Comparison · NCT00073021-sae
Asacol 2.4 g/Day vs Asacol 4.8 g/Day: 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. Asacol 2.4 g/Day vs Asacol 4.8 g/Day: serious adverse events. Trial comparisons, record NCT00073021-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00073021-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 | 0.0288 | 0.0112 | 0.0717 | wilson | |
| Risk in group 2 | 0.00775 | 0.00137 | 0.0426 | wilson | |
| Risk difference, group 1 minus group 2 | 0.021 | -0.018 | 0.0644 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.71 | 0.42 | 32.8 | log | |
| Odds ratio, group 1 over group 2 | 3.79 | 0.418 | 34.4 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Asacol 2.4 g/Day than on Asacol 4.8 g/Day | 47.6 | 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 | Asacol 2.4 g/Day | Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening). | 4 | 139 | EG000 |
| Group 2 | Asacol 4.8 g/Day | Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening). | 1 | 129 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 6 week treatment period for each subject, February 28, 2001 thru April 15 2004
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis
- NCT number
- NCT00073021
- Phases
- PHASE3
- Conditions
- Ulcerative Colitis
- Interventions
- Asacol 800 mg (mesalamine), Asacol 400 mg (mesalamine)
- Lead sponsor
- Warner Chilcott
- Results first posted
- 2011-07-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00073021?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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