chufangao/CTO huggingface dataset:
Clinical trial NCT04372927: ADMIRAL Trial: Adaptive Mediastinal Radiation With Chemo-Immunotherapy
Official title: Adaptive-Dose to Mediastinum With Immunotherapy (Durvalumab MEDI4736) and Radiation in Locally-Advanced Non-Small Cell Lung Cancer
Sponsor: University of Washington (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Terminated due to slow accrual
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-12-10
Primary completion date: 2022-04-23
Completion date: 2022-04-23
Limitations and caveats: We enrolled one participant, then trial closed due to poor accrual. Early termination leading to small numbers of subjects analyzed.
Plan to share individual participant data: NO
Clinical trial NCT03605680: A Trial Evaluating the Efficacy, Safety, & Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder
Official title: A Phase 3, Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group Trial Evaluating the Efficacy, Safety, and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-deficit/Hyperactivity Disorder
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 604.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-01-16
Primary completion date: 2020-04-11
Completion date: 2020-04-11
Baseline population: Participants who participated only in the Run-in Period and Full Analysis Set (FAS) including all participants in the safety sample who had a Baseline value and at least one valid post-randomization efficacy evaluation for adult ADHD investigator symptom rating scale (AISRS) total score in the Double-blind Treatment Period.
Plan to share individual participant data: YES
IPD sharing description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
IPD time frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
IPD access criteria: Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
Clinical trial NCT04582409: A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of HSY244 in Participants With Atrial Fibrillation
Official title: A Randomized, Placebo-controlled, Investigator- and Participant-blinded Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of HSY244 in Participants With Atrial Fibrillation
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Terminated due to business decision
Enrollment: 13.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-11-30
Primary completion date: 2022-07-11
Completion date: 2022-07-11
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 NCT03980223: Evaluation of Doxycycline Post-exposure Prophylaxis to Reduce Sexually Transmitted Infections in PrEP Users and HIV-infected Men Who Have Sex With Men
Official title: Evaluation of Doxycycline Post-exposure Prophylaxis to Reduce Sexually Transmitted Infections in PrEP Users and HIV-infected Men Who Have Sex With Men
Sponsor: University of California, San Francisco (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 641.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-11-26
Primary completion date: 2023-06-12
Completion date: 2023-06-12
Baseline population: Overall number of baseline participants does not include participants who had not yet reached their month 3 visit at the time of the analysis and those who were lost to FU after month 3.
Plan to share individual participant data: NO
IPD sharing description: IPD will not be shared with other researchers outside of the study team
Clinical trial NCT02949752: Aripiprazole as an Adjunct to Atypical Antipsychotics for Weight Reduction and Improvement in Metabolic Profile
Official title: Aripiprazole as an Adjunct to Atypical Antipsychotics for Weight Reduction and Improvement in Metabolic Profile
Sponsor: Institute of Mental Health, Singapore (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 67.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-08-31
Primary completion date: 2019-10-01
Completion date: 2020-01-01
Plan to share individual participant data: NO
Clinical trial NCT04887831: Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab
Official title: A Phase 2, Randomized, Open-Label Study of Trilaciclib Administered With First-Line Platinum-Based Chemotherapy and Avelumab Maintenance Therapy in Patients With Untreated, Locally Advanced or Metastatic Urothelial Carcinoma (PRESERVE 3)
Acronym: PRESERVE3
Sponsor: G1 Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor no longer pursuing trila for the indication.
Enrollment: 92.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-06-04
Primary completion date: 2023-04-07
Completion date: 2024-03-01
Plan to share individual participant data: NO
Clinical trial NCT03333031: A Study of HS-196, an HSP90 Inhibitor-linked NIR Probe for Solid Malignancies
Official title: A Phase I Study of HS-196, an HSP90 Inhibitor-linked Near Infrared Probe for Detection of Solid Malignancies
Sponsor: Duke University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Funding ended
Enrollment: 7.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-08-10
Primary completion date: 2020-10-15
Completion date: 2022-09-07
Plan to share individual participant data: UNDECIDED
Clinical trial NCT02017717: A Study of the Effectiveness and Safety of Nivolumab Compared to Bevacizumab and of Nivolumab With or Without Ipilimumab in Glioblastoma Patients
Official title: A Randomized Phase 3 Open Label Study of Nivolumab Versus Bevacizumab and Multiple Phase 1 Safety Cohorts of Nivolumab or Nivolumab in Combination With Ipilimumab Across Different Lines of Glioblastoma
Acronym: CheckMate 143
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 529.0 (ACTUAL)
Number of arms: 3.0
Start date: 2014-02-07
Primary completion date: 2019-06-17
Completion date: 2024-06-21
Baseline population: Cohorts 1b and 1c/1d (Part A) baseline characteristics are in regards to Treated Participants, while Cohorts 1, 1c/1d (Part B) and 2 baseline characteristics are in regards to Randomized Participants.
Clinical trial NCT04418765: A Study to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Participants That Are Not Helped by Previous Preventive Treatments
Official title: Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study With an Extension Period to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Patients With Unsuccessful Prior Preventive Treatments
Acronym: DELIVER
Sponsor: H. Lundbeck A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 892.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-06-01
Primary completion date: 2021-07-15
Completion date: 2022-09-15
Baseline population: Full analysis set (FAS) included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of monthly migraine days (MMDs) in Weeks 1 to 12.
Plan to share individual participant data: YES
Clinical trial NCT03713944: Carboplatin Plus Pemetrexed Plus Atezolizumab Plus Bevacizumab in Chemotherapy and Immunotherapy-naïve Patients With Stage IV Non-squamous Non-small Cell Lung Cancer
Official title: A Phase II Study of Carboplatin Plus Pemetrexed Plus Atezolizumab Plus Bevacizumab in Chemotherapy and Immunotherapy-naïve Patients With Stage IV Non-squamous Non-small Cell Lung Cancer: Big Ten Cancer Research Consortium BTCRC-LUN17-139
Sponsor: Big Ten Cancer Research Consortium (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Extreme toxicity, thromboembolic events
Enrollment: 30.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-11-15
Primary completion date: 2021-12-16
Completion date: 2021-12-16
Plan to share individual participant data: NO
Clinical trial NCT03827655: A Study of TAK-954 to Treat Gastrointestinal Dysfunction in Adults After Surgery
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of 2 Dose Regimens of Intravenous TAK-954 for the Prophylaxis and Treatment of Postoperative Gastrointestinal Dysfunction in Patients Undergoing Large- and Small-Bowel Resection
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 209.0 (ACTUAL)
Number of arms: 5.0
Start date: 2019-03-07
Primary completion date: 2022-05-27
Completion date: 2022-05-27
Baseline population: Randomized Set included all participants who were randomized in the study.
Plan to share individual participant data: YES
IPD sharing description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Clinical trial NCT03611751: An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently Available Treatment in Participants With Moderate-to-Severe Plaque Psoriasis
Official title: A Multi-Center, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Phase 3 Study With Randomized Withdrawal and Retreatment to Evaluate the Efficacy and Safety of BMS-986165 in Subjects With Moderate-to-Severe Plaque Psoriasis
Acronym: POETYK-PSO-2
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1020.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-07-26
Primary completion date: 2020-11-29
Completion date: 2020-11-30
Clinical trial NCT03516760: Dose-escalating Phase I Trial With GEM333 in Patients With Acute Myeloid Leukemia
Official title: A Multicenter, Open-label, Dose-escalating, Phase I Trial With GEM333, a CD33 Targeted Bispecific Antibody Engaging T-cells, in Relapsed or Refractory Acute Myeloid Leukemia
Sponsor: AvenCell Europe GmbH (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The actions and measures to be taken to restart the trial could not be implemented which made the premature termination inevitability.
Enrollment: 36.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-04-11
Primary completion date: 2022-06-14
Completion date: 2022-06-14
Plan to share individual participant data: NO
Clinical trial NCT04628780: Study to Test the Safety and Tolerability of PF-07209960 in Advanced or Metastatic Solid Tumors
Official title: A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMIC, AND ANTI-TUMOR ACTIVITY OF PF-07209960 IN PARTICIPANTS WITH ADVANCED OR METASTATIC SOLID TUMORS
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Pfizer has made an internal business decision to not continue further development of PF-07209960. This decision was not based on safety or regulatory considerations
Enrollment: 37.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-12-16
Primary completion date: 2023-05-03
Completion date: 2023-05-26
Baseline population: Baseline analysis population included all participants who were randomized.
Limitations and caveats: The study was planned to have 2 parts: a single agent dose escalation (Part 1) followed by a dose expansion (Part 2).~Due to the early termination of the study, Part 2 study was never initiated and the overall study consisted of only Part 1. The data displayed are from the Part 1 study which is the only 1 period of the study. Besides, the pharmacokinetic (PK) endpoints of this study were not conducted. Therefore no results of PK parameters are displayed.
Plan to share individual participant data: NO
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 NCT02164916: S1406 Phase II Study of Irinotecan and Cetuximab With or Without Vemurafenib in BRAF Mutant Metastatic Colorectal Cancer
Official title: Randomized Phase II Study of Irinotecan and Cetuximab With or Without Vemurafenib in BRAF Mutant Metastatic Colorectal Cancer
Sponsor: SWOG Cancer Research Network (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 106.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-11-30
Primary completion date: 2017-11-13
Completion date: 2020-11-19
Baseline population: All eligible patients.
Clinical trial NCT05250947: Study Evaluating the Safety and Feasibility of Platelet-rich Plasma to Treat Facetogenic Low Back Pain
Official title: A Phase I Study Evaluating the Safety and Feasibility of Platelet-rich Plasma for the Treatment of Facetogenic Low Back Pain
Sponsor: Mayo Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Projected cost to continue was not supported by the study budget and additional funds could not be obtained so the decision to close the study was made.
Enrollment: 4.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-01-05
Primary completion date: 2024-05-20
Completion date: 2024-05-20
Plan to share individual participant data: NO
Clinical trial NCT04994106: A Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD5462 Following Single and Multiple Ascending Dose Administration to Healthy Volunteers
Official title: A Phase I Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD5462 Following Single and Multiple Ascending Dose Administration to Healthy Volunteers
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 98.0 (ACTUAL)
Number of arms: 17.0
Start date: 2021-07-27
Primary completion date: 2022-09-20
Completion date: 2022-09-20
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 requests 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 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 patientlevel 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 NCT04340544: Hydroxychloroquine for the Treatment of Mild COVID-19 Disease
Official title: Hydroxychloroquine for the Treatment of Mild COVID-19 Disease
Acronym: COMIHY
Sponsor: University Hospital Tuebingen (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: It appeared to be impossible for the study centres to recruit the targeted number of patients, due to reduced incidence and reduced acceptance to IMP
Enrollment: 17.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-22
Primary completion date: 2020-10-12
Completion date: 2020-10-12
Clinical trial NCT04100330: A Study of Ficlatuzumab With HiDAC and HiDAC Alone in Adults With Relapsed or Refractory Acute Myeloid Leukemia
Official title: A Phase 2, Randomized, Open-Label, Multicenter Study of Ficlatuzumab in Combination With High-Dose Cytarabine (HiDAC) and HiDAC Alone in Adults With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Acronym: CyFi2
Sponsor: AVEO Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Urgent shift among clinical sites toward efforts to combat COVID-19 pandemic;impacted feasibility of completing study within shelf-life of current IP supply
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-31
Primary completion date: 2020-03-27
Completion date: 2020-03-27
Plan to share individual participant data: NO
Clinical trial NCT02706873: A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate
Official title: A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects With Moderately to Severely Active Rheumatoid Arthritis
Acronym: SELECT-EARLY
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1002.0 (ACTUAL)
Number of arms: 4.0
Start date: 2016-02-23
Primary completion date: 2018-03-15
Completion date: 2022-11-10
Baseline population: The full analysis set included all randomized participants who received at least 1 dose of study drug.
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 NCT03610061: A Trial of Radiotherapy and Durvalumab in DLBCL and FL
Official title: Phase I Dose Escalation Study of Radiotherapy and Durvalumab in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL) and Follicular Lymphoma (FL): The RaDD Study
Acronym: RaDD
Sponsor: Austin Health (OTHER_GOV)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 34.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-11-01
Primary completion date: 2023-04-05
Completion date: 2024-04-08
Plan to share individual participant data: UNDECIDED
IPD sharing description: IPD is the property of the Sponsor (Olivia Newton John Cancer Research Institute). Results from the research intends to be published/presented in relevant publications/conferences for colleague review
Clinical trial NCT05571111: Clinical Research Study to Learn About the Effect and Safety of Different Doses of FE 999302 When Given as a Single Dose for Final Development of the Eggs After Ovarian Stimulation
Official title: A Randomised, Assessor-blind, Active-controlled, Parallel-group, Dose-finding Trial to Investigate the Efficacy and Safety of FE 999302 for Triggering of Final Follicular Maturation in Women Undergoing Controlled Ovarian Stimulation
Acronym: TIFFANY
Sponsor: Ferring Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Based on company decision to close the project. No trial participants received any study drug.
Enrollment: 0.0 (ACTUAL)
Number of arms: 5.0
Start date: 2022-10-04
Primary completion date: 2024-03-25
Completion date: 2024-06-25
Plan to share individual participant data: NO
Clinical trial NCT03682497: Study in HFpEF Patients to Compare the Effect of AZD9977 and Spironolactone on Serum Potassium
Official title: A Phase I, Open Label, Randomized, Parallel Group, Multicentre Study to Compare the Effect of AZD9977 and Spironolactone on Serum Potassium [sK+] During 28 Days in Patients With HFmrEF or HFpEF and eGFR in the Range of ≥40 and ≤70 mL/Min/1.73m2.
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Attendance at study sites carries risk of COVID-19 infection. Non-attendance at planned study site visits has unacceptable study related patient safety risk.
Enrollment: 68.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-11-01
Primary completion date: 2020-03-31
Completion date: 2020-03-31
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.