Comparison · NCT01395017-sae
Dasatinib + GEM vs Placebo + GEM: 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. Dasatinib + GEM vs Placebo + GEM: serious adverse events. Trial comparisons, record NCT01395017-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01395017-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 | 0.541 | 0.442 | 0.636 | wilson | |
| Risk in group 2 | 0.475 | 0.381 | 0.572 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0656 | -0.0722 | 0.2 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.14 | 0.865 | 1.5 | log | |
| Odds ratio, group 1 over group 2 | 1.3 | 0.745 | 2.27 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Dasatinib + GEM than on Placebo + GEM | 15.3 | 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 | Dasatinib + GEM | GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth QD | 53 | 98 | EG000 |
| Group 2 | Placebo + GEM | GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD. | 48 | 101 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable.
Source ClinicalTrials.gov
Trial
- Title
- Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer
- NCT number
- NCT01395017
- Phases
- PHASE2
- Conditions
- Pancreatic Cancer
- Interventions
- dasatinib, Placebo
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Results first posted
- 2015-03-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01395017?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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