Comparison · NCT03785964-sae
Double-Blind Phase - Nirogacestat vs Double-Blind Phase - 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
Cite this record
ConductScience Library. Double-Blind Phase - Nirogacestat vs Double-Blind Phase - Placebo: serious adverse events. Trial comparisons, record NCT03785964-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03785964-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.203 | 0.125 | 0.312 | wilson | |
| Risk in group 2 | 0.111 | 0.0574 | 0.204 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0918 | -0.0297 | 0.214 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.83 | 0.818 | 4.08 | log | |
| Odds ratio, group 1 over group 2 | 2.04 | 0.795 | 5.22 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Double-Blind Phase - Nirogacestat than on Double-Blind Phase - Placebo | 10.9 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Double-Blind Phase - Nirogacestat | Nirogacestat 150 mg by mouth, twice daily~Nirogacestat oral tablet: Nirogacestat tablet | 14 | 69 | EG000 |
| Group 2 | Double-Blind Phase - Placebo | Placebo by mouth, twice daily~Placebo Oral Tablet: Sugar pill manufactured to mimic nirogacestat 50 mg tablet | 8 | 72 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- 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
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03785964?tab=results
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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