Comparison · NCT01920477-sae
Ofatumumab SC 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
Cite this record
ConductScience Library. Ofatumumab SC vs Placebo: serious adverse events. Trial comparisons, record NCT01920477-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01920477-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 | 0.0588 | 0.0105 | 0.27 | wilson | |
| Risk in group 2 | 0.0556 | 0.00988 | 0.258 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00327 | -0.204 | 0.219 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.06 | 0.0718 | 15.6 | log | |
| Odds ratio, group 1 over group 2 | 1.06 | 0.0612 | 18.5 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Ofatumumab SC than on Placebo | 306 | 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 | Ofatumumab SC | Subject will receive subcutaneous administration of ofatumumab 20 mg once every 4 weeks through Week 56, with an additional 20 mg dose (that is 40mg total) at both Week 0 and Week 4. | 1 | 17 | EG000 |
| Group 2 | Placebo | Subject will receive subcutaneous administration of matching placebo of ofatumumab once every 4 weeks through Week 56, with an additional dose at both Week 0 and Week 4. | 1 | 18 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Ofatumumab in Treatment of Pemphigus Vulgaris
- NCT number
- NCT01920477
- Phases
- PHASE3
- Conditions
- Pemphigus Vulgaris
- Interventions
- Ofatumumab, Placebo
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2019-06-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01920477?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.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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