データセット概要
有害薬物反応監視データセットはChangsha 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.
| データセット名 | 有害薬物反応監視データセット |
| データ種別 | SDS ADR report + signal mining structured data + structured JSON |
| 核心内容 | 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 |
| ソースデータ | National Drug Negative Response Monitoring System (RSS), voluntary report of the ADR of the medical institution, and documentary case safety report (ICSR) |
| 活用シーン | Drug alert AI, security signal mining, adverse event causality assessment, post-market evaluation of drugs, development of risk management plan (RMP) |
| フォーマット 出力 | Structured JSON + CSV 导出 + API 接口 |
| 状态 | 近日公開 |
核心データ次元
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.
| サイズ:大类 | フィールド数 | 代表的なフィールド | 价值层级 |
|---|---|---|---|
| レポート标识 | 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 | 基础标识 |
| 患者情報 | 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 |
| 不良事件 | 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 | 中心次元 |
| 怀疑药品 | 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 | 中心次元 |
| 合并用药 | 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 | 高级分析 |
| 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 | 高级分析 |
| 信号检测 | 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 | 信号挖掘 |
| メタデータ | 6 | Date of data entry, source system, data quality rating, completeness rating, dissensitisation, version number | 品質管理 |
AI活用シーン
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(アクバ 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.
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