Temodal (Temozolomide) Post Marketing Surveillance Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 682
- 主要终点
- Number of Temozolomide Misuse or Abuse Events
研究概览
简要总结
The purpose of this surveillance is to evaluate the postmarketing safety and efficacy of Temodal capsule (temozolomide) under actual conditions of use, and to understand some of the following points that are in question and doubt:
- Incidence of adverse events under actual conditions of use (Serious and Nonserious Adverse Events);
- Adverse Drug Reactions not shown in the directions for use (will be stated as Unexpected Adverse Reaction);
- Adverse Event caused by misuse, abuse, or drug interactions;
- Other information concerned with safety or efficacy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who are prescribed with temozolomide by local labeling:
- •participants with newly diagnosed glioblastoma multiforme;
- •participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
排除标准
- 未提供
研究组 & 干预措施
All Participants
Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).
干预措施: Temozolomide (Drug)
All Participants
Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Number of Temozolomide Misuse or Abuse Events
时间窗: Complete study duration & 30 days after completion (up to approximately 7.5 months)
Drug abuse was defined as the use of the study drug for a non-therapeutic effect. Misuse was defined as use of the study medication in a way that was not prescribed.
Number of Participants Experiencing Adverse Events (AEs)
时间窗: Complete study duration & 30 days after completion (up to approximately 7.5 months)
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of vaccine, whether or not considered related to the medicinal product.
Number of Participants Experiencing Unexpected Adverse Drug Reactions (ADRs)
时间窗: Complete study duration & 30 days after completion (up to approximately 7.5 months)
An unexpected ADR was defined as an adverse reaction, whose nature, severity, specificity, or outcome is not consistent with the term or description used in the applicable product information.
Number of Temozolomide Drug Interactions
时间窗: Complete study duration & 30 days after completion (up to approximately 7.5 months)
Drug interaction was defined as a chemical or physiological reaction that can occur when two different drugs are taken together.
Efficacy: Number of Participants Experiencing Complete Response (CR), Partial Response (PR), or Stable Disease(SD)
时间窗: Complete study duration (up to approximately 6.5 months)
The response ratings were based on the judgment of the investigator.
次要结局
未报告次要终点