Potential ICSR Workbench

Case PV-2026-0142 · Cardiomab 10mg → Acute liver injury

🤖 AI-extractedStage 7 of 8Continue to QC →

⚠AI-extracted fields are suggestions only. The system may mark a criterion as “potentially present,” but only a human reviewer can mark a case “valid for processing.” Do not submit regulatory reports from this prototype.

Four Minimum Criteria for ICSR

Valid for processing: Not yet

Criterion	AI Extracted	System Status	Source Evidence	Status
Identifiable Patient	AI64-year-old woman	Potentially present	Page 3, Paragraph 2: ““A 64-year-old female presented to the hepatology clinic with jaundice and elevated transaminases…””	Awaiting reviewer
Identifiable Reporter	AICorresponding author (Dr. M. Reinholt)	Potentially present	Article metadata — corresponding author block: ““Corresponding author: M. Reinholt, Department of Hepatology, Aarhus University Hospital.””	Awaiting reviewer
Suspect Product	AICardiomab 10mg	Potentially present	Page 3, Paragraph 2: ““The patient had been receiving Cardiomab 10mg daily for six weeks for atrial fibrillation…””	Awaiting reviewer
Suspected Adverse Reaction	AIAcute liver injury	Potentially present	Page 4: ““Laboratory findings and biopsy were consistent with acute drug-induced liver injury (DILI, R-value >5).””	Awaiting reviewer

The system labels each criterion “potentially present” based on AI extraction. Only when a reviewer confirms or edits all four can the case be marked valid for processing.

Case Information

AI-extracted structured data. Reviewer can edit any field; edits are tracked. Unconfirmed fields are highlighted in the QC stage.

Patient InformationUnconfirmed

Female, 64 years

Source: Page 3 ¶2

Reporter InformationUnconfirmed

Physician (hepatology)

Source: Article metadata

Suspect ProductUnconfirmed

Cardiomab 10mg, oral, once daily

Source: Page 3 ¶2

Concomitant ProductsUnconfirmed

Metformin 500mg BID; atorvastatin 20mg QD

Source: Page 3 ¶3

Reactions / EventsUnconfirmed

Acute liver injury; jaundice; ALT 1,420 U/L; ALP 280 U/L

Source: Page 4 ¶1

Medical HistoryUnconfirmed

Type 2 diabetes; atrial fibrillation; hyperlipidemia

Source: Page 3 ¶3

Lab TestsUnconfirmed

ALT 1,420; ALP 280; total bilirubin 8.2; INR 1.4

Source: Page 4 ¶1 (Table 1)

Seriousness CriteriaUnconfirmed

Serious — required/prolonged hospitalisation

Source: Page 4 ¶2

OutcomesUnconfirmed

Recovering — liver enzymes trending down at discharge

Source: Page 4 ¶3

Dechallenge / RechallengeUnconfirmed

Positive dechallenge (drug withdrawn); no rechallenge reported

Source: Page 4 ¶2

Author Causality AssessmentUnconfirmed

Probable (Roussel Uclaf Causality Assessment Method)

Source: Page 5 ¶1

Country of OriginUnconfirmed

Denmark

Source: Affiliation block

Literature CitationUnconfirmed

Reinholt M, et al. Acute liver injury associated with Cardiomab. J Hepatol. 2026;71(3):412–418.

Source: Article citation

Company CommentsUnconfirmed

— none —

Source: Reviewer-entered

Narrative Copilot

🤖 Draft assistance

Chronological draft using only source-supported information. Each sentence is tagged as fact or interpretation and linked to its source passage. Missing or conflicting information is flagged — the copilot will not invent dates, doses, or outcomes.

1. A 64-year-old woman with a history of type 2 diabetes, atrial fibrillation, and hyperlipidemia was receiving Cardiomab 10mg orally once daily for six weeks. [Source: Page 3 ¶2–3 — fact]

2. She also received metformin 500mg twice daily and atorvastatin 20mg once daily. [Source: Page 3 ¶3 — fact]

3. The patient presented to the hepatology clinic with jaundice. Laboratory evaluation revealed ALT 1,420 U/L, ALP 280 U/L (R-value >5), total bilirubin 8.2 mg/dL, and INR 1.4. [Source: Page 4 ¶1, Table 1 — fact]

4. A liver biopsy was consistent with acute drug-induced liver injury. [Source: Page 4 ¶1 — fact]

5. Cardiomab was discontinued (positive dechallenge). No rechallenge was reported. [Source: Page 4 ¶2 — fact]

6. At discharge, liver enzymes were trending downward; the patient was hospitalised for 9 days. [Source: Page 4 ¶2–3 — fact]

7. The authors assessed causality as “probable” using the RUCAM method. [Source: Page 5 ¶1 — fact; interpretation attributed to article authors]

⚠ Missing information: exact event-onset date is not stated in the source. [Flag — do not invent]

⚠ Conflicting information: outcome described as “recovering” in Results but “persistent cholestasis at 6-month follow-up” in Discussion. [Flag — requires reviewer resolution]

⚠ 2 flags: missing onset date, conflicting outcome

AI-Flagged Discrepancies

The AI Quality Agent flags potential inconsistencies. These remain suggestions until accepted by QC in the next stage.

warningSuspect Product — Dose

Article mentions “Cardiomab 10mg” in narrative but “10 mg” in Table 2 — possible discrepancy.

Suggestion: Confirm intended dose unit (mg vs. mL) and update the structured field accordingly.

infoEvent Onset Date

No explicit event-onset date found in the source; only “six weeks” of therapy reported.

Suggestion: Do not invent a date — flag as missing and request source verification.

criticalOutcome

Narrative states “recovering” but Discussion mentions “persistent cholestasis at 6-month follow-up.”

Suggestion: Resolve conflicting outcome descriptions before finalising the narrative.

Regulatory Clock

Time remaining (Day Zero + 30)

15 days

Escalation: None

Search Execution Date

Abstract Availability Date

Full-text Receipt Date

Proposed Day Zero AI

AI proposes the earliest awareness date.

Human-Confirmed Day Zero

Reviewer must confirm or correct before clock starts.

Reason for Correction

Configurable Due Date

Default: Day Zero + 30 calendar days.

Escalation Status

Day Zero evidence: Full-text received 2026-07-12 (PubMed search executed 2026-07-10; abstract available same day). AI proposes Day Zero = full-text receipt date per ICH E2D literature guidance. Reviewer confirmation required.

Progress: 0/4 criteria reviewed · 0/14 fields confirmed · 0/3 discrepancies acknowledged

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