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Comparison · NCT02446899-30e82d2b

Anifrolumab 300 mg vs Placebo: Number of Participants With a Potentially Clinically Important Change From Baseline in Vital Sign Measurements

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Anifrolumab 300 mg vs Placebo: Number of Participants With a Potentially Clinically Important Change From Baseline in Vital Sign Measurements. Trial comparisons, record NCT02446899-30e82d2b. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02446899-30e82d2b

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.250.1920.318wilson
Risk in group 20.2470.190.315wilson
Risk difference, group 1 minus group 20.00275-0.0860.0915newcombe hybrid score
Risk ratio, group 1 over group 21.010.7071.45log
Odds ratio, group 1 over group 21.010.631.63log
Number needed to treat, for one more participant with the outcome on Anifrolumab 300 mg than on Placebo364from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Anifrolumab 300 mgAnifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).45180OG000
Group 2PlaceboMatching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).45182OG001

Outcome

Type
SECONDARY
Title
Number of Participants With a Potentially Clinically Important Change From Baseline in Vital Sign Measurements
Description
Vital sign measurements included oral temperature, blood pressure (BP), pulse rate, and respiratory rate.~Vital signs were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose \[Week 48\]), or until Week 52 for participants who enrolled onto the long term extension (LTE).
Time frame
Baseline to end of study (Maximum of 60 weeks)
Population
Full Analysis Set: All participants who were randomized and received at least one dose of study drug.

Source ClinicalTrials.gov

Trial

Title
Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
NCT number
NCT02446899
Phases
PHASE3
Conditions
Active Systemic Lupus Erythematosus
Interventions
Anifrolumab, Placebo
Lead sponsor
AstraZeneca
Results first posted
2020-03-18

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
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

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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