Comparison · NCT04924608-sae
Selumetinib 25 mg/m2 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
Cite this record
ConductScience Library. Selumetinib 25 mg/m2 vs Placebo: serious adverse events. Trial comparisons, record NCT04924608-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04924608-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 | 0.141 | 0.0783 | 0.24 | wilson | |
| Risk in group 2 | 0.122 | 0.0653 | 0.215 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0192 | -0.0934 | 0.133 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.16 | 0.5 | 2.68 | log | |
| Odds ratio, group 1 over group 2 | 1.18 | 0.451 | 3.11 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Selumetinib 25 mg/m2 than on Placebo | 52 | 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 | Selumetinib 25 mg/m2 | Actual Treatment Group | 10 | 71 | EG000 |
| Group 2 | Placebo | Actual Treatment Group | 9 | 74 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All-cause mortality (death due to any cause) and Treatment emergent adverse events during randomised period, which is from the first dose of study intervention until the first date when selumetinib kit(s) are dispensed at Cycle 12 Day 28 (about 1 year), or 30 days after study intervention discontinuation, or up to one day prior to start of subsequent therapy, whichever occurs first. The medians of total treatment duration were 336 days for Selumetinib group and 335 days for Placebo group.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Selumetinib in Adults With NF1 Who Have Symptomatic, Inoperable Plexiform Neurofibromas
- NCT number
- NCT04924608
- Phases
- PHASE3
- Conditions
- Neurofibromatosis 1, Plexiform Neurofibroma (PN)
- Interventions
- Selumetinib, Placebo
- Lead sponsor
- AstraZeneca
- Results first posted
- 2025-10-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04924608?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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