Post-marketing surveillance of Raiatt MIBG-I 131 Injection (all-case surveillance)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 主要终点
- Case composition
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- No limit 至 No limit（—）
- 性别
- All
入选标准
- •All patients who received Raiatt MIBG-I 131 Injection
排除标准
- 未提供
结局指标
主要结局
Case composition
- Number of registered cases, number of cases for which questionnaires were collected, number of cases for safety analysis, number of cases for efficacy analysis - Number of cases excluded from analysis and reasons for exclusion - Number of institutions (contract, registration)
Safety items
- The rate of adverse drug reactions - The rate of serious adverse drug reactions
Efficacy
时间窗: Every time, after about 3 months from administration of Raiatt MIBG-I 131 Injection
- Clinical tests for efficacy evaluation (Blood pressure, pulse rate, blood catecholamines, urinary catecholamines) - Efficacy evaluation (effect on tumor, transition of clinical symptoms) - Effect on tumor (evaluation by 123I-MIBG scintigraphy) - Effect on tumor (evaluation by morphological image diagnosis [CT, MRI, etc.]) - Transition of clinical symptoms
次要结局
未报告次要终点