Comparison · NCT00004563-sae
Cylophosphamide vs Placebo: 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. Cylophosphamide vs Placebo: serious adverse events. Trial comparisons, record NCT00004563-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00004563-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 | 0.0633 | 0.0273 | 0.14 | wilson | |
| Risk in group 2 | 0.0633 | 0.0273 | 0.14 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0845 | 0.0845 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.301 | 3.32 | log | |
| Odds ratio, group 1 over group 2 | 1 | 0.278 | 3.6 | log | |
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Cylophosphamide | Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram.~Cyclophosphamide: Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram. | 5 | 79 | EG000 |
| Group 2 | Placebo | Matching gel caps at a dose of 25 mg~Placebo: Matching gelcaps 25 mgs | 5 | 79 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 12 months
Source ClinicalTrials.gov
Trial
- Title
- Scleroderma Lung Disease
- NCT number
- NCT00004563
- Phases
- PHASE3
- Conditions
- Lung Diseases, Pulmonary Fibrosis, Systemic Scleroderma, Scleroderma, Systemic
- Interventions
- Cyclophosphamide, Placebo
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Results first posted
- 2015-03-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00004563?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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