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Comparison · NCT00787254-sae

Lansoprazole 15 mg QD vs Gefarnate 50 mg BID: 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. Lansoprazole 15 mg QD vs Gefarnate 50 mg BID: serious adverse events. Trial comparisons, record NCT00787254-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00787254-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 10.1580.1130.218wilson
Risk in group 20.09390.05950.145wilson
Risk difference, group 1 minus group 20.0645-0.004250.134newcombe hybrid score
Risk ratio, group 1 over group 21.690.9622.96log
Odds ratio, group 1 over group 21.820.963.44log
Number needed to harm, for one more participant with a serious adverse event on Lansoprazole 15 mg QD than on Gefarnate 50 mg BID15.5from the risk difference intervalthe interval includes no difference

Groups2

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

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Lansoprazole 15 mg QDLansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.29183EG000
Group 2Gefarnate 50 mg BIDGefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.17181EG001

Harm

What it counts
Total, serious adverse events
Time frame
Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication, and up to 24 months after the permanent discontinuation of the double-blind study medication.

Source ClinicalTrials.gov

Trial

Title
Efficacy and Safety of Lansoprazole on Gastric and Duodenal Ulcers in Patients Taking Nonsteroidal Anti-Inflammatory Drugs
NCT number
NCT00787254
Phases
PHASE3
Conditions
Stomach Ulcer, Duodenal Ulcer
Interventions
Lansoprazole, Gefarnate
Lead sponsor
Takeda
Results first posted
2011-05-10

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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