Comparison · NCT01724021-d8bc8c41
Arm A vs Arm B: Number of Participants With Treatment Emergent Adverse Events (AEs)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Arm A vs Arm B: Number of Participants With Treatment Emergent Adverse Events (AEs). Trial comparisons, record NCT01724021-d8bc8c41. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01724021-d8bc8c41
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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 | 0.949 | 0.921 | 0.967 | wilson | |
| Risk in group 2 | 0.94 | 0.911 | 0.96 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00841 | -0.0255 | 0.0426 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.01 | 0.974 | 1.04 | log | |
| Odds ratio, group 1 over group 2 | 1.17 | 0.625 | 2.21 | log | |
| Number needed to treat, for one more participant with the outcome on Arm A than on Arm B | 119 | 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 | Arm A | Participants in Arm A received one cycle of rituximab 375 mg/m\^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m\^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator. | 352 | 371 | OG000 |
| Group 2 | Arm B | Participants in Arm B received four cycles of rituximab 375 mg/m\^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator. | 347 | 369 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Treatment Emergent Adverse Events (AEs)
- Description
An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
- Time frame
- Randomization of first participant to clinical cutoff date (Up to 4 years)
- Population
The safety population included all participants who received at least one dose of rituximab. Number of participants analyzed specifies number of participants who were evaluable for the outcome measure.
Source ClinicalTrials.gov
Trial
- Title
A Study of Participant Preference With Subcutaneous Versus Intravenous MabThera/Rituxan in Participants With CD20+ Diffuse Large B-Cell Lymphoma or CD20+ Follicular Non-Hodgkin's Lymphoma Grades 1, 2 or 3a
- NCT number
- NCT01724021
- Phases
- PHASE3
- Conditions
- Diffuse Large B-Cell Lymphoma, Non-Hodgkin's Lymphoma
- Interventions
- Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP), Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP), Bendamustine, Rituximab, Rituximab, Rituximab, Rituximab
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2016-08-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01724021?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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