Comparison · NCT02370693-sae
Bortezomib Plus Mycophenolate Mofetil vs Placebo Plus Mycophenolate Mofetil: 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. Bortezomib Plus Mycophenolate Mofetil vs Placebo Plus Mycophenolate Mofetil: serious adverse events. Trial comparisons, record NCT02370693-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02370693-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 | 0.333 | 0.0615 | 0.792 | wilson | |
| Risk in group 2 | 0.25 | 0.0456 | 0.699 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0833 | -0.442 | 0.586 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.33 | 0.129 | 13.7 | log | |
| Odds ratio, group 1 over group 2 | 1.5 | 0.0554 | 40.6 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Bortezomib Plus Mycophenolate Mofetil than on Placebo Plus Mycophenolate Mofetil | 12 | 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 | Bortezomib Plus Mycophenolate Mofetil | Bortezomib 1.3 mg/m² subcutaneously (or IV push if unable to tolerate subcutaneous injection) once per week for the first two weeks per month and mycophenolate mofetil 1.5 g orally twice daily for 24 weeks~Bortezomib: Bortezomib 1.3 mg/m² subcutaneously (or IV push if unable to tolerate subcutaneous injection) once per week for the first two weeks per month for 24 weeks~Mycophenolate mofetil: Mycophenolate mofetil 1.5 g twice a day orally for 24 weeks | 1 | 3 | EG000 |
| Group 2 | Placebo Plus Mycophenolate Mofetil | Placebo (normal saline) 1.3 mg/m² subcutaneously (or IV push if unable to tolerate subcutaneous injection) once per week for the first two weeks per month and mycophenolate mofetil 1.5 g orally twice daily for 24 weeks~Placebo: Placebo (normal saline) 1.3 mg/m² subcutaneously (or IV push if unable to tolerate subcutaneous injection) once per week for the first two weeks per month for 24 weeks~Mycophenolate mofetil: Mycophenolate mofetil 1.5 g twice a day orally for 24 weeks | 1 | 4 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- First dosing day to last study visit day: Mean duration 8 months.
Source ClinicalTrials.gov
Trial
- Title
- Comparing and Combining Bortezomib and Mycophenolate in SSc Pulmonary Fibrosis
- NCT number
- NCT02370693
- Phases
- PHASE2
- Conditions
- Lung Diseases, Interstitial, Systemic Sclerosis, Scleroderma
- Interventions
- Bortezomib, Placebo, Mycophenolate mofetil
- Lead sponsor
- Northwestern University
- Results first posted
- 2021-08-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02370693?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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