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Comparison · NCT01515176-deaths

Dose Level I: Treatment (Ofatumumab, Dinaciclib) vs Dose Level II: Treatment (Ofatumumab, Dinaciclib): deaths from any cause

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. Dose Level I: Treatment (Ofatumumab, Dinaciclib) vs Dose Level II: Treatment (Ofatumumab, Dinaciclib): deaths from any cause. Trial comparisons, record NCT01515176-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01515176-deaths

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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 1000.49wilson
Risk in group 20.03130.005540.157wilson
Risk difference, group 1 minus group 2-0.0313-0.1570.459newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to treat, for one fewer death from any cause on Dose Level I: Treatment (Ofatumumab, Dinaciclib) than on Dose Level II: Treatment (Ofatumumab, Dinaciclib)32from the risk difference intervalthe interval includes no difference

Groups2

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

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Dose Level I: Treatment (Ofatumumab, Dinaciclib)
Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib 7 mg/m2 as a 2-hour infusion on cycle 2 day 2, escalated to 10 mg/m2 beginning with cycle 2 day 8 and continuing thereafter.
04EG000
Group 2Dose Level II: Treatment (Ofatumumab, Dinaciclib)
Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib 7 mg/m2 as a 2-hour infusion on cycle 2 day 2, escalated to 10 mg/m2 as a 2-hour infusion on cycle 2 day 8, and to 14 mg/m2 on cycle 2 day 15 and continuing thereafter
132EG001

Harm

What it counts
Total, all-cause mortality
Time frame

Source ClinicalTrials.gov

Trial

Title
Ofatumumab and Dinaciclib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-Cell Prolymphocytic Leukemia
NCT number
NCT01515176
Phases
PHASE1, PHASE2
Conditions
Chronic Lymphocytic Leukemia, Prolymphocytic Leukemia, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia
Interventions
Dinaciclib, Laboratory Biomarker Analysis, Ofatumumab, Pharmacological Study
Lead sponsor
National Cancer Institute (NCI)
Results first posted
2018-03-15

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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