Comparison · NCT00883129-sae
Mycophenolate Arm vs Cyclophosphamide Arm: 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. Mycophenolate Arm vs Cyclophosphamide Arm: serious adverse events. Trial comparisons, record NCT00883129-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00883129-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 | 0.391 | 0.285 | 0.509 | wilson | |
| Risk in group 2 | 0.301 | 0.208 | 0.414 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0899 | -0.0653 | 0.24 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.3 | 0.822 | 2.05 | log | |
| Odds ratio, group 1 over group 2 | 1.49 | 0.743 | 2.99 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Mycophenolate Arm than on Cyclophosphamide Arm | 11.1 | 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 | Mycophenolate Arm | Participants treated with oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated | 27 | 69 | EG000 |
| Group 2 | Cyclophosphamide Arm | Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years. | 22 | 73 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Randomization to withdrawal from taking study drug or completion of the 24 month treatment protocol.
Source ClinicalTrials.gov
Trial
- Title
- Comparison of Therapeutic Regimens for Scleroderma Interstitial Lung Disease (The Scleroderma Lung Study II)
- NCT number
- NCT00883129
- Phases
- PHASE2
- Conditions
- Scleroderma, Interstitial Lung Disease
- Interventions
- Mycophenolate mofetil, Cyclophosphamide, Placebo
- Lead sponsor
- Michael Roth
- Results first posted
- 2017-02-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00883129?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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