Trial Outcomes & Findings for Relenza® Sentinel Site Monitoring Program in Japan (NCT NCT01199744)

NCT ID: NCT01199744

Last Updated: 2017-07-06

Results Overview

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."

• Recruitment status: COMPLETED
• Target enrollment: 1575 participants
• Primary outcome timeframe: 5 months (November 2009 to March 2010)
• Results posted on: 2017-07-06

Participant Flow

This Sentinel Site Monitoring Program collected the patient background and safety data of Relenza administered in the Japanese population per the requirements of the Japanese Ministry of Health, Labour and Welfare (MHLW).

Participant milestones

Measure	Relenza Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
Overall Study STARTED	1575
Overall Study COMPLETED	1575
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Relenza® Sentinel Site Monitoring Program in Japan

Baseline characteristics by cohort

Measure	Relenza n=1575 Participants Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
Age, Customized >=3 to <7 years	195 participants n=5 Participants
Age, Customized >=7 to <15 years	790 participants n=5 Participants
Age, Customized >=15 to <65 years	586 participants n=5 Participants
Age, Customized >=65 to <74 years	4 participants n=5 Participants
Sex: Female, Male Female	827 Participants n=5 Participants
Sex: Female, Male Male	748 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 months (November 2009 to March 2010)

Population: 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

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."

Outcome measures

Measure	Relenza n=1575 Participants Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
Number of Participants With Any Adverse Drug Reaction	4 participants

SECONDARY outcome

Timeframe: 5 months (November 2009 to March 2010)

Population: 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

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.

Outcome measures

Measure	Relenza n=1575 Participants Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
Number of Participants With Any Serious Adverse Drug Reaction (ADR)	1 participants

SECONDARY outcome

Timeframe: 5 months (November 2009 to March 2010)

Population: 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

Outcome measures

Measure	Relenza n=1575 Participants Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
Number of Male and Female Participants With Either a Serious or Non-serious Adverse Drug Reaction Male	3 participants
Number of Male and Female Participants With Either a Serious or Non-serious Adverse Drug Reaction Female	1 participants

SECONDARY outcome

Timeframe: 5 months (November 2009 to March 2010)

Population: 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

Outcome measures

Measure	Relenza n=1575 Participants Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
Number of Participants in the Indicated Age Categories With Either a Serious or Non-serious Adverse Drug Reaction >=3 to <7 years	0 participants
Number of Participants in the Indicated Age Categories With Either a Serious or Non-serious Adverse Drug Reaction >=7 to <15 years	3 participants
Number of Participants in the Indicated Age Categories With Either a Serious or Non-serious Adverse Drug Reaction >=15 to <65 years	1 participants
Number of Participants in the Indicated Age Categories With Either a Serious or Non-serious Adverse Drug Reaction >=65 to <74 years	0 participants

SECONDARY outcome

Timeframe: 5 months (November 2009 to March 2010)

Population: 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

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.

Outcome measures

Measure	Relenza n=1575 Participants Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Categorized by Reason for the Use of Relenza Prophylaxis	0 participants
Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Categorized by Reason for the Use of Relenza Treatment	4 participants

SECONDARY outcome

Timeframe: 5 months (November 2009 to March 2010)

Population: 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

A complication is defined as asthma.

Outcome measures

Measure	Relenza n=1575 Participants Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Categorized by Either Having Complications or Having no Complications Complications	1 participants
Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Categorized by Either Having Complications or Having no Complications No complications	3 participants

SECONDARY outcome

Timeframe: 5 months (November 2009 to March 2010)

Population: 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

Risk factors are defined as pregnancy; infancy; being elderly; and having chronic respiratory disease, cardiocirculatory disease, and/or diabetes.

Outcome measures

Measure	Relenza n=1575 Participants Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
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 Risk factor	1 participants
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 No risk factor	3 participants

SECONDARY outcome

Timeframe: 5 months (November 2009 to March 2010)

Population: 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 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.

Outcome measures

Measure	Relenza n=1575 Participants Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Also in the Indicated High-risk Categories Infant (<7 years of age)	0 participants
Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Also in the Indicated High-risk Categories Elderly (>=65 years of age)	0 participants
Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Also in the Indicated High-risk Categories Chronic respiratory disease	1 participants
Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Also in the Indicated High-risk Categories Cardiocirculatory disease	0 participants
Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Also in the Indicated High-risk Categories Diabetes	0 participants
Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Also in the Indicated High-risk Categories Pregnant	0 participants

SECONDARY outcome

Timeframe: 5 months (November 2009 to March 2010)

Population: 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

Outcome measures

Measure	Relenza n=1575 Participants Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Vaccinated for Influenza Vaccinated	1 participants
Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Vaccinated for Influenza Not vaccinated	3 participants

SECONDARY outcome

Timeframe: 5 months (November 2009 to March 2010)

Population: 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

Concomitant medications are defined as drugs used during the administration of Relenza.

Outcome measures

Measure	Relenza n=1575 Participants Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Also Taking Concomitant Medications No concomitant medication	0 participants
Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Also Taking Concomitant Medications Concomitant medication	4 participants

Adverse Events

Relenza

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Relenza n=1575 participants at risk Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
Nervous system disorders Depressed level of consciousness	0.06% 1/1575

Other adverse events

Measure	Relenza n=1575 participants at risk Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
Psychiatric disorders Abnormal behavior	0.13% 2/1575
Gastrointestinal disorders Vomiting	0.13% 2/1575
Gastrointestinal disorders Diarrhea	0.06% 1/1575

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER