N/A
N=1,575
Relenza® Sentinel Site Monitoring Program in Japan
Influenza, Human
Bottom Line
View on ClinicalTrials.gov: NCT01199744 ↗Enrolled (actual)
1,575
Serious AEs
0.1%
Results posted
Apr 2011
Primary outcome: Primary: Number of Participants With Any Adverse Drug Reaction — 4 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- zanamivir (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Any Adverse Drug Reaction |
4 | — |
| SECONDARY Number of Participants With Any Serious Adverse Drug Reaction (ADR) |
1 | — |
| SECONDARY Number of Male and Female Participants With Either a Serious or Non-serious Adverse Drug Reaction |
3; 1 | — |
| SECONDARY Number of Participants in the Indicated Age Categories With Either a Serious or Non-serious Adverse Drug Reaction |
0; 3; 1; 0 | — |
| SECONDARY Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Categorized by Reason for the Use of Relenza |
4; 0 | — |
| SECONDARY Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Categorized by Either Having Complications or Having no Complications |
1; 3 | — |
| SECONDARY Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Categorized by Either Having Risk Factors for Influenza or Having no Risk Factors |
1; 3 | — |
| SECONDARY Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Also in the Indicated High-risk Categories |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Vaccinated for Influenza |
1; 3 | — |
| SECONDARY Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Also Taking Concomitant Medications |
4; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
Prescribed Relenza® for the purpose of either treatment or prophylaxis of influenza
Exclusion Criteria
N/A
Data sourced from ClinicalTrials.gov (NCT01199744). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.