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Comparison · NCT01829477-sae

Fasiglifam 50 mg 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. Fasiglifam 50 mg vs Placebo: serious adverse events. Trial comparisons, record NCT01829477-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01829477-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 1000.194wilson
Risk in group 2000.184wilson
Risk difference, group 1 minus group 20-0.1840.194newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to harmfrom the risk difference intervalthe two groups' risks are equal

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Fasiglifam 50 mgFasiglifam 50 mg, tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.016EG001
Group 2PlaceboFasiglifam placebo-matching tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.017EG000

Harm

What it counts
Total, serious adverse events
Time frame
Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug.

Source ClinicalTrials.gov

Trial

Title
Comparison of TAK-875 to Placebo as an Add-on to Glimepiride in Patients With Type 2 Diabetes
NCT number
NCT01829477
Phases
PHASE3
Conditions
Diabetes Mellitus, Type 2
Interventions
TAK-875, TAK-875 Placebo, Glimepiride
Lead sponsor
Takeda
Results first posted
2016-06-01

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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