Post-marketing surveillance of LUTATHERA Injection (All Case Study)

JRCT ID: jRCT2031220065

Registered date:17/05/2022

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: Somatostatin receptor-positive neuroendocrine tumors
• Date of first enrollment: 20/12/2021
• Target sample size: 300
• Study type: Observational

Outcome(s)

Primary Outcome

1. Case composition
Number of registered cases, number of cases for which questionnaires were collected, number of cases
for safety analysis
Number of cases excluded from analysis and reasons for exclusion
2. Safety items
The rate of adverse drug reactions
The rate of serious adverse drug reactions
The rate of adverse drug reactions related to the safety specifications in this study
3. Others
Treatment results with this drug

• Secondary Outcome: none

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include criteria: All patients who received LUTATHERA Injection
• Exclude criteria: none

Related Information

• Primary Sponsor: Maki Keiji