Comparison · NCT03824587-sae
Tenapanor 30 mg BID vs Placebo: 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. Tenapanor 30 mg BID vs Placebo: serious adverse events. Trial comparisons, record NCT03824587-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03824587-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 | 0.0256 | 0.00876 | 0.0727 | wilson | |
| Risk in group 2 | 0.042 | 0.0181 | 0.0946 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0164 | -0.0716 | 0.0364 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.61 | 0.149 | 2.5 | log | |
| Odds ratio, group 1 over group 2 | 0.6 | 0.14 | 2.57 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Tenapanor 30 mg BID than on Placebo | 61.1 | 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 | Tenapanor 30 mg BID | During the Double-Blind Treatment Period, subjects will receive tenapanor starting at a dose of 30 mg bid (three 10 mg tablets each time).~Investigators may decrease or increase the dose of study medication based on s-P levels and/or gastrointestinal (GI) tolerability in 10 mg increments to a minimum of 10 mg bid or a maximum of 30 mg bid at any time during the Double-Blind Treatment Period.~Tenapanor: Active Drug~Phosphate Binder Agents: standard of care phosphate binder use at study entry was maintained throughout the entire study | 3 | 117 | EG000 |
| Group 2 | Placebo | same size, weight and appearance of experimental drug~Placebo: Inactive Drug~Phosphate Binder Agents: standard of care phosphate binder use at study entry was maintained throughout the entire study | 5 | 119 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were collected for the 4 week (28 days) treatment period.
Source ClinicalTrials.gov
Trial
- Title
- Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy
- NCT number
- NCT03824587
- Phases
- PHASE2, PHASE3
- Conditions
- Hyperphosphatemia
- Interventions
- Tenapanor, Placebo, Phosphate Binder Agents
- Lead sponsor
- Ardelyx
- Results first posted
- 2023-03-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03824587?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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