Comparison · NCT01866709-sae
Sodium Polystyrene Sulfonate vs Silicified Microcrystalline Cellulose: 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. Sodium Polystyrene Sulfonate vs Silicified Microcrystalline Cellulose: serious adverse events. Trial comparisons, record NCT01866709-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01866709-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 | 0.133 | 0.0374 | 0.379 | wilson | |
| Risk in group 2 | 0 | 0 | 0.184 | wilson | |
| Risk difference, group 1 minus group 2 | 0.133 | -0.0745 | 0.379 | 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 harm, for one more participant with a serious adverse event on Sodium Polystyrene Sulfonate than on Silicified Microcrystalline Cellulose | 7.5 | from the risk difference interval | the interval includes no difference |
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 | Sodium Polystyrene Sulfonate | Oral suspension in water of 15g sodium polystyrene sulfonate administered three times (tid) daily for 48 hours without co-administration of Sorbitol.~Sodium polystyrene sulfonate (ACTIVE): Participants were solicited for adverse events at each study visit (i.e. Days 1, 2 and 9) by systematic regular investigator assessment. | 2 | 15 | EG000 |
| Group 2 | Silicified Microcrystalline Cellulose | Oral suspension of placebo blended with pigment to have the same appearance, taste, odor and mode of administration as SPS.~Silicified microcrystalline cellulose (PLACEBO): Participants were solicited for adverse events at each study visit (i.e. Days 1, 2 and 9) by systematic regular investigator assessment. | 0 | 17 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Each study visit: Days 1, 2 and 9
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy of Sodium Polystyrene Sulfonate in Hyperkalemia
- NCT number
- NCT01866709
- Phases
- PHASE4
- Conditions
- Hyperkalemia
- Interventions
- Sodium polystyrene sulfonate, Silicified microcrystalline cellulose
- Lead sponsor
- ZS Pharma, Inc.
- Results first posted
- 2014-09-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01866709?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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