Evidence map›Paper›PMID 40038564›Full record

ArticleBMC pharmacology & toxicology2025

A disproportionality analysis of real-world events from the FDA Adverse Event Reporting System (FAERS) for Atezolizumab.

Zhuoyang Li, Ning Zhu, Yuwei Liu, Yan Yu, Tianhong Wang, Congcong Zou, Siman Wang, Xiaofeng Ou

Abstract read
In one paragraph

Article in BMC pharmacology & toxicology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Zhuoyang Li *School of Medicine, Wuhan University of Science and Technology, Wuhan, 430065, China.ORCID 0009-0003-1631-3634
Ning Zhu *Division of Head & Neck Tumor Multimodality Treatment, Cancer Center, West China Hospital, Sichuan University/West China School of Nursing, Sichuan University, Chengdu, Sichuan Province, China.
Yuwei LiuSchool of Medicine, Wuhan University of Science and Technology, Wuhan, 430065, China.ORCID 0009-0005-7178-3895
Yan YuWest China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu, China.
Tianhong WangThe Department of Clinical Research, West China Hospital, Sichuan University, Chengdu, 610041, China.
Congcong ZouAnesthesia and Surgery Center of West China Xiamen Hospital, Sichuan University, 699 Jinyuan West Road, Xingbin Street, Jimei District, Xiamen, Fujian Province, China.
Siman WangDepartment of Anesthesiology, West China Hospital, Sichuan University, Chengdu, 610041, China.
Xiaofeng OuDepartment of Critical Care Medicine, West China Hospital of Sichuan University, Chengdu, Sichuan Province, China. hxxiaoou@126.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAn increasing number of clinical studies have highlighted the use of atezolizumab in tumor immunotherapy. However, There is still a lack of comprehensive research on its associated adverse events (AEs). To improve our understanding of its toxicological profile and to provide valuable clinical insights regarding into the effectiveness of immunotherapy, this study utilized data from the US Food and Drug Administration Adverse Event Reporting System (FAERS) to conduct a retrospective analysis of AEs linked to atezolizumab.

methodsWe extracted the reports of AEs related to atezolizumab from the FAERS database from the first quarter of 2004 to the first quarter of 2024. We quantified them using the reporting odds ratio (ROR) and proportional reporting ratio (PRR), along with chi-square value (χ²), and conducted systematic classification of the AE signal mining results through SAS 9.4 software.

resultsA total of 19,563 valid reports were incorporated, involving 20 distinct system organ class categories. The AEs related to atezolizumab, reported at the preferred term level, mainly encompassed anemia [ROR 2.33, 95% confidence interval (CI) lower limit 2.09, PRR 2.31, χ² 255.977], febrile neutropenia (ROR 2.81, 95% CI lower limit 2.50, PRR 2.79, χ² 333.586), neutrophil count decreased (ROR 2.14, 95% CI lower limit 1.89, PRR 2.13, χ² 150.688), white blood cell count decreased (ROR 2.35, 95% CI lower limit 2.03, PRR 2.34, χ² 136.673), sepsis (ROR 2.21, 95% CI lower limit 1.91, PRR 2.20, χ² 117.741), alanine aminotransferase increased (ALT) (ROR 2.86, 95% CI lower limit 2.44, PRR 2.85, χ² 180.031), and aspartate aminotransferase increased (AST) (ROR 2.79, 95% CI lower limit 2.38, PRR 2.78, χ² 170.955).

conclusionsApart from various degrees of hepatotoxicity, such as increased ALT and AST, the immune-related hematological toxicity of atezolizumab should also be noted. In clinical practice, healthcare providers should always be vigilant for the occurrence of such medication-related AEs and take measures to enhance the safety of clinical medication use.

Indexed as

Adverse Drug Reaction Reporting SystemsAntibodies, Monoclonal, HumanizedAntineoplastic AgentsDrug-Related Side Effects and Adverse ReactionsHumansRetrospective StudiesUnited StatesUnited States Food and Drug AdministrationAntibodies, Monoclonal, HumanizedAntineoplastic AgentsatezolizumabAdverse eventsAtezolizumabFAERSHepatotoxicityMyelosuppressionPD-L1

Identifiers

PMID40038564
PMCPMC11881481

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.