Comparison · NCT01231581-sae
Trametinib + Gemcitabine vs Placebo + 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. Trametinib + Gemcitabine vs Placebo + Gemcitabine: serious adverse events. Trial comparisons, record NCT01231581-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01231581-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 | 0.525 | 0.417 | 0.631 | wilson | |
| Risk in group 2 | 0.463 | 0.357 | 0.571 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0625 | -0.0906 | 0.212 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.14 | 0.828 | 1.56 | log | |
| Odds ratio, group 1 over group 2 | 1.28 | 0.69 | 2.39 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Trametinib + Gemcitabine than on Placebo + Gemcitabine | 16 | 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 | Trametinib + Gemcitabine | Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m\^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason. | 42 | 80 | EG000 |
| Group 2 | Placebo + Gemcitabine | Participants received placebo orally once daily in combination with 1000 mg/m\^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason. | 37 | 80 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Serious adverse events (SAEs) and non-serious AEs were collected from the time the first dose of study treatment was administered until 28 days following discontinuation of study treatment or until the data cutoff of 15-March-2013 (up to 21 months).
Source ClinicalTrials.gov
Trial
- Title
- Study of GSK1120212 Plus Gemcitabine vs Placebo Plus Gemcitabine in Metastatic Pancreatic Cancer
- NCT number
- NCT01231581
- Phases
- PHASE2
- Conditions
- Cancer
- Interventions
- GSK1120212, Gemcitabine, Placebo
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2013-09-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01231581?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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