Comparison · NCT01124786-sae
CO-1.01 vs Gemcitabine: 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. CO-1.01 vs Gemcitabine: serious adverse events. Trial comparisons, record NCT01124786-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01124786-sae
On this page
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 | 0.458 | 0.387 | 0.531 | wilson | |
| Risk in group 2 | 0.453 | 0.382 | 0.526 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00506 | -0.0968 | 0.107 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.01 | 0.807 | 1.27 | log | |
| Odds ratio, group 1 over group 2 | 1.02 | 0.674 | 1.55 | log | |
| Number needed to harm, for one more participant with a serious adverse event on CO-1.01 than on Gemcitabine | 198 | 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 | CO-1.01 | CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks | 82 | 179 | EG000 |
| Group 2 | Gemcitabine | Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks | 82 | 181 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were assessed from the time of informed consent to 28 days after the last study drug administration, up to 1.5 years.
Source ClinicalTrials.gov
Trial
- Title
- A Study Comparing CO-1.01 With Gemcitabine as First Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma (LEAP)
- NCT number
- NCT01124786
- Phases
- PHASE2
- Conditions
- Metastatic Pancreatic Adenocarcinoma
- Interventions
- CO-1.01, Gemcitabine
- Lead sponsor
- Clovis Oncology, Inc.
- Results first posted
- 2014-04-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01124786?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT01124786-sae