Comparison · NCT02385110-sae
Group 1: Alemtuzumab + Etoposide + Dexamethasone vs Group 2: Etoposide + Dexamethasone + Tocilizumab: 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. Group 1: Alemtuzumab + Etoposide + Dexamethasone vs Group 2: Etoposide + Dexamethasone + Tocilizumab: serious adverse events. Trial comparisons, record NCT02385110-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02385110-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 | 0.5 | 0.0945 | 0.905 | wilson | |
| Risk in group 2 | 0.563 | 0.332 | 0.769 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0625 | -0.518 | 0.404 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.889 | 0.208 | 3.8 | log | |
| Odds ratio, group 1 over group 2 | 0.778 | 0.041 | 14.7 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Group 1: Alemtuzumab + Etoposide + Dexamethasone than on Group 2: Etoposide + Dexamethasone + Tocilizumab | 16 | 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 | Group 1: Alemtuzumab + Etoposide + Dexamethasone | Induction Phase: Participants receive Alemtuzumab daily on Days 1 - 4 with weekly Etoposide, and Dexamethasone by vein on Days 1-7 during the 8-weeks. Participants with central nervous system involvement receive intrathecal methotrexate 12 mg once a week for 5 weeks.~Dexamethasone by vein on Days 1-7 of the induction phase.~Maintenance Phase: Starts Post Induction Phase for16 weeks. Participants receive Alemtuzumab once every 4 weeks and Dexamethasone three times per week. Participants who have evidence of budding relapse may revert back to receiving Etoposide.~If participant responds to study drugs, they will receive a phone call by study staff every 3 - 6 months for up to 5 years after completion of treatment. Each call will last about 5-10 minutes. | 1 | 2 | EG000 |
| Group 2 | Group 2: Etoposide + Dexamethasone + Tocilizumab | Induction Phase: Participants receive Tocilizumab by vein over 60 minutes on Day 1 or Day 2. Participants receive Alemtuzumab daily on Days 1 - 4 with weekly Etoposide and Dexamethasone by vein on Days 1-7 during the 8-weeks. Participants with central nervous system involvement receive intrathecal methotrexate 12 mg once a week for 5 weeks.~Maintenance Phase: Starts Post Induction Phase and will last 16 weeks. Tocilizumab not given in the Maintenance Phase. Dexamethasone three times per week.~If participant responds to study drugs, they will receive a phone call by study staff every 3 - 6 months for up to 5 years after completion of treatment. Each call will last about 5-10 minutes | 9 | 16 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 7 years, 3 months
Source ClinicalTrials.gov
Trial
- Title
- Alemtuzumab or Tocilizumab in Combination With Etoposide and Dexamethasone for the Treatment of Adult Patients With Hemophagocytic Lymphohistiocytosis
- NCT number
- NCT02385110
- Phases
- PHASE2
- Conditions
- Leukemia
- Interventions
- Alemtuzumab, Etoposide, Dexamethasone, Methotrexate, Phone Call, Tocilizumab
- Lead sponsor
- M.D. Anderson Cancer Center
- Results first posted
- 2024-01-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02385110?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.
For software
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