Comparison · NCT02489500-sae
Melphalan vs Melphalan + Bortezomib: 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. Melphalan vs Melphalan + Bortezomib: serious adverse events. Trial comparisons, record NCT02489500-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02489500-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 | 1 | 0.342 | 1 | wilson | |
| Risk in group 2 | 1 | 0.207 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.658 | 0.793 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 1 | 1 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
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 | Melphalan | Neupogen 16mcg/kg x 4 days Stem cell collection Drug: high dose melphalan 140 or 200 mg/m2 stem cell infusion~Melphalan: Conditioning Regimen:~Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Stem Cell Transplant: D 0~Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days~Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells~Stem cell infusion: infusion of previously collected autologous stem cells | 2 | 2 | EG000 |
| Group 2 | Melphalan + Bortezomib | Neupogen 16mcg/kg x 4 days Stem Cell collection drug: high-dose melphalan 140 or 200 mg/m2 drug: Bortezomib 1.0 mg/m2/dose x 4 doses stem cell infusion~Bortezomib: Conditioning Regimen:~Drug: Bortezomib: 1.0 mg/m2/dose D -6, D -3, D +1, D + 4 Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1~Melphalan: Conditioning Regimen:~Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Stem Cell Transplant: D 0~Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days~Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells~Stem cell infusion: infusion of previously collected autologous stem cells | 1 | 1 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 3 months
Source ClinicalTrials.gov
Trial
- Title
- Trial of High Dose Melphalan/Stem Cell Transplant With or Without Bortezomib
- NCT number
- NCT02489500
- Phases
- PHASE3
- Conditions
- AL Amyloidosis
- Interventions
- Bortezomib, Melphalan, Neupogen, Stem Cell Collection, Stem cell infusion
- Lead sponsor
- Boston Medical Center
- Results first posted
- 2018-08-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02489500?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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