RITUXIMAB BS Intravenous Infusion 100mg ・ 500mg [Pfizer] Post-marketing Database Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 2,703
- 试验地点
- 1
- 主要终点
- Incidence of infections which requires procedures, medication or hospitalization
研究概览
简要总结
To evaluate the incidence of the outcomes for the safety specifications in patients of Medical Data Vision database in Japan diagnosed with CD20 positive B-cell non- Hodgkin's lymphoma who were treated with Rituximab Pfizer to compare it with outcomes in patients who were treated with Rituxan from 01 January 2020 through 31 December 2024
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have prescription of Rituximab Pfizer or Rituxan within the enrollment period (Index Date: first prescription date within the enrollment period).
- •Have diagnosis of CD20 positive B-cell non- Hodgkin's lymphoma on the index month or within 6 months before index date
- •Have at least 6 months of Look back period and at least one medical record prior to 7 months before the Index date.
- •Have not prescription of Rituximab product before index date(Comparative Analysis Set only).
排除标准
- •1. Have any diagnosis of other indications of rituximab products other than CD20 positive B-cell non- Hodgkin's lymphoma before index date .
研究组 & 干预措施
Exposed group
patients treated with Rituximab Pfizer
干预措施: Rituximab Pfizer (Drug)
Comparative group
patients treated with Rituxan
干预措施: Rituxan (Drug)
结局指标
主要结局
Incidence of infections which requires procedures, medication or hospitalization
时间窗: From index date up to 180 days after last dose
until the first incidence of an event, date of switch to another Rituximab product, the end of continuous treatment plus 180 days risk window, death, loss to follow up or the end of study period
Incidence of Infections Which Requires Procedures, Medication or Hospitalization
时间窗: From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period)
Infection was expected to occur after the exposure. An incident event occurring during the 180-day risk window was counted in the numerator for the analysis and the person-time accrued until the first incidence of an event, date of switch to another Rituximab product, the end of continuous treatment plus 180 days risk window, death, loss to follow up (the last date of the disease name data, medical practice data, or hospitalization data on DPC form 1 existing on the MDV database) or the end of study period. Additionally, two types of analyses based on propensity score were conducted.
次要结局
- Incidence of 'pancytopenia, leukocytopenia, Neutropenia, agranulocytosis, thrombocytopenia'(From index date up to 180 days after last dose)
- Incidence of Infusion reactions(From index date up to next day after last dose)
- Incidence of hepatic function disorder, jaundice(From index date up to 180 days after last dose)
- Incidence of cardiac disorder(From index date up to 180 days after last dose)
- Incidence of gastrointestinal perforation/obstruction(From index date up to 180 days after last dose)
- Incidence of hypotension(From index date up to next day after last dose)
- Incidence of development of malignant tumor(From index date up to maximum of 5 years (the end of the study period))
- Incidence of 'Pancytopenia, Leukocytopenia, Neutropenia, Agranulocytosis, Thrombocytopenia' (Cytopenias)(From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period))
- Incidence of Infusion Reactions(From index date up to next day after last dose, with a maximum of 5 years (the end of the study period))
- Incidence of Hepatic Function Disorder (HFD), Jaundice(From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period))
- Incidence of Cardiac Disorder(From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period))
- Incidence of Gastrointestinal (GI) Perforation/Obstruction(From index date up to 180 days after last dose, with a maximum of 5 years (the end of the study period))
- Incidence of Hypotension(From index date up to next day after last dose, with a maximum of 5 years (the end of the study period))
- Incidence of Development of Malignant Tumor(From index date up to maximum of 5 years (the end of the study period))