Comparison · NCT04043455-480d5ad3
LTE Period: Olorinab 25 mg vs LTE Period: Olorinab 50 mg: LTE Study: Number of Participants With Clinically Significant Abnormal Vital Signs
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. LTE Period: Olorinab 25 mg vs LTE Period: Olorinab 50 mg: LTE Study: Number of Participants With Clinically Significant Abnormal Vital Signs. Trial comparisons, record NCT04043455-480d5ad3. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04043455-480d5ad3
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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 | 0.0676 | wilson | |
| Risk in group 2 | 0 | 0 | 0.07 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.07 | 0.0676 | 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 | LTE Period: Olorinab 25 mg | Participants who successfully completed 12 weeks of treatment in the Main Study received Olorinab 25 mg TID for 52 weeks. During the Main study, participants in this arm had received Olorinab 25 mg or had received Olorinab 10 mg or placebo and were then re-randomized to the 25 mg dose for the LTE Period. | 0 | 53 | OG000 |
| Group 2 | LTE Period: Olorinab 50 mg | Participants who successfully completed 12 weeks of treatment in the Main Study received Olorinab 50 mg TID for 52 weeks. During the Main study, participants in this arm had received Olorinab 50 mg or had received Olorinab 10 mg or placebo and were then re-randomized to the 50 mg dose for the LTE Period. | 0 | 51 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- LTE Study: Number of Participants With Clinically Significant Abnormal Vital Signs
- Description
Parameters assessed for vital signs included blood pressure (systolic and diastolic blood pressure), HR, body temperature, and respiratory rate. The investigator was responsible for reviewing vital signs for clinically significant abnormalities.
- Time frame
- Baseline to Week 54 (of LTE)
- Population
- LTE Safety Set.
Source ClinicalTrials.gov
Trial
- Title
- Olorinab in Irritable Bowel Syndrome With Predominant Constipation (IBS-C) and Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D)
- NCT number
- NCT04043455
- Phases
- PHASE2
- Conditions
- Irritable Bowel Syndrome
- Interventions
- Olorinab, Olorinab, Olorinab, Placebo, Olorinab, Olorinab
- Lead sponsor
- Arena Pharmaceuticals
- Results first posted
- 2022-10-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04043455?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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