Comparison · NCT01205503-sae
Mesna vs Saline: 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. Mesna vs Saline: serious adverse events. Trial comparisons, record NCT01205503-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01205503-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 | 0.0313 | 0.00554 | 0.157 | wilson | |
| Risk in group 2 | 0.0313 | 0.00554 | 0.157 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.129 | 0.129 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.0653 | 15.3 | log | |
| Odds ratio, group 1 over group 2 | 1 | 0.0598 | 16.7 | log | |
| 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 | Mesna | Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during cycle assigned by randomization~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 2, day 1. Infused over 15 minutes | 1 | 32 | EG000 |
| Group 2 | Saline | Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during cycle assigned by randomization~Infused over 15 minutes | 1 | 32 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
Source ClinicalTrials.gov
Trial
- Title
- Trial of Mesna to Prevent Doxorubicin-induced Plasma Protein Oxidation and Tumor Necrosis Factor Alpha (TNF-α) Release
- NCT number
- NCT01205503
- Phases
- PHASE2
- Conditions
- Breast Cancer, Non-Hodgkin's Lymphoma
- Interventions
- Mesna, Saline, Doxorubicin, Cyclophosphamide
- Lead sponsor
- Mara Chambers
- Results first posted
- 2016-02-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01205503?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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