Trial · NCT01729455
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events of Special Interest (AESI) Using Initial Exposure Intent-to-Treat (ITT) Strategy | Up to 63 Months | An adverse event (AE) is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. AESIs included mortality, malignancies (excluding non-melanoma skin cancers \[NMSC\]), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events. Initial exposure ITT strategy assigned exposure status of participants based on SLE medication (Benlysta or Non-Benlysta) at enrollment (Day 0). This exposure strategy analyzed all accrued AESI data during the whole follow-up period irrespective of treatment switching from Benlysta to Non-Benlysta or vice-versa. |
| Primary | Incidence Rate of AESI Up to 12 Months Using As-Exposed - Time Varying Strategy | Up to 12 Months | An AE is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. AESIs including mortality, malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. Hence, a participant's exposure group could change over time depending on the SLE medication in use at specific time during study follow-up. For Benlysta, a 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Incidence rate is calculated as: Number of first events divided by (/) Total participant-years at risk of event expressed per 100 participant-years. |
| Primary | Incidence Rate of AESI Up to 24 Months Using As-Exposed - Time Varying Strategy | Up to 24 Months | An AE is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. AESIs including mortality, malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. Hence, a participant's exposure group could change over time depending on the SLE medication in use at specific time during study follow-up. For Benlysta, a 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Incidence rate is calculated as: Number of first events / Total participant-years at risk of event expressed per 100 participant-years. |
| Primary | Incidence Rate of AESI Up to 36 Months Using As-Exposed - Time Varying Strategy | Up to 36 Months | An AE is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. AESIs including mortality, malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. Hence, a participant's exposure group could change over time depending on the SLE medication in use at specific time during study follow-up. For Benlysta, a 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Incidence rate is calculated as: Number of first events / Total participant-years at risk of event expressed per 100 participant-years. |
| Primary | Incidence Rate of AESI Up to 48 Months Using As-Exposed - Time Varying Strategy | Up to 48 Months | An AE is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. AESIs including mortality, malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. Hence, a participant's exposure group could change over time depending on the SLE medication in use at specific time during study follow-up. For Benlysta, a 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Incidence rate is calculated as: Number of first events / Total participant-years at risk of event expressed per 100 participant-years. |
| Primary | Incidence Rate of AESI Up to 63 Months Using As-Exposed - Time Varying Strategy | Up to 63 Months | An AE is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. AESIs including mortality, malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. Hence, a participant's exposure group could change over time depending on the SLE medication in use at specific time during study follow-up. For Benlysta, a 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Incidence rate is calculated as: Number of first events / Total participant-years at risk of event expressed per 100 participant-years. |
| Primary | Event Rate of AESI Up to 12 Months Using As-Exposed - Time Varying Strategy | Up to 12 Months | An AE is any unfavorable or unintended sign, symptom, or disease that is temporally associated with use of study agent but is not necessarily caused by study agent. AESIs including malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As event rate was computed for potentially recurrent events, no event rate was computed for mortality. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. So, a participant's exposure group could change over time depending on SLE medication in use at specific time during study follow-up. For Benlysta, 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Event rate is calculated as: Number of all events / Total participant-years at risk of event expressed per 100 participant-years. |
| Primary | Event Rate of AESI Up to 24 Months Using As-Exposed - Time Varying Strategy | Up to 24 Months | An AE is any unfavorable or unintended sign, symptom, or disease that is temporally associated with use of study agent but is not necessarily caused by study agent. AESIs including malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As event rate was computed for potentially recurrent events, no event rate was computed for mortality. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. So, a participant's exposure group could change over time depending on SLE medication in use at specific time during study follow-up. For Benlysta, 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Event rate is calculated as: Number of all events / Total participant-years at risk of event expressed per 100 participant-years. |
| Primary | Event Rate of AESI Up to 36 Months Using As-Exposed - Time Varying Strategy | Up to 36 Months | An AE is any unfavorable or unintended sign, symptom, or disease that is temporally associated with use of study agent but is not necessarily caused by study agent. AESIs including malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As event rate was computed for potentially recurrent events, no event rate was computed for mortality. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. So, a participant's exposure group could change over time depending on SLE medication in use at specific time during study follow-up. For Benlysta, 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Event rate is calculated as: Number of all events / Total participant-years at risk of event expressed per 100 participant-years. |
| Primary | Event Rate of AESI Up to 48 Months Using As-Exposed - Time Varying Strategy | Up to 48 Months | An AE is any unfavorable or unintended sign, symptom, or disease that is temporally associated with use of study agent but is not necessarily caused by study agent. AESIs including malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As event rate was computed for potentially recurrent events, no event rate was computed for mortality. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. So, a participant's exposure group could change over time depending on SLE medication in use at specific time during study follow-up. For Benlysta, 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Event rate is calculated as: Number of all events / Total participant-years at risk of event expressed per 100 participant-years. |
| Primary | Event Rate of AESI Up to 63 Months Using As-Exposed - Time Varying Strategy | Up to 63 Months | An AE is any unfavorable or unintended sign, symptom, or disease that is temporally associated with use of study agent but is not necessarily caused by study agent. AESIs including malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As event rate was computed for potentially recurrent events, no event rate was computed for mortality. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. So, a participant's exposure group could change over time depending on SLE medication in use at specific time during study follow-up. For Benlysta, 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Event rate is calculated as: Number of all events / Total participant-years at risk of event expressed per 100 participant-years. |
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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