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Comparison · NCT00923247-sae

Phase 1 vs Phase 2 A: 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. Phase 1 vs Phase 2 A: serious adverse events. Trial comparisons, record NCT00923247-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00923247-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 10.190.07670.4wilson
Risk in group 210.2071wilson
Risk difference, group 1 minus group 2-0.81-0.9230.0111newcombe hybrid score
Risk ratio, group 1 over group 20.190.07890.46log
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to treat, for one fewer participant with a serious adverse event on Phase 1 than on Phase 2 A1.24from 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 1Phase 1
Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 \& 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 \& 11 every 28 days in adults
421EG000
Group 2Phase 2 A
Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 \& 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 \& 11 every 28 days in adults
11EG001

Harm

What it counts
Total, serious adverse events
Time frame
Date treatment consent signed to date off study, approximately 7 years and 9 days.

Source ClinicalTrials.gov

Trial

Title
A Targeted Phase I/II Trial of ZD6474 (Vandetanib; ZACTIMA) Plus the Proteasome Inhibitor, Bortezomib (Velcade ), in Adults With Solid Tumors With a Focus on Hereditary or Sporadic, Locally Advanced or Metastatic Medullary Thyroid Cancer (MTC)
NCT number
NCT00923247
Phases
PHASE1, PHASE2
Conditions
Medullary Thyroid Carcinoma
Interventions
Bortezomib, Vandetanib
Lead sponsor
National Cancer Institute (NCI)
Results first posted
2017-05-17

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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