A Study to Characterize Adverse Events Occurring Within One Day of TEGSEDI Administration to Adult Participants With hATTR-PN

Summary

The objective of the study was to characterize adverse events (AEs) occurring within one day of TEGSEDI administration to adult participants with hATTR-PN overall and in individual participants with respect to time course of AE onset, vital sign changes, preventive measures, treatment required, risk factors, and subsequent adverse outcomes.

Timeline

Start

2021-01-21

Primary completion

2024-03-20

Completion

2024-03-20

Outcome

Outcome not reported

Stopped: “Withdrawal of TEGSEDI from sale was not related to any safety issues.”

Drugs

Indications