Comparison · NCT03781089-sae
Patiromer Oral Powder Product vs Usual Care Arm: 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. Patiromer Oral Powder Product vs Usual Care Arm: serious adverse events. Trial comparisons, record NCT03781089-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03781089-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 | 0.118 | 0.0329 | 0.343 | wilson | |
| Risk in group 2 | 0.125 | 0.035 | 0.36 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00735 | -0.257 | 0.236 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.941 | 0.15 | 5.91 | log | |
| Odds ratio, group 1 over group 2 | 0.933 | 0.115 | 7.55 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Patiromer Oral Powder Product than on Usual Care Arm | 136 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: usual care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Patiromer Oral Powder Product | Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K \< 4.0 mEq/L, and patiromer will be discontinued if K \< 3.5 mEq/L.~Patiromer Oral Powder Product: Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K \< 4.0 mEq/L, and patiromer will be discontinued if K \< 3.5 mEq/L. Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol | 2 | 17 | EG000 |
| Group 2 | Usual Care Arm | Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol | 2 | 16 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 6 weeks
Source ClinicalTrials.gov
Trial
- Title
- Patiromer Efficacy to Reduce Episodic Hyperkalemia in End Stage Renal Disease Patients
- NCT number
- NCT03781089
- Phases
- PHASE4
- Conditions
- Hyperkalemia, End Stage Renal Disease
- Interventions
- Patiromer Oral Powder Product
- Lead sponsor
- Duke University
- Results first posted
- 2025-05-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03781089?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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