NCT04169503Unknown不适用
Immune Checkpoint Inhibitors Rechallenge After Immune-related Adverse Events in Patients With Cancer: an Observational and Retrospective Study Using the WHO Pharmacovigilance Database
适应症
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 17,562
- 试验地点
- 1
- 主要终点
- Rate of occurrence of second immune-related adverse events (irAEs)
研究概览
简要总结
Although immune checkpoint inhibitors (ICIs) have proved effective in treating many cancers, patients receiving ICIs may experience immune-related adverse events (irAEs). Little evidence exists on the safety of resuming these treatments after an irAE.
Our objective was to investigate the safety of ICI rechallenge after an irAE using the WHO pharmacovigilance database
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Case reported in the World Health Organization (WHO) database (VigiBase) of individual safety case reports at the time of the extraction,
- •consecutive individual case safety reports present in VigiBase reporting an irAEs associated to at least one immune checkpoint inhibitor.
排除标准
- •Chronology not compatible between the drug and the toxicity.
结局指标
主要结局
Rate of occurrence of second immune-related adverse events (irAEs)
时间窗: Number of case reported in the World Health Organization (WHO) of individual safety case reports, through study completion (an average of 2 months).
percentage of cases experiencing a second irAE among the rechallenged cases
次要结局
- Description of cases experiencing an initial irAEs(Number of case reported in the World Health Organization (WHO) of individual safety case reports, through study completion (an average of 2 months)..)
- Description of the rechallenge cases(Number of case reported in the World Health Organization (WHO) of individual safety case reports, through study completion (an average of 2 months)..)
- Description of the clinical features of cases experiencing a second irAEs(Number of case reported in the World Health Organization (WHO) of individual safety case reports, through study completion (an average of 2 months)..)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Immune Checkpoint Inhibitor Associated Cardiovascular Adverse Events in Patients With CancerCardiovascular DiseasesArterial ThrombosisCancerStrokeMyocardial InfarctionAtherosclerosisCoronary Artery DiseaseNCT06519292Hanneke W. M. van Laarhoven214
招募中
不适用
Montreal Immune-Related Adverse Events (MIRAE) StudyImmune System DisorderInflammatory ReactionAutoimmune DiseasesCancerNCT05139706Sir Mortimer B. Davis - Jewish General Hospital1,000
尚未招募
2 期
Comprehensive Bladder Preservation Therapy on Patients With Muscle Invasive Bladder CancerUrinary Bladder NeoplasmsNCT05445648First Affiliated Hospital Xi'an Jiaotong University65
已完成
不适用
Immuno-Oncology Database and BioregistryMalignancyImmune System DiseasesAutoimmune DiseasesNCT04656873UNC Lineberger Comprehensive Cancer Center32
招募中
不适用
Chemotherapy With or Without Immune Checkpoint Inhibitors for Lung CancerNon Small Cell Lung CancerNCT05059951Hunan Province Tumor Hospital15,000