Comparison · NCT04598451-sae
Efgartigimod PH20 SC vs Placebo 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 PH20 SC vs Placebo PH20 SC: serious adverse events. Trial comparisons, record NCT04598451-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04598451-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 | 0.122 | 0.0789 | 0.185 | wilson | |
| Risk in group 2 | 0.133 | 0.0741 | 0.228 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0109 | -0.115 | 0.0755 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.918 | 0.446 | 1.89 | log | |
| Odds ratio, group 1 over group 2 | 0.907 | 0.396 | 2.08 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Efgartigimod PH20 SC than on Placebo PH20 SC | 91.9 | 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 PH20 SC | Patients randomized to receive weekly administrations of efgartigimod PH20 until CRmin (complete remission on minimal prednisone therapy) or end of treatment period or early roll-over to the open-label extension study ARGX-113-1905. All participants received concurrent oral prednisone (or equivalent) at a starting dosage of 0.5 mg/kg/day. The dose of prednisone was adjusted according to recommendations as per protocol | 18 | 147 | EG000 |
| Group 2 | Placebo PH20 SC | Patients randomized to receive weekly administrations of placebo PH20 SC until CRmin (complete remission on minimal prednisone therapy) or end of treatment period or early roll-over to the open-label extension study ARGX-113-1905. All participants received concurrent oral prednisone (or equivalent) at a starting dosage of 0.5 mg/kg/day. The dose of prednisone was adjusted according to recommendations as per protocol | 10 | 75 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 38 weeks
Source ClinicalTrials.gov
Trial
- Title
- A Study to Assess the Efficacy and Safety of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus)
- NCT number
- NCT04598451
- Phases
- PHASE3
- Conditions
- Pemphigus Vulgaris, Pemphigus Foliaceus
- Interventions
- efgartigimod PH20 SC, Placebo, prednisone
- Lead sponsor
- argenx
- Results first posted
- 2024-10-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04598451?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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