Comparison · NCT02106884-sae
Arm A (Nab-Paclitaxel + Gemcitabine) vs Arm B (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. Arm A (Nab-Paclitaxel + Gemcitabine) vs Arm B (Gemcitabine): serious adverse events. Trial comparisons, record NCT02106884-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02106884-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 | 0.694 | 0.58 | 0.789 | wilson | |
| Risk in group 2 | 0.649 | 0.535 | 0.748 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0458 | -0.105 | 0.193 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.07 | 0.853 | 1.34 | log | |
| Odds ratio, group 1 over group 2 | 1.23 | 0.616 | 2.46 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Arm A (Nab-Paclitaxel + Gemcitabine) than on Arm B (Gemcitabine) | 21.8 | 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 | Arm A (Nab-Paclitaxel + Gemcitabine) | Nab-paclitaxel - IV - 125 mg/m2 - 3xq4wks Gemcitabine - IV - 1000 mg/m2 - 3xq4wks | 50 | 72 | EG000 |
| Group 2 | Arm B (Gemcitabine) | Gemcitabine - IV - 1000 mg/m2 - 3xq4wks | 48 | 74 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
Source ClinicalTrials.gov
Trial
- Title
- Quality of Life in Locally Advanced or Metastatic Pancreatic Cancer Treated With Gemcitabine and Nab-paclitaxel
- NCT number
- NCT02106884
- Phases
- PHASE2
- Conditions
- Pancreatic Cancer
- Interventions
- Nab-paclitaxel, Gemcitabine
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Results first posted
- 2019-10-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02106884?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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