正文
获取原文件REPORT_TEMPLATE.md
Report File Structure
File: [DRUG]_adverse_event_report.md
# Adverse Drug Event Signal Detection Report: [DRUG]
**Generated**: [Date] | **Drug**: [Generic Name] | **ChEMBL ID**: [ID]
**Safety Signal Score**: [XX/100] ([INTERPRETATION])
---
## Executive Summary
[2-3 paragraph summary of key findings]
**Key Safety Signals**:
1. [Strongest signal with PRR/ROR]
2. [Second signal]
3. [Third signal]
**Regulatory Status**: [Boxed warning Y/N] | [Withdrawn Y/N] | [Restrictions]
---
## 1. Drug Identification
[Phase 0 output]
## 2. FAERS Adverse Event Profile
[Phase 1 output]
## 3. Disproportionality Analysis
[Phase 2 output]
## 4. FDA Label Safety Information
[Phase 3 output]
## 5. Mechanism-Based Context
[Phase 4 output]
## 6. Comparative Safety Analysis
[Phase 5 output]
## 7. Drug-Drug Interactions & PGx Risk
[Phase 6 output]
## 8. Literature Evidence
[Phase 7 output]
## 9. Risk Assessment
[Phase 8 output]
## 10. Clinical Recommendations
### 10.1 Monitoring Recommendations
| Parameter | Frequency | Rationale |
|-----------|-----------|-----------|
| [Lab test] | [Frequency] | [Why] |
### 10.2 Risk Mitigation Strategies
| Risk | Mitigation | Evidence |
|------|-----------|----------|
| [Risk] | [Strategy] | [Source] |
### 10.3 Patient Counseling Points
- [Point 1]
- [Point 2]
### 10.4 Populations at Higher Risk
| Population | Risk Factor | Recommendation |
|-----------|-------------|----------------|
| [Group] | [Factor] | [Action] |
---
## 11. Completeness Checklist
[See below]
## 12. Data Sources
[All tools and databases used with timestamps]
Completeness Checklist
Phase 0: Drug Disambiguation
- Generic name resolved
- ChEMBL ID obtained
- DrugBank ID obtained
- Drug class identified
- Mechanism of action stated
- Primary target identified
- Blackbox/withdrawal status checked
Phase 1: FAERS Profiling
- Top adverse events queried (>=15 events)
- Seriousness distribution obtained
- Outcome distribution obtained
- Age distribution obtained
- Death-related events counted
- Reporter country distribution obtained
Phase 2: Disproportionality Analysis
- PRR calculated for >= 10 adverse events
- ROR with 95% CI for each event
- IC with 95% CI for each event
- Signal strength classified for each
- Demographics stratified for strong signals
Phase 3: FDA Label
- Boxed warnings checked (or confirmed none)
- Contraindications extracted
- Warnings and precautions extracted
- Adverse reactions from label
- Drug interactions from label
- Special populations (pregnancy, geriatric, pediatric)
Phase 4: Mechanism Context
- Target safety profile (OpenTargets)
- OpenTargets adverse events queried
- ADMET predictions (if SMILES available)
Phase 5: Comparative Analysis
- At least 1 class comparison performed
- Class-wide vs drug-specific signals identified
- Aggregate class AEs computed (if applicable)
Phase 6: DDIs & PGx
- DDIs from FDA label extracted
- PharmGKB queried
- Dosing guidelines checked
- FDA PGx biomarkers checked
Phase 7: Literature
- PubMed searched (>=10 articles)
- OpenAlex citation analysis (if time permits)
- Key safety publications cited
Phase 8: Risk Assessment
- Safety Signal Score calculated (0-100)
- Each signal evidence-graded (T1-T4)
- Score interpretation provided
Phase 9: Report
- Report file created and saved
- Executive summary written
- Monitoring recommendations provided
- Risk mitigation strategies listed
- Patient counseling points included
- All sources cited