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Comparison · NCT05001737-sae

Cohort 1 (sJIA and AOSD) vs Cohort 2 (SLE): serious adverse events

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. Cohort 1 (sJIA and AOSD) vs Cohort 2 (SLE): serious adverse events. Trial comparisons, record NCT05001737-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05001737-sae

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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 10.720.5240.857wilson
Risk in group 20.50.2150.785wilson
Risk difference, group 1 minus group 20.22-0.1260.536newcombe hybrid score
Risk ratio, group 1 over group 21.440.6913log
Odds ratio, group 1 over group 22.570.513.2log
Number needed to harm, for one more participant with a serious adverse event on Cohort 1 (sJIA and AOSD) than on Cohort 2 (SLE)4.55from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Cohort 1 (sJIA and AOSD)MAS in the context of systemic juvenile idiopathic arthritis and adult onset Still's disease (sJIA and AOSD)~Emapalumab: Emapalumab iv infusion1825EG000
Group 2Cohort 2 (SLE)MAS in the context of systemic lupus erythematosus (SLE)~Emapalumab: Emapalumab iv infusion48EG001

Harm

What it counts
Total, serious adverse events
Time frame
From signature of informed consent (i.e. screening) until EOS (1 year)

Source ClinicalTrials.gov

Trial

Title
Evaluate Efficacy, Safety and Tolerability, PK and PD of Emapalumab in Children and Adults With MAS in Still's or SLE
NCT number
NCT05001737
Phases
PHASE3
Conditions
Macrophage Activation Syndrome, Secondary Hemophagocytic Lymphohistiocytosis, Still Disease, Systemic Lupus Erythematosus, SJIA, AOSD, MAS
Interventions
Emapalumab
Lead sponsor
Swedish Orphan Biovitrum
Results first posted
2026-02-19

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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