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Comparison · NCT03172702-sae

Correction Phase vs Maintenance Phase: 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. Correction Phase vs Maintenance Phase: serious adverse events. Trial comparisons, record NCT03172702-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03172702-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.006670.001180.0368wilson
Risk in group 20.180.1270.249wilson
Risk difference, group 1 minus group 2-0.173-0.243-0.112newcombe hybrid score
Risk ratio, group 1 over group 20.0370.00510.269log
Odds ratio, group 1 over group 20.03060.00410.228log
Number needed to treat, for one fewer participant with a serious adverse event on Correction Phase than on Maintenance Phase5.774.128.92from the risk difference interval

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Correction PhaseCP (up to 3 days):~Patients received 10 g ZS TID for a maximum of 72 hours.1150EG000
Group 2Maintenance PhaseMP (up to 12 months):~Patients received a starting dose of 5 g ZS QD which could be increased to 10 g or 15 g QD or decreased to 5 g QOD or 2.5 g QD.27150EG001

Harm

What it counts
Total, serious adverse events
Time frame
For the CP, from Day 1 to last CP dose + 1 day or first MP dose -1 day. For the MP, from the first MP dose up to 1 day (2 days for QOD regimen) after last MP dose. Overall, approximately 12 months.

Source ClinicalTrials.gov

Trial

Title
Open-label Safety of Sodium Zirconium Cyclosilicate for up to 12 Months in Japanese Subjects With Hyperkalemia
NCT number
NCT03172702
Phases
PHASE3
Conditions
Hyperkalemia
Interventions
Zirconium Cyclosilicate
Lead sponsor
AstraZeneca
Results first posted
2020-05-01

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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