Transverse Myelitis Related to SARS-CoV-2 Vaccines in Patients: an Observational and Retrospective Study Using the WHO's Pharmacovigilance Database
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 580
- 试验地点
- 1
- 主要终点
- TM reportes related to SARS-CoV-2 vaccine
研究概览
简要总结
Few patients receiving SARS-CoV-2 vaccines may experience rare but serious adverse events such as transverse myelitis (TM). Today, data about TM are scarce.
The objective was to investigate reports of TM adverse events related to SARS-CoV-2 vaccines labelled by FDA and EMA, including ChAdOx1nCov-19 (Oxford-AstraZeneca), BNT162b2 (Pfizer/BioNTech), mRNA-1273 (Moderna) and Ad26.COV2.S (Janssen/Johnson & Johnson) and using the World Health Organization's (WHO) pharmacovigilance database: VigiBase.
详细描述
Here, investigators use the World Health Organization's (WHO) database of individual safety case reports, to identify cases of TM related to SARS-CoV-2 vaccines.
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
- 性别
- All
- 接受健康志愿者
- 是
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,
排除标准
- •chronology not compatible between the SARS-CoV-2 vaccine adminisration and onset of TM.
- •vaccines non-labelled by FDA/EMA (data cutoff december 10, 2021)
结局指标
主要结局
TM reportes related to SARS-CoV-2 vaccine
时间窗: date of the first AE related to a SARS-CoV-2 vaccine to December 10, 2021
次要结局
- Description of patients who experienced co-reported adverse events(date of the first AE related to a SARS-CoV-2 vaccine to December 10, 2021)
- Description of the outcomes following TM(date of the first AE related to a SARS-CoV-2 vaccine to December 10, 2021)
- Description of the latency period since SARS-CoV-2 vaccine exposure.(date of the first AE related to a SARS-CoV-2 vaccine to December 10, 2021)