Comparison · NCT02101736-384d93d0
Cohort A vs Cohort B: Number of Participants With Adverse Events
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. Cohort A vs Cohort B: Number of Participants With Adverse Events. Trial comparisons, record NCT02101736-384d93d0. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02101736-384d93d0
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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 | 0.87 | 0.679 | 0.955 | wilson | |
| Risk in group 2 | 0.955 | 0.782 | 0.992 | wilson | |
| Risk difference, group 1 minus group 2 | -0.085 | -0.279 | 0.107 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.911 | 0.759 | 1.09 | log | |
| Odds ratio, group 1 over group 2 | 0.317 | 0.0304 | 3.31 | log | |
| Number needed to treat, for one fewer participant with the outcome on Cohort A than on Cohort B | 11.8 | 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 | Cohort A | Cohort A (≥ 16 years - closed to accrual): Starting cabozantinib of 40 mg daily by mouth per cycle. Duration of each cycle is 28 days. Subjects will dose escalate after 2 cycles to 60 mg based on dose tolerability. Subjects who do not tolerate 40 mg will dose reduce to 20 mg. Doses will be capped at 60 mg.~Each cohort A and B will enroll up to 24 evaluable subjects with a target minimum of 17 evaluable subjects per cohort.~Cabozantinib: This is an open label Phase II clinical trial. For both cohorts, subjects will receive cabozantinib orally in continuous cycles. Each cycle is 28 days. In absence of progressive disease or dose limiting toxicity (DLT), subjects may continue therapy for a total of 24 cycles. Subjects with radiographic response (20% or greater reduction in tumor volume) at the end of 12 cycles can continue on therapy for up to an additional year. However, for Cohort A, subjects who do not achieve 15% reduction in tumor volume after 8 cycles will be considered treatment failure and taken off study. | 20 | 23 | OG000 |
| Group 2 | Cohort B | Cohort B (3 - 15 years). The starting cabozantinib dose is 30 mg/m2/day by mouth per cycle. Duration of each cycle is 28 days. Subjects will dose escalate after 2 cycles to 40 mg/m2/day based on dose tolerability. Subjects who do not tolerate 30 mg/m2/day will dose reduce to 23 mg/m2/day. Doses will be capped at 60 mg/day max daily dose~Each cohort A and B will enroll up to 24 evaluable subjects with a target minimum of 17 evaluable subjects per cohort.~Cabozantinib: This is an open label Phase II clinical trial. Subjects will receive cabozantinib orally in continuous 28 day cycles. In absence of progressive disease or dose limiting toxicity (DLT), subjects may continue therapy for a total of 24 cycles. Subjects with 20% or greater reduction in tumor volume at the end of 12 cycles can continue on therapy for up to an additional year. For Cohort B, the criteria that subjects who do not achieve 15% reduction by 8 cycles are considered treatment failure and taken off study was eliminated. | 21 | 22 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Adverse Events
- Description
- This is the number of participants with one or more adverse events.
- Time frame
- baseline to 24 months
- Population
Source ClinicalTrials.gov
Trial
- Title
- Cabozantinib for Plexiform Neurofibromas (PN) in Subjects With NF1 in Children and Adults
- NCT number
- NCT02101736
- Phases
- PHASE2
- Conditions
- NF1, Neurofibromatosis, Plexiform Neurofibromas
- Interventions
- Cabozantinib
- Lead sponsor
- University of Alabama at Birmingham
- Results first posted
- 2023-05-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02101736?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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