Comparison · NCT03245840-sae
BOS-BOS vs PBO-BOS: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. BOS-BOS vs PBO-BOS: serious adverse events. Trial comparisons, record NCT03245840-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03245840-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 | 0.0909 | 0.0515 | 0.155 | wilson | |
| Risk in group 2 | 0 | 0 | 0.278 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0909 | -0.189 | 0.155 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm, for one more participant with a serious adverse event on BOS-BOS than on PBO-BOS | 11 | 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 | BOS-BOS | Participants who were randomized to BOS and PBO in Study SHP621-301 (NCT02605837) and to BOS in Study SHP621-302 (NCT02736409), were enrolled in Study SHP621-303 to receive 10 mL of BOS at a concentration of 0.2 mg/mL, twice daily, for up to 4 years 5 months. | 11 | 121 | EG000 |
| Group 2 | PBO-BOS | Participants who were randomized to and fully responded to BOS treatment in Study SHP621-301 (NCT02605837), were randomized to PBO in Study SHP621-302 (NCT02736409) and enrolled in Study SHP621-303 to receive 10 mL of BOS at a concentration of 0.2 mg/mL, twice daily, for up to 4 years 5 months. | 0 | 10 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From start of study drug administration up to EOS (Up to Month 53)
Source ClinicalTrials.gov
Trial
- Title
- Continuation Study With Budesonide Oral Suspension (BOS) for Adolescent and Adult Participants With Eosinophilic Esophagitis (EoE)
- NCT number
- NCT03245840
- Phases
- PHASE3
- Conditions
- Eosinophilic Esophagitis (EoE)
- Interventions
- Budesonide oral suspension
- Lead sponsor
- Shire
- Results first posted
- 2022-12-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03245840?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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