Evidence map›Paper›PMID 40062164›Full record

ArticleCureus2025

Analysis of Bevacizumab-Induced Gastrointestinal Perforation Using the Japanese Adverse Drug Event Report Database.

Kana Sugishita, Mika Maezawa, Koumi Miyasaka, Sakiko Hirofuji, Moe Yamashita, Yuka Nokura, Nanaka Ichihara, Satoshi Nakao, Hideyuki Tanaka, Tomofumi Yamazaki and 4 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Cureus, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
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

14 authors.

Kana SugishitaLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, JPN.
Mika MaezawaLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, JPN.
Koumi MiyasakaLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, JPN.
Sakiko HirofujiLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, JPN.
Moe YamashitaLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, JPN.
Yuka NokuraLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, JPN.
Nanaka IchiharaLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, JPN.
Satoshi NakaoLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, JPN.
Hideyuki TanakaLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, JPN.
Tomofumi YamazakiLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, JPN.
Kazuya NonomuraLaboratory of Community Pharmacy, Gifu Pharmaceutical University, Gifu, JPN.
Hirofumi TamakiLaboratory of Community Pharmacy, Gifu Pharmaceutical University, Gifu, JPN.
Kazuhiro IguchiLaboratory of Community Pharmacy, Gifu Pharmaceutical University, Gifu, JPN.
Mitsuhiro NakamuraLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, JPN.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionBevacizumab is a recombinant humanized monoclonal antibody against human vascular endothelial growth factor (VEGF), which inhibits angiogenesis in tumor tissues by blocking VEGF activity. Although rare, bevacizumab-induced gastrointestinal perforation (BIGP) can reduce patients' quality of life and even lead to death. We aimed to evaluate the time to BIGP onset according to the indication, its outcome, and the effect of bevacizumab in combination with various anticancer agents.

methodAdverse events in the Japanese Adverse Drug Reaction Reports (JADER) database were defined according to the Medical Dictionary for Regulatory Activities, and "gastrointestinal perforation (SMQ 'standardized MedDRA inquiry' 20000107)" was extracted. Reasons for use were categorized by seven indications, and other diseases were classified as "other" and were evaluated for time-to-onset analysis and outcomes. Association rule mining was used to assess the risk of BIGP associated with the administration of bevacizumab combined with various anticancer agents.

resultsThe JADER database includes 887,704 reports submitted between April 2004 and March 2024, including 2,112 reports of BIGP. The times to BIGP onset (quartile range) for non-small cell lung, colorectal, and ovarian cancers were 46.0 (11.0-122.0), 77.0 (29.0-196.0), and 67.0 (23.0-203.0) days, respectively. The log-rank test demonstrated that BIGP occurred earlier in patients with non-small cell lung cancer than in patients with colorectal (P < 0.0001) or ovarian (P = 0.0033) cancer. Association rule mining results showed that for the consequent (right-hand side) "1-100 days onset," drugs used to treat non-small cell lung cancer were at the top. However, for "101-200 days onset," irinotecan and drugs for colorectal cancer were at the top of the association rule. BIGP outcomes in the JADER report were 64.7% "improvement" and 35.3% "no improvement."

conclusionIn non-small cell lung cancer, the time to BIGP onset is earlier than that in colorectal and ovarian cancers. This finding suggests that healthcare providers can detect and intervene BIGP at early stages.

Indexed as

bevacizumabgastrointestinal perforationjapanese adverse drug event report databasenon-small cell lung cancertime-to-onset analysis

Identifiers

PMID40062164
PMCPMC11888994

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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.