Comparison · NCT00477971-sae
Low-Dose Melphalan vs High-Dose Melphalan + Autologous HSC: 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. Low-Dose Melphalan vs High-Dose Melphalan + Autologous HSC: serious adverse events. Trial comparisons, record NCT00477971-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00477971-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 | 0.176 | 0.0835 | 0.335 | wilson | |
| Risk in group 2 | 0.0545 | 0.0187 | 0.149 | wilson | |
| Risk difference, group 1 minus group 2 | 0.122 | -0.0103 | 0.285 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.24 | 0.866 | 12.1 | log | |
| Odds ratio, group 1 over group 2 | 3.71 | 0.863 | 16 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Low-Dose Melphalan than on High-Dose Melphalan + Autologous HSC | 8.2 | 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 | Low-Dose Melphalan | Patients receive low-dose melphalan 20 mg/m\^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.) | 6 | 34 | EG000 |
| Group 2 | High-Dose Melphalan + Autologous HSC | Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m\^2 IV for low risk or 200 mg/m\^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0. | 3 | 55 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Low-Dose Melphalan and Dexamethasone Compared With High-Dose Melphalan Followed By Autologous Stem Cell Transplant in Treating Patients With Primary Systemic Amyloidosis
- NCT number
- NCT00477971
- Phases
- PHASE3
- Conditions
- Multiple Myeloma and Plasma Cell Neoplasm
- Interventions
- filgrastim, dexamethasone, melphalan, autologous hematopoietic stem cell transplantation
- Lead sponsor
- Mayo Clinic
- Results first posted
- 2015-07-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00477971?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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