Comparison · NCT03792256-3ec83f48
Stratum 1 With 50 mg/m^2 vs Stratum PK With 50 mg/m^2: Frequency of Dose Limiting Toxicities of Palbociclib
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. Stratum 1 With 50 mg/m^2 vs Stratum PK With 50 mg/m^2: Frequency of Dose Limiting Toxicities of Palbociclib. Trial comparisons, record NCT03792256-3ec83f48. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03792256-3ec83f48
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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 | 0.0301 | 0.564 | wilson | |
| Risk in group 2 | 0 | 0.0000000000000000278 | 0.39 | wilson | |
| Risk difference, group 1 minus group 2 | 0.167 | -0.247 | 0.564 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one more participant with the outcome on Stratum 1 With 50 mg/m^2 than on Stratum PK With 50 mg/m^2 | 6 | 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 | Stratum 1 With 50 mg/m^2 | Patients known to be CNS3 at study entry may receive ITT on Day 1 rather than IT ARAC. | 1 | 6 | OG000 |
| Group 2 | Stratum PK With 50 mg/m^2 | Patients known to be CNS3 at study entry may receive ITT on Day 1 rather than IT ARAC. | 0 | 6 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Frequency of Dose Limiting Toxicities of Palbociclib
- Description
- The frequency (%) of patients experiencing a cycle 1 dose limiting toxicity at least possibly attributable to Palbociclib by study part and dose level.
- Time frame
- Up to 32 days
- Population
- All enrolled patients
Source ClinicalTrials.gov
Trial
- Title
- Palbociclib in Combination With Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL)
- NCT number
- NCT03792256
- Phases
- PHASE1
- Conditions
- Leukemia, Lymphocytic, Lymphoblastic Lymphoma, T-cell Lymphoma, T-cell Leukemia, Recurrent Disease, Acute Leukemia
- Interventions
- Palbociclib, Cytarabine, Methotrexate, Hydrocortisone, Doxorubicin, Prednisolone, Vincristine, Pegaspargase, Hydrocortisone, Prednisone
- Lead sponsor
- Children's Oncology Group
- Results first posted
- 2024-08-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03792256?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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