Relenza® Sentinel Site Monitoring Program in Japan

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

To collect background information of patients receiving a prescription for Relenza® and study risk factors etc. for adverse drug reactions collected through spontaneous reporting. In particular, to characterize the types and incidences of adverse events, serious adverse events, and adverse drug reactions and to investigate risk factors for them in patient populations that are regarded to be at high risk for novel influenza A (H1N1)and in which the use experience of Relenza® has not been enough (such as pregnant women, infants, elderly persons, and those with decreased physical function) in accordance with the PFSB/SD Notification 0904, No.2 of the Safety Division, Pharmaceutical and Food Safety Bureau, MHLW, dated 4th September 2009.

To compare the data with the safety data collected in overseas sentinel site monitoring programs.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Zanamivir

Criteria

Inclusion Criteria:

Prescribed Relenza® for the purpose of either treatment or prophylaxis of influenza

Exclusion Criteria:

N/A