Comparison · NCT01014208-sae
Rituximab + Chemotherapy vs Ofatumumab + Chemotherapy: serious adverse events
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. Rituximab + Chemotherapy vs Ofatumumab + Chemotherapy: serious adverse events. Trial comparisons, record NCT01014208-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01014208-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 | 0.516 | 0.45 | 0.58 | wilson | |
| Risk in group 2 | 0.532 | 0.466 | 0.596 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0158 | -0.108 | 0.0764 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.97 | 0.813 | 1.16 | log | |
| Odds ratio, group 1 over group 2 | 0.938 | 0.647 | 1.36 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Rituximab + Chemotherapy than on Ofatumumab + Chemotherapy | 63.1 | 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 | Rituximab + Chemotherapy | Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin \[DHAP\]) or the DVD regimen (DHAP-VIM \[etoposide, ifosfamide, mesna, methotrexate\]-DHAP). Rituximab (375 milligrams per meters squared \[mg/m\^2\]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m\^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m\^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m\^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m\^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram \[kg\] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m\^2 IV on Days 1 and 5). | 115 | 223 | EG000 |
| Group 2 | Ofatumumab + Chemotherapy | Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter \[mL\]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/\[m\^2\]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m\^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m\^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m\^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m\^2 IV on Days 1 and 5). | 118 | 222 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events (AEs) were collected up to 60 days after the last dose of study treatment, or the commencement of high-dose chemotherapy, or anti-cancer therapy, whichever occurred first (up to approximately 16 study weeks).
Source ClinicalTrials.gov
Trial
- Title
- Ofatumumab Versus Rituximab Salvage Chemoimmunotherapy Followed by Autologous Stem Cell Transplant in Relapsed or Refractory Diffuse Large B Cell Lymphoma
- NCT number
- NCT01014208
- Phases
- PHASE3
- Conditions
- Lymphoma, Large-Cell, Diffuse
- Interventions
- OFATUMUMAB + DHAP, RITUXIMAB + DHAP
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2014-10-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01014208?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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