Comparison · NCT00380250-sae
Lubiprostone Study Period I vs Placebo Study Period I: 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. Lubiprostone Study Period I vs Placebo Study Period I: serious adverse events. Trial comparisons, record NCT00380250-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00380250-sae
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 | 0.0126 | 0.0054 | 0.0292 | wilson | |
| Risk in group 2 | 0.0104 | 0.00286 | 0.0372 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00221 | -0.0255 | 0.0204 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.21 | 0.237 | 6.19 | log | |
| Odds ratio, group 1 over group 2 | 1.21 | 0.234 | 6.32 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Lubiprostone Study Period I than on Placebo Study Period I | 453 | 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 | Lubiprostone Study Period I | 8 mcg capsules twice daily (BID) | 5 | 396 | EG000 |
| Group 2 | Placebo Study Period I | Matching placebo capsules twice daily (BID) | 2 | 192 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 12 weeks
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Lubiprostone in Patients With Irritable Bowel Syndrome With Constipation
- NCT number
- NCT00380250
- Phases
- PHASE3
- Conditions
- Irritable Bowel Syndrome With Constipation
- Interventions
- Lubiprostone, Placebo
- Lead sponsor
- Sucampo Pharma Americas, LLC
- Results first posted
- 2014-02-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00380250?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/NCT00380250-sae