Comparison · NCT01200758-sae
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) vs Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP): 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. Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) vs Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP): serious adverse events. Trial comparisons, record NCT01200758-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01200758-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 | 0.362 | 0.3 | 0.429 | wilson | |
| Risk in group 2 | 0.376 | 0.311 | 0.445 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0137 | -0.107 | 0.0793 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.963 | 0.747 | 1.24 | log | |
| Odds ratio, group 1 over group 2 | 0.943 | 0.63 | 1.41 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) than on Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 72.8 | 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 | Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | Eight cycles of rituximab IV infusion (375 mg/m\^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m\^2) once every 8 weeks for 24 months. | 76 | 210 | EG000 |
| Group 2 | Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | First cycle of rituximab IV infusion (375 mg/m\^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months. | 74 | 197 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline up to data cutoff date of 31 Oct 2017 (up to 6 years)
Source ClinicalTrials.gov
Trial
- Title
- A Study of Rituximab (MabThera) Subcutaneous (SC) Versus Rituximab (MabThera) Intravenous in Participannts With Follicular Non-Hodgkin's Lymphoma
- NCT number
- NCT01200758
- Phases
- PHASE3
- Conditions
- Non-Hodgkin's Lymphoma
- Interventions
- Rituximab SC, Rituximab IV, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone/Prednisolone
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2015-08-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01200758?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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