Comparison · NCT01750697-sae
Remission Induction Phase: Rituximab vs Overall Follow-up Phase: Rituximab: 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. Remission Induction Phase: Rituximab vs Overall Follow-up Phase: Rituximab: serious adverse events. Trial comparisons, record NCT01750697-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01750697-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 | 0.28 | 0.143 | 0.476 | wilson | |
| Risk in group 2 | 0.48 | 0.3 | 0.665 | wilson | |
| Risk difference, group 1 minus group 2 | -0.2 | -0.43 | 0.0657 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.583 | 0.276 | 1.23 | log | |
| Odds ratio, group 1 over group 2 | 0.421 | 0.13 | 1.36 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Remission Induction Phase: Rituximab than on Overall Follow-up Phase: Rituximab | 5 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Remission Induction Phase: Rituximab | Participants received rituximab as an IV infusion of 375 mg/m\^2 once a week on Days 1, 8, 15 and 22 during Remission Induction Phase (Day 1 (baseline) to Month 6) | 7 | 25 | EG000 |
| Group 2 | Overall Follow-up Phase: Rituximab | Participants who received rituximab during the remission induction phase were followed for a minimum of 18 months during the follow-up phase and could receive additional rituximab or other treatments for GPA/MPA (Day 1 (baseline) up to 4.5 yrs) | 12 | 25 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to approximately 5 years
Source ClinicalTrials.gov
Trial
- Title
- A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis
- NCT number
- NCT01750697
- Phases
- PHASE2
- Conditions
- Granulomatosis With Polyangiitis
- Interventions
- Rituximab
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2019-06-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01750697?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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