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Comparison · NCT04188379-sae

Efgartigimod vs Placebo: 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. Efgartigimod vs Placebo: serious adverse events. Trial comparisons, record NCT04188379-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04188379-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 10.08140.040.159wilson
Risk in group 20.1560.07750.288wilson
Risk difference, group 1 minus group 2-0.0742-0.2130.0357newcombe hybrid score
Risk ratio, group 1 over group 20.5230.1961.4log
Odds ratio, group 1 over group 20.4810.1571.47log
Number needed to treat, for one fewer participant with a serious adverse event on Efgartigimod than on Placebo13.5from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1EfgartigimodPatient receiving efgartigimod~efgartigimod: Intravenous infusion of efgartigimod786EG000
Group 2PlaceboPatients receiving placebo~Placebo: Intravenous infusion of placebo745EG001

Harm

What it counts
Total, serious adverse events
Time frame
Full study duration (31 Weeks).

Source ClinicalTrials.gov

Trial

Title
A Study to Assess the Efficacy and Safety of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP).
NCT number
NCT04188379
Phases
PHASE3
Conditions
Primary Immune Thrombocytopenia
Interventions
efgartigimod, Placebo
Lead sponsor
argenx
Results first posted
2025-03-13

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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