Comparison · NCT04099641-e3eadb6b
Group 1 (CPI Naïve) vs Group 2 (CPI Relapse): Number of Patients With Treatment Emergent Adverse Events (TEAE)
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. Group 1 (CPI Naïve) vs Group 2 (CPI Relapse): Number of Patients With Treatment Emergent Adverse Events (TEAE). Trial comparisons, record NCT04099641-e3eadb6b. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04099641-e3eadb6b
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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 | 1 | 0.941 | 1 | wilson | |
| Risk in group 2 | 1 | 0.832 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0592 | 0.168 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 1 | 1 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
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 | Group 1 (CPI Naïve) | Group 1 participants had progressed on standard chemotherapy and were naïve to CPI therapy.~Participants received bavituximab at 3 mg/kg on Days 1, 8, and 15 of a 3-week cycle through IV infusion. Participants received pembrolizumab at 200 mg on Day 1 of a 3-week cycle through IV infusion. | 61 | 61 | OG000 |
| Group 2 | Group 2 (CPI Relapse) | Group 2 participants had achieved SD or better and then subsequently progressed following treatment with CPI either alone or in combination with chemotherapy.~Participants received bavituximab at 3 mg/kg on Days 1, 8, and 15 of a 3-week cycle through IV infusion. Participants received pembrolizumab at 200 mg on Day 1 of a 3-week cycle through IV infusion. | 19 | 19 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Patients With Treatment Emergent Adverse Events (TEAE)
- Description
Incidence of TEAEs graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0, including changes in clinical laboratory parameters. TEAEs: any AE that emerged on or after first dose, and within 30 days of the last dose.
- Time frame
- From first dose through 30 days after last dose. Maximum exposure: 567 days.
- Population
- Analysis was performed on the safety population.
Source ClinicalTrials.gov
Trial
- Title
- An Open Label Study of Bavituximab and Pembrolizumab in Advanced Gastric and GEJ Cancer Patients
- NCT number
- NCT04099641
- Phases
- PHASE2
- Conditions
- Gastric Cancer, GastroEsophageal Cancer
- Interventions
- Bavituximab, Pembrolizumab Injection
- Lead sponsor
- OncXerna Theraputics, Inc.
- Results first posted
- 2023-02-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04099641?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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