chufangao/CTO huggingface dataset:
Clinical trial NCT02714218: A Study of Two Different Dose Combinations of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma
Official title: Phase IIIb/IV, Randomized, Double Blinded, Study of Nivolumab 3 mg/kg in Combination With Ipilimumab 1 mg/kg vs Nivolumab 1 mg/kg in Combination With Ipilimumab 3 mg/kg in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 387.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-04-04
Primary completion date: 2017-04-20
Completion date: 2021-05-28
Clinical trial NCT02178657: Intra-arterial Bone-marrow Mononuclear Cells Infusion for Acute Ischemic Stroke
Official title: Intra-arterial Autologous Bone-marrow Mononuclear Cells Infusion for Acute Ischemic Stroke. A Phase II, Open-label, Multicenter, Randomized and Controlled Clinical Trial.
Sponsor: Andalusian Initiative for Advanced Therapies (OTHER_GOV)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 76.0 (ACTUAL)
Number of arms: 3.0
Start date: 2015-04-30
Primary completion date: 2021-10-27
Completion date: 2023-04-12
Clinical trial NCT04348786: Comparing Efficacy of 14-day Therapy Doxycycline With Bismuth Subsalicylate Versus Levofloxacin With Tinadizole on Treatment Helicobacter Pylori
Official title: Comparing the Efficacy of 14-day Therapy Doxycycline With Bismuth Subsalicylate Versus Levofloxacin With Tinidazole on Rate of Eradication of Helicobacter Pylori Infected Patients on Syrian Population
Sponsor: Damascus Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 78.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-02-01
Primary completion date: 2020-08-30
Completion date: 2020-09-01
Plan to share individual participant data: YES
IPD time frame: Within 5 year of study completion
Clinical trial NCT01908192: Adaptive Phase II Study to Evaluate the Safety & Efficacy of NaBen®
Official title: An Adaptive, Phase IIb/III, Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy OF NaBen® , A D-Amino Acid Oxidase Inhibitor, as an Add-on Treatment for Schizophrenia in Adolescents
Sponsor: SyneuRx International (Taiwan) Corp (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Enrollment: 60.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-06-30
Primary completion date: 2023-10-26
Completion date: 2023-10-26
Clinical trial NCT02042989: MLN9708 and Vorinostat in Patients With Advanced p53 Mutant Malignancies
Official title: A Phase I Study of MLN9708 and Vorinostat to Target Autophagy in Patients With Advanced p53 Mutant Malignancies
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 68.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-06-27
Primary completion date: 2020-01-22
Completion date: 2020-01-22
Clinical trial NCT03743051: A Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Official title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Sponsor: Helsinn Healthcare SA (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 318.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-03-05
Primary completion date: 2023-02-11
Completion date: 2023-02-11
Clinical trial NCT04091750: Nivolumab/Ipilimumab Plus Cabozantinib in Patients With Unresectable Advanced Melanoma
Official title: Phase II Study of Nivolumab/Ipilimumab Plus Cabozantinib in Patients With Unresectable Advanced Melanoma
Sponsor: Georgetown University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: SUSPENDED 
Why stopped: futility stage with the first 14 subjects completed
Enrollment: 27.0 (ESTIMATED)
Number of arms: 1.0
Start date: 2020-03-02
Primary completion date: 2023-03-03
Completion date: 2024-05-31
Clinical trial NCT04958642: Adrabetadex to Treat Niemann-Pick Type C1 (NPC1) Disease
Official title: A Phase 2B/3 Prospective, Randomized, Double-Blind, Sham-Controlled Trial of VTS-270 (2-hydroxypropyl-β-cyclodextrin) in Subjects With Neurologic Manifestations of Niemann-Pick Type C1 (NPC1) Disease
Sponsor: Mandos LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Terminated by previous Sponsor decision
Enrollment: 66.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-12-23
Primary completion date: 2022-04-11
Completion date: 2022-04-11
Baseline population: The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.
Limitations and caveats: The development program for adrabetadex was discontinued and Part C of the study was terminated by the Sponsor.
Plan to share individual participant data: NO
Clinical trial NCT04316611: Potassium Chloride in Out-of-hospital Cardiac Arrest Due to Refractory Ventricular Fibrillation
Official title: Evaluation of the Effectiveness of Potassium Chloride in the Management of Out-of-hospital Cardiac Arrest by Refractory Ventricular Fibrillation
Acronym: POTACREH
Sponsor: Assistance Publique - Hôpitaux de Paris (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: As the inclusion period in the study has ended and regulatory authorizations have expired on 26/12/2023, with no inclusions conducted.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-12-31
Primary completion date: 2024-12-31
Completion date: 2024-12-31
Plan to share individual participant data: NO
Clinical trial NCT05666453: A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in ABO-Incompatible Liver Transplantation
Official title: A Multi-center, Prospective, Randomized, Controlled, Open-label, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of Intravenous Immunoglobulin to Prevent Biliary Complications After ABO Incompatible Adult to Adult Living Donor Liver Transplantation
Sponsor: SK Plasma Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Change of Clincal Development Plan
Enrollment: 59.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-04-25
Primary completion date: 2024-05-07
Completion date: 2024-07-01
Clinical trial NCT01741038: AlloStim® In-Situ Vaccine in Pre-Treated Metastatic Colorectal Cancer
Official title: A Phase II/III, Randomized, Open Label, Controlled, Two Arm Study Comparing Overall Survival of AlloStim® Combined With Cryoablation to a Physician's Choice Combined With Cryoablation in 3rd Line Treatment for Metastatic Colorectal Cancer
Sponsor: Mirror Biologics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: WITHDRAWN 
Why stopped: moved study to USA
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-12-31
Primary completion date: 2019-12-31
Completion date: 2020-10-31
Plan to share individual participant data: NO
Clinical trial NCT03730961: An Investigational Study of Continuous 8-Hour Intravenous Administrations of BMS-986231 in Participants With Heart Failure and Reduced Heart Function Given a Standard Dose of Loop Diuretic
Official title: A Randomized, Double-Blind, Placebo-Controlled, Cross-over Phase 2 Study of Continuous 8-Hour Intravenous Infusions of BMS-986231 in Patients With Heart Failure and Impaired Systolic Function Given a Standard Dose of Loop Diuretic
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 23.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-01-17
Primary completion date: 2019-12-11
Completion date: 2020-01-09
Clinical trial NCT03399786: Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia
Sponsor: Regeneron Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 65.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-01-18
Primary completion date: 2019-06-10
Completion date: 2020-03-17
Clinical trial NCT02736552: Compare S-1 for 6 Months to 1 Year as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer Staged II , IIIA or IIIB.
Official title: A Prospective,Multicentral,Open-label,Randomized,Controlled,Phase III Clinical Trial to Compare S-1 for 6 Months to 1 Year as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer Staged II , IIIA or IIIB.
Sponsor: Fudan University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-03-31
Primary completion date: 2019-03-31
Completion date: 2023-03-31
Clinical trial NCT03476928: A Study to Assess the Safety and Efficacy of Vilaprisan in Japanese Subjects With Uterine Fibroids and Heavy Menstrual Bleeding
Official title: An Open-label, Parallel-group, Randomized, Multicenter Study to Assess the Safety and Efficacy of Vilaprisan in Japanese Subjects With Uterine Fibroids and Heavy Menstrual Bleeding
Acronym: ASTEROID 8
Sponsor: Bayer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Due to a change in the development program, the study was closed prematurely.
Enrollment: 153.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-03-30
Primary completion date: 2021-07-12
Completion date: 2021-07-12
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, time point 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 NCT06024174: A Study of BMS-986466 With Adagrasib With or Without Cetuximab in Participants With Kirsten Rat Sarcoma Virus Glycine 12 to Cysteine (KRAS G12C)-Mutant Solid Tumors
Official title: Phase 1/2 Open-label Study of BMS-986466 in Combination With Adagrasib With or Without Cetuximab in Participants With KRAS G12C-mutant Advanced Solid Tumors
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Business objectives have changed
Enrollment: 5.0 (ACTUAL)
Number of arms: 3.0
Start date: 2023-11-09
Primary completion date: 2024-05-13
Completion date: 2024-05-13
Plan to share individual participant data: YES
IPD sharing description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
IPD time frame: See Plan Description
IPD access criteria: See Plan Description
Clinical trial NCT02509052: Leflunomide in Treating Patients With Relapsed or Refractory Multiple Myeloma
Official title: A Phase I/II Dose-Escalation Trial of Leflunomide in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma
Sponsor: City of Hope Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 12.0 (ACTUAL)
Number of arms: 3.0
Start date: 2015-12-02
Primary completion date: 2018-09-18
Completion date: 2022-06-09
Baseline population: Because we obtained preclinical data indicating a synergistic effect between leflunomide and lenalidomide, we determined that investigating leflunomide-based combinational therapy was favorable over pursuing a phase 2 study of single-agent leflunomide. There were no dose de-escalations, so there were no patients accrued to the arms for 10mg, 30mg, or 50mg.
Clinical trial NCT02530502: Radiation Therapy With Temozolomide and Pembrolizumab in Treating Patients With Newly Diagnosed Glioblastoma
Official title: Phase I Trial of Radiation Therapy Plus Temozolomide With MK-3475 in Patients With Newly Diagnosed Glioblastoma (GBM)
Sponsor: Northwestern University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The protocol was amendment to be stopped after phase I (phase 2 removed from protocol)
Enrollment: 4.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-09-30
Primary completion date: 2016-05-10
Completion date: 2020-02-12
Clinical trial NCT03207815: Study to Evaluate the Efficacy and Safety of Filgotinib in Adults With Active Noninfectious Uveitis
Official title: A Phase 2, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Filgotinib in Subjects With Active Noninfectious Uveitis
Acronym: HUMBOLDT
Sponsor: Gilead Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Development program terminated
Enrollment: 74.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-07-26
Primary completion date: 2020-12-29
Completion date: 2021-04-22
Baseline population: Safety Analysis Set included all participants who received at least 1 dose of study drug.
Limitations and caveats: Study was terminated early due to termination of the development program. Due to early termination and small sample size, pharmacokinetic (PK) analysis was not performed for this study.
Plan to share individual participant data: NO
Clinical trial NCT02054559: R-CHOP Alone vs. R-CHOP Plus Radiotherapy for Localized CD20+ DLBCL
Official title: Randomized Phase III Trial Comparing R-CHOP Alone and R-CHOP Plus Radiotherapy for Localized CD20+ Diffuse Large B-cell Lymphoma (DLBCL)
Acronym: ASPIRE
Sponsor: Asan Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: No consensus among trial centers regarding protocol
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Primary completion date: 2020-01-31
Completion date: 2020-01-31
Clinical trial NCT04036461: A Study of CC-99712, a BCMA Antibody-Drug Conjugate, in Participants With Relapsed and Refractory Multiple Myeloma
Official title: A Phase 1, Multicenter, Open-label, Dose Finding Study of CC-99712, a BCMA Antibody-Drug Conjugate, in Subjects With Relapsed and Refractory Multiple Myeloma
Sponsor: Celgene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Slow accrual
Enrollment: 47.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-26
Primary completion date: 2024-07-08
Completion date: 2024-08-19
Plan to share individual participant data: YES
IPD sharing description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link:~https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
IPD time frame: See Plan Description
IPD access criteria: See Plan Description
Clinical trial NCT05676853: A Study of Safety of Weekly Subcutaneous Pegzilarginase in Subjects With Arginase 1 Deficiency
Official title: A Phase 3 Open-Label Study of Safety of Weekly Subcutaneous Pegzilarginase in Subjects With Arginase 1 Deficiency
Sponsor: Aeglea Biotherapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Sponsor Decision
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-04-04
Primary completion date: 2023-04-27
Completion date: 2023-04-27
Clinical trial NCT02824354: Nalmefene in Patients With Alcoholic Compensated Cirrhosis for the Treatment of Alcohol Dependence.
Official title: Multicentre, Randomised, Double-blind, Placebo-controlled Trial of Nalmefene in Patients With Alcoholic Compensated Cirrhosis for the Treatment of Alcohol Dependence.
Acronym: NalmeCir
Sponsor: Centre Hospitalier Universitaire, Amiens (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: no participants enrolled
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-12-01
Primary completion date: 2022-12-01
Completion date: 2022-12-01
Clinical trial NCT03595982: Is Procardia XL 60 mg Q Daily Equivalent to 30 mg XL Given Twice Daily?
Official title: Is Procardia XL 60 mg Q Daily Equivalent to 30 mg XL Given Twice Daily?
Sponsor: Icahn School of Medicine at Mount Sinai (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Low enrollment
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-09-15
Primary completion date: 2020-02-20
Completion date: 2020-02-20
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04242498: A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa
Acronym: BE HEARD II
Sponsor: UCB Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 509.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-03-02
Primary completion date: 2021-11-09
Completion date: 2022-09-28
Plan to share individual participant data: YES
IPD sharing description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
IPD time frame: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
IPD access criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Clinical trial NCT03697109: A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome
Official title: Glucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of Relacorilant
Acronym: GRACE
Sponsor: Corcept Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 152.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-11-15
Primary completion date: 2024-04-08
Completion date: 2024-04-15
Plan to share individual participant data: NO
Clinical trial NCT05514002: Comparison of Recombinant Influenza Vaccine Versus Standard Egg-Based Inactivated Influenza Vaccine in Adults 18-64 Years
Official title: Randomized Participant- and Investigator-Blinded Trial to Compare the Clinical Efficacy of Recombinant Influenza Vaccine to Standard Dose Egg-Based Inactivated Influenza Vaccine Among Adults Aged 18-64 Years in the United States
Sponsor: Centers for Disease Control and Prevention (FED)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Insufficient funding.
Enrollment: 3988.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-09-13
Primary completion date: 2023-12-31
Completion date: 2023-12-31
Plan to share individual participant data: YES
IPD sharing description: Upon the completion of all study deliverables and after a suitable moratorium, external parties may request de-identified study data from the steering committee as specified in U.S. Government Data Sharing guidelines.
IPD time frame: Upon the completion of all study deliverables and dissemination of analyses to meet the protocol objectives.
Clinical trial NCT02220855: A Study of BKM120 (Buparlisib) in Relapsed or Refractory Thymomas
Official title: A Phase II Study of BKM120 (Buparlisib) in Relapsed or Refractory Thymomas
Sponsor: Indiana University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 14.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-10-01
Primary completion date: 2017-03-27
Completion date: 2021-03-09
Clinical trial NCT03894969: Study to Assess the Immunogenicity and Safety of GSK's Investigational Vaccine (GSK3277511A) When Given to Healthy Smokers and Ex-smokers After Administration of Shingrix Vaccine
Official title: Immunogenicity and Safety Study of GSK's Investigational Vaccine (GSK3277511A) When Administered in Healthy Smokers and Ex-smokers Following Receipt of Shingrix Vaccine
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 541.0 (ACTUAL)
Number of arms: 5.0
Start date: 2019-04-23
Primary completion date: 2020-08-31
Completion date: 2021-08-13
Plan to share individual participant data: YES
IPD sharing description: GSK will assess requests from qualified researchers for anonymized individual patient-level data (IPD) and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf
IPD time frame: Anonymized IPD is 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.