent COVID-19 Disease Amongst Healthcare Workers (PROVIDE): A Parallel Randomized Controlled Trial
Acronym: PROVIDE
Sponsor: St. Joseph's Healthcare Hamilton (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Study was not initiated due to evidence becoming available that did not support the use of hydroxychloroquine in this population, with potential risk of added harm
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-01
Primary completion date: 2020-07-31
Completion date: 2020-08-30
Plan to share individual participant data: NO
Clinical trial NCT03713619: This Was a Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS).
Official title: A Randomized, Double-blind, Multi-center Study Assessing Short (16 Weeks) and Long-term Efficacy (up to 1 Year), Safety, and Tolerability of 2 Subcutaneous Secukinumab Dose Regimens in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (SUNSHINE).
Acronym: SUNSHINE
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 544.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-01-31
Primary completion date: 2021-10-01
Completion date: 2022-07-26
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