Comparison · NCT02605837-sae
Oral Budesonide Suspension (OBS) 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 Budesonide Suspension (OBS) vs Placebo: serious adverse events. Trial comparisons, record NCT02605837-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02605837-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 | 0.00939 | 0.00258 | 0.0336 | wilson | |
| Risk in group 2 | 0.00952 | 0.00168 | 0.052 | wilson | |
| Risk difference, group 1 minus group 2 | -0.000134 | -0.0431 | 0.0253 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.986 | 0.0904 | 10.7 | log | |
| Odds ratio, group 1 over group 2 | 0.986 | 0.0884 | 11 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Oral Budesonide Suspension (OBS) than on Placebo | 7,450 | 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 | Oral Budesonide Suspension (OBS) | Post placebo lead in phase (4 weeks) participants received OBS 10 ml (2 mg) twice daily up to 12 weeks. | 2 | 213 | EG001 |
| Group 2 | Placebo | Participants received oral dose of 10 milliliter (ml) placebo matched with the Oral Budesonide Suspension (OBS) twice daily up to 16 weeks. | 1 | 105 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From start of study drug administration up to follow-up (Week 20)
Source ClinicalTrials.gov
Trial
- Title
- A Study in Adolescents and Adults With Eosinophilic Esophagitis (EoE) Measuring Histologic Response and Determine if Reduction in Dysphagia is Achieved
- NCT number
- NCT02605837
- Phases
- PHASE3
- Conditions
- Eosinophilic Esophagitis (EoE)
- Interventions
- Oral Budesonide Suspension (OBS), Placebo
- Lead sponsor
- Shire
- Results first posted
- 2020-03-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02605837?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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