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Comparison · NCT01391962-sae

AZD2171 (Cediranib) 30 mg vs Sunitinib Malate 37.5 mg: 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. AZD2171 (Cediranib) 30 mg vs Sunitinib Malate 37.5 mg: serious adverse events. Trial comparisons, record NCT01391962-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01391962-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 10.2410.1220.421wilson
Risk in group 20.2590.1320.447wilson
Risk difference, group 1 minus group 2-0.0179-0.240.202newcombe hybrid score
Risk ratio, group 1 over group 20.9310.3762.31log
Odds ratio, group 1 over group 20.9090.2713.05log
Number needed to treat, for one fewer participant with a serious adverse event on AZD2171 (Cediranib) 30 mg than on Sunitinib Malate 37.5 mg55.9from 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 1AZD2171 (Cediranib) 30 mg
Treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 participants are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).
729EG000
Group 2Sunitinib Malate 37.5 mg
Treatment assignment code 2. Part I: Participants will be randomized to receive sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 participants are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), patients will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable
727EG001

Harm

What it counts
Total, serious adverse events
Time frame
Date treatment consent signed to date off study, an average of 523 days

Source ClinicalTrials.gov

Trial

Title
Sunitinib or Cediranib for Alveolar Soft Part Sarcoma
NCT number
NCT01391962
Phases
PHASE2
Conditions
Sarcoma, Alveolar Soft Part
Interventions
Cediranib, Sunitinib, Prochlorperazine, Promethazine, Benzodiazepine, Filgrastim, Sargramostim, Lomotil, Loperamide, Vitamin B6, Aquaphor, Acetaminophen, Levothyroxine, Warfarin
Lead sponsor
National Cancer Institute (NCI)
Results first posted
2024-09-19

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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