Comparison · NCT03680092-sae
Cyclophosphamide and Abatacept vs Methotrexate and Tacrolimus: 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. Cyclophosphamide and Abatacept vs Methotrexate and Tacrolimus: serious adverse events. Trial comparisons, record NCT03680092-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03680092-sae
On this page
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 | 0.36 | 0.202 | 0.555 | wilson | |
| Risk in group 2 | 0.867 | 0.621 | 0.963 | wilson | |
| Risk difference, group 1 minus group 2 | -0.507 | -0.691 | -0.193 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.415 | 0.237 | 0.727 | log | |
| Odds ratio, group 1 over group 2 | 0.0865 | 0.0158 | 0.473 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Cyclophosphamide and Abatacept than on Methotrexate and Tacrolimus | 1.97 | 1.45 | 5.17 | from the risk difference interval |
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 | Cyclophosphamide and Abatacept | The GVHD prophylaxis regimen on the experimental arm will consist of high dose Cyclophosphamide on Days +3 and +4 followed by abatacept for 6 months. Abatacept at a dose of 10mg/kg will be administered on days +5, +14 and +28, +56, +84, +112, +140, +168~Cyclophosphamide: Day 3 and day 4 following transplant. Dosing will be based on patients' actual weight up to 120% of ideal body weight, above which it will be based on adjusted ideal body weight (ideal weight plus 50% of the difference between ideal and actual weight).~abatacept: Abatacept at a dose of 10mg/kg will be administered on days +5, +14 and +28, +56, +84, +112, +140, +168 | 9 | 25 | EG000 |
| Group 2 | Methotrexate and Tacrolimus | The GVHD prophylaxis regimen on the standard of care arm will consist of methotrexate on Days +1,+3, +6 and +11 and tacrolimus~Methotrexate: standard of care Methotrexate 5 mg/m2 on Days 1, 3, 6 and 11~Tacrolimus: Tacrolimus per institutional guidelines | 13 | 15 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 1 year
Source ClinicalTrials.gov
Trial
- Title
- Comparing Cyclophosphamide and Abatacept With Standard of Care Treatment Following Stem Cell Transplantation
- NCT number
- NCT03680092
- Phases
- PHASE2
- Conditions
- GVHD, Hematologic Neoplasms
- Interventions
- Cyclophosphamide, abatacept, Methotrexate, Tacrolimus
- Lead sponsor
- Dimitrios Tzachanis, MD PhD
- Results first posted
- 2024-10-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03680092?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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GET https://conductscience.org/api/comparisons/v1/NCT03680092-sae