Comparison · NCT01232556-sae
Inotuzumab Ozogamicin+Rituximab vs Rituximab+Gemcitabine or Rituximab+Bendamustine: 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. Inotuzumab Ozogamicin+Rituximab vs Rituximab+Gemcitabine or Rituximab+Bendamustine: serious adverse events. Trial comparisons, record NCT01232556-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01232556-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 | 0.372 | 0.302 | 0.448 | wilson | |
| Risk in group 2 | 0.377 | 0.307 | 0.453 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00529 | -0.108 | 0.0981 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.986 | 0.746 | 1.3 | log | |
| Odds ratio, group 1 over group 2 | 0.978 | 0.626 | 1.53 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Inotuzumab Ozogamicin+Rituximab than on Rituximab+Gemcitabine or Rituximab+Bendamustine | 189 | 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 | Inotuzumab Ozogamicin+Rituximab | Participants received rituximab 375 mg/m\^2 via IV infusion on Day 1 and inotuzumab ozogamicin 1.8 mg/m\^2 via IV infusion on Day 2 of each 28-day cycle for a maximum of 6 cycles. | 61 | 164 | EG000 |
| Group 2 | Rituximab+Gemcitabine or Rituximab+Bendamustine | Participants received either R-bendamustine (rituximab 375 mg/m\^2 via IV infusion on Day 1 and bendamustine 120 mg/m\^2 via IV infusion on Days 1 and 2 in 28-day cycles for a maximum of 6 cycles) or R-gemcitabine (rituximab 375 mg/m\^2 via IV infusion on Days 1, 8, 15 and 22 of Cycle 1 and on Day 1 for all other cycles, and gemcitabine 1000 mg/m\^2 via IV infusion on Days 1, 8 and 15 of each 28-day cycle for a maximum of 6 cycles). Choice of therapy was at the discretion of the investigator. | 63 | 167 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 22 weeks after the informed consent
Source ClinicalTrials.gov
Trial
- Title
- A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy
- NCT number
- NCT01232556
- Phases
- PHASE3
- Conditions
- Lymphoma, Non-Hodgkin
- Interventions
- Inotuzumab ozogamicin, Rituximab, rituximab + gemcitabine, rituximab +bendamustine
- Lead sponsor
- Pfizer
- Results first posted
- 2018-08-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01232556?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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