CAR-T Therapy Endocrine Toxicity Signals from FAERS and Literature Review

A 2026 analysis of 269 endocrine adverse event reports from the FDA Adverse Event Reporting System (FAERS) from 2017 to Q2 2025, integrated with a structured literature review. The dataset, authored by Jizhou Liang and shared under CC-BY-4.0, identifies 14 significant disproportionality signals for toxicities like hyperglycemia and estrogen deficiency. It links these signals to clinical outcomes, including mortality when endocrine events overlap with cytokine release syndrome (CRS).

Use Cases

• Identify high-risk endocrine toxicity signals based on disproportionality analysis metrics (ROR, IC)
• Investigate the clinical overlap between endocrine adverse events and cytokine release syndrome (CRS) based on reported mortality data
• Validate pharmacovigilance signals using published clinical evidence, such as case reports of Hashimoto’s thyroiditis
• Analyze the association between specific CAR-T products (e.g., axicabtagene) and pituitary axis disorders

Strengths

• Integrates data from two sources: 269 reports from the FAERS database and a structured literature review for validation.
• Reports specific signal strengths, such as an ROR of 14.93 for estrogen deficiency.
• Includes a defined temporal scope for the FAERS data (2017 to Q2 2025).

Limitations

• The primary data file is a 139.4 KB DOCX document, which is a small supplementary file rather than a raw dataset.
• Row count and column-level documentation for the underlying FAERS analysis are unknown.
• Data may reflect reporting bias inherent to the voluntary FAERS pharmacovigilance system.

Provenance

Source

FDA Adverse Event Reporting System (FAERS) and structured literature review.

Collection Method

Retrospective disproportionality analysis and literature review.

Time Range

2017 to Q2 2025 for FAERS data.

Freshness

Last updated 2026-04-14 04:21:21; freshness should be verified.