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Comparison · NCT02743364-sae

Arm I (Simvastatin) vs Arm II (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. Arm I (Simvastatin) vs Arm II (Placebo): serious adverse events. Trial comparisons, record NCT02743364-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02743364-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 10.8330.4360.97wilson
Risk in group 20.50.09450.905wilson
Risk difference, group 1 minus group 20.333-0.2340.761newcombe hybrid score
Risk ratio, group 1 over group 21.670.3986.97log
Odds ratio, group 1 over group 250.15167log
Number needed to harm, for one more participant with a serious adverse event on Arm I (Simvastatin) than on Arm II (Placebo)3from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Arm I (Simvastatin)
Patients receive simvastatin PO QD for 6 months.~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies~Simvastatin: Given PO
56EG000
Group 2Arm II (Placebo)
Patients receive placebo PO QD for 6 months.~Laboratory Biomarker Analysis: Correlative studies~Placebo Administration: Given PO~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies
12EG001

Harm

What it counts
Total, serious adverse events
Time frame
AEs collected from the time informed consent was signed and baseline procedures were completed through 90 days post-intervention. In total AEs collected for a period of 9 months.

Source ClinicalTrials.gov

Trial

Title
Simvastatin in Reducing Pancreatitis in Patients With Recurrent, Acute or Chronic Pancreatitis
NCT number
NCT02743364
Phases
PHASE2
Conditions
Acute Pancreatitis
Interventions
Laboratory Biomarker Analysis, Placebo Administration, Quality-of-Life Assessment, Questionnaire Administration, Simvastatin
Lead sponsor
National Cancer Institute (NCI)
Results first posted
2022-01-04

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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