Comparison · NCT03295396-a9f12d54
Arm A vs Arm B: Number of Patients With Overall Response
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. Arm A vs Arm B: Number of Patients With Overall Response. Trial comparisons, record NCT03295396-a9f12d54. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03295396-a9f12d54
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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 | 0.116 | 0.0507 | 0.245 | wilson | |
| Risk in group 2 | 0.167 | 0.0734 | 0.336 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0504 | -0.232 | 0.108 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.698 | 0.221 | 2.2 | log | |
| Odds ratio, group 1 over group 2 | 0.658 | 0.173 | 2.51 | log | |
| Number needed to treat, for one fewer participant with the outcome on Arm A than on Arm B | 19.8 | 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 | Arm A | Patients received 625 mg dordaviprone (ONC201) once weekly.~Arm A included patients with recurrent H3 K27M-mutant glioma including those with diffuse intrinsic pontine glioma (DIPG), primary spinal tumors, and some atypical histologies. Notably, patients with DIPG and primary spinal tumors are historically not evaluable for response using RANO-HGG criteria. | 5 | 43 | OG000 |
| Group 2 | Arm B | Patients received 625 mg dordaviprone (ONC201) once weekly.~Arm B included patients with recurrent H3 K27M-mutant glioma, but excluded patients with the following:~* Primary malignant lesion located in the pons or spinal cord.~* Atypical non-astrocytic histologies such as ependymoma, ganglioma and pleomorphic xanthoastrocytoma, or pilocytic astrocytoma and subependymal giant cell astrocytoma (SEGA).~* Prior bevacizumab treatment of \>4 doses of \>7.5 mg/kg | 5 | 30 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Patients With Overall Response
- Description
Quantitative thresholds for objective response by Response Assessment in Neuro-Oncology (RANO) criteria for target lesions on radiographic imaging are Complete Response (CR) is the disappearance of all target lesions; Partial Response (PR) requires a ≥50% decrease in the sum of products of perpendicular diameters of target lesions from baseline. Other considerations for RANO response include assessments of non-target lesions, corticosteroids, and performance status. The Overall Response Rate is the proportion of patients who achieve either CR or PR. Tumor assessments were conducted at 8 weeks (±1 week) following the initiation of therapy and every 8 weeks (±1 week) thereafter.~All patients who received at least one dose of dordaviprone (ONC201) were included in the analysis, including patients with diffuse intrinsic pontine glioma (DIPG) or primary spinal tumors, which are historically not assessable for response using RANO-HGG criteria due to anatomical or imaging limitations.
- Time frame
- From first dose of study treatment through study completion, an average of 1 year
- Population
Note: A total of 9 (21%) patients in Arm A, including 7 with primary spinal tumors and 2 with DIPG, were included in the overall analysis (i.e. Overall Response Rate) despite not being assessable for response per RANO-HGG.
Source ClinicalTrials.gov
Trial
- Title
- ONC201 in Adults With Recurrent H3 K27M-mutant Glioma
- NCT number
- NCT03295396
- Phases
- PHASE2
- Conditions
- Glioma
- Interventions
- Dordaviprone (ONC201)
- Lead sponsor
- Jazz Pharmaceuticals
- Results first posted
- 2025-07-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03295396?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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