AI Screening Queue
Title / abstract screening — run SR-2026-0142 (Cardiomab) · 14 articles · 14 awaiting decision
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| # | Article · abstract | Source ID | AI score | AI classification | Suspect product / event | Patients | Full text | Reviewer status | Decision | |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | Acute myocarditis following Cardiomab infusion in a 62-year-old male: a case report Halvorsen K, et al. · J. Cardiovasc. Pharmacol. Ther. (2026) A 62-year-old male developed chest pain and troponin elevation (9.8 ng/mL) 24 hours after the third Cardiomab infusion. Cardiac MRI confirmed myocarditis. The patient recovered fol… | PMID: 37891022 | 0.94 | AI suggestion Potential individual ICSR confidence: high | Cardiomab Myocarditis | 1 | required | Unassigned | ||
| 2 | Cardiomab-associated ventricular arrhythmia in a patient with prior cardiomyopathy Tanaka M, Sato H, et al. · Cardiovasc. Drugs Ther. (2026) A 54-year-old woman with dilated cardiomyopathy developed sustained ventricular tachycardia six hours after Cardiomab infusion. She was cardioverted and admitted to the coronary ca… | PMID: 37890888 | 0.88 | AI suggestion Potential individual ICSR confidence: high | Cardiomab Ventricular arrhythmia | 1 | required | Escalated Dr. E. Vasquez | ||
| 3 | Severe hypotension after first Cardiomab dose in a patient on beta-blocker therapy O'Connor D, Walsh B, et al. · Br. J. Clin. Pharmacol. (2026) A 71-year-old male on metoprolol developed symptomatic hypotension (BP 78/45) within 30 minutes of his first Cardiomab infusion, requiring IV fluids and temporary discontinuation. | PMID: 37892110 | 0.91 | AI suggestion Potential individual ICSR confidence: high | Cardiomab Hypotension | 1 | required | Unassigned | ||
| 4 | Cardiac tamponade complicating Cardiomab therapy: a rare but life-threatening adverse event Nordström A, Lundgren J, et al. · Eur. Heart J. Case Rep. (2026) A 58-year-old man developed pericardial effusion with tamponade physiology 11 days after his second Cardiomab dose, requiring emergent pericardiocentesis. Patient recovered after d… | PMID: 37894420 | 0.93 | AI suggestion Potential individual ICSR confidence: high | Cardiomab Cardiac tamponade | 1 | required | Unassigned | ||
| 5 | Acute infusion reaction to Cardiomab treated with premedication: case report and literature review Bauer L, Kowalski T, et al. · J. Allergy Clin. Immunol. Pract. (2026) A 48-year-old woman developed urticaria, dyspnoea and hypotension during her second Cardiomab infusion. Symptoms resolved after stopping the infusion and administering antihistamin… | PMID: 37891501 | 0.76 | AI suggestion Potential individual ICSR confidence: medium | Cardiomab Infusion reaction | 1 | required | In review Dr. E. Vasquez | ||
| 6 | Hepatotoxicity associated with novel JAK inhibitors: a case series of seven patients Mehta R, Patel S, Okafor C, et al. · Hepatol. Commun. (2026) Seven patients treated across three centres developed grade 3 transaminase elevations within 8 weeks of initiating JAK inhibitor therapy. Two cases required hospitalisation; one re… | DOI: 10.1002/hep4.2190 | 0.71 | AI suggestion Potential multiple-patient confidence: medium | JAK inhibitors (class) Hepatotoxicity | 7 | required | Unassigned | ||
| 7 | Cardiomab and progressive multifocal leukoencephalopathy: a safety signal warranting surveillance Andersson E, Berg M, Holm J, et al. · Drug Saf. (2026) Reviewing 12 case reports of PML in patients exposed to Cardiomab and related antibodies. Authors call for enhanced surveillance and updated risk management plan. | DOI: 10.1007/s40264-026-01377-z | 0.82 | AI suggestion Potential signal confidence: high | Cardiomab PML | 12 | recommended | In review Dr. E. Vasquez | ||
| 8 | Real-world tolerability of monoclonal antibody therapies for ATTR cardiomyopathy: a 24-month registry analysis Pereira J, Gomez A, Lindqvist P, et al. · Eur. Heart J. - Digital Health (2026) Pooled registry data from 1,820 patients receiving monoclonal antibodies for ATTR cardiomyopathy showed overall tolerability consistent with pivotal trials. Discontinuation rates w… | DOI: 10.1093/ehjdh/ztab041 | 0.49 | AI suggestion Aggregate safety information confidence: low | mAb class (incl. Cardiomab) — | 1820 | not required | Unassigned | ||
| 9 | Special situation: Cardiomab exposure during first trimester pregnancy — a retrospective cohort description Ferraro G, Conti M, et al. · Reprod. Toxicol. (2026) Eleven women with inadvertent first-trimester Cardiomab exposure were followed to delivery. Outcomes included one spontaneous abortion and one infant with a ventricular septal defe… | DOI: 10.1016/j.reprotox.2026.06.003 | 0.57 | AI suggestion Special situation confidence: medium | Cardiomab Pregnancy exposure / congenital anomaly | 11 | required | Unassigned | ||
| 10 | Product quality complaint: particulate matter observed in Cardiomab vial lot CM-2440-X Regulatory Affairs, manufacturer · Manufacturer field report (2026) Hospital pharmacy reported visible particulate matter in three vials of Cardiomab lot CM-2440-X. Lot quarantined; root-cause investigation initiated by manufacturer. | 0.84 | AI suggestion Product quality issue confidence: high | Cardiomab (lot CM-2440-X) Particulate matter / product quality | — | not required | Escalated QA Lead | |||
| 11 | A systematic review of monoclonal antibody-associated infusion reactions in oncology and cardiology Lee Y, Chen L, Park S, et al. · Clin. Ther. (2026) Systematic review of 84 publications describing infusion reactions to monoclonal antibodies. The authors summarise incidence, severity grading and premedication strategies across i… | DOI: 10.1016/j.clinthera.2026.04.009 | 0.31 | AI suggestion Review article confidence: low | mAb class — | — | not required | Completed S. Patel | ||
| 12 | Preclinical pharmacokinetics and cardiac safety margin of mab-127 in cynomolgus monkeys Iwata K, Nakamura R, et al. · Toxicol. Lett. (2026) mab-127 was administered intravenously to cynomolgus monkeys at 1×, 3× and 10× clinical dose. No cardiac findings were observed at any dose level through 13 weeks of dosing. | DOI: 10.1016/j.toxlet.2026.05.013 | 0.22 | AI suggestion Non-human / preclinical confidence: high | Cardiomab — | — | not required | Completed S. Patel | ||
| 13 | Drug-induced liver injury in patients on monoclonal antibodies for cardiac amyloidosis Svensson A, Lind M, et al. · Aliment. Pharmacol. Ther. (2026) Three cases of cholestatic hepatotoxicity in patients receiving anti-amyloid antibodies. One case overlaps with a previously submitted report (Cardiomab case CR-2026-088). | PMID: 37893001 | 0.68 | AI suggestion Potential individual ICSR confidence: medium | Cardiomab Hepatotoxicity | 3 | required | Completed S. Patel | ||
| 14 | Outcomes after Cardiomab discontinuation due to adverse events: a single-centre observational study Kim D, Park J, Yoon S, et al. · Cardiovasc. Revasc. Med. (2026) Retrospective single-centre review of 64 patients who discontinued Cardiomab. Abstract does not enumerate individual adverse events; full-text review recommended to identify report… | DOI: 10.1016/j.carrev.2026.05.012 | 0.43 | AI suggestion Insufficient information confidence: low | Cardiomab — | — | required | Unassigned |
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⚠️Every AI classification shown above is labelled “AI suggestion” with a confidence indicator. AI output is decision support only and must never autonomously exclude an article or determine reportability. All exclusions require a controlled reason selected by a human reviewer. Prototype — not a validated safety database.