Comparison · NCT00520130-sae
A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm vs B - Cyclosporine (AC) Arm: 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. A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm vs B - Cyclosporine (AC) Arm: serious adverse events. Trial comparisons, record NCT00520130-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00520130-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 | 0.818 | 0.68 | 0.905 | wilson | |
| Risk in group 2 | 0.911 | 0.793 | 0.965 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0929 | -0.241 | 0.0539 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.898 | 0.76 | 1.06 | log | |
| Odds ratio, group 1 over group 2 | 0.439 | 0.122 | 1.58 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm than on B - Cyclosporine (AC) Arm | 10.8 | 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 | A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | TMS Arm~Rituximab: Rituximab: 375 mg/m2 IV, day 1 for patients with CD20-positive disease~Allogenic stem cell transplant (ASCT): Allogenic stem cell transplant~Conditioning Chemotherapy: Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3 Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3 Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3~TMS: Tacrolimus: 0.02 mg/kg , start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated Methotrexate: 5 mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.~FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5 Cytarabine: 2,000 mg/m2 IV over 4 hours,on Days 1, 2, 3, 4, 5 Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy | 36 | 44 | EG000 |
| Group 2 | B - Cyclosporine (AC) Arm | AC Arm~Rituximab: Rituximab: 375 mg/m2 IV, day 1 for patients with CD20-positive disease~Cyclosporine: Cyclosporine: IV over 2 hours or orally every 12 hours on days -1 to 100, followed by a taper if GVHD does not develop.~Allogenic stem cell transplant (ASCT): Allogenic stem cell transplant~Conditioning Chemotherapy: Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3 Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3 Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3~FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5 Cytarabine: 2,000 mg/m2 IV over 4 hours,on Days 1, 2, 3, 4, 5 Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy EPOCH-F: Fludarabine:25 mg/m2 per day IV infusion over 30 minutes, daily on days 1-4 Etoposide :50 mg/m2 per day continuous IV infusion over 24 hours on days 1-4 Doxorubicin:10 mg/m2/d | 41 | 45 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 103 months and 22 days
Source ClinicalTrials.gov
Trial
- Title
- Chemotherapy and Unrelated Donor Stem Cell Transplantation for Patients With Cancers of the Blood and Immune System
- NCT number
- NCT00520130
- Phases
- PHASE1, PHASE2
- Conditions
- Myelodysplastic Syndrome, Hodgkin's Lymphoma, Non-Hodgkin's Disease, Acute Leukemia, Multiple Myeloma
- Interventions
- Rituximab, Cyclosporine, Allogenic stem cell transplant (ASCT), Conditioning Chemotherapy, TMS, FLAG, EPOCH-F, Alemtuzumab
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2017-08-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00520130?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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