Comparison · NCT04175912-sae
Arm A (Pevonedistat) vs Arm B (Pevonedistat, Paclitaxel, Carboplatin): 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. Arm A (Pevonedistat) vs Arm B (Pevonedistat, Paclitaxel, Carboplatin): serious adverse events. Trial comparisons, record NCT04175912-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04175912-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 | 0.471 | 0.262 | 0.69 | wilson | |
| Risk in group 2 | 0.706 | 0.469 | 0.867 | wilson | |
| Risk difference, group 1 minus group 2 | -0.235 | -0.499 | 0.0881 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.667 | 0.369 | 1.2 | log | |
| Odds ratio, group 1 over group 2 | 0.37 | 0.0902 | 1.52 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm A (Pevonedistat) than on Arm B (Pevonedistat, Paclitaxel, Carboplatin) | 4.25 | 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 | Arm A (Pevonedistat) | Patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. | 8 | 17 | EG000 |
| Group 2 | Arm B (Pevonedistat, Paclitaxel, Carboplatin) | Patients receive pevonedistat IV over 1 hour on days 1, 3, and 5, paclitaxel IV over 3 hours on day 1, and carboplatin IV over 15-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Starting cycle 5, patients may receive pevonedistat monotherapy at the discretion of treating physician. | 12 | 17 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years
Source ClinicalTrials.gov
Trial
- Title
- Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver
- NCT number
- NCT04175912
- Phases
- PHASE2
- Conditions
Metastatic Cholangiocarcinoma, Metastatic Hepatocellular Carcinoma, Stage III Hepatocellular Carcinoma AJCC v8, Stage III Intrahepatic Cholangiocarcinoma AJCC v8, Stage IIIA Hepatocellular Carcinoma AJCC v8, Stage IIIA Intrahepatic Cholangiocarcinoma AJCC v8, Stage IIIB Hepatocellular Carcinoma AJCC v8, Stage IIIB Intrahepatic Cholangiocarcinoma AJCC v8, Stage IV Hepatocellular Carcinoma AJCC v8, Stage IV Intrahepatic Cholangiocarcinoma AJCC v8, Stage IVA Hepatocellular Carcinoma AJCC v8, Stage IVB Hepatocellular Carcinoma AJCC v8, Unresectable Cholangiocarcinoma, Unresectable Hepatocellular Carcinoma, Unresectable Intrahepatic Cholangiocarcinoma
- Interventions
- Carboplatin, Paclitaxel, Pevonedistat
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2025-01-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04175912?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.
For software
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GET https://conductscience.org/api/comparisons/v1/NCT04175912-sae