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Comparison · NCT00853307-sae

Alisertib 50 mg (Platinum-Refractory) vs Alisertib 50 mg (Platinum-Resistant): 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. Alisertib 50 mg (Platinum-Refractory) vs Alisertib 50 mg (Platinum-Resistant): serious adverse events. Trial comparisons, record NCT00853307-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00853307-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 10.6670.30.903wilson
Risk in group 20.280.1430.476wilson
Risk difference, group 1 minus group 20.387-0.0290.66newcombe hybrid score
Risk ratio, group 1 over group 22.381.025.55log
Odds ratio, group 1 over group 25.140.76334.7log
Number needed to harm, for one more participant with a serious adverse event on Alisertib 50 mg (Platinum-Refractory) than on Alisertib 50 mg (Platinum-Resistant)2.59from 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 1Alisertib 50 mg (Platinum-Refractory)
Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).Platinum-refractory disease is characterized by a lack of response, progression, or recurrence of disease during a course of platinum-based therapy.
46EG000
Group 2Alisertib 50 mg (Platinum-Resistant)
Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-resistant disease is characterized by progression or recurrence of malignant disease within 6 months after completion of a platinum-based regimen.
725EG001

Harm

What it counts
Total, serious adverse events
Time frame
First dose of study drug to 30 past last dose of study drug (Up to18.9 Months)

Source ClinicalTrials.gov

Trial

Title
MLN8237 for Treatment of Participants With Ovarian, Fallopian Tube, or Peritoneal Carcinoma
NCT number
NCT00853307
Phases
PHASE2
Conditions
Ovarian Carcinoma
Interventions
Alisertib
Lead sponsor
Millennium Pharmaceuticals, Inc.
Results first posted
2018-03-27

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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