Comparison · NCT00400400-sae
Enteric-coated Mycophenolate Sodium vs 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
Cite this record
ConductScience Library. Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil: serious adverse events. Trial comparisons, record NCT00400400-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00400400-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 | 0.0352 | 0.0171 | 0.0708 | wilson | |
| Risk in group 2 | 0.0558 | 0.0315 | 0.0972 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0207 | -0.0658 | 0.0225 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.63 | 0.249 | 1.59 | log | |
| Odds ratio, group 1 over group 2 | 0.616 | 0.234 | 1.62 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Enteric-coated Mycophenolate Sodium than on Mycophenolate Mofetil | 48.4 | 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 | Enteric-coated Mycophenolate Sodium | Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study. | 7 | 199 | EG000 |
| Group 2 | Mycophenolate Mofetil | Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study. | 11 | 197 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With Gastrointestinal (GI) Intolerance
- NCT number
- NCT00400400
- Phases
- PHASE4
- Conditions
- Renal Transplantation
- Interventions
- Enteric-coated mycophenolate sodium (EC-MPS), Mycophenolate mofetil, Placebo to mycophenolate sodium, Placebo to mycophenolate mofetil
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2011-08-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00400400?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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