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Clinical Trial Data requests that resulted in disclosure of patient-level clinical data or Clinical Study Reports (CSRs).

Title of Proposed Study Affiliation Date request received Date approved
Do antipsychotics increase the risk for sudden death and serious adverse events, and what are risk factors? Department of Psychiatry and Psychotherapy, Technische Universität München March 9, 2016 August 24 2016
INCIDENCE AND PREDICTORS OF RELAPSE IN PATIENTS ADHERENT WITH LONG ACTING INJECTABLES: AN INDIVIDUAL PATIENT-LEVEL META-ANALYSIS Zucker Hillside Hospital, Psychiatry Research, Northwell Health, Glen Oaks, NY, USA April 19, 2018 September 7, 2018
Variability of antipsychotic response: A meta-analysis Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King's College London November 18, 2018 February 8, 2019

Clinical Trial Data Requested but Unapproved

Study title Study ID Date request received Reasons for non-disclose
A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease 156-04-251 2018/06/02
May 25, 2018
The ICF prohibits patient-level data sharing to third parties and onlyallows disclosure to regulatory authorities and Otsuka designees
A Multicenter, Double Blind, Factorial Design, Phase IV Trial to Compare the Efficacy and Safety of Cilostazol Long-term Treatment With Aspirin in Ischemic Stroke Patients With High Risk of Cerebral Hemorrhage for the Prevention of Cerebral Hemorrhage and Cardiovascular Events and to Compare the Preventive Effect of Probucol in the Same Patient Group With Non-drug User Group for the Prevention of Cardiovascular Events NCT01013532 June 8, 2017 Data include non-English language
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