Related Experiment Video

Updated: Sep 17, 2025

Multiplexed Immunofluorescence Analysis and Quantification of Intratumoral PD-1+ Tim-3+ CD8+ T Cells
09:32

Multiplexed Immunofluorescence Analysis and Quantification of Intratumoral PD-1+ Tim-3+ CD8+ T Cells

Published on: February 8, 2018

14.8K

Disproportionality analysis of adverse events associated with ipilimumab and nivolumab combination therapy based on

Xianyu Dai1, Hongliang Cao1, Jiajun Li2

  • 1Department of Urology, The First Hospital of Jilin University, Changchun, China.

Scientific Reports
|July 2, 2025
PubMed

The combination of immune checkpoint inhibitors (ICIs), such as ipilimumab and nivolumab, has revolutionized cancer treatment, particularly for advanced melanoma and other solid tumors. However, rare adverse events (AEs) associated with this combination are often underreported in clinical trials. This study aimed to investigate the safety profile of these drugs using the FDA Adverse Event Reporting System (FAERS) database. A retrospective analysis of data from 2015 to the first quarter of 2024 was conducted, focusing on AEs submitted by healthcare professionals. Disproportionality analysis, using algorithms like Reporting Odds Ratio (ROR) and Bayesian Confidence Propagation Neural Network (BCPNN), identified AE signals. A total of 19,462 reports related to the combination therapy were retrieved, spanning 20 System Organ Classes (SOCs), with endocrine and hepatobiliary disorders being most affected. Additionally, 125 unexpected significant AEs were identified, including thyrotoxic crisis, diabetes insipidus, immune-mediated optic neuritis, cystitis, eyelid ptosis, complete atrioventricular block, etc. The highest frequency of AEs occurred within the first 30 days of treatment (38.1%), with a decrease in incidence over time, as indicated by the Weibull Shape Parameter (WSP) test. These findings highlight the importance of continuous monitoring of ICIs in clinical practice.

Keywords:
Adverse eventsFAERSIpilimumabNivolumabPharmacovigilance

More Related Videos

Inverse Probability of Treatment Weighting Propensity Score using the Military Health System Data Repository and National Death Index06:55

Inverse Probability of Treatment Weighting Propensity Score using the Military Health System Data Repository and National Death Index

Published on: January 8, 2020

14.6K
Potentiation of Anticancer Antibody Efficacy by Antineoplastic Drugs: Detection of Antibody-drug Synergism Using the Combination Index Equation15:04

Potentiation of Anticancer Antibody Efficacy by Antineoplastic Drugs: Detection of Antibody-drug Synergism Using the Combination Index Equation

Published on: January 19, 2019

12.3K

Related Concept Videos

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
182
Pharmacovigilance01:19

Pharmacovigilance

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
1.0K
Relative Risk01:12

Relative Risk

Relative risk (RR) is a statistical measure commonly used in epidemiology to compare the likelihood of a particular event occurring between two groups. This metric is important for evaluating the relationship between exposure to a specific risk factor and the probability of a particular outcome. It plays a crucial role in medical research, public health studies, and risk assessment. Relative risk quantifies how much more (or less) likely an event is to occur in an exposed group compared to an...
361
Combination Therapies and Personalized Medicine02:50

Combination Therapies and Personalized Medicine

Combining two or more treatment methods increases the life span of cancer patients while reducing damage to vital organs or tissue from the overuse of a single treatment. Combination therapy also targets different cancer-inducing pathways, thus reducing the chances of developing resistance to treatment.
The combination of the drug acetazolamide and sulforaphane is a good example of combination therapy to treat cancer. The cells in the interior of a large tumor often die due to the hypoxic and...
5.1K
Hazard Ratio01:12

Hazard Ratio

The hazard ratio (HR) is a widely used measure in clinical trials to compare the risk of events, such as death or disease recurrence, between two groups over time. It reflects the ratio of hazard rates—the instantaneous risk of the event occurring—between a treatment group and a control group. This measure provides valuable insights into the relative effectiveness of a treatment by assessing how the risk of an event differs between the two groups.
For example, in a clinical trial...
259
Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF01:24

Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF

Tumor Necrosis Factor (TNF), a proinflammatory cytokine, contributes significantly to the inflammation seen in Crohn's disease. It exists as soluble TNF and membrane-bound TNF, with actions mediated through TNF receptors (TNFR). TNFR activation leads to the release of proinflammatory cytokines, T-cell activation, collagen production, and leukocyte migration, all contributing to inflammation in Crohn's disease. Anti-TNF monoclonal antibodies, namely infliximab (Remicade), adalimumab...
239