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Comparison · NCT03792256-sae

Stratum 1 With 50 mg/m^2 vs Stratum PK With 50 mg/m^2: serious 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. Stratum 1 With 50 mg/m^2 vs Stratum PK With 50 mg/m^2: serious adverse events. Trial comparisons, record NCT03792256-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03792256-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 110.611wilson
Risk in group 210.611wilson
Risk difference, group 1 minus group 20-0.390.39newcombe hybrid score
Risk ratio, group 1 over group 2111log
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to harmfrom the risk difference intervalthe two groups' risks are equal

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Stratum 1 With 50 mg/m^2Patients known to be CNS3 at study entry may receive ITT on Day 1 rather than IT ARAC.66EG000
Group 2Stratum PK With 50 mg/m^2Patients known to be CNS3 at study entry may receive ITT on Day 1 rather than IT ARAC.66EG001

Harm

What it counts
Total, serious adverse events
Time frame
Up to 26 months

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

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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