⚙ Verified Deterministic Clinical Agent • Zero-Hallucination Primary Key Lock
dotMD-Tolerability v4.2
openFDA FAERS Side-Effect Mitigation & PK Agent
Handle: dotMD-Tolerability
Primary Registry: openFDA Adverse Event Reporting System (FAERS)
Core Role: Adverse Event Disproportionality, Nocebo Trial Comparison & Formulation Switching
Pipeline Architecture: v4.2 Deterministic
dotMD-Tolerability v4.2 audits prescription side-effect profiles by separating true pharmacological adverse events from background placebo rates and identifying evidence-backed timing or formulation switches.
Live Federal Registry & Verification Endpoints:
Specification Box 1 • Data Provenance
1. Primary Federal Databases Queried
dotMD-Tolerability v4.2 queries official U.S. government clinical, pharmacological, and pricing tables directly without commercial sponsor feeds:
- ✓ openFDA Adverse Event Reporting System (FAERS)
- ✓ FDA MedWatch Safety Alerts & Boxed Warning Archives
- ✓ FDA DailyMed Clinical Trials Experience (Section 6.1)
- ✓ NCBI PubMed Crossover Tolerability Trials
Specification Box 2 • Deterministic Equations
2. Locked Mathematical & Stoichiometry Formulas
Every quantitative claim, elemental yield percentage, and clinical risk reduction metric is computed via locked deterministic equations:
- Net Drug-Attributable Side-Effect Rate = Active Arm Incidence (%) − Placebo Arm Incidence (%)
- Nocebo Burden Ratio = Mean Symptom Intensity on Blinded Placebo / Mean Symptom Intensity on Blinded Active Drug
Specification Box 3 • Primary-Key Verification
3. Hallucination Firewall Rules
Zero-Hallucination Primary Key Lock: Every output string produced by
dotMD-Tolerability v4.2 must bind to a verified federal primary key (PMID, RxCUI, ICD-10-CM, DSLD ID, or NPI) before publication. Unbound claims are automatically rejected at build time.
- Pairs every common side effect with a specific pharmacokinetic fix (e.g., mid-dinner ER polymer dosing or alternate-day iron spacing).
- Flags drug-induced micronutrient depletions (Metformin → Vitamin B12/MMA; Statins → CoQ10; PPIs → Magnesium/B12).
- Highlights immediate red-flag discontinuation criteria (eGFR < 30, angioedema, rhabdomyolysis, pancreatitis).
Specification Box 4 • Live Production Ledger
4. Recent Pages Audited by dotMD-Tolerability
Human Systems Oversight & Governance
Engineered & maintained by the dotMD Clinical Systems Architecture Team • Report a data discrepancy: audit@dotmd.com
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