Comparison · NCT03896295-sae
Nipocalimab-Nipocalimab vs Placebo-Nipocalimab: 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. Nipocalimab-Nipocalimab vs Placebo-Nipocalimab: serious adverse events. Trial comparisons, record NCT03896295-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03896295-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 | 0.133 | 0.0531 | 0.297 | wilson | |
| Risk in group 2 | 0.143 | 0.0257 | 0.513 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00952 | -0.388 | 0.192 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.933 | 0.122 | 7.11 | log | |
| Odds ratio, group 1 over group 2 | 0.923 | 0.0868 | 9.82 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Nipocalimab-Nipocalimab than on Placebo-Nipocalimab | 105 | 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 | Nipocalimab-Nipocalimab | Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | 4 | 30 | EG001 |
| Group 2 | Placebo-Nipocalimab | Participants who received placebo in MOM-M281-004 (NCT03772587) study rolled-over and received intravenous (IV) infusion of nipocalimab (M281) 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W). | 1 | 7 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 257 days post-baseline (Day 1)
Source ClinicalTrials.gov
Trial
- Title
- An Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia Gravis
- NCT number
- NCT03896295
- Phases
- PHASE2
- Conditions
- Generalized Myasthenia Gravis
- Interventions
- M281
- Lead sponsor
- Momenta Pharmaceuticals, Inc.
- Results first posted
- 2022-02-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03896295?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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