Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

1 to 11 of 11

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Adverse Events of Special Interest (AESI) Using Initial Exposure Intent-to-Treat (ITT) Strategy	Up to 63 Months	Evaluable Population included participants in the Eligible Population with a collection of enrollment data and at least one post-baseline assessment.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Incidence Rate of AESI Up to 12 Months Using As-Exposed - Time Varying Strategy	Up to 12 Months	Evaluable Population. As time varying strategy was used for this analysis, participants could be counted in Benlysta or Non-Benlysta group, depending on the exposure status at the time of occurrence of the event. Here, 'Overall Number of Participants Analyzed' for Benlysta or Non-Benlysta groups included participants assigned to the respective treatment at the time of enrollment (Day 0).	Events per 100 participant-years	NUMBER
PRIMARY	Incidence Rate of AESI Up to 24 Months Using As-Exposed - Time Varying Strategy	Up to 24 Months	Evaluable Population. As time varying strategy was used for this analysis, participants could be counted in Benlysta or Non-Benlysta group, depending on the exposure status at the time of occurrence of the event. Here, 'Overall Number of Participants Analyzed' for Benlysta or Non-Benlysta groups included participants assigned to the respective treatment at the time of enrollment (Day 0).	Events per 100 participant-years	NUMBER
PRIMARY	Incidence Rate of AESI Up to 36 Months Using As-Exposed - Time Varying Strategy	Up to 36 Months	Evaluable Population. As time varying strategy was used for this analysis, participants could be counted in Benlysta or Non-Benlysta group, depending on the exposure status at the time of occurrence of the event. Here, 'Overall Number of Participants Analyzed' for Benlysta or Non-Benlysta groups included participants assigned to the respective treatment at the time of enrollment (Day 0).	Events per 100 participant-years	NUMBER
PRIMARY	Incidence Rate of AESI Up to 48 Months Using As-Exposed - Time Varying Strategy	Up to 48 Months	Evaluable Population. As time varying strategy was used for this analysis, participants could be counted in Benlysta or Non-Benlysta group, depending on the exposure status at the time of occurrence of the event. Here, 'Overall Number of Participants Analyzed' for Benlysta or Non-Benlysta groups included participants assigned to the respective treatment at the time of enrollment (Day 0).	Events per 100 participant-years	NUMBER
PRIMARY	Incidence Rate of AESI Up to 63 Months Using As-Exposed - Time Varying Strategy	Up to 63 Months	Evaluable Population. As time varying strategy was used for this analysis, participants could be counted in Benlysta or Non-Benlysta group, depending on the exposure status at the time of occurrence of the event. Here, 'Overall Number of Participants Analyzed' for Benlysta or Non-Benlysta groups included participants assigned to the respective treatment at the time of enrollment (Day 0).	Events per 100 participant-years	NUMBER
PRIMARY	Event Rate of AESI Up to 12 Months Using As-Exposed - Time Varying Strategy	Up to 12 Months	Evaluable Population. As time varying strategy was used for this analysis, participants could be counted in Benlysta or Non-Benlysta group, depending on the exposure status at the time of occurrence of the event. Here, 'Overall Number of Participants Analyzed' for Benlysta or Non-Benlysta groups included participants assigned to the respective treatment at the time of enrollment (Day 0).	Events per 100 participant-years	NUMBER
PRIMARY	Event Rate of AESI Up to 24 Months Using As-Exposed - Time Varying Strategy	Up to 24 Months	Evaluable Population. As time varying strategy was used for this analysis, participants could be counted in Benlysta or Non-Benlysta group, depending on the exposure status at the time of occurrence of the event. Here, 'Overall Number of Participants Analyzed' for Benlysta or Non-Benlysta groups included participants assigned to the respective treatment at the time of enrollment (Day 0).	Events per 100 participant-years	NUMBER
PRIMARY	Event Rate of AESI Up to 36 Months Using As-Exposed - Time Varying Strategy	Up to 36 Months	Evaluable Population. As time varying strategy was used for this analysis, participants could be counted in Benlysta or Non-Benlysta group, depending on the exposure status at the time of occurrence of the event. Here, 'Overall Number of Participants Analyzed' for Benlysta or Non-Benlysta groups included participants assigned to the respective treatment at the time of enrollment (Day 0).	Events per 100 participant-years	NUMBER
PRIMARY	Event Rate of AESI Up to 48 Months Using As-Exposed - Time Varying Strategy	Up to 48 Months	Evaluable Population. As time varying strategy was used for this analysis, participants could be counted in Benlysta or Non-Benlysta group, depending on the exposure status at the time of occurrence of the event. Here, 'Overall Number of Participants Analyzed' for Benlysta or Non-Benlysta groups included participants assigned to the respective treatment at the time of enrollment (Day 0).	Events per 100 participant-years	NUMBER
PRIMARY	Event Rate of AESI Up to 63 Months Using As-Exposed - Time Varying Strategy	Up to 63 Months	Evaluable Population. As time varying strategy was used for this analysis, participants could be counted in Benlysta or Non-Benlysta group, depending on the exposure status at the time of occurrence of the event. Here, 'Overall Number of Participants Analyzed' for Benlysta or Non-Benlysta groups included participants assigned to the respective treatment at the time of enrollment (Day 0).	Events per 100 participant-years	NUMBER

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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GET https://conductscience.org/api/trials/v1/NCT01729455/outcomes

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