Comparison · NCT02481219-sae
Bowel Preparation Regimen -Control vs Bowel Preparation Regimen-Test: 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. Bowel Preparation Regimen -Control vs Bowel Preparation Regimen-Test: serious adverse events. Trial comparisons, record NCT02481219-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02481219-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 | 0 | 0.0611 | wilson | |
| Risk in group 2 | 0.0161 | 0.00285 | 0.0859 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0161 | -0.0859 | 0.0464 | 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, for one fewer participant with a serious adverse event on Bowel Preparation Regimen -Control than on Bowel Preparation Regimen-Test | 62 | 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 | Bowel Preparation Regimen -Control | Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Control~Senna tablets~PEG~Metoclopramide~Erythromycin~SUPREP oral sulfate solution~Bisacodyl | 0 | 59 | EG000 |
| Group 2 | Bowel Preparation Regimen-Test | Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Test~Senna tablets~PEG~Metoclopramide~Erythromycin~Bisacodyl~SUPREP oral sulfate solution with Gastrografin | 1 | 62 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse Events (AE) were collected starting from the screening visit and until 5-9 following the PillCam procedure day.
Source ClinicalTrials.gov
Trial
- Title
- Optimization of the Bowel Preparation Regimen for the PillCam® COLON 2 Capsule Endoscopy Procedure
- NCT number
- NCT02481219
- Phases
- NA
- Conditions
- Colorectal Cancer Screening
- Interventions
- PillCam® COLON 2 procedure-CONTROL, Senna tablets, PEG, Metoclopramide, Erythromycin, SUPREP oral sulfate solution, Bisacodyl, SUPREP oral sulfate solution with Gastrografin
- Lead sponsor
- Medtronic - MITG
- Results first posted
- 2016-07-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02481219?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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