Comparison · NCT04598477-sae
Efgartigimod-efgartigimod PH20 SC vs Placebo-efgartigimod PH20 SC: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Efgartigimod-efgartigimod PH20 SC vs Placebo-efgartigimod PH20 SC: serious adverse events. Trial comparisons, record NCT04598477-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04598477-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.158 | 0.0999 | 0.242 | wilson | |
| Risk in group 2 | 0.0833 | 0.0329 | 0.196 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0751 | -0.0514 | 0.173 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.9 | 0.672 | 5.38 | log | |
| Odds ratio, group 1 over group 2 | 2.07 | 0.653 | 6.57 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Efgartigimod-efgartigimod PH20 SC than on Placebo-efgartigimod PH20 SC | 13.3 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Efgartigimod-efgartigimod PH20 SC | Participants who received efgartigimod PH20 SC in antecedent study ARGX-113-1904. | 16 | 101 | EG000 |
| Group 2 | Placebo-efgartigimod PH20 SC | Participants who received placebo PH20 SC in antecedent study ARGX-113-1904. | 4 | 48 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 60 weeks
Source ClinicalTrials.gov
Trial
- Title
- A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus)
- NCT number
- NCT04598477
- Phases
- PHASE3
- Conditions
- Pemphigus Vulgaris, Pemphigus Foliaceus
- Interventions
- efgartigimod PH20 SC, prednisone
- Lead sponsor
- argenx
- Results first posted
- 2025-03-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04598477?tab=results
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.govNone 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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