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Comparison · NCT03230318-deaths

Substudy 1 vs Substudy 2: 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. Substudy 1 vs Substudy 2: deaths from any cause. Trial comparisons, record NCT03230318-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03230318-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 10.7180.6250.796wilson
Risk in group 20.5680.4220.703wilson
Risk difference, group 1 minus group 20.15-0.01390.316newcombe hybrid score
Risk ratio, group 1 over group 21.260.9511.68log
Odds ratio, group 1 over group 21.940.934.04log
Number needed to harm, for one more death from any cause on Substudy 1 than on Substudy 26.65from 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 1Substudy 1Substudy 1 comprised of patients with inoperable or advanced iCCA with FGFR2 fusions~Derazantinib was administered orally at 300 mg once daily74103EG000
Group 2Substudy 2Substudy 2 comprised of patients with with inoperable or advanced iCCA with FGFR2 mutations or amplifications~Derazantinib was administered orally at 300 mg once daily2544EG001

Harm

What it counts
Total, all-cause mortality
Time frame
All AEs were assessed from first day of treatment and until 28-35-day post-treatment follow-up period. The AE assessment period for the whole study lasted up to 50 months.

Source ClinicalTrials.gov

Trial

Title
Derazantinib in Subjects With FGFR2 Gene Fusion-, Mutation- or Amplification- Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma
NCT number
NCT03230318
Phases
PHASE2
Conditions
Intrahepatic Cholangiocarcinoma, Combined Hepatocellular and Cholangiocarcinoma
Interventions
derazantinib
Lead sponsor
Basilea Pharmaceutica
Results first posted
2023-12-19

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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