Comparison · NCT03245840-447d32a2
BOS-BOS vs PBO-BOS: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
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. BOS-BOS vs PBO-BOS: Number of Participants With Clinically Significant Change From Baseline in Vital Signs. Trial comparisons, record NCT03245840-447d32a2. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03245840-447d32a2
On this page
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 | 0 | 0.0308 | wilson | |
| Risk in group 2 | 0 | 0 | 0.278 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.278 | 0.0308 | 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 treat | from the risk difference interval | the two groups' risks are equal |
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. | 0 | 121 | OG000 |
| 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 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Clinically Significant Change From Baseline in Vital Signs
- Description
Participants were assessed by investigator for any clinically significant changes in vital parameters like temperature, systolic and diastolic blood pressure, pulse, respiratory rate, BMI, and weight. Vital signs were assessed after the participant had been in a supine position for at least 5 minutes immediately prior to the assessment. The criteria for clinically significant change was as per the investigators discretion.
- Time frame
- From start of study drug administration up to EOS (Up to Month 53)
- Population
- The safety set consisted of all participants who received at least 1 dose of BOS.
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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT03245840-447d32a2