Comparison · NCT03962543-sae
Treatment Phase - Pediatric Cohort Mirdametinib (PD-0325901) vs Treatment Phase - Adult Cohort Mirdametinib (PD-0325901): 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. Treatment Phase - Pediatric Cohort Mirdametinib (PD-0325901) vs Treatment Phase - Adult Cohort Mirdametinib (PD-0325901): serious adverse events. Trial comparisons, record NCT03962543-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03962543-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 | 0.143 | 0.0742 | 0.257 | wilson | |
| Risk in group 2 | 0.172 | 0.0964 | 0.289 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0296 | -0.165 | 0.108 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.829 | 0.353 | 1.95 | log | |
| Odds ratio, group 1 over group 2 | 0.8 | 0.291 | 2.2 | log | |
Number needed to treat, for one fewer participant with a serious adverse event on Treatment Phase - Pediatric Cohort Mirdametinib (PD-0325901) than on Treatment Phase - Adult Cohort Mirdametinib (PD-0325901) | 33.8 | 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 | Treatment Phase - Pediatric Cohort Mirdametinib (PD-0325901) | Patients aged 2 to 17 years old at the time of informed consent. Mirdametinib (PD-0325901) capsule or dispersible tablet 2 mg/m\^2 (maximum dose of 4 mg) by mouth twice daily | 8 | 56 | EG000 |
| Group 2 | Treatment Phase - Adult Cohort Mirdametinib (PD-0325901) | Patients aged 18 and above at the time of informed consent. Mirdametinib (PD-0325901) capsule or dispersible tablet 2 mg/m\^2 (maximum dose of 4 mg) by mouth twice daily | 10 | 58 | 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 year and 10 months and up to 3 years and 10 months.
Source ClinicalTrials.gov
Trial
- Title
- MEK Inhibitor Mirdametinib (PD-0325901) in Patients With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas
- NCT number
- NCT03962543
- Phases
- PHASE2
- Conditions
- Plexiform Neurofibroma, Neurofibromatosis Type 1 (NF1)
- Interventions
- Mirdametinib (PD-0325901) oral capsule or dispersible tablet
- Lead sponsor
- SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
- Results first posted
- 2025-08-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03962543?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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