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Trial · NCT01705977

Results by group42

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Number of Deaths - On Treatment Period (Week 52)Placebo8Participants
Number of Deaths - On Treatment Period (Week 52)Belimumab 10 mg/kg10Participants
Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52)PlaceboSerious Infections, n=2001, 200282Participants
Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52)Belimumab 10 mg/kgSerious Infections, n=2001, 200275Participants
Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52)PlaceboOpportunistic Infections and Other Infections of Interest, n=2001, 200250Participants
Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52)Belimumab 10 mg/kgOpportunistic Infections and Other Infections of Interest, n=2001, 200236Participants
Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52)PlaceboMalignancies (Excluding NMSC), n=2001, 20025Participants
Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52)Belimumab 10 mg/kgMalignancies (Excluding NMSC), n=2001, 20025Participants
Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52)PlaceboNMSC, n=2001, 20023Participants
Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52)Belimumab 10 mg/kgNMSC, n=2001, 20024Participants
Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52)PlaceboPsychiatric Events Suggesting Serious Mood Disorders and Anxiety (Serious depression), n=2001, 20021Participants
Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52)Belimumab 10 mg/kgPsychiatric Events Suggesting Serious Mood Disorders and Anxiety (Serious depression), n=2001, 20027Participants
Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52)PlaceboSuicidality (C-SSRS), n=1986, 197223Participants
Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52)Belimumab 10 mg/kgSuicidality (C-SSRS), n=1986, 197228Participants
Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52)PlaceboSIHR, n=2001, 20022Participants
Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52)Belimumab 10 mg/kgSIHR, n=2001, 20028Participants
Number of Participants With Serious Adverse Events (SAEs) Reported During On-treatment Period (Week 52)Placebo222Participants
Number of Participants With Serious Adverse Events (SAEs) Reported During On-treatment Period (Week 52)Belimumab 10 mg/kg220Participants
Number of Deaths Reported - On-study Period (Week 52)Placebo22Participants
Number of Deaths Reported - On-study Period (Week 52)Belimumab 10 mg/kg13Participants

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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