Comparison · NCT02352831-sae
Phase I (Tosedostat + Capecitabine) vs Phase II (Tosedostat + Capecitabine): 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. Phase I (Tosedostat + Capecitabine) vs Phase II (Tosedostat + Capecitabine): serious adverse events. Trial comparisons, record NCT02352831-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02352831-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 | 0.5 | 0.188 | 0.812 | wilson | |
| Risk in group 2 | 0.3 | 0.108 | 0.603 | wilson | |
| Risk difference, group 1 minus group 2 | 0.2 | -0.235 | 0.567 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.67 | 0.483 | 5.76 | log | |
| Odds ratio, group 1 over group 2 | 2.33 | 0.287 | 19 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Phase I (Tosedostat + Capecitabine) than on Phase II (Tosedostat + Capecitabine) | 5 | 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 | Phase I (Tosedostat + Capecitabine) | * The phase I study will be conducted in the standard 6-patient-per-cohort dose de-escalation fashion.~* Tosedostat by mouth daily Days 1-21 of each 21-day cycle. Dose Level 0 (starting dose) = 120 mg PO daily and Dose Level -1 = 60 mg PO daily. All 6 patients in the Phase 1 received 120 mg starting dose of tosedostat.~* Capecitabine 1000 mg/m\^2 by mouth BID Days 1-14 of each 21-day cycle~* Fresh tissue biopsy: Patients who have a partial response at the end of cycle 2 will be required to undergo biopsy if deemed safe for the patient and tissue is feasible to obtain. | 3 | 6 | EG000 |
| Group 2 | Phase II (Tosedostat + Capecitabine) | * Tosedostat (dose determined by Phase I portion of study) by mouth daily Days 1-21 of each 21-day cycle~* Capecitabine by mouth BID Days 1-14 of each 21-day cycle~* Fresh tissue biopsy: Patients who have a partial response at the end of cycle 2 will be required to undergo biopsy if deemed safe for the patient and tissue is feasible to obtain. | 3 | 10 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events and all-cause mortality were collected from baseline through 30 days after treatment ended.
Source ClinicalTrials.gov
Trial
- Title
- Tosedostat With Capecitabine in Patients With Metastatic Pancreatic Adenocarcinoma
- NCT number
- NCT02352831
- Phases
- PHASE1, PHASE2
- Conditions
- Pancreatic Cancer, Cancer of Pancreas, Cancer of the Pancreas, Pancreas Cancer
- Interventions
- Tosedostat, Capecitabine, Fresh tissue biopsy
- Lead sponsor
- Washington University School of Medicine
- Results first posted
- 2018-12-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02352831?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.govNone 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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