Comparison · NCT01767857-sae
Xilonix vs Placebo: 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. Xilonix vs Placebo: serious adverse events. Trial comparisons, record NCT01767857-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01767857-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 | 0.411 | 0.365 | 0.459 | wilson | |
| Risk in group 2 | 0.42 | 0.354 | 0.489 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00881 | -0.0923 | 0.0731 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.979 | 0.802 | 1.2 | log | |
| Odds ratio, group 1 over group 2 | 0.964 | 0.685 | 1.36 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Xilonix than on Placebo | 114 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Xilonix | Participants received 7.5 milligram per kilogram (mg/kg) Xilonix (MABp1) via intravenous (IV) injection once every 2 weeks until evidence of radiographic or clinical progression along with best supportive care (BSC) (up to 18 months). | 169 | 411 | EG000 |
| Group 2 | Placebo | Participants received placebo via IV injection once every 2 weeks until evidence of radiographic or clinical progression plus BSC (up to 18 months). | 84 | 200 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 18 months
Source ClinicalTrials.gov
Trial
- Title
- A Phase III Study of Xilonix in Patients With Advanced Colorectal Cancer
- NCT number
- NCT01767857
- Phases
- PHASE3
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Xilonix, Placebo
- Lead sponsor
- Janssen Research & Development, LLC
- Results first posted
- 2021-06-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01767857?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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