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Comparison · NCT01442038-sae

Ranolazine 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. Ranolazine vs Placebo: serious adverse events. Trial comparisons, record NCT01442038-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01442038-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 10.390.3640.417wilson
Risk in group 20.3740.3480.401wilson
Risk difference, group 1 minus group 20.0164-0.02080.0535newcombe hybrid score
Risk ratio, group 1 over group 21.040.9471.15log
Odds ratio, group 1 over group 21.070.9151.25log
Number needed to harm, for one more participant with a serious adverse event on Ranolazine than on Placebo61.1from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Ranolazine
Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
5161,322EG000
Group 2Placebo
Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
4851,297EG001

Harm

What it counts
Total, serious adverse events
Time frame
Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days

Source ClinicalTrials.gov

Trial

Title
Ranolazine for Incomplete Vessel Revascularization Post-Percutaneous Coronary Intervention (PCI)
NCT number
NCT01442038
Phases
PHASE3
Conditions
Coronary Artery Disease, Angina Pectoris
Interventions
Ranolazine, Placebo
Lead sponsor
Gilead Sciences
Results first posted
2016-07-15

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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