Comparison · NCT03230318-sae
Substudy 1 vs Substudy 2: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Substudy 1 vs Substudy 2: serious adverse events. Trial comparisons, record NCT03230318-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03230318-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.359 | 0.273 | 0.455 | wilson | |
| Risk in group 2 | 0.364 | 0.238 | 0.511 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00441 | -0.175 | 0.154 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.988 | 0.618 | 1.58 | log | |
| Odds ratio, group 1 over group 2 | 0.981 | 0.471 | 2.04 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Substudy 1 than on Substudy 2 | 227 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Substudy 1 | Substudy 1 comprised of patients with inoperable or advanced iCCA with FGFR2 fusions~Derazantinib was administered orally at 300 mg once daily | 37 | 103 | EG000 |
| Group 2 | Substudy 2 | Substudy 2 comprised of patients with with inoperable or advanced iCCA with FGFR2 mutations or amplifications~Derazantinib was administered orally at 300 mg once daily | 16 | 44 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- 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
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03230318?tab=results
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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