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Comparison · NCT00385580-9d3e26d1

Dasatinib 100 mg Once Daily (QD) vs Dasatinib 100 mg or 70 mg Twice Daily (BID): Number of Participants With QTc Prolongation

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. Dasatinib 100 mg Once Daily (QD) vs Dasatinib 100 mg or 70 mg Twice Daily (BID): Number of Participants With QTc Prolongation. Trial comparisons, record NCT00385580-9d3e26d1. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00385580-9d3e26d1

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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 10.06250.02150.168wilson
Risk in group 20.2130.120.349wilson
Risk difference, group 1 minus group 2-0.15-0.293-0.00945newcombe hybrid score
Risk ratio, group 1 over group 20.2940.08621log
Odds ratio, group 1 over group 20.2470.06320.963log
Number needed to treat, for one fewer participant with the outcome on Dasatinib 100 mg Once Daily (QD) than on Dasatinib 100 mg or 70 mg Twice Daily (BID)6.653.42106from the risk difference interval

Groups2

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

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Dasatinib 100 mg Once Daily (QD)
Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
348OG000
Group 2Dasatinib 100 mg or 70 mg Twice Daily (BID)
Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or \>=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1047OG001

Outcome

Type
SECONDARY
Title
Number of Participants With QTc Prolongation
Description
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. QTc is the QT interval corrected for heart rate. A prolonged QT interval is a risk factor for ventricular tachyarrhythmias and sudden death.
Time frame
From start of study drug therapy up to 30 days after the last dose.
Population
All treated participants.

Source ClinicalTrials.gov

Trial

Title
Phase II Study of Dasatinib (BMS-354825) for Androgen-deprived Progressive Prostate Cancer
NCT number
NCT00385580
Phases
PHASE2
Conditions
Prostate Cancer
Interventions
dasatinib, dasatinib
Lead sponsor
Bristol-Myers Squibb
Results first posted
2011-03-01

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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