chufangao/CTO huggingface dataset:
Clinical trial NCT03329092: A Study to Determine the Efficacy, Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI) ± Metronidazole (MTZ) Versus Meropenem (MER) ± Colistin (COL) for the Treatment of Serious Infections Due to Gram Negative Bacteria.
Official title: A PHASE 3 PROSPECTIVE, RANDOMIZED, MULTICENTER, OPEN-LABEL, CENTRAL ASSESSOR-BLINDED, PARALLEL GROUP, COMPARATIVE STUDY TO DETERMINE THE EFFICACY, SAFETY AND TOLERABILITY OF AZTREONAM-AVIBACTAM (ATM-AVI) ±METRONIDAZOLE (MTZ) VERSUS MEROPENEM±COLISTIN (MER±COL) FOR THE TREATMENT OF SERIOUS INFECTIONS DUE TO GRAM NEGATIVE BACTERIA, INCLUDING METALLO-Β-LACTAMASE (MBL) - PRODUCING MULTIDRUG RESISTANT PATHOGENS, FOR WHICH THERE ARE LIMITED OR NO TREATMENT OPTIONS
Acronym: REVISIT
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 422.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-04-05
Primary completion date: 2023-02-23
Completion date: 2023-02-23
Baseline population: The Intent to Treat (ITT) analysis set included all randomized participants regardless of receipt of study drug. Participants were analyzed according to the treatment to which they were randomized.
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 NCT03323437: Biomarkers of Conversion Risk and Treatment Response in Early-Stage Schizophrenia
Official title: Biomarkers of Conversion Risk and Treatment Response in Early-Stage Schizophrenia
Sponsor: Weill Medical College of Cornell University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 26.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-09-15
Primary completion date: 2023-05-31
Completion date: 2023-05-31
Baseline population: There are only 9 control subjects in the overall number of baseline participants as 4 of the 13 control subjects who were eligible decided to withdraw before completing the baseline procedures.
Plan to share individual participant data: UNDECIDED
Clinical trial NCT02704403: Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Nonalcoholic Steatohepatitis (NASH) and Fibrosis
Acronym: RESOLVE-IT
Sponsor: Genfit (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Study did not meet the predefined primary surrogate efficacy endpoint, no safety issues identified
Enrollment: 2157.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-03-31
Primary completion date: 2020-10-28
Completion date: 2020-10-28
Limitations and caveats: The study was prematurely terminated based upon limited efficacy at time of the interim analysis, not due to safety concerns, and the conclusion that there would be limited benefit for participants to continue in the trial. Therefore, the results for efficacy endpoints other than the primary and key secondary endpoints are not presented in the disclosure of these results.
Plan to share individual participant data: UNDECIDED
Clinical trial NCT02627677: A Study Comparing Ponatinib and Nilotinib in Participants With Chronic Myeloid Leukemia
Official title: A Randomized, Open-label Study of Ponatinib Versus Nilotinib in Patients With Chronic Myeloid Leukemia in Chronic Phase Following Resistance to Imatinib
Acronym: OPTIC-2L
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The study was stopped due to operational feasibility and not due to any safety concerns
Enrollment: 44.0 (ACTUAL)
Number of arms: 3.0
Start date: 2015-12-31
Primary completion date: 2020-10-29
Completion date: 2021-01-20
Baseline population: Safety Population included all participants who have received at least 1 dose of study drug.
Limitations and caveats: This study was terminated due to operational feasibility and not due to any safety concerns.
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 NCT04709835: Study to Evaluate the Effects of AT-527 in Non-Hospitalized Adult Patients With Mild or Moderate COVID-19
Official title: A Phase II Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Antiviral Activity, Safety, Pharmacokinetics, and Efficacy of RO7496998 (AT-527) in Non-Hospitalized Adult Patients With Mild or Moderate COVID-19
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 104.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-02-03
Primary completion date: 2021-09-17
Completion date: 2021-10-13
Baseline population: The modified ITT infected (mITTi) population was defined as all participants randomized in the study who received any amount of study drug and had at least one positive SARS-CoV-2 RT-PCR test result above or equal to the limit of quantification (LOQ) during the study, with participants grouped according to the treatment assignment at randomization.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm)
Clinical trial NCT04200066: A Study of Maprotiline in Combination With Tamoxifen and Temozolomide for Recurrent Glioblastoma
Official title: A Phase 1 Study of Maprotiline in Combination With Tamoxifen and Temozolomide for Recurrent Glioblastoma
Sponsor: University of Rochester (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: One of the drugs for the study is not commercially available.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-06-01
Primary completion date: 2023-10-01
Completion date: 2024-02-01
Clinical trial NCT04017130: A Study of MT-0169 in Participants With Relapsed or Refractory Multiple Myeloma
Official title: A Phase 1, Open-Label, Dose-Escalation, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MT-0169 in Patients With Relapsed or Refractory Multiple Myeloma
Sponsor: Molecular Templates, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sparse/no patient enrollment
Enrollment: 14.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-02-05
Primary completion date: 2023-12-13
Completion date: 2023-12-13
Plan to share individual participant data: NO
Clinical trial NCT02896855: A Study to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel Versus Placebo + Trastuzumab + Docetaxel in Previously Untreated Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer
Official title: A Phase III, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Pertuzumab+Herceptin+Docetaxel Versus Placebo+Herceptin+Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer
Acronym: PUFFIN
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 243.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-09-13
Primary completion date: 2018-06-27
Completion date: 2021-01-22
Baseline population: Intent-to-Treat (ITT) population: consists of all randomized participants, regardless of whether they received any study treatment. Participants are grouped according to the treatment group to which they were randomized.
Clinical trial NCT01730950: Bevacizumab With or Without Radiation Therapy in Treating Patients With Recurrent Glioblastoma
Official title: Randomized Phase II Trial of Concurrent Bevacizumab and Re-Irradiation Versus Bevacizumab Alone as Treatment for Recurrent Glioblastoma
Sponsor: Radiation Therapy Oncology Group (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 182.0 (ACTUAL)
Number of arms: 2.0
Start date: 2012-12-20
Primary completion date: 2018-09-03
Completion date: 2022-12-22
Baseline population: Eligible participants
Clinical trial NCT05111249: A Dose Range Finding Study With Open-Label Extension to Evaluate the Safety of Oral LMI070/Branaplam in Early Manifest Huntington's Disease
Official title: A Randomized, Double-Blind, Placebo-Controlled Dose Range Finding Study With Open-Label Extension to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of LMI070/Branaplam Administered as Weekly Oral Doses in Participants With Early Manifest Huntington's Disease
Acronym: VIBRANT-HD
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 26.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-12-08
Primary completion date: 2023-10-27
Completion date: 2023-10-27
Clinical trial NCT05204758: Prophylactic TCM for Mitigation of EGFR-TKI Related Dermatological Adverse Effect
Official title: Prophylactic TCM for Mitigation of EGFR-TKI Related Dermatological Adverse Effect
Sponsor: China Medical University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 30.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-05-12
Primary completion date: 2017-12-31
Completion date: 2021-02-28
Plan to share individual participant data: NO
Clinical trial NCT04335786: Valsartan for Prevention of Acute Respiratory Distress Syndrome in Hospitalized Patients With SARS-COV-2 (COVID-19) Infection Disease
Official title: PRAETORIAN-COVID: A Double-blind, Placebo-controlled Randomized Clinical Trial With Valsartan for PRevention of Acute rEspiraTORy dIstress Syndrome in hospitAlized patieNts With SARS-COV-2 (COVID-19) Infection Disease
Sponsor: Radboud University Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Enrollment was stopped to facilitate successful enrollment for the ACE2RAS-domain of the REMAP-CAP trial.
Enrollment: 23.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-17
Primary completion date: 2021-05-25
Completion date: 2021-05-25
Clinical trial NCT03655080: Pulsed Abraxane and Radiotherapy for Improving and Maintaining Ambulation After Cancer-Related Cord Compression
Official title: Novel Approach of Pulsed Abraxane and Radiotherapy for Improving and Maintaining Ambulation After Cancer-Related Cord Compression
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Pharmaceutical company decided to close study
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-01-09
Primary completion date: 2021-02-22
Completion date: 2021-06-15
Plan to share individual participant data: NO
Clinical trial NCT03486197: Neutron Radiation Therapy and Pembrolizumab in Treating Participants With Advanced Urothelial Carcinoma
Official title: Phase II Trial of Neutron Radiotherapy With Concurrent Checkpoint Inhibitor Immunotherapy (Pembrolizumab) in Patients With Advanced Urothelial Carcinoma
Sponsor: University of Washington (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Closed per SRC Low Accrual Policy
Enrollment: 13.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-01-17
Primary completion date: 2023-11-01
Completion date: 2024-05-01
Plan to share individual participant data: NO
Clinical trial NCT04063865: Everolimus Monotherapy as Immunosuppression After Liver Transplant
Official title: Protection of Renal Function After Liver Transplant Using Everolimus Monotherapy as the Immunosuppression Regimen
Sponsor: Indiana University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Study was larger than expected and became a burden to faculty and staff resources.
Enrollment: 14.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-09
Primary completion date: 2020-07-02
Completion date: 2020-07-02
Plan to share individual participant data: NO
Clinical trial NCT04310865: Yinhu Qingwen Granula for the Treatment of Severe CoVID-19
Official title: An Adaptive, Randomized, Double-blind, Parallel-controlled Clinical Trial of Yinhu Qingwen Granula for the Treatment of Severe CoVID-19
Sponsor: China Academy of Chinese Medical Sciences (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: SUSPENDED 
Why stopped: There were no eligible patients with CoVID-19 in the paticipated centers.
Enrollment: 116.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2021-11-30
Primary completion date: 2022-12-31
Completion date: 2023-04-30
Clinical trial NCT03735316: Vitamin B12a Vasoplegic Syndrome
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study for High-Dose Hydroxocobalamin (Vitamin B12A) for Vasopressor Refractory Hypotension Following Cardiopulmonary Bypass
Sponsor: Mayo Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Insufficient recruitment over study period
Enrollment: 8.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-04-25
Primary completion date: 2022-04-01
Completion date: 2022-04-01
Limitations and caveats: Terminated study. Insufficient recruitment over study period
Plan to share individual participant data: NO
Clinical trial NCT02569476: BGB 3111 in Combination With Obinutuzumab in Participants With B-Cell Lymphoid Malignancies
Official title: A Phase 1b Study to Assess Safety, Tolerability and Antitumor Activity of the Combination of BGB 3111 With Obinutuzumab in Subjects With B-Cell Lymphoid Malignancies
Sponsor: BeiGene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 119.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-01-13
Primary completion date: 2020-09-02
Completion date: 2020-09-02
Plan to share individual participant data: YES
Clinical trial NCT04778592: Efficacy and Safety of ETX-018810 in Subjects With Lumbosacral Radicular Pain
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of ETX-018810 in Subjects With Lumbosacral Radicular Pain
Sponsor: Eliem Therapeutics (UK) Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 149.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-19
Primary completion date: 2022-05-16
Completion date: 2022-05-25
Baseline population: The ITT population included all randomized subjects who received at least one dose of study treatment. One subject randomized to ETX-018810 withdrew consent to participate in the study before receiving their first dose of study medication.
Plan to share individual participant data: NO
Clinical trial NCT04335071: Tocilizumab in the Treatment of Coronavirus Induced Disease (COVID-19)
Official title: CORON-ACT - a Multicenter, Double-blind, Randomized Controlled Phase II Trial on the Efficacy and Safety of Tocilizumab in the Treatment of Coronavirus Induced Disease (COVID-19)
Acronym: CORON-ACT
Sponsor: Insel Gruppe AG, University Hospital Bern (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: 1.) Not possible to recruit the planned number of patients during the planned study period; 2.) Dexamethason was included in the standard of care for the study population during the course of the study and inclusion criteria could no longer be met.
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-26
Primary completion date: 2020-09-27
Completion date: 2020-09-27
Plan to share individual participant data: NO
Clinical trial NCT04411134: E7 TCR T Cell Immunotherapy for High-Grade Cervical Intraepithelial Neoplasia
Official title: A Phase I Study of E7 TCR T Cell Immunotherapy for High-Grade Cervical Intraepithelial Neoplasia
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Closed based on the lack of perceived clinical activity observed from a different study treating a similar patient population with same study agent.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-28
Primary completion date: 2020-07-14
Completion date: 2020-07-14
Clinical trial NCT02431325: A Study of the Gut Barrier and Blood Vessel Inflammation in Individuals With and Without HIV
Official title: A Study to Investigate Gastrointestinal Epithelial Integrity and Arterial Inflammation in Individuals With and Without HIV
Sponsor: Massachusetts General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 32.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-12-31
Primary completion date: 2020-01-21
Completion date: 2021-01-21
Clinical trial NCT05783492: INK Feasibility Study
Official title: Intranasal Ketamine for Procedural Sedation: a Feasibility Cohort Study
Sponsor: Lawson Health Research Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Lack of availability of drug
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2024-01-01
Primary completion date: 2024-03-31
Completion date: 2024-04-30
Plan to share individual participant data: NO
Clinical trial NCT02707055: A Novel Compound for Alcoholism Treatment: A Translational Strategy - Part II
Official title: A Novel Compound for Alcoholism Treatment: A Translational Strategy - Part II
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Early termination of the study due to the COVID-19 pandemic
Enrollment: 42.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-06-15
Primary completion date: 2020-02-20
Completion date: 2020-09-09
Limitations and caveats: Early termination of the study due to the COVID-19 pandemic resulted in a smaller number of participants analyzed, compared to the planned sample.
Clinical trial NCT04241315: ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting
Official title: A Phase 3, Randomized,Single Dose, Open-Label Study to Investigate the Safety and Efficacy of OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules
Acronym: Elucidate
Sponsor: On Target Laboratories, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 112.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-03-26
Primary completion date: 2021-10-07
Completion date: 2021-11-01
Plan to share individual participant data: NO
Clinical trial NCT05644600: A Study to Assess the Effect of AZD5055 on the Pharmacokinetics (PK) of Nintedanib in Healthy Participants.
Official title: An Open Label, Randomised Study in Healthy Participants to Investigate the Effect of AZD5055 on the Pharmacokinetics of Nintedanib.
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The study was terminated as no drug-drug interactions were observed in Part-A of the study and therefore Part-B of the study was not required as per protocol.
Enrollment: 18.0 (ACTUAL)
Number of arms: 4.0
Start date: 2023-05-26
Primary completion date: 2023-07-17
Completion date: 2023-07-17
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers can request access to anonymized individual subject-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please 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 deidentified individual subject-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Clinical trial NCT04497948: Acalabrutinib Study With Best Supportive Care in Participants Hospitalized With COVID-19
Official title: An Open-label, Multiple-dose Study of Acalabrutinib, Co Administered With a Proton-pump Inhibitor, in Participants Hospitalized With COVID-19
Sponsor: Acerta Pharma BV (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Data from the CALAVI Phase II trials for Acalabrutinib in patients hospitalized with COVID-19 did not meet their primary efficacy endpoints.~Based on this higher management made the decision to prematurely terminate the D822FC00005 PK study.
Enrollment: 9.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-09-21
Primary completion date: 2020-11-18
Completion date: 2020-11-18
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.