Comparison · NCT03410693-sae
Rogaratinib (BAY1163877) vs Chemotherapy: 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. Rogaratinib (BAY1163877) vs Chemotherapy: serious adverse events. Trial comparisons, record NCT03410693-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03410693-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 | 0.453 | 0.353 | 0.558 | wilson | |
| Risk in group 2 | 0.402 | 0.303 | 0.511 | wilson | |
| Risk difference, group 1 minus group 2 | 0.051 | -0.0969 | 0.196 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.13 | 0.793 | 1.6 | log | |
| Odds ratio, group 1 over group 2 | 1.23 | 0.668 | 2.27 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Rogaratinib (BAY1163877) than on Chemotherapy | 19.6 | 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 | Rogaratinib (BAY1163877) | Participants who were randomized to this group following a 1:1 ratio received rogaratinib 600 mg orally twice a day (b.i.d.) continuously, during a 21-day treatment cycle. | 39 | 86 | EG000 |
| Group 2 | Chemotherapy | Participants who were randomized to this group following a 1:1 ratio received chemotherapy (docetaxel, paclitaxel or vinflunine) at the discretion of the investigator, as intravenous (i.v.) infusion once every three weeks (on day 1 of a 21-day cycle). | 33 | 82 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Approximately 29 months
Source ClinicalTrials.gov
Trial
- Title
- Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma
- NCT number
- NCT03410693
- Phases
- PHASE2, PHASE3
- Conditions
- Carcinoma, Transitional Cell
- Interventions
- Rogaratinib (BAY1163877), Chemotherapy
- Lead sponsor
- Bayer
- Results first posted
- 2021-12-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03410693?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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