Evidence map›Paper›PMID 39696696›Full record

ArticleJournal of pharmaceutical health care and sciences2024

Safety of talimogene laherparepvec: a real-world retrospective pharmacovigilance study based on FDA Adverse Event Reporting System (FAERS).

Yifan Hong, Kebin Cheng, Han Qu, Yuting Wang, Yuanyuan Wang, Guorong Fan, Zhenghua Wu

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of pharmaceutical health care and sciences, 2024. 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. Review
  2. Review
  3. Review
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

7 authors.

Yifan Hong *School of Pharmacy, Shanghai Jiao Tong University, Shanghai, 200240, China.ORCID http://orcid.org/0009-0007-6079-5895
Kebin Cheng *Department of Respiratory and Critical Care Medicine, School of Medicine, Shanghai Pulmonary Hospital, Tongji University, 507 Zhengmin Road, Shanghai, 200433, China.ORCID http://orcid.org/0000-0002-2617-9702
Han QuDepartment of Pharmacy, Shanghai Fourth People's HospitalAffiliated to, Tongji University School of Medicine, Shanghai, China.
Yuting WangSchool of Pharmacy, Shanghai Jiao Tong University, Shanghai, 200240, China.
Yuanyuan WangDepartment of Clinical Pharmacy, School of Medicine, Shanghai General Hospital, Shanghai Jiaotong University, Shanghai, 200080, China.
Guorong FanDepartment of Clinical Pharmacy, School of Medicine, Shanghai General Hospital, Shanghai Jiaotong University, Shanghai, 200080, China.
Zhenghua WuDepartment of Clinical Pharmacy, School of Medicine, Shanghai General Hospital, Shanghai Jiaotong University, Shanghai, 200080, China. wuzhenghua@sjtu.edu.cn.ORCID http://orcid.org/0000-0001-8639-9689

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOncolytic virus therapy is a rapidly evolving emerging approach for the medical management of cancer. Talimogene laherparepvec (T-VEC) is the first and only Food and Drug Administration (FDA)-approved oncolytic virus therapy. Considering that exactly how T-VEC works is not known, there is a strong need for a comprehensive pharmacovigilance study to identify safety signals of potential risks with T-VEC.

objectiveThe objective of this study was to assess the risk of adverse events (AEs) related to T-VEC.

methodsWe implemented a pharmacovigilance study utilizing individual case safety reports (ICSRs) reported to the FDA Adverse Event Reporting System (FAERS) database dated from 2004 quarter 1 to 2023 quarter 3. In this study, we used two algorithms, reporting odds ratio (ROR) and information component (IC), to assess the risk of AEs related to T-VEC.

resultsA total of 1138 ICSRs of patients who received the T-VEC and reported to the FDA dated from 2004 quarter 1 to 2023 quarter 3 were available. A total of seven system organ classes (SOCs) demonstrated statistically significant signals, i.e. General disorders and administration site conditions, Injury, poisoning and procedural complication, Infections and infestations, Neoplasms benign, malignant and unspecified, Skin and subcutaneous tissue disorders, Hepatobiliary disorders, and Endocrine disorders. From the preferred term level perspective, the most reported AEs in T-VEC-treated patients were pyrexia, illness, influenza, influenza-like illness, and chills. Unexpected significant AEs were detected, such as sepsis, encephalitis, syncope, and lymphadenopathy.

conclusionsMost AEs in T-VEC-treated patients have been previously mentioned in the prescriptive information or documented in other clinical trials. But safety signals were also be detected in 4 unexpected AEs (sepsis, encephalitis, syncope, and lymphadenopathy). Further clinical trials need to be undertaken to facilitate a more comprehensive comprehension of the safety profile of T-VEC.

Indexed as

FAERS databaseOncolytic virusPharmacovigilanceTalimogene laherparepvec

Identifiers

PMID39696696
PMCPMC11654148

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Registered trials

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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.