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Trial · NCT00979654

Results by group17

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

OutcomeGroupCategoryValueSpreadUnits
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)TEAEs101participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)TESAEs27participants
Maximum Observed Serum Concentration (Cmax) for SifalimumabSifalimumab (MEDI-545) 500 or 600 Milligram (mg)225.569Standard Deviation 78.842microgram per milliliter (mcg/mL)
Time to Reach Maximum Observed Plasma Concentration (Tmax) of SifalimumabSifalimumab (MEDI-545) 500 or 600 Milligram (mg)0.049Full Range 0.04 to 0.13days
Time to Last Quantifiable Plasma Concentration (Tlast) of SifalimumabSifalimumab (MEDI-545) 500 or 600 Milligram (mg)14.413Standard Deviation 1.693days
Minimum Observed Serum Concentration (Ctrough) of SifalimumabSifalimumab (MEDI-545) 500 or 600 Milligram (mg)65.009Standard Deviation 30.516mcg/mL
Area Under the Serum Concentration-time Curve Over the Dosing Interval (AUCtau) of SifalimumabSifalimumab (MEDI-545) 500 or 600 Milligram (mg)2084.180Standard Deviation 665.882microgram.day per milliliter(mcg*day/mL)
Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of SifalimumabSifalimumab (MEDI-545) 500 or 600 Milligram (mg)78.731Standard Deviation 53.942mcg/mL
Accumulation Index for Minimum Observed Serum Concentration (Ctrough) of SifalimumabSifalimumab (MEDI-545) 500 or 600 Milligram (mg)1.217Standard Deviation 0.808ratio
Number of Participants With Positive Anti-Drug AntibodySifalimumab (MEDI-545) 500 or 600 Milligram (mg)Day 15Participants
Number of Participants With Positive Anti-Drug AntibodySifalimumab (MEDI-545) 500 or 600 Milligram (mg)Week 120Participants
Number of Participants With Positive Anti-Drug AntibodySifalimumab (MEDI-545) 500 or 600 Milligram (mg)Week 240Participants
Number of Participants With Positive Anti-Drug AntibodySifalimumab (MEDI-545) 500 or 600 Milligram (mg)Week 521Participants
Number of Participants With Positive Anti-Drug AntibodySifalimumab (MEDI-545) 500 or 600 Milligram (mg)Week 1044Participants
Number of Participants With Positive Anti-Drug AntibodySifalimumab (MEDI-545) 500 or 600 Milligram (mg)Week 1561Participants
Number of Participants With Positive Anti-Drug AntibodySifalimumab (MEDI-545) 500 or 600 Milligram (mg)Week 1684Participants
Number of Participants With Positive Anti-Drug AntibodySifalimumab (MEDI-545) 500 or 600 Milligram (mg)Any Day Post Baseline9Participants

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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