chufangao/CTO huggingface dataset:
Clinical trial NCT03685591: PF-06952229 Treatment in Adult Patients With Advanced Solid Tumors
Official title: A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY EVALUATING SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF 06952229 IN ADULT PATIENTS WITH ADVANCED SOLID TUMORS
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The decision to stop enrollment was due to strategic considerations and not due to any specific safety reasons or request from a regulatory authority.
Enrollment: 49.0 (ACTUAL)
Number of arms: 15.0
Start date: 2018-10-04
Primary completion date: 2022-03-30
Completion date: 2022-03-30
Baseline population: All enrolled participants who received at least one dose of study treatment.
Limitations and caveats: The trial began on 04 October 2018 with LPLV occurring on 30 March 2022 following Pfizer's strategic decision (not due to any specific safety reasons or request from a regulatory authority) to terminate the study, which included the period during which the COVID-19 pandemic was occurring globally since 11 March 2020.
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 NCT04750473: Fluciclovine and PSMA PET/CT for the Classification and Improved Staging of Invasive Lobular Breast Cancer
Official title: Phase 1 Feasibility Trial: Improved Staging of Lobular Breast Cancer With Novel Amino Acid Metabolic and Tumor Neovasculature Receptor Imaging
Sponsor: Emory University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 22.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-07-16
Primary completion date: 2023-03-21
Completion date: 2024-03-21
Clinical trial NCT02659761: Triumeq As an Integrase Single Tablet Regimen in People With HIV Who Inject Drugs
Official title: A Prospective, Single Arm, Open-label 96 Week Observational Trial of the Tolerability, Adherence and Efficacy of a Dolutegravir/Abacavir/Lamivudine Single Tablet Regimen in HIV-1 Antibody Positive People Living With HIV With a History of Injection Drug Use Switching From Existing ART or Starting Treatment After Discontinuation of ART
Acronym: TAISTR
Sponsor: University College Dublin (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Sponsor decision due to slow recruitment rates and no future recruitment foreseen
Enrollment: 33.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-11-30
Primary completion date: 2021-09-30
Completion date: 2021-09-30
Clinical trial NCT02856113: Phase 3 Alogliptin Pediatric Study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Alogliptin Compared With Placebo in Pediatric Subjects With Type 2 Diabetes Mellitus
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 152.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-10-14
Primary completion date: 2021-08-06
Completion date: 2022-02-14
Baseline population: Safety Set included all participants who took at least 1 dose of study medication.
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 Participant 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 NCT04322305: Pregabalin Trial for the Treatment of Alcohol Use Disorder
Official title: A Double-blind, Placebo-Controlled Trial of Pregabalin for the Treatment of Alcohol Use Disorder
Acronym: GABI2
Sponsor: New York State Psychiatric Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: SUSPENDED 
Why stopped: U.S. Department of Health and Human Services OHRP issued an FWA restriction on NYSPI research that included a pause of human subjects research as of June 23, 2023. This study will resume recruitment after OHRP has approved the resumption of research.
Enrollment: 50.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2021-01-11
Primary completion date: 2024-12-31
Completion date: 2024-12-31
Plan to share individual participant data: YES
IPD sharing description: Individual participant data that underlie the results published in this report (after de-identification) (text, tables, figures)
IPD time frame: beginning 12 months and ending 5 years after article publication
IPD access criteria: to researcher who provides a methodologically sound proposal to achieve aims in the approved proposal
Clinical trial NCT04341493: Hydroxychloroquine vs Nitazoxanide in Patients With COVID-19
Official title: Treatment With Hydroxychloroquine vs Nitazoxanide + Hydroxychloroquine in Patients With COVID-19 With Risk Factors for Poor Outcome
Sponsor: Materno-Perinatal Hospital of the State of Mexico (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Concerns about safety of Hydroxychloroquine
Enrollment: 44.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-06
Primary completion date: 2020-08-30
Completion date: 2020-12-30
Plan to share individual participant data: YES
IPD sharing description: If the final selected medical journal to send the paper of our research request it, we will add the full database of the studied population.
IPD time frame: After finishing the study.
IPD access criteria: Requested by the journal or after publication if any researcher in the world express interest if the information of this survey.
Clinical trial NCT05733390: A Study of JZP541 in Adults With Irritability Associated With Autism Spectrum Disorder
Official title: A Phase 2, Randomized, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of JZP541 in Adults With Irritability Associated With Autism Spectrum Disorder
Sponsor: Jazz Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: A decision has been made to prioritize other pipeline programs and terminate this study.
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-06-30
Primary completion date: 2023-11-09
Completion date: 2023-11-09
Clinical trial NCT02408861: Nivolumab and Ipilimumab in Treating Patients With HIV Associated Relapsed or Refractory Classical Hodgkin Lymphoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery
Official title: A Phase I Study of Ipilimumab and Nivolumab in Advanced HIV Associated Solid Tumors With an Expansion Cohort in HIV Associated Solid Tumors and a Cohort of HIV-Associated Classical Hodgkin Lymphoma
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Inadequate accrual rate
Enrollment: 95.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-10-21
Primary completion date: 2024-05-01
Completion date: 2024-08-31
Clinical trial NCT02245230: Cardiovascular Effects of Angiotensin (1-7) in Essential Hypertension
Official title: Cardiovascular Effects of Angiotensin (1-7) in Essential Hypertension
Sponsor: Vanderbilt University Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: We were not able to enroll adequate number of participants that met the inclusion/exclusion criteria, and we run out of funding.
Enrollment: 24.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-01-31
Primary completion date: 2023-12-31
Completion date: 2023-12-31
Plan to share individual participant data: NO
Clinical trial NCT05276830: An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associated With Dementia
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of BXCL501 For The Treatment of Agitation Associated With Dementia
Sponsor: BioXcel Therapeutics Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study was terminated for business reasons; not due to safety or efficacy concerns
Enrollment: 5.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-02-08
Primary completion date: 2022-04-01
Completion date: 2022-04-01
Limitations and caveats: The study was terminated prematurely due to business reasons. There were no Safety or Efficacy Concerns.
Clinical trial NCT04918069: Capsaicin to Prevent Delayed Chemotherapy Induced Nausea and Vomiting (CapCIN)
Official title: Single-blinded, Randomized Study of Capsaicin to Prevent Delayed Chemotherapy-induced Nausea and Vomiting
Acronym: CapCIN
Sponsor: Christian Medical College, Vellore, India (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 160.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-18
Primary completion date: 2022-05-14
Completion date: 2022-05-14
Plan to share individual participant data: UNDECIDED
IPD sharing description: IPD may be shared depending on prevailing local institutional policies.
Clinical trial NCT01590225: Efficacy and Safety of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P08034)
Official title: A Phase 3 Study to Assess the Efficacy and Safety of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin in Pediatric Subjects With Chronic Hepatitis C Genotype 1
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-01-28
Primary completion date: 2021-08-18
Completion date: 2021-08-18
Clinical trial NCT01743989: A Randomized Phase III Study to Assess the Effect of a Longer Duration of Consolidation Treatment With Nilotinib on TFR in CP CML.
Official title: A Prospective, Randomized, Open Label, Two Arm Phase III Study to Evaluate Treatment Free Remission (TFR) Rate in Patients With Philadelphia-positive CML After Two Different Durations of Consolidation Treatment With Nilotinib 300mg BID.
Acronym: ENESTPath
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 620.0 (ACTUAL)
Number of arms: 3.0
Start date: 2013-04-15
Primary completion date: 2020-07-08
Completion date: 2020-07-08
Plan to share individual participant data: YES
IPD sharing description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Clinical trial NCT04178460: A Study of Niraparib Combined With MGD013 in Patients With Advanced or Metastatic Solid Tumor Who Failed Prior Treatment
Official title: A Multicenter, Open-label, Single-arm, Phase Ib Dose Escalation and Multi-cohort Expansion Clinical Study to Assess the Safety and Antitumor Activity of Niraparib in Combination With MGD013 in Patients With Advanced or Metastatic Solid Tumor Who Failed Prior Treatment
Sponsor: Zai Lab (Hong Kong), Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: This termination decision is a business decision and is not due to any safety concerns.
Enrollment: 60.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-02-03
Primary completion date: 2022-03-02
Completion date: 2022-03-02
Clinical trial NCT04455620: BNT151 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With Solid Tumors
Official title: Phase I/IIa, First-in-human, Open-label, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BNT151 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With Solid Tumors
Sponsor: BioNTech SE (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 62.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-01-26
Primary completion date: 2024-05-28
Completion date: 2024-05-28
Plan to share individual participant data: NO
Clinical trial NCT03817931: Higher Neural Changes Following Anticholinergic, Beta 3 Agonist, or Placebo in Patients With Overactive Bladder
Official title: Higher Neural and Cognitive Changes Following Anticholinergic Versus Beta 3 Agonist Versus Placebo Treatments in Female Patients With Overactive Bladder: a Multicenter Randomized Controlled Pilot Trial
Sponsor: Baylor Research Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 12.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-08-05
Primary completion date: 2022-02-02
Completion date: 2022-02-26
Plan to share individual participant data: NO
IPD sharing description: There is not a plan.
Clinical trial NCT01995513: Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients
Official title: A PHASE 4, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF CONTINUED ENZALUTAMIDE TREATMENT BEYOND PROGRESSION IN PATIENTS WITH CHEMOTHERAPY-NAÏVE METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
Acronym: PLATO
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 509.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-10-22
Primary completion date: 2016-11-15
Completion date: 2022-08-31
Baseline population: ITT (Intent to treat) population included all participants randomly assigned to study treatment.
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 NCT04807972: Study to Evaluate Adverse Events and Change in Disease Activity When Intravenous (IV) Infusion of ABBV-927 is Administered in Combination With IV Modified FOLFIRINOX (mFFX) With or Without IV Budigalimab Compared to mFFX in Adult Participants With Untreated Pancreatic Cancer Metastasis
Official title: A Phase 1b/2, Randomized, Controlled, Open-Label Study Evaluating the Safety and Efficacy of ABBV-927 Administered in Combination With Modified FOLFIRINOX (mFFX) With or Without Budigalimab Compared to mFFX in Subjects With Untreated Metastatic Pancreatic Adenocarcinoma
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Strategic considerations
Enrollment: 40.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-05-28
Primary completion date: 2024-03-25
Completion date: 2024-03-25
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 NCT05582707: Safety and Suitability of Supplementing Early MIP Surgery (MIPS) of ICH With Pioglitazone
Official title: A Non-Randomized Controlled Trial to Examine the Safety and Suitability of Supplementing Early Minimally Invasive Parafascicular Surgery (MIPS) for Clot Evacuation of Basal Ganglia Intracerebral Hemorrhage (ICH) With Pioglitazone
Acronym: ENRICHPLUS
Sponsor: University of Maryland, Baltimore (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Loss of Financial Sponsor
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-05-08
Primary completion date: 2024-09-19
Completion date: 2024-09-19
Clinical trial NCT05487040: A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease
Official title: A PHASE 1, OPEN-LABEL, NON-RANDOMIZED STUDY TO INVESTIGATE THE SAFETY AND PK FOLLOWING MULTIPLE ORAL DOSES OF PF-07321332 (NIRMATRELVIR)/RITONAVIR IN ADULT PARTICIPANTS WITH COVID-19 AND SEVERE RENAL IMPAIRMENT EITHER ON HEMODIALYSIS OR NOT ON HEMODIALYSIS
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Decision to terminate study was due to slow enrolment and FDA input that available data may be enough for dosing recommendations for severe renal disease (subject to review by FDA).
Enrollment: 15.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-09-07
Primary completion date: 2023-07-11
Completion date: 2023-07-11
Baseline population: The baseline population was the safety analysis set (SAS) which was all participants enrolled and took at least 1 dose of study intervention.
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 NCT01455389: TUSC2-nanoparticles and Erlotinib in Stage IV Lung Cancer
Official title: Phase I/II Clinical Trial Combining TUSC2-nanoparticles and Erlotinib in Stage IV Lung Cancer
Sponsor: Genprex, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Trial terminated by sponsor after decision to evaluate combination of quaratusugene ozeplasmid and osimertinib instead of further evaluating quaratusugene ozeplasmid and erlotinib.
Enrollment: 25.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-02-28
Primary completion date: 2016-10-27
Completion date: 2020-09-28
Clinical trial NCT03352557: Phase 2 Study of BIIB092 in Participants With Early Alzheimer's Disease
Official title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety, Tolerability, and Efficacy of BIIB092 in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease or With Mild Alzheimer's Disease
Acronym: TANGO
Sponsor: Biogen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study (NCT03352557) was terminated based on lack of efficacy following the placebo-controlled period readout.
Enrollment: 654.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-05-03
Primary completion date: 2021-08-30
Completion date: 2021-08-30
Baseline population: Randomized participants included enrolled participants who received a randomization treatment assignment from the Interactive Response Technology (BIIB092 or placebo).
Limitations and caveats: The study was terminated based on lack of efficacy following the placebo-controlled period readout.
Plan to share individual participant data: YES
IPD sharing description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/
Clinical trial NCT02929589: Ibuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy
Official title: Ibuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy: A Prospective, Placebo-Controlled, Double-Blind, Randomized Controlled Trial
Sponsor: Mike O'Callaghan Military Hospital (FED)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The use of robotic surgery made this study obsolete.
Enrollment: 18.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-07-05
Primary completion date: 2021-08-23
Completion date: 2021-08-23
Baseline population: Study was terminated before any subject data collected could be analyzed. Raw data are reported. No data collected was analyzed by a biostatistician.
Limitations and caveats: This study was terminated early as the advent of the use of robotic surgery made this study obsolete.
Plan to share individual participant data: NO
Clinical trial NCT03710291: Evaluation of Effect of TRC101 on Progression of Chronic Kidney Disease in Subjects With Metabolic Acidosis
Official title: A Phase 3b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of TRC101 in Delaying Chronic Kidney Disease Progression in Subjects With Metabolic Acidosis
Acronym: VALOR-CKD
Sponsor: Tricida, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Administrative reasons
Enrollment: 1480.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-11-20
Primary completion date: 2022-08-23
Completion date: 2022-09-27
Plan to share individual participant data: NO
Clinical trial NCT05312632: A Study to Evaluate the Efficacy and Safety of Safinamide Mesilate as Add-on Therapy to Levodopa in Parkinson's Disease Participants With Motor Fluctuation in South Korea
Official title: A Multi-center, Open-label Phase 4 Study Evaluating the Efficacy and Safety of Safinamide Mesilate as Add-on Therapy to Levodopa in Parkinson's Disease Patients With Motor Fluctuation in South Korea
Sponsor: Eisai Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 201.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-04-05
Primary completion date: 2023-05-25
Completion date: 2023-05-25
Baseline population: The safety analysis population included participants who received at least 1 dose of study drug and completed at least 1 post-dose safety assessment.
Plan to share individual participant data: YES
IPD sharing description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.