Comparison · NCT01997333-sae
Capecitabine vs CDX-011: 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. Capecitabine vs CDX-011: serious adverse events. Trial comparisons, record NCT01997333-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01997333-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 | 0.207 | 0.136 | 0.3 | wilson | |
| Risk in group 2 | 0.333 | 0.273 | 0.399 | wilson | |
| Risk difference, group 1 minus group 2 | -0.127 | -0.223 | -0.0157 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.62 | 0.398 | 0.965 | log | |
| Odds ratio, group 1 over group 2 | 0.521 | 0.292 | 0.929 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Capecitabine than on CDX-011 | 7.89 | 4.49 | 63.9 | 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 | Capecitabine | Capecitabine administered on Days 1 through 14 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. | 19 | 92 | EG000 |
| Group 2 | CDX-011 | CDX-011 administered on Day 1 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. | 71 | 213 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse event data were collected from the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
Source ClinicalTrials.gov
Trial
- Title
- Study of Glembatumumab Vedotin (CDX-011) in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer
- NCT number
- NCT01997333
- Phases
- PHASE2
- Conditions
- Metastatic gpNMB Over-expressing Triple Negative Breast Cancer
- Interventions
- CDX-011, Capecitabine
- Lead sponsor
- Celldex Therapeutics
- Results first posted
- 2019-03-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01997333?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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