Comparison · NCT00116207-sae
ORAL ANTIOXIDANT 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. ORAL ANTIOXIDANT vs Placebo: serious adverse events. Trial comparisons, record NCT00116207-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00116207-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 | 0.0455 | 0.00807 | 0.218 | wilson | |
| Risk in group 2 | 0.0455 | 0.00807 | 0.218 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.177 | 0.177 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.0667 | 15 | log | |
| Odds ratio, group 1 over group 2 | 1 | 0.0586 | 17.1 | 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 | ORAL ANTIOXIDANT | Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo | 1 | 22 | EG000 |
| Group 2 | Placebo | Placebo administered twice daily.~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo | 1 | 22 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- At each subject visit adverse events were reviewed with the subject.
Source ClinicalTrials.gov
Trial
- Title
- An Intervention Trial for Cardiac Neuropathy in Type 1 Diabetes
- NCT number
- NCT00116207
- Phases
- PHASE3
- Conditions
- Diabetic Autonomic Neuropathy
- Interventions
- ORAL ANTIOXIDANT
- Lead sponsor
- University of Michigan
- Results first posted
- 2016-01-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00116207?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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