Comparison · NCT03959241-sae
PTCY/Tacrolimus/MMF vs Tacrolimus/Methotrexate: 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. PTCY/Tacrolimus/MMF vs Tacrolimus/Methotrexate: serious adverse events. Trial comparisons, record NCT03959241-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03959241-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 | 0.0337 | 0.0164 | 0.0678 | wilson | |
| Risk in group 2 | 0.066 | 0.0397 | 0.108 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0324 | -0.0776 | 0.0107 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.51 | 0.21 | 1.24 | log | |
| Odds ratio, group 1 over group 2 | 0.493 | 0.195 | 1.25 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on PTCY/Tacrolimus/MMF than on Tacrolimus/Methotrexate | 30.9 | 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 | PTCY/Tacrolimus/MMF | Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide: Mobilized PBSC grafts will be administered on Day 0 to all patients. Stem cells are administered through an indwelling central venous catheter.~Tacrolimus: Tacrolimus will be given per institutional practices, orally at a dose of 0.05-0.06 mg/kg/day or intravenously at a dose of 0.02-0.03 mg/kg/day starting Day +5. Serum levels of tacrolimus will be measured at Day +7 and then should be checked weekly thereafter, the dose adjusted accordingly to maintain a suggested level of 5-15 ng/mL. Tacrolimus taper can be initiated at 90 days post HCT if there is no evidence of active GVHD. The tapering rate will be based on institutional practices, patients should be off tacrolimus by Day 180 post HCT if there is no evidence of active GVHD.~Mycophenolate Mofetil: MMF will be given at a dose of 15 mg/kg/dose ter in die (TID) with the maximum total daily dose not to exceed 3 grams (1g TID, IV or PO). MMF prophylaxis will start Day +5 and discontinue after the last dose on Day +35, or may be continued if active GVHD is present.~Cyclophosphamide: Cyclophosphamide \[50 mg/kg ideal body weight (IBW); if actual body weight (ABW) \< IBW, use ABW\] will be given on Day +3 (between 60 and 72 hours after the start of the PBSC infusion) and on Day +4 post-transplant (approximately 24 hours after Day +3 cyclophosphamide). Cyclophosphamide will be given as an IV infusion over 1-2 hours. | 7 | 208 | EG000 |
| Group 2 | Tacrolimus/Methotrexate | Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Methotrexate: Mobilized PBSC grafts will be administered on Day 0 to all patients according to individual institutional guidelines after appropriate processing and quantification has been performed by the local laboratory. Stem cells are administered through an indwelling central venous catheter. If infusion occurs over two days, Day 0 is the first day the infusion is initiated.~Tacrolimus: Tacrolimus will be given per institutional practices, orally at a dose of 0.05-0.06 mg/kg/day or intravenously at a dose of 0.02-0.03 mg/kg/day starting on Day -3. Subsequent dosing will be based on blood levels per institutional guidelines with a suggested range of 5-15. If patients are on medications which alter the metabolism of tacrolimus, the initial starting dose and subsequent doses should be altered as per institutional practices. Tacrolimus taper can be initiated at a minimum of 90 days post HCT if there is no evidence of active GVHD. The rate of tapering will be done according institutional practices and patients should be off tacrolimus by Day 180 post HCT if there is no evidence of active GVHD.~Methotrexate: Methotrexate will be administered at the doses of 15 mg/m2 IV bolus on Day +1, and 10 mg/m2 IV bolus on Days +3, +6 and +11 after hematopoietic stem cell infusion. Methotrexate should be dose reduced, given with leucovorin rescue, or held for complications such as severe mucositis per institutional guidelines. | 14 | 212 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Deaths were assessed for all randomized participants. Adverse Events were assessed only for participants who underwent transplant throughout the study, an average of 1 year. More deaths are reported in the AE module than that in the secondary outcome section because deaths reported in the AE module were counted starting at randomization and throughout the study, whereas deaths reported in survival analysis were counted starting at transplant and throughout one-year post-transplant.
Source ClinicalTrials.gov
Trial
- Title
- TAC/MTX vs. TAC/MMF/PTCY for Prevention of Graft-versus-Host Disease and Microbiome and Immune Reconstitution Study (BMT CTN 1703/1801)
- NCT number
- NCT03959241
- Phases
- PHASE3
- Conditions
- Acute Leukemia, Chronic Myelogenous Leukemia (CML), Myelodysplasia, Lymphoma
- Interventions
Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Methotrexate, Tacrolimus, Methotrexate, Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide, Tacrolimus, Mycophenolate Mofetil, Cyclophosphamide
- Lead sponsor
- Medical College of Wisconsin
- Results first posted
- 2024-01-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03959241?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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