ArticlePharmacoepidemiology and drug safety2020
Analysis of immune-related adverse events caused by immune checkpoint inhibitors using the Japanese Adverse Drug Event Report database.
Article in Pharmacoepidemiology and drug safety, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 3 of them syntheses that pooled it.
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Who cites it
26 citing papers in PubMed, 3 syntheses or guidelines pooled it, 40 citations in OpenAlex.
- Safety of immune checkpoint inhibitors: A systematic review of disproportionality analysis studies.European journal of clinical pharmacology · 2026Pooled it
- Comparative cardiotoxicity risk of pembrolizumab versus nivolumab in cancer patients undergoing immune checkpoint inhibitor therapy: A meta-analysis.Frontiers in oncology · 2023Pooled it
- Exploring the role of immune checkpoint inhibitors in the etiology of myasthenia gravis and Lambert-Eaton myasthenic syndrome: A systematic review.Frontiers in neurology · 2022Pooled it
- Multinational pharmacovigilance assessment of drug-associated esophageal ulceration and perforation: evidence from FAERS, JADER, and Canada Vigilance.BMC pharmacology & toxicology · 2026Article
- A case/non-case study of a national pharmacovigilance database to explore drug-induced acute kidney injury.International journal of clinical pharmacy · 2025Article
- Atrial fibrillation signals associated with overactive bladder drugs across JADER and FAERS: disproportionality and time-to-onset analyses.Frontiers in pharmacology · 2025Article
- Self-Organizing Map-Based Assessment of Immune-Related Adverse Events Caused by Immune Checkpoint Inhibitors.Cureus · 2025Article
- Immune-Related Adverse Events due to Concomitant Use of Immune Checkpoint Inhibitors and Chinese Herbal Medicines: A Study Based on a Japanese Adverse Event Database.Asian Pacific journal of cancer prevention : APJCP · 2024Article
- Pituitary-Related Adverse Events and Onset Patterns Caused by Immune Checkpoint Inhibitors: Analysis Using the Japanese Adverse Drug Event Report Database.Medicina (Kaunas, Lithuania) · 2023Article
- Evaluation of neuroleptic malignant syndrome induced by antipsychotic drugs using spontaneous reporting system.Heliyon · 2023Article
- The safety profile of nivolumab plus ipilimumab combination therapy in Japanese patients with renal cell carcinoma: results from post-marketing surveillance.Japanese journal of clinical oncology · 2023Article
- Review
- Prognostic Significance of the Severity of Immune-Related Adverse Events in Advanced Cancer Patients Treated with PD-1/PD-L1 Inhibitors: A Real-World Data Analysis.Targeted oncology · 2023Article
- Pulmonary adverse events following immune checkpoint inhibitors.Current opinion in pulmonary medicine · 2022Review
- Multisystem immune-related adverse events due to toripalimab: Two cases-based review.Frontiers in cardiovascular medicine · 2022Article
- Analysis of drug-induced hand-foot syndrome using a spontaneous reporting system database.Therapeutic advances in drug safety · 2022Article
- Hypothyroidism and hypopituitarism as immune-related adverse events due to lenvatinib plus pembrolizumab therapy in the immediate postoperative period after laparoscopic hepatectomy for liver metastases from gastric cancer: a case report.Surgical case reports · 2021Article
- Pharmacovigilance study of anti-infective-related acute kidney injury using the Japanese adverse drug event report database.BMC pharmacology & toxicology · 2021Article
- Spontaneous and Immune Checkpoint Inhibitor-Induced Autoimmune Diseases: Analysis of Temporal Information by Using the Japanese Adverse Drug Event Report Database.Clinical drug investigation · 2021Article
- Analysis of chemotherapy-induced peripheral neuropathy using the Japanese Adverse Drug Event Report database.Scientific reports · 2021Article
Corrections and comments
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Authors and funding
13 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe aim of our study was to characterize the clinical features of immune-related adverse events (irAEs) associated with immune checkpoint inhibitors (ICIs) in a real-world setting using the Japanese Adverse Drug Event Report (JADER) database.
methodsThe irAEs were defined using the preferred terms of the Medical Dictionary for Regulatory Activities. irAEs were categorized as follows: adrenal insufficiency, colitis, eye diseases, hematological disorder, hepatitis, hyperthyroidism, hypopituitarism, hypothyroidism, myasthenia gravis, myocarditis, nephritis/renal dysfunction, pneumonitis, rash, and type 1 diabetes mellitus. We used several indices such as reporting odds ratio (ROR) to assess disproportionality in pharmacovigilance data, time-to-onset analysis using Weibull shape parameters, and the association rule mining technique to evaluate possible risk factors between variables in the spontaneous reporting system database.
resultsThe JADER database contained 534 688 reports from April 2004 to June 2018. The RORs of pneumonitis including interstitial lung disease for nivolumab, pembrolizumab, and ipilimumab were 7.02 (95% confidence interval: 6.55-7.52), 9.08 (8.28-9.97), and 1.74 (1.27-2.38), respectively. The median onsets (quartiles, 25-75%) of myocarditis caused by nivolumab and pembrolizumab were 28.0 (15.5-60.5) and 18.0 (13.0-44.5) days, respectively. Co-therapy with nivolumab and ipilimumab may be associated with irAEs in several categories as per the association rule mining analysis.
conclusionOur results demonstrated a potential risk of irAEs associated with ICIs, based on RORs and time-to-onset analysis. Furthermore, our findings indicated that patients receiving nivolumab and ipilimumab as co-therapy should be carefully monitored.
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