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A Phase IV, Post-Authorization Safety Study to Investigate the Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Adult Participants With Prostate Cancer
Primary: Incidence and proportion of participants with selected Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: every visit up to 10 years after 1st dose of AAA617 received in parent treatment study ]
Selected AEs include xerostomia, xerophtalmia, myelosupression, renal toxicity and second primary malignancy and their complication. Only SAEs considered causally related to previous treatment with AAA617 will be considered.
Secondary: Incidence and proportion of death [ Time Frame: every visit up to 10 years after 1st dose of AAA617 received in parent treatment study ]
The proportion of patients who die during the long-term follow-up will be summarized by indication.
Primary: Incidence and proportion of participants with selected Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: every visit up to 10 years after 1st dose of AAA617 received in parent treatment study ]
Selected AEs include xerostomia, xerophtalmia, myelosupression, renal toxicity and second primary malignancy and their complication. Only SAEs considered causally related to previous treatment with AAA617 will be considered.
Secondary: Incidence and proportion of death [ Time Frame: every visit up to 10 years after 1st dose of AAA617 received in parent treatment study ]
The proportion of patients who die during the long-term follow-up will be summarized by indication.
Recruitment Status
Current Studies