Comparison · NCT03801915-sae
Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1) vs Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1): 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. Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1) vs Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1): serious adverse events. Trial comparisons, record NCT03801915-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03801915-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 | 0.25 | 0.0715 | 0.591 | wilson | |
| Risk in group 2 | 1 | 0.207 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | -0.75 | -0.929 | 0.114 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.25 | 0.0753 | 0.83 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
Number needed to treat, for one fewer participant with a serious adverse event on Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1) than on Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1) | 1.33 | 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 | Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1) | Pre-operative escalation doses of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment~MVT-5873: 1 mg/kg for pre-operative dose, 1 mg/kg during post-operative period~pancreatectomy or hepatectomy: Pancreatectomy or hepatectomy~Participants having low elevated liver function tests (LFTs), enrolled into pre-operative MVT-5873 escalation dose levels. | 2 | 8 | EG000 |
| Group 2 | Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1) | Pre-operative RD of MVT-5873, pancreatectomy or hepatectomy and post-operative MVT-5873 treatment~MVT-5873: 1 mg/kg for pre-operative dose, 1 mg/kg during post-operative period~pancreatectomy or hepatectomy: Pancreatectomy or hepatectomy~Participants having moderate elevated liver function tests (LFTs), enrolled into pre-operative MVT-5873 escalation dose levels. | 1 | 1 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Date treatment consent signed to date off study, approximately 29 months and 11 days, and 22 months and 21 days for cohort 1 and cohort 2 respectively.
Source ClinicalTrials.gov
Trial
- Title
- Perioperative MVT-5873, a Fully Human Monoclonal Antibody Against a CA 19-9 Epitope, for Operable CA 19-9 Producing Pancreatic Cancers, Cholangiocarcinomas, and Metastatic Colorectal Cancers
- NCT number
- NCT03801915
- Phases
- PHASE2
- Conditions
- Colon Cancer, Pancreatic Cancer, Cholangiocarcinoma, Metastatic Colon Carcinoma, Liver Metastasis
- Interventions
- MVT-5873, pancreatectomy or hepatectomy
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2023-03-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03801915?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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