Comparison · NCT02715804-sae
PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine vs AG: Placebo + Nab-Paclitaxel + 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
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ConductScience Library. PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine vs AG: Placebo + Nab-Paclitaxel + Gemcitabine: serious adverse events. Trial comparisons, record NCT02715804-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02715804-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 | 0.575 | 0.521 | 0.628 | wilson | |
| Risk in group 2 | 0.513 | 0.435 | 0.59 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0626 | -0.0318 | 0.156 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.12 | 0.938 | 1.34 | log | |
| Odds ratio, group 1 over group 2 | 1.29 | 0.877 | 1.89 | log | |
| Number needed to harm, for one more participant with a serious adverse event on PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine than on AG: Placebo + Nab-Paclitaxel + 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 | PAG: PEGPH20 + Nab-Paclitaxel + Gemcitabine | Participants received 3.0 μg/kg PEGPH20 as an IV infusion, twice weekly for Weeks 1 to 3 of Cycle 1 (each cycle consisted of 4 weeks \[Week 4 of every cycle was a rest week with no treatment\]), then once weekly for Weeks 1 to 3 of Cycle 2 and beyond in combination with 125 mg/m\^2 nab-paclitaxel as an IV infusion and 1000 mg/m\^2 gemcitabine as an IV infusion, once weekly for Weeks 1 to 3 of all treatment cycles. Treatment was continued until disease progression, unacceptable toxicity, death, or withdrawal of consent (Maximum exposure: 150.1 weeks). | 187 | 325 | EG000 |
| Group 2 | AG: Placebo + Nab-Paclitaxel + Gemcitabine | Participants received placebo matching to PEGPH20 as an IV infusion, twice weekly for Weeks 1 to 3 of Cycle 1 (each cycle consisting of 4 weeks \[Week 4 of every cycle will be a rest week with no treatment\]), then once weekly for Weeks 1 to 3 of Cycle 2 and beyond in combination with 125 mg/m\^2 nab-paclitaxel as an IV infusion and 1000 mg/m\^2 gemcitabine as an IV infusion, once weekly for Weeks 1 to 3 of all treatment cycles. Treatment was continue until disease progression, unacceptable toxicity, death, or withdrawal of consent (Maximum exposure: 83.9 weeks). | 80 | 156 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From administration of first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 150.1 weeks for PAG, and 83.9 weeks for AG)
Source ClinicalTrials.gov
Trial
- Title
A Study of PEGylated Recombinant Human Hyaluronidase in Combination With Nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus Nab-Paclitaxel and Gemcitabine in Participants With Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma
- NCT number
- NCT02715804
- Phases
- PHASE3
- Conditions
- Pancreatic Ductal Carcinoma
- Interventions
- Biological: PEGylated Recombinant Human Hyaluronidase (PEGPH20), Placebo, nab-Paclitaxel, Gemcitabine
- Lead sponsor
- Halozyme Therapeutics
- Results first posted
- 2020-07-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02715804?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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