Comparison · NCT03291288-sae
Part 1: Drug-drug Interaction Phase vs Part 2: Pexidartinib Only: 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. Part 1: Drug-drug Interaction Phase vs Part 2: Pexidartinib Only: serious adverse events. Trial comparisons, record NCT03291288-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03291288-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 | 0.167 | 0.0734 | 0.336 | wilson | |
| Risk in group 2 | 0.2 | 0.0886 | 0.391 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0333 | -0.246 | 0.169 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.833 | 0.272 | 2.55 | log | |
| Odds ratio, group 1 over group 2 | 0.8 | 0.203 | 3.15 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Part 1: Drug-drug Interaction Phase than on Part 2: Pexidartinib Only | 30 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Part 1: Drug-drug Interaction Phase | On Day 1, participants received the single oral dose of midazolam (2 mg) and tolbutamide (500 mg).~On Day 3, pexidartinib (800 mg/day) administered as 400 mg twice daily (BID) was initiated and continued throughout the remainder of Part 1 and into Part 2. On the first day of pexidartinib treatment (Day 3), a single dose of midazolam (2 mg) and tolbutamide (500 mg) was co-administered with the morning pexidartinib dose (400 mg).~On Day 13, a single dose of midazolam (2 mg) and tolbutamide (500 mg) was co-administered with the morning dose of pexidartinib (400 mg). | 5 | 30 | EG000 |
| Group 2 | Part 2: Pexidartinib Only | All participants received pexidartinib twice daily (BID) dosing in 28-day cycles at the 400 mg/day dose for up to one year. | 5 | 25 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were collected after first dose up to 28 days after the last dose of study drug, up to 1 year.
Source ClinicalTrials.gov
Trial
- Title
- Effect of Pexidartinib on the Way the Body Processes CYP3A4 and CYP2C9 Substrates (Pharmacokinetics)
- NCT number
- NCT03291288
- Phases
- PHASE1
- Conditions
- Drug Interaction Potential
- Interventions
- Tolbutamide, Midazolam, Pexidartinib
- Lead sponsor
- Daiichi Sankyo
- Results first posted
- 2020-03-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03291288?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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