chufangao/CTO huggingface dataset:
Clinical trial NCT02362451: Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccination in Men With Stage D0 Prostate Cancer
Official title: A Randomized, Placebo-Controlled Phase II Study of Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccination in Men With Stage D0 Prostate Cancer
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Slow accrual.
Enrollment: 7.0 (ACTUAL)
Number of arms: 3.0
Start date: 2015-07-10
Primary completion date: 2020-02-13
Completion date: 2020-02-13
Plan to share individual participant data: YES
IPD sharing description: All IPD recorded in the medical record will be shared with intramural investigators upon request. All collected individual participant data (IPD) will be shared with collaborators under the terms of collaborative agreements.
IPD time frame: Clinical data available during the study and indefinitely.
IPD access criteria: Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).
Clinical trial NCT03261193: ITM + Bupivacaine QLB vs. ITM + Sham Saline QLB for Cesarean Delivery Pain
Official title: QL Block for Post-cesarean Delivery Pain
Acronym: qlcsection
Sponsor: University of Pittsburgh (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: limited resources for recruitment
Enrollment: 21.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-09-05
Primary completion date: 2018-06-25
Completion date: 2022-11-11
Plan to share individual participant data: NO
IPD sharing description: No plans to share
Clinical trial NCT04457765: Betadine Effect on Nasal Mucosa Cilia
Official title: Povidine-Iodine Effect on Nasal Mucosa Cilia in Rhinoplasty Patients
Sponsor: Boston Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: The IRB did not approve the study to be conducted at the home institution.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-04-30
Primary completion date: 2022-09-30
Completion date: 2022-09-30
Plan to share individual participant data: NO
Clinical trial NCT05168904: A Study to Investigate Fadraciclib (CYC065), in Subjects With Leukemia or Myelodysplastic Syndrome (MDS)
Official title: A Phase 1/2, Open Label, Multicenter Study to Investigate the Safety and Efficacy of Fadraciclib (CYC065), an Oral CDK 2/9 Inhibitor, in Subjects With Leukemias or Myelodysplastic Syndrome (MDS)
Sponsor: Cyclacel Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: SUSPENDED 
Why stopped: Slow enrollment and financial limitations
Enrollment: 210.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2021-10-22
Primary completion date: 2024-10-31
Completion date: 2024-12-31
Plan to share individual participant data: NO
Clinical trial NCT04276207: A Study of LY900014 Versus Insulin Lispro (Humalog) on High Blood Sugar in Participants With Type 1 Diabetes Who Use Insulin Pumps
Official title: Effects of LY900014 on Recovery From Hyperglycemia Compared to Humalog in Subjects With Type 1 Diabetes Mellitus (T1DM) on Continuous Subcutaneous Insulin Infusion
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 32.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-02-25
Primary completion date: 2020-08-10
Completion date: 2020-08-10
Baseline population: All randomized participants.
Plan to share individual participant data: NO
Clinical trial NCT03951077: Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome
Official title: Phase 2, Multicenter, Double-blind (Sponsor-unblinded), Randomized, Placebo-Controlled Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 118.0 (ACTUAL)
Number of arms: 6.0
Start date: 2019-08-12
Primary completion date: 2021-02-10
Completion date: 2021-02-10
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 and 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, please refer to the link below.
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 (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
Clinical trial NCT04663269: Regional Erector Spinae Analgesic Block vs Standard of Care Undergoing Percutaneous Nephrolithotomy
Official title: Randomized, Prospective Trial of Regional Erector Spinae Analgesic Block Versus Standard of Care in Patients Undergoing Percutaneous Nephrolithotomy
Sponsor: Indiana University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Drop out from surgeons from 3 to 1. It will take too long to feasibly accrue with only one provider.
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-02-24
Primary completion date: 2020-09-11
Completion date: 2020-09-24
Plan to share individual participant data: NO
Clinical trial NCT02832037: Clinical Trial of BI 425809 Effect on Cognition and Functional Capacity in Schizophrenia
Official title: A Phase II Randomised, Double-blinded, Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of 4 Oral Doses of BI 425809 Once Daily Over 12 Week Treatment Period in Patients With Schizophrenia
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 509.0 (ACTUAL)
Number of arms: 5.0
Start date: 2016-07-25
Primary completion date: 2019-12-27
Completion date: 2020-01-29
Baseline population: The Treated Set included all participants who were randomized and were treated with at least 1 dose of trial medication.
Limitations and caveats: After identifying a new major metabolite (BI 761036), the sponsor communicated a voluntary hold of Phase II to relevant competent authorities on 16-Sep-2016. This was formalized to a full clinical hold of the development program by the Food and Drug Administration (FDA) on 26-Oct-2016. Before start of the hold, 1 patient was screened, but not randomized. Clinical hold was removed by FDA on 21-Nov-2017, the trial was re-initiated with version 3 of the clinical trial protocol, dated 13-Dec-2017.
Clinical trial NCT05788185: Safety & Immunogenicity of RVM-V001/RVM-V002 or RVMV001+RVMV002 (Co Administered as Separate Injections) in Healthy Individuals
Official title: Phase 1b, Randomized, Open-label Study to Evaluate the Safety, Tolerability, and Immunogenicity of RVM-V001 Only, RVM-V002 Only, or RVM V001 + RVM V002 (Co Administered as Separate Injections) in Healthy Adults Previously Vaccinated With an Inactivated Virus or mRNA-based COVID-19 Vaccine in Singapore
Sponsor: RVAC Medicines (US), Inc. (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Changes in COVID-19 pandemic landscape
Enrollment: 24.0 (ACTUAL)
Number of arms: 6.0
Start date: 2023-03-22
Primary completion date: 2023-09-21
Completion date: 2023-09-21
Clinical trial NCT02600507: Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression
Official title: Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of ITI-007 Adjunctive to Lithium or Valproate in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder
Sponsor: Intra-Cellular Therapies, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 529.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-03-07
Primary completion date: 2020-07-02
Completion date: 2020-07-02
Clinical trial NCT05579977: Trial to Learn About the Study Medicine (PF-07081532) and Rybelsus in People With Type 2 Diabetes and Separately PF-07081532 in People With Obesity
Official title: A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, DOSE RANGING, DOSE FINDING, PARALLEL GROUP STUDY TO ASSESS EFFICACY AND SAFETY OF PF-07081532, AND OPEN LABEL ORAL SEMAGLUTIDE, IN ADULTS WITH TYPE 2 DIABETES MELLITUS (T2DM) INADEQUATELY CONTROLLED ON METFORMIN, AND SEPARATELY PF-07081532 COMPARED TO MATCHING PLACEBO IN ADULTS WITH OBESITY BUT WITHOUT T2DM
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The decision to terminate clinical development of PF-07081532 is based on pharmacokinetic data from Phase 1 drug-drug-interaction studies and laboratory measurements of elevated transaminases in these Phase 1 studies as well as a Phase 2 study.
Enrollment: 902.0 (ACTUAL)
Number of arms: 13.0
Start date: 2022-10-27
Primary completion date: 2023-07-14
Completion date: 2023-09-22
Baseline population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Limitations and caveats: 1 participant in placebo (T2DM) arm with withdrawal reason as Death in treatment phase was also counted in follow-up with the reason for discontinuation as death since exact date of last dose was unknown.
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 NCT04409873: Antiseptic Mouthwash / Pre-Procedural Rinse on SARS-CoV-2 Load (COVID-19)
Official title: Effect of Antiseptic Mouthwash/Gargling Solutions and Pre-procedural Rinse on SARS-CoV-2 Load (COVID-19)
Acronym: AMPoL
Sponsor: University of California, San Francisco (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The funder decided not to continue funding, causing enrollment to cease prematurely and curtailing originally planned analyses. Participants with any samples collected after the baseline pre-rinse samples were included in the analysis.
Enrollment: 54.0 (ACTUAL)
Number of arms: 5.0
Start date: 2021-03-31
Primary completion date: 2022-09-10
Completion date: 2022-09-10
Limitations and caveats: Study support was withdrawn by Funder, so enrollment ended, and only a priori planned interim analyses were performed.
Plan to share individual participant data: NO
Clinical trial NCT03875560: IC14 in Adult Patients With Dengue Fever
Official title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Safety, Pharmacokinetic, Pharmacodynamic and Preliminary Efficacy Study of IC14 in Adult Patients With Dengue Fever
Sponsor: Implicit Bioscience (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: seeking funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 5.0
Start date: 2019-05-31
Primary completion date: 2020-01-31
Completion date: 2020-06-30
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03977480: Phase II Study of Hemay007 in Patients With Active Ulcerative Colitis
Official title: A Multicenter, Randomized, Double-blind, Placebo Parallel Controlled Clinical Study on the Effecacy and Safety of Different Dosing Regimens of Hemay007 in Patients With Active Ulcerative Colitis
Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Due to the difficulty to recruit enough patients, the study was terminated.
Enrollment: 70.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-08-13
Primary completion date: 2022-08-12
Completion date: 2022-08-12
Plan to share individual participant data: NO
Clinical trial NCT04051957: Isosorbide Mononitrate For Anti-Vascular Endothelial Growth Factor (VEGF) Induced Kidney Injury
Official title: Isosorbide Mononitrate For Anti-Vascular Endothelial Growth Factor (VEGF) Induced Kidney Injury
Sponsor: The University of Texas Health Science Center, Houston (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Delays due to COVID and loss of research coordinator.
Enrollment: 9.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-26
Primary completion date: 2021-02-12
Completion date: 2021-02-12
Limitations and caveats: Early termination due to the COVID pandemic and limited clinical face-to-face appointments leading to small numbers of subjects analyzed.
Plan to share individual participant data: NO
Clinical trial NCT03472560: A Study of Avelumab in Combination With Axitinib In Non-Small Cell Lung Cancer (NSCLC) or Urothelial Cancer (Javelin Medley VEGF)
Official title: A PHASE 2, OPEN LABEL STUDY TO EVALUATE SAFETY AND CLINICAL ACTIVITY OF AVELUMAB (BAVENCIO (REGISTERED)) IN COMBINATION WITH AXITINIB (INLYTA (REGISTERED)) IN PATIENTS WITH ADVANCED OR METASTATIC PREVIOUSLY TREATED NON-SMALL CELL LUNG CANCER OR TREATMENT NAÏVE CISPLATIN-INELIGIBLE UROTHELIAL CANCER JAVELIN MEDLEY VEGF
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study was terminated since there was no need for further safety or efficacy data to be collected. The participants having benefit from the Investigational treatments have been moved to a continuation study (NCT05059522)
Enrollment: 61.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-05-02
Primary completion date: 2023-02-09
Completion date: 2023-02-09
Baseline population: Full Analysis Set included all participants who received at least one dose of avelumab and axitinib.
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 NCT05035680: Proof of Concept Trial of Adjuvant Activity of SWE, a Squalene-based -Oil-in-water Emulsion
Official title: Proof of Concept Trial of Adjuvant Activity of SWE, a Squalene-based -Oil-in-water Emulsion
Sponsor: Bill & Melinda Gates Medical Research Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Study cancelled
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-07-14
Primary completion date: 2023-03-25
Completion date: 2023-11-25
Clinical trial NCT03078465: Ticagrelor Versus High-dose Clopidogrel in Patients With High Platelet Reactivity on Clopidogrel After PCI
Official title: Ticagrelor Versus High-dose Clopidogrel in Patients With High Platelet Reactivity on Clopidogrel After Percutaneous Coronary Intervention: The PL-PLATELET Randomized Trial
Acronym: PL-PLATELET
Sponsor: Nanjing First Hospital, Nanjing Medical University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Competitive studies were conducted at the same time, and enrollment was suspended.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-06-20
Primary completion date: 2021-05-30
Completion date: 2021-05-30
Plan to share individual participant data: NO
Clinical trial NCT03188445: Intravenous Iron Isomaltoside Versus Oral Iron Supplementation for Treatment of Iron Deficiency in Pregnancy.
Official title: Intravenous Iron Isomaltoside Versus Oral Iron Supplementation for Treatment of Iron Deficiency in Pregnancy: a Randomised, Comparative, Open-label Trial
Sponsor: Pharmacosmos A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 201.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-07-11
Primary completion date: 2020-06-26
Completion date: 2020-08-18
Plan to share individual participant data: NO
Clinical trial NCT05722301: Does Testosterone Therapy Improve Patient-Reported Outcomes in Age-Related Testosterone Deficient Patients Undergoing Total Hip Replacement: A Randomized-Controlled Trial
Official title: Does Testosterone Therapy Improve Patient-Reported Outcomes in Age-Related Testosterone Deficient Patients Undergoing Total Hip Replacement: A Randomized-Controlled Trial
Sponsor: American Hip Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Study was never initiated.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-11-01
Primary completion date: 2020-11-01
Completion date: 2021-11-01
Plan to share individual participant data: NO
Clinical trial NCT03896295: An Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia Gravis
Official title: An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia Gravis
Sponsor: Momenta Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study was originally halted due to the COVID-19 pandemic. The study was later terminated prematurely as the participants will have the option to enter into an open-label extension portion of a planned future study. It was not due to safety concerns.
Enrollment: 37.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-08-06
Primary completion date: 2020-12-09
Completion date: 2020-12-09
Limitations and caveats: Study was originally halted due to the COVID-19 pandemic. The study was later terminated prematurely due to the continuing COVID-19 pandemic, and because the participants will have the option to enter into an open-label extension portion of a planned future study. It was not due to safety concerns.
Plan to share individual participant data: NO
Clinical trial NCT03809013: A Open-label, Single-arm, Multicenter, Phase II Study of RC48-ADC to Evaluate the Efficacy and Safety of Subjects With HER2 Overexpressing Locally Advanced or Metastatic Urothelial Cancer
Official title: A Open-label, Single-arm, Multicenter, Phase II Study of RC48-ADC to Evaluate the Efficacy and Safety of Subjects With HER2 Overexpressing Locally Advanced or Metastatic Urothelial Cancer
Sponsor: RemeGen Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 64.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-01-07
Primary completion date: 2021-03-04
Completion date: 2023-06-05
Plan to share individual participant data: UNDECIDED
Clinical trial NCT02949128: Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
Official title: Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-naïve Adult and Adolescent Patients With Atypical Hemolytic Uremic Syndrome (aHUS)
Sponsor: Alexion Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 58.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-01-11
Primary completion date: 2023-01-24
Completion date: 2023-01-24
Baseline population: Full Analysis Set (FAS): all participants who received at least 1 dose of ravulizumab, had at least 1 post-baseline efficacy assessment, and met pre-specified eligibility criteria.
Clinical trial NCT02619760: ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-2 Study
Official title: ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-2 Study
Acronym: STOPDAPT-2
Sponsor: Kyoto University, Graduate School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 3045.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-12-31
Primary completion date: 2018-12-08
Completion date: 2023-12-31
Clinical trial NCT04870073: Retrograde Autologous Priming and Mannitol for Reducing Hemodilution in Cardiac Surgery
Official title: Retrograde Autologous Priming for Preserving Hemoglobin Peri-operatively With or Without Mannitol: A Pilot Study
Acronym: RAPPER-MAN
Sponsor: Hamilton Health Sciences Corporation (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Financial support could not be obtained for the study
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-09-21
Primary completion date: 2022-09-21
Completion date: 2022-09-21
Plan to share individual participant data: NO
Clinical trial NCT02525029: Study of Pregnyl as Adjunct Therapy for High-Risk or Refractory Acute GVHD
Official title: Phase I/II Study of Human Chorionic Gonadotropin and Epidermal Growth Factor Supplementation (Pregnyl®) to Support Tolerance and Repair As Adjunct Therapy in High-Risk or Refractory Acute Graft-Versus-Host Disease
Sponsor: Masonic Cancer Center, University of Minnesota (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 53.0 (ACTUAL)
Number of arms: 20.0
Start date: 2016-03-31
Primary completion date: 2021-05-31
Completion date: 2022-04-30
Clinical trial NCT04516746: Phase III Double-blind, Placebo-controlled Study of AZD1222 for the Prevention of COVID-19 in Adults
Official title: A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study in Adults, to Determine the Safety, Efficacy, and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 32450.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-28
Primary completion date: 2021-03-05
Completion date: 2023-02-10
Baseline population: All randomized participants analysis set included all participants who enrolled into the study.
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
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 rerefer 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