SR-2026-0142
IncompleteCardiomab (mab-127) · Cardiomab LSV v3.2
Source
PubMed, Embase, Local journals, Conference abstracts
Executed at
2026-07-22 09:14 UTC
Coverage period
2026-06-01 → 2026-06-30
Executed by
svc_litsurveillance
Result count
326
Raw result file
raw/SR-2026-0142_cardiomab_202606.jsonl
API checksum
sha256:9f3a…c1e7
326
Results retrieved
47
Exact duplicates
19
Possible duplicates
260
Unique
14
Priority
5
Potential patient cases
1
Source incomplete
🚨
Day Zero alert — high priority
Action requiredAI has detected an abstract that may satisfy the four minimum ICSR criteria (identifiable patient, reportable event, suspect product, documentation). The search execution date (2026-07-22 09:14 UTC) may constitute the regulatory Day Zero. Human confirmation of reportability is required to start the case clock.
Search completeness
1 source incomplete| Source | Status | Results | Notes |
|---|---|---|---|
| PubMed | Complete | 218 | — |
| Embase | Complete | 96 | — |
| Local journals | Incomplete | 12 | Connection timed out after 4 of 7 journals. Partial fetch — 3 journals pending. |
| Conference abstracts | Complete | 0 | — |
⚠️
Source failure — escalation required
Local journals did not complete in run SR-2026-0142. The results set is partial and may miss reportable ICRs. An escalation task has been generated to the Search Strategy owner and system administrator to restore connectivity and re-run the failed source(s).
Articles (14 of 14)
| Article | Source ID | Flags | AI classification | AI score | Review status |
|---|---|---|---|---|---|
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 p… | PMID: 37891022 | PriorityICSRFull text | AI suggestion Potential individual ICSR | 0.94 | Pending |
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 hos… | DOI: 10.1002/hep4.2190 | ICSRSignalFull text | AI suggestion Potential multiple-patient | 0.71 | Pending |
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 admitte… | PMID: 37890888 | PriorityICSR | AI suggestion Potential individual ICSR | 0.88 | Escalated |
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. Dis… | DOI: 10.1093/ehjdh/ztab041 | AI uncertain | AI suggestion Aggregate safety information | 0.49 | Pending |
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 admini… | PMID: 37891501 | ICSRFull text | AI suggestion Potential individual ICSR | 0.76 | In review |
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 wee… | DOI: 10.1016/j.toxlet.2026.05.013 | Non-human | AI suggestion Non-human / preclinical | 0.22 | Screened |
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 pla… | DOI: 10.1007/s40264-026-01377-z | PrioritySignal | AI suggestion Potential signal | 0.82 | In review |
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 tempora… | PMID: 37892110 | PriorityICSRFull text | AI suggestion Potential individual ICSR | 0.91 | Pending |
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… | DOI: 10.1016/j.clinthera.2026.04.009 | — | AI suggestion Review article | 0.31 | Screened |
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… | PMID: 37893001 | ICSRDuplicate | AI suggestion Potential individual ICSR | 0.68 | Screened |
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 ven… | DOI: 10.1016/j.reprotox.2026.06.003 | ICSRAI uncertain | AI suggestion Special situation | 0.57 | Pending |
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 manufact… | Priority | AI suggestion Product quality issue | 0.84 | Escalated | |
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 recommende… | DOI: 10.1016/j.carrev.2026.05.012 | AI uncertain | AI suggestion Insufficient information | 0.43 | Pending |
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. Patie… | PMID: 37894420 | PriorityICSRFull text | AI suggestion Potential individual ICSR | 0.93 | Pending |
⚠️AI classifications are decision-support suggestions, not validated safety determinations. All reportability decisions require human review. Prototype — not a validated safety database.