Trial · NCT01199744
Relenza® Sentinel Site Monitoring Program in Japan
NCT01199744, Completed, GlaxoSmithKline; results first posted 2011-04-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Relenza® Sentinel Site Monitoring Program in Japan. Trials, record NCT01199744. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01199744
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Relenza® Sentinel Site Monitoring Program in Japan
- NCT number
- NCT01199744
- Status
- Completed
- Enrollment
- 1,575 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Influenza, Human
- Interventions
- zanamivir
- First posted
- 2010-09-13
- Last updated
- 2017-07-06
- Results first posted
- 2011-04-12
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Any Adverse Drug Reaction | 5 months (November 2009 to March 2010) | An adverse drug reaction is defined as a drug adverse event that a physician has determined to be related to the use of Relenza. A drug adverse event is defined as any unfavorable or unintended sign (including laboratory test abnormalities), symptom, or disease that occurs when a drug is administered, regardless of the relationship to the drug. For a complete list of all adverse drug reactions recorded during the study, see the section entitled "Other (Non-serious) Adverse Events." |
| Secondary | Number of Participants With Any Serious Adverse Drug Reaction (ADR) | 5 months (November 2009 to March 2010) | A serious ADR is defined as a serious adverse drug event (ADE) that a physician has determined to be related to the use of Relenza. Serious ADE: death caused by an ADR; an event that is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in severe symptoms requiring treatment so that symptoms do not lead to previously mentioned outcomes, and a congenital anomaly/birth defect. For a complete list of all serious ADRs recorded during the study, see "Serious Adverse Events" section. |
| Secondary | Number of Male and Female Participants With Either a Serious or Non-serious Adverse Drug Reaction | 5 months (November 2009 to March 2010) | |
| Secondary | Number of Participants in the Indicated Age Categories With Either a Serious or Non-serious Adverse Drug Reaction | 5 months (November 2009 to March 2010) | |
| Secondary | Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Categorized by Reason for the Use of Relenza | 5 months (November 2009 to March 2010) | The dose given for treatment of influenza is 10 mg twice daily for 5days. Prophylaxis is defined as a measure taken for the prevention of a disease or condition. The prophylactic dose of Relenza is 10 mg once daily for 10 days. |
| Secondary | Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Categorized by Either Having Complications or Having no Complications | 5 months (November 2009 to March 2010) | A complication is defined as asthma. |
| 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 | 5 months (November 2009 to March 2010) | Risk factors are defined as pregnancy; infancy; being elderly; and having chronic respiratory disease, cardiocirculatory disease, and/or diabetes. |
| Secondary | Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Also in the Indicated High-risk Categories | 5 months (November 2009 to March 2010) | Participants with only hypertension were excluded from the cardiocirculatory disease category. Participants in high-risk categories are at risk for the aggravation of both infection and symptoms. |
| Secondary | Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Vaccinated for Influenza | 5 months (November 2009 to March 2010) | |
| Secondary | Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Also Taking Concomitant Medications | 5 months (November 2009 to March 2010) | Concomitant medications are defined as drugs used during the administration of Relenza. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Any Adverse Drug Reaction | 5 months (November 2009 to March 2010) | All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza | participants | NUMBER |
| SECONDARY | Number of Participants With Any Serious Adverse Drug Reaction (ADR) | 5 months (November 2009 to March 2010) | All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza | participants | NUMBER |
| SECONDARY | Number of Male and Female Participants With Either a Serious or Non-serious Adverse Drug Reaction | 5 months (November 2009 to March 2010) | All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza | participants | NUMBER |
| SECONDARY | Number of Participants in the Indicated Age Categories With Either a Serious or Non-serious Adverse Drug Reaction | 5 months (November 2009 to March 2010) | All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza | participants | NUMBER |
| SECONDARY | Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Categorized by Reason for the Use of Relenza | 5 months (November 2009 to March 2010) | All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza | participants | NUMBER |
| SECONDARY | Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Categorized by Either Having Complications or Having no Complications | 5 months (November 2009 to March 2010) | All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza | participants | NUMBER |
| 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 | 5 months (November 2009 to March 2010) | All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza | participants | NUMBER |
| SECONDARY | Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Also in the Indicated High-risk Categories | 5 months (November 2009 to March 2010) | All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza | participants | NUMBER |
| SECONDARY | Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Vaccinated for Influenza | 5 months (November 2009 to March 2010) | All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza | participants | NUMBER |
| SECONDARY | Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Also Taking Concomitant Medications | 5 months (November 2009 to March 2010) | All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza | participants | NUMBER |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Any Adverse Drug Reaction | Relenza | 4 | participants | ||
| Number of Participants With Any Serious Adverse Drug Reaction (ADR) | Relenza | 1 | participants | ||
| Number of Male and Female Participants With Either a Serious or Non-serious Adverse Drug Reaction | Relenza | Male | 3 | participants | |
| Number of Male and Female Participants With Either a Serious or Non-serious Adverse Drug Reaction | Relenza | Female | 1 | participants | |
| Number of Participants in the Indicated Age Categories With Either a Serious or Non-serious Adverse Drug Reaction | Relenza | >=3 to <7 years | 0 | participants | |
| Number of Participants in the Indicated Age Categories With Either a Serious or Non-serious Adverse Drug Reaction | Relenza | >=7 to <15 years | 3 | participants | |
| Number of Participants in the Indicated Age Categories With Either a Serious or Non-serious Adverse Drug Reaction | Relenza | >=15 to <65 years | 1 | participants | |
| Number of Participants in the Indicated Age Categories With Either a Serious or Non-serious Adverse Drug Reaction | Relenza | >=65 to <74 years | 0 | participants | |
| Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Categorized by Reason for the Use of Relenza | Relenza | Treatment | 4 | participants | |
| Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Categorized by Reason for the Use of Relenza | Relenza | Prophylaxis | 0 | participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Relenza | 1,575 | |
| Overall Study | COMPLETED | Relenza | 1,575 | |
| Overall Study | NOT COMPLETED | Relenza | 0 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abnormal behavior | Psychiatric disorders | Relenza | 2 | 1,575 | |
| other | Vomiting | Gastrointestinal disorders | Relenza | 2 | 1,575 | |
| other | Diarrhea | Gastrointestinal disorders | Relenza | 1 | 1,575 | |
| serious | Depressed level of consciousness | Nervous system disorders | Relenza | 1 | 1,575 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Relenza | ||
| Total, other adverse events | Relenza | 4 | 1,575 |
| Total, serious adverse events | Relenza | 1 | 1,575 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01199744
GET https://conductscience.org/api/trials/v1/NCT01199744/results?page=2