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Comparison · NCT03785964-deaths

Double-Blind Phase - Nirogacestat vs Double-Blind Phase - Placebo: deaths from any cause

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. Double-Blind Phase - Nirogacestat vs Double-Blind Phase - Placebo: deaths from any cause. Trial comparisons, record NCT03785964-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03785964-deaths

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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 100.000000000000000003470.0527wilson
Risk in group 20.01390.002460.0746wilson
Risk difference, group 1 minus group 2-0.0139-0.07460.0401newcombe 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 treat, for one fewer death from any cause on Double-Blind Phase - Nirogacestat than on Double-Blind Phase - Placebo72from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Double-Blind Phase - NirogacestatNirogacestat 150 mg by mouth, twice daily~Nirogacestat oral tablet: Nirogacestat tablet069EG000
Group 2Double-Blind Phase - PlaceboPlacebo by mouth, twice daily~Placebo Oral Tablet: Sugar pill manufactured to mimic nirogacestat 50 mg tablet172EG001

Harm

What it counts
Total, all-cause mortality
Time frame
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment, an average of 1 years and 4 months and up to 2 years and 10 months. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.

Source ClinicalTrials.gov

Trial

Title
Nirogacestat for Adults With Desmoid Tumor/Aggressive Fibromatosis (DT/AF)
NCT number
NCT03785964
Phases
PHASE3
Conditions
Desmoid Tumor, Aggressive Fibromatosis
Interventions
Nirogacestat oral tablet, Placebo Oral Tablet
Lead sponsor
SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
Results first posted
2024-06-12

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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