Comparison · NCT00604383-sae
Ruboxistaurin 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. Ruboxistaurin vs Placebo: serious adverse events. Trial comparisons, record NCT00604383-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00604383-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 | 0.42 | 0.369 | 0.473 | wilson | |
| Risk in group 2 | 0.462 | 0.409 | 0.515 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0415 | -0.115 | 0.0327 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.91 | 0.769 | 1.08 | log | |
| Odds ratio, group 1 over group 2 | 0.845 | 0.625 | 1.14 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Ruboxistaurin than on Placebo | 24.1 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Ruboxistaurin | One 32-mg tablet, orally, daily, for up to 42 months | 145 | 345 | EG000 |
| Group 2 | Placebo | 1 tablet, orally, daily, for up to 42 months | 157 | 340 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Protein Kinase C (PKC) Inhibitor-Diabetic Retinopathy Phase 3 Study
- NCT number
- NCT00604383
- Phases
- PHASE3
- Conditions
- Diabetic Retinopathy
- Interventions
- ruboxistaurin, placebo
- Lead sponsor
- Chromaderm, Inc.
- Results first posted
- 2016-01-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00604383?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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