Neurological and related adverse events in immune checkpoint inhibitors: a pharmacovigilance study from the Japanese Adverse Drug Event Report database

Sato, Kenichiro; Mano, Tatsuo; Iwata, Atsushi; Toda, Tatsushi

doi:10.1007/s11060-019-03273-1

Cited by 80 publications

(95 citation statements)

References 22 publications

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“…For each included drug (chloroquine or mefloquine), we calculated the reporting odds ratio (ROR), to assess the potential drug-AE links for chloroquine (or mefloquine) and the reported neuropsychiatric symptoms. The crude ROR was calculated by a 2 × 2 contingency table as described previously (13)(14)(15), where all the reports were classified by two factors for each AE term and for each drug, as described above. When the lower limit of the 95% confidential interval (CI) for the adjusted ROR was > 1, the AE was considered to be significantly highly reported following the use of the drug of interest, compared with the report of the same AE following the use of all other drugs.…”

Section: Statistical Analysesmentioning

confidence: 99%

Neuropsychiatric adverse events of chloroquine: a real-world pharmacovigilance study using the FDA Adverse Event Reporting System (FAERS) database

Sato

Mano

Iwata

et al. 2020

BST

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Section: Statistical Analysesmentioning

confidence: 99%

Neuropsychiatric adverse events of chloroquine: a real-world pharmacovigilance study using the FDA Adverse Event Reporting System (FAERS) database

Sato

Mano

Iwata

et al. 2020

BST

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“…19 Other reviews and papers 3,6,9,11 listed other irAEs such as colitis, hyperthyroidism, and hypothyroidism. Furthermore, the research using the SRS database focuses on myasthenia gravis, 14 and myocarditis. 13 Using the FAERS database, Ji et al 10 comprehensively evaluated AE profiles, including irAEs using Standardized MedDRA Queries 20 that consist of PTs grouped according to the level that relates to a defined medical condition.…”

Section: Target Drugs and Iraesmentioning

confidence: 99%

“…Neurological and related AEs of ICIs have been reported using the reporting odds ratio (ROR) and median onset of AEs, based on the JADER database. 14 The detailed time-to-onset profiles of irAEs in many organs are not clear in clinical settings; therefore, we focused on this aspect in our present study. Furthermore, association rule mining has been proposed as a novel analytical technique to identify undetected relationships such as possible risk factors between variables in the SRS database.…”

Section: Introductionmentioning

confidence: 99%

Analysis of immune‐related adverse events caused by immune checkpoint inhibitors using the Japanese Adverse Drug Event Report database

Hasegawa

Ikesue

Nakao

et al. 2020

Pharmacoepidemiology and Drug

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The aim of our study was to characterize the clinical features of immunerelated adverse events (irAEs) associated with immune checkpoint inhibitors (ICIs) in a real-world setting using the Japanese Adverse Drug Event Report (JADER) database. Methods: The 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.

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“…Using RORs allowed adjustments by multivariate logistic regression analysis and offered the advantage of controlling for covariates [6,[19][20][21][22]. We calculated the adjusted RORs according to previous reports [21,22]. To calculate adjusted RORs, only reports containing reporting year, sex, age, and the number of administered anti-infectives were used.…”

Section: Methodsmentioning

confidence: 99%

Risk Assessment for Anti-Infectives-Related Acute Kidney Injury Using the Japanese Adverse Drug Event Report Database

Nakao

Hasegawa

Umetsu

et al. 2020

Preprint

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Background: Acute kidney injury (AKI) is associated with significant increases in short- and long-term morbidity and mortality. Drug-induced AKI is a major concern in the present healthcare system. Our spontaneous reporting system (SRS) analysis assessed links between AKIs, along with patients’ age, as healthcare-associated risks and administered anti-infectives. We also generated anti-infectives-related AKI-onset profiles.Method: We calculated adjusted reporting odds ratios (RORs) for reports of anti-infectives-related AKIs (per Medical Dictionary for Regulatory Activities) in the Japanese Adverse Drug Event Report database and evaluated associations between anti-infectives and age by association rule mining. We evaluated time-to-onset data and hazard types using the Weibull parameter.Results: Among 534,688 reports (submission period: April 2004–June 2018), there were 21,727 AKI events. Anti-infective treatments including glycopeptide antibacterials, fluoroquinolones, third-generation cephalosporins, triazole derivatives, and carbapenems were associated with 596, 494, 341, 315, and 313 AKI incidences, respectively. Adjusted RORs of anti-infectives-related AKIs increased among older patients and were higher in anti-infective combination therapies [anti-infectives, ≥ 2; ROR, 2.75 (2.56–2.95)] than in monotherapies [ROR, 1.52 (1.45–1.61)]. In association rule mining, the number of anti-infectives and age were associated with anti-infectives-related AKI lift values (as consequent). Moreover, 48.1% of AKIs occurred within 5 days (median, 5.0 days) of anti-infective therapy initiation.Conclusion: Thus, adjusted RORs derived from our new SRS analysis indicate potential AKI risks linked to age and number of administered anti-infectives.

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Neurological and related adverse events in immune checkpoint inhibitors: a pharmacovigilance study from the Japanese Adverse Drug Event Report database

Cited by 80 publications

References 22 publications

Neuropsychiatric adverse events of chloroquine: a real-world pharmacovigilance study using the FDA Adverse Event Reporting System (FAERS) database

Neuropsychiatric adverse events of chloroquine: a real-world pharmacovigilance study using the FDA Adverse Event Reporting System (FAERS) database

Analysis of immune‐related adverse events caused by immune checkpoint inhibitors using the Japanese Adverse Drug Event Report database

Risk Assessment for Anti-Infectives-Related Acute Kidney Injury Using the Japanese Adverse Drug Event Report Database

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