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738 results for “Adverse events”
Isotonic Solutions and Major Adverse Renal Events Trial in the Non-Medical Intensive Care Unit (SMART-SURG)
ClinicalTrials.gov study NCT02547779. IPD Sharing: Not stated. Countries: 1. Publications: 6.
Domperidone and the Risk of Serious Adverse Events
ClinicalTrials.gov study NCT07098078. IPD Sharing: NO. Countries: 1. Publications: 27.
Escitalopram and the Risk of Serious Adverse Events
ClinicalTrials.gov study NCT07274241. IPD Sharing: NO. Countries: 1. Publications: 1.
A Phase 3 Clinical Outcomes Study to Compare the Incidence of Major Adverse Cardiovascular Events in Subjects Presenting With Acute Coronary Syndrome Treated With Losmapimod Compared to Placebo (LATIT
ClinicalTrials.gov study NCT02145468. IPD Sharing: YES. Countries: 34. Publications: 3.
Tamsulosin and the Risk of Serious Adverse Events
ClinicalTrials.gov study NCT07274228. IPD Sharing: NO. Countries: 1. Publications: 4.
Outcomes and adverse events of pre- and extensively drug-resistant tuberculosis patients in Kinshasa, Democratique Republic of the Congo: retrospective cohort study
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Schistosomiasis and soil-transmitted helminthiasis preventive chemotherapy: Adverse events in children from 2 to 15 years in Bengo province, Angola - Dataset
<p>In the context of a targeted drug administration, between December 2012 and September 2013, we conducted two surveys after co-administrating single oral doses of praziquantel and albendazole tablets to children 2 to 15 years of age. About 24 hours after each treatment, participants answered a questionnaire about adverse events. At baseline, 605 children (55.0% male; mean age: 9.7 years) were treated; 460 were interviewed and 257 (55.9%) reported at least one adverse event, 62.3% (160/257) of children being infected with<em> schistosoma haematobium</em>. After six months of treatment, among 339 children surveyed, 184 (54.3%) reported adverse events, with 49.5% (91/184) of infected children. Adverse events were most common in preschool-aged children, with no significant difference between genders. The most frequent adverse events in the two surveys were abdominal pain (18.5%, 25.7%), headache (20.9%, 23.0%) and dizziness (15.7%, 19.8%). Children aged 12 to 15 years (adjusted OR=0.40, <em>p</em>=0.040) and those with mixed infection (adjusted OR=0.04<em>, p</em>=0.011) had lower odds of adverse events. After the second treatment, those with heavy infection (adjusted OR=2.72<em>, p</em>=0.018) and aged 9-11 years (adjusted OR=2.01, <em>p</em>=0.049) had significantly fewer adverse events. About 2.0% of children experienced severe adverse events.</p>
Data from: A curated and standardized adverse drug event resource to accelerate drug safety research
Identification of adverse drug reactions (ADRs) during the post-marketing phase is one of the most important goals of drug safety surveillance. Spontaneous reporting systems (SRS) data, which are the mainstay of traditional drug safety surveillance, are used for hypothesis generation and to validate the newer approaches. The publicly available US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) data requires substantial curation before they can be used appropriately, and applying different strategies for data cleaning and normalization can have material impact on analysis results. We provide a curated and standardized version of FAERS removing duplicate case records, applying standardized vocabularies with drug names mapped to RxNorm concepts and outcomes mapped to SNOMED-CT concepts, and pre-computed summary statistics about drug-outcome relationships for general consumption. This publicly available resource, along with the source code, will accelerate drug safety research by reducing the amount of time spent performing data management on the source FAERS reports, improving the quality of the underlying data, and enabling standardized analyses using common vocabularies.
US FDA FAERS Drug Adverse Event Dataset Processed as Relational CSV
<p>WARNING: This is an early attempt at processing a large dataset, and I have not yet completely validated the processing scripts or the resulting CSV files.</p> <p>This is a compressed archive of the US FDA FAERS Drug Averse Event database, obtained from open.fda.gov (https://open.fda.gov) and processed with scripts that I wrote (https://github.com/dbuijs/faers2csv) to convert the 100 GB of JSON files into relational CSV that take up approximately 6 GB of space and are suitable for loading into a relational database such as PostgreSQL. </p> <p>This version of the data was processed on January 29, 2016. </p> <p>faerscsv.tar.bz2 expands into a folder called csv, with 4 relational CSV files for each source JSON file.</p> <p>faerstats.tar.bz2 expands into a folder called stats, with a text file for each CSV file containing summary statistics generated by csvstat (Python CSVkit).</p>
Dataset and additional info for "Serious adverse events of special interest following mRNA vaccination in randomized trials" (Fraiman et al. 2022)
<p>Dataset for:</p> <p>Fraiman J, Erviti J, Jones M, Greenland S, Whelan P, Kaplan RM, Doshi P. Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults. Vaccine. 2022 Aug 30;40(40):5798–805. doi: 10.1016/j.vaccine.2022.08.036. Epub ahead of print. PMID: 36055877; PMCID: PMC9428332. <a href="https://doi.org/10.1016/j.vaccine.2022.08.036">https://doi.org/10.1016/j.vaccine.2022.08.036</a> </p>
Clinical and physical parameters of cardiovascular disease patients and occurence of adverse events during exercise
<h2>Supplementary data for the publication available at doi: 10.1038/s41598-024-68223-y.</h2> <p>The article aimed to evaluate the predictive power of physical and clinical parameters to predict the rate of adverse events during exercise-based cardiac rehabilitation.</p> <p>Here the reader can find all anonymized data and complete analysis of results that support the findings reported in the cited publication.</p>
Psychometric properties of Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE®) in breast cancer patients: the prospective observational multicenter VIP study.
<p>Dataset for the proposed manuscript Psychometric properties of Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE®) in breast cancer patients: the prospective observational multicenter VIP study. </p>
Clinical and genomic predictors of adverse events in newly diagnosed glioblastoma
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Data from: Adverse events associated with risdiplam use
<p>Risdiplam is a new drug for treating spinal muscular atrophy (SMA). However, pharmacovigilance analyses are necessary to objectively evaluate its safety—a crucial step in preventing severe adverse events (AEs). Accordingly, the primary objective of the current study was to examine the AEs associated with risdiplam use based on real-world data obtained from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. More specifically, we examined incidents reported between the third quarter of 2020 and the second quarter of 2023. The imbalance of risdiplam-related AEs was evaluated by computing the reporting odds ratio. A total of 5,406,334 reports were thoroughly reviewed. By removing duplicate reports, we identified 1588 reports in which risdiplam was the main suspected drug whose use was accompanied by 3470 associated AEs. Among the included AEs, 703 were categorized as serious and 885 as non-serious. Risdiplam use induced AEs across 18 organ systems, resulting in 130 positive signals. Notably, we detected new AE signals, including cardiac arrest, nephrolithiasis, tachycardia, loss of libido, and elevated hepatic enzyme activities; however, no ophthalmologic toxicity was reported. Although these new adverse reaction signals associated with risdiplam have been defined, long-term clinical studies are needed to confirm these findings. Nevertheless, our findings provide a valuable reference for improving the clinical management of SMA.</p>
Proteomic and Metabolomic Profiling of Plasma Predict Immune-related Adverse Events in Older Patients with Advanced Non-small Cell Lung Cancer
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Data from: Methods for estimating causal relationships of adverse events with dietary supplements
Objective: Dietary supplement use has increased over past decades, resulting in reports of potentially serious adverse events. The aim of this study was to develop optimised methods to evaluate the causal relationships between adverse events and dietary supplements, and to test these methods using case reports. Design: Causal relationship assessment using prospectively collected data. Setting and participants: 4 dietary supplement experts, 4 pharmacists and 11 registered dietitians (5 men and 14 women) examined 200 case reports of suspected adverse events using the modified Naranjo scale and the modified Food and Drug Administration (FDA) algorithm. Primary outcome measures: The distribution of evaluation results was analysed and inter-rater reliability was evaluated for the two modified methods employed using intraclass correlation coefficients (ICC) and Fleiss' κ. Results: Using these two methods, most of the 200 case reports were categorised as 'lack of information' or 'possible' adverse events. Inter-rater reliability among entire assessors ratings for the two modified methods, based on ICC and Fleiss' κ, were classified as more than substantial (modified Naranjo scale: ICC (95% CI) 0.873 (0.850 to 0.895); Fleiss' κ (95% CI) 0.615 (0.615 to 0.615). Modified FDA algorithm: Fleiss' κ (95% CI) 0.622 (0.622 to 0.622). Conclusions: These methods may help to assess the causal relationships between adverse events and dietary supplements. By conducting additional studies of these methods in different populations, researchers can expand the possibilities for the application of our methods.
Dataset for "Assessing muscle-related adverse events in randomized trials of statins"
<p>Contains our extraction sheets with additional notes/comments on methods used in our study.</p>
GWAS summary stats in "A web-based genome-wide association study reveals the susceptibility loci of common adverse events following COVID-19 vaccination in the Japanese population."
<p>Summary stats of the genome-wide meta-analysis with METAL software in the article "A web-based genome-wide association study reveals the susceptibility loci of common adverse events following COVID-19 vaccination in the Japanese population."</p><p>https://doi.org/10.1038/s41598-023-47632-5<br>Due to the absence of cases in either population, we were unable to perform GWAS for the following conditions.<br>constipation at BNT162b1 1st dose<br>dyspnea at BNT162b1 1st dose<br>eczema (long-term rash) at BNT162b1 1st dose<br>dyspnea at BNT162b1 2nd dose<br>sneeze at mRNA-1273 1st dose<br>dyspnea at mRNA-1273 1st dose</p>
Study to Assess Adverse Events and Compare How Crushed, Ground, and Intact Oral Tablets Venetoclax Moves Through the Body of Healthy Female Adult Volunteers
ClinicalTrials.gov study NCT05909553. IPD Sharing: NO. Countries: 1. Publications: 1.
Study to Assess Adverse Events and Compare How Oral Ubrogepant and Oral Atogepant Moves Through the Body of Healthy Female Adult Volunteers
ClinicalTrials.gov study NCT05892757. IPD Sharing: NO. Countries: 1. Publications: 1.
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These curated guides explain access requirements, typical timelines, costs, and reuse considerations for widely used research datasets.
Allen Brain Atlas
Allen Brain Atlas is an Allen Institute collection of brain map atlases, datasets, APIs, and analysis tools covering mouse, human, and non-human primate brain resources.
Annotated Behaviour and Observability Dataset (ABODe)
ABODe is a University of Edinburgh DataShare dataset for behavior classification in group-housed mice using home-cage video, identities, bounding boxes, ground-plate positions, and annotator labels.
DANDI Archive for NWB datasets
DANDI is a BRAIN Initiative archive for publishing and sharing neurophysiology data, including electrophysiology, optophysiology, and behavioral data packaged as NWB and related standards.
International Brain Laboratory public data
The International Brain Laboratory public data releases expose standardized mouse decision-making experiments, including Neuropixels recordings, widefield calcium imaging, behavior, and session metadata accessed through the ONE API.
OpenNeuro
OpenNeuro is a free, open platform for sharing neuroimaging datasets, with public search, dataset pages, and download paths for web, S3, DataLad, and the OpenNeuro CLI.