Dataset Overview
Data on adverse effects of pharmaceuticals Setis provided byChangsha Langhui Information Technology Co., Ltd.The core dimensions of the drug-incident combination (PRR/ROR/IC/EBGM) are supported by strict de-sensitization, by the compilation of data from the self-reported system (SRS) on the adverse drug response and structured signal mining, covering the description of the adverse event, the severity rating (CTRAE), the causality assessment (Naranjo/WHO-UMC), the drug-incident combination (PRR/ROR/IC/EBGM) and subsequent evaluation.
| Dataset Name | Data on adverse effects of pharmaceuticals Set |
| Data Type | SDS ADR report + signal mining structured data + structured JSON |
| Core Content | Defective incident description (MedDRA code), severity classification (CTCAE), causality assessment (Naranjo/WHO-UMC), suspected drugs/mergers, drug-incident combination signals, PRR/ROR/IC/EBGM signal detection indicators |
| Source Data | National Drug Negative Response Monitoring System (RSS), voluntary report of the ADR of the medical institution, and documentary case safety report (ICSR) |
| Use Cases | Drug alert AI, security signal mining, adverse event causality assessment, post-market evaluation of drugs, development of risk management plan (RMP) |
| Format Output | Structured JSON + CSV Export + API Access |
| Status | Coming Soon |
Core Data Dimensions
The data set is organized in accordance with the ICH drug alert guide (E2B/E2C/E2D) and covers the full life cycle of ADR reporting and signal management links.
| Dimension Category | Field Count | Typical Fields | Value Tier |
|---|---|---|---|
| Report identifier | 8 | Report number (sole global case marking), type of report (sponsible/documentation/research), source of report, date of report, reporting country/area, reporting person ' s qualifications (doctor/pharmacist/patient), severity mark, emergency report mark | Basic Identifier |
| Patient Information | 8 | Age of patients (dissensitization group), gender, weight (dissensitization zone), history of adverse reaction of past drugs, relevant medical history (MedDRA code), combination of diseases, pregnancy/lactation mark, fate (rehabilitation/improved/unresilient/infective/death) | 上下文信息 |
| Bad event | 14 | Defective (MedDRA LLT/PT code), classification of organs in the MedDRA SOC system, date of occurrence, end date, duration, severity classification (CTRAE v. 5.0 1 - 5), criteria for determination of serious adverse events (SAE) (death/threatening/hospital extension/disability/incapacitation), ending of incident | Core Dimensions |
| Suspected drugs | 12 | Suspected generic/trade name, approval number, ATC code, formulation, route of delivery, quantity of use, date of commencement of use, drug adaptation certificate, stop-to-use response, re-inducing response, drug batch number (dissensitization), drug producer | Core Dimensions |
| Combined medicine | 8 | Combined drug use name, date of commencement of drug use, certificate of adaptation, route of delivery, relevance to bad event time, combination drug-incident interaction mark, DDI risk assessment, CYP450 enzyme-related interaction | Advanced Analysis |
| Causation assessment | 10 | Naranjo Quantum Rating ( ⁇ 9: positive; 5-8: likely; 1-4: possible; ⁇ 0: suspicious); WHO-UMC Causation Rating (positive/possible/possible/not possible/not possible/not possible), to stimulate reactions, re-inducing reactions, time reasonableness, laboratory examination support, exclusion of other causes | Advanced Analysis |
| Signal detection | 12 | Medicines - Event combination (DEC), PRR values and 95% CI, ROR values and 95% CI, IC values and 95% CI (Bayes), EBGM values and 90% CI (Empirical Bayes), signal threshold determination (PRR ⁇ 2 and ⁇ 4 and N ⁇ 3), signal intensity classification, signal verification status | Signal mining |
| Metadata | 6 | Date of data entry, source system, data quality rating, completeness rating, dissensitisation, version number | Quality Management |
AI Application Scenarios
Drug alert signal intelligence dig.
Based on the ADR report coded with MedDRA, automatic detection, prioritization and signal validation of drug event signals are achieved using signal detection algorithms such as PRR/ROR/IC/EBGM.
ACVA AI
Naranjo/WHO-UMC training NLP model for the assessment dimension of causation, resulting in automatic causality assessment and structured entry in an example safety report (ICSR).
Post-market security re-evaluation
The real world ADR data-aided medicines are re-evaluated for safety, identifying rare/late-incident adverse events, assessing benefit-risk balance, and supporting the development of risk management plans (RMPs).
Medicinal Alert 'Aide.
The ADR reports automatic classification, stratification and projection of gravity, and the auxiliary drug alert team conducts efficient case-by-case and aggregated analysis.
Common problems
Need a customized data solution？
Changsha Langhui Information Technology Co., Ltd. The DataAssetsAPI platform is dedicated to providing high-quality, compliant data assets to AI enterprises and scientific institutions.
Data sample preview · Customized data solution · ProSupport