Comparison · NCT03888066-sae
Patiromer 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
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ConductScience Library. Patiromer vs Placebo: serious adverse events. Trial comparisons, record NCT03888066-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03888066-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 | 0.123 | 0.0955 | 0.157 | wilson | |
| Risk in group 2 | 0.132 | 0.104 | 0.167 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00911 | -0.0535 | 0.0353 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.931 | 0.659 | 1.32 | log | |
| Odds ratio, group 1 over group 2 | 0.921 | 0.62 | 1.37 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Patiromer than on Placebo | 110 | 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 | Patiromer | Randomized participants who received a daily dose of patiromer, with possible dose adjustments based on subsequent local serum potassium level, during the Treatment Phase.~The starting dose of patiromer was 1 packet/day taken either with food or without food. Based upon the K+ management algorithms, patiromer was to be increased by 1 packet per day in intervals of at least 1 week (±3 days). If hypokalemia developed during the Treatment Phase, then the study drug was to be down titrated (lowest acceptable dose was 0 packets/day) until local serum K+ ≥4.0 mEq/l. Doses of patiromer were 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose). | 54 | 439 | EG000 |
| Group 2 | Placebo | Randomized participants who received a daily dose of placebo, with possible dose adjustments based on subsequent local serum potassium level, during the Treatment Phase.~The starting dose of placebo was 1 packet/day taken either with food or without food. Based upon the K+ management algorithms, placebo was to be increased by 1 packet per day in intervals of at least 1 week (±3 days). If hypokalemia developed during the Treatment Phase, then the study drug was to be down-titrated (lowest acceptable dose was 0 packets/day) until local serum K+ ≥4.0 mEq/l. Doses of placebo were 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose). | 58 | 439 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo
Source ClinicalTrials.gov
Trial
- Title
- Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure (DIAMOND)
- NCT number
- NCT03888066
- Phases
- PHASE3
- Conditions
- Hyperkalemia
- Interventions
- Patiromer, Placebos
- Lead sponsor
- Vifor Pharma, Inc.
- Results first posted
- 2023-02-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03888066?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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