Comparison · NCT01919697-739894d5
Plecanatide 3 mg vs Plecantide 6 mg: Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE)
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. Plecanatide 3 mg vs Plecantide 6 mg: Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE). Trial comparisons, record NCT01919697-739894d5. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01919697-739894d5
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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 | 0.549 | 0.484 | 0.613 | wilson | |
| Risk in group 2 | 0.289 | 0.27 | 0.308 | wilson | |
| Risk difference, group 1 minus group 2 | 0.26 | 0.192 | 0.327 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.9 | 1.66 | 2.18 | log | |
| Odds ratio, group 1 over group 2 | 3 | 2.27 | 3.96 | log | |
| Number needed to treat, for one more participant with the outcome on Plecanatide 3 mg than on Plecantide 6 mg | 3.84 | 3.06 | 5.21 | from the risk difference interval |
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 | Plecanatide 3 mg | Plecanatide 3 mg, one tablet by mouth daily for 72 weeks | 123 | 224 | OG000 |
| Group 2 | Plecantide 6 mg | Plecanatide 6 mg, one tablet by mouth daily for 72 weeks | 620 | 2,146 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE)
- Description
All clinically significant findings upon Physical Examinations of the Safety Population during the treatment period were reported as TEAEs. Safety was evaluated based on number of patients who experienced at least one TEAE.
- Time frame
- From first dose up to 72 weeks
- Population
- The Safety Population consisted of all enrolled patients who had received at least one dose of the study drug.
Source ClinicalTrials.gov
Trial
- Title
- Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)
- NCT number
- NCT01919697
- Phases
- PHASE3
- Conditions
- Chronic Idiopathic Constipation
- Interventions
- Plecanatide
- Lead sponsor
- Bausch Health Americas, Inc.
- Results first posted
- 2019-07-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01919697?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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