Comparison · NCT03773302-9690db59
Infigratinib (BGJ398) 125 mg vs Gemcitabine + Cisplatin: Number of Participants With Serious Adverse Events (SAEs)
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. Infigratinib (BGJ398) 125 mg vs Gemcitabine + Cisplatin: Number of Participants With Serious Adverse Events (SAEs). Trial comparisons, record NCT03773302-9690db59. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03773302-9690db59
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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 | 0.345 | 0.199 | 0.527 | wilson | |
| Risk in group 2 | 0 | 0 | 0.184 | wilson | |
| Risk difference, group 1 minus group 2 | 0.345 | 0.11 | 0.527 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one more participant with the outcome on Infigratinib (BGJ398) 125 mg than on Gemcitabine + Cisplatin | 2.9 | 1.9 | 9.09 | from the risk difference interval |
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 | Infigratinib (BGJ398) 125 mg | Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off. | 10 | 29 | OG000 |
| Group 2 | Gemcitabine + Cisplatin | Gemcitabine: Gemcitabine 1000 mg/m2 IV D1 and D8 for a 21-day cycle.~Cisplatin: Cisplatin 25 mg/m2 IV D1 and D8 for a 21-day cycle. | 0 | 17 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Serious Adverse Events (SAEs)
- Description
Safety analyses were performed for subjects in the safety analysis population for each group. Unless otherwise specified, summaries were provided only for the on-treatment safety assessments, which are the assessments occurring or taken during the on-treatment period
- Time frame
- From baseline to last dose date of study treatment + 30 days (an average of 7.5 months for the infigratinib arm and 5 months for the gemcitabine + cisplatin arm).
- Population
- Safety
Source ClinicalTrials.gov
Trial
- Title
- Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations
- NCT number
- NCT03773302
- Phases
- PHASE3
- Conditions
- Advanced Cholangiocarcinoma, FGFR2 Gene Mutation
- Interventions
- BGJ398, Gemcitabine, Cisplatin
- Lead sponsor
- QED Therapeutics, a BridgeBio company
- Results first posted
- 2024-05-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03773302?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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