Comparison · NCT01445821-sae
Cyclophosphamide rATG/HSCT vs Cyclophosphamide rATG/Fludarabine/HSCT: 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. Cyclophosphamide rATG/HSCT vs Cyclophosphamide rATG/Fludarabine/HSCT: serious adverse events. Trial comparisons, record NCT01445821-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01445821-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 | 0.0909 | 0.0253 | 0.278 | wilson | |
| Risk in group 2 | 0.136 | 0.0475 | 0.333 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0455 | -0.253 | 0.162 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.667 | 0.123 | 3.61 | log | |
| Odds ratio, group 1 over group 2 | 0.633 | 0.0951 | 4.22 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Cyclophosphamide rATG/HSCT than on Cyclophosphamide rATG/Fludarabine/HSCT | 22 | 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 | Cyclophosphamide rATG/HSCT | Control arm will have the same conditioning regimen used in ASSIST study. The conditioning regimen will be 200 mg/kg of intravenous cyclophosphamide given in 4 equal fractions on days -5 through -2 with intravenous mesna. Rabbit antithymocyte globulin (rATG) (Thymoglobulin®) will be dosed at 0.5 mg/kg on day-5 and then 1.5 mg/kg from day-4 thru day -1. Methylprednisolone 1000 mg will be used infused intravenously before each dose of rATG. Peripheral blood stem cells (PBSC) will be infused intravenously on day 0. Filgrastim 5-10 mcg/kg will be started on day + 5 and continued until neutrophil engraftment.~Peripheral Blood Stem Cells: Mobilized leukapheresis product~Cyclophosphamide: An alkylating agent which causes prevention of cell division by forming adducts with DNA~Mesna: Medication used to decrease the risk of hemorrhagic cystitis prophylaxis~rATG: A predominantly lymphocyte-specific immunosuppressive agent which contains antibodies specific to the antigens commonl | 2 | 22 | EG000 |
| Group 2 | Cyclophosphamide rATG/Fludarabine/HSCT | Conditioning regimen will be 120 mg/kg of IV cyclophosphamide given in 2 equal fractions on days -3 and -2 with IV mesna. Rabbit antithymocyte globulin (rATG) (Thymoglobulin®) will be dosed at 0.5 mg/kg on day-5 then 1.5 mg/kg from day-4 thru day -1. Fludarabine 30 mg/m2 will be given IV on days -5, -4, and -3. Methylprednisolone 1000 mg will be used infused IV before each dose of rATG. PBSC will be infused IV on day 0. Filgrastim 5-10 mcg/kg will be started on day + 5 and cont. until neutrophil engraftment.~Peripheral Blood Stem Cells: Mobilized leukapheresis product~Cyclophosphamide: Alkylating agent~Mesna: Used to decrease the risk of hemorrhagic cystitis~rATG: Immunosuppressive agent which contains antibodies specific to the antigens~Methylprednisolone: Steroid~Filgrastim: Granulocyte-colony stimulating factor (G-CSF);glycoprotein that stimulates the bone marrow to produce granulocytes/stem cells~Fludarabine: Purine analog which inhibits DNA synthesis/repair | 3 | 22 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- during treatment at 6 months then yearly for up to 5 years post transplant
Source ClinicalTrials.gov
Trial
- Title
- Autologous Stem Cell Systemic Sclerosis Immune Suppression Trial
- NCT number
- NCT01445821
- Phases
- PHASE3
- Conditions
- Scleroderma, Systemic
- Interventions
- Peripheral Blood Stem Cells, Cyclophosphamide, Mesna, rATG, Methylprednisolone, Filgrastim, Fludarabine
- Lead sponsor
- Northwestern University
- Results first posted
- 2020-07-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01445821?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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