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Comparison · NCT01839487-deaths

PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine vs AG: Nab-paclitaxel + Gemcitabine: deaths from any cause

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: Nab-paclitaxel + Gemcitabine: deaths from any cause. Trial comparisons, record NCT01839487-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01839487-deaths

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.7890.7210.844wilson
Risk in group 20.770.6840.838wilson
Risk difference, group 1 minus group 20.0192-0.07710.121newcombe hybrid score
Risk ratio, group 1 over group 21.020.9021.16log
Odds ratio, group 1 over group 21.120.6291.99log
Number needed to harm, for one more death from any cause on PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine than on AG: Nab-paclitaxel + Gemcitabine52from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine
Participants received 3.0 mcg/kg PEGPH20 with 125 mg/m\^2 NAB and 1000 mg/m\^2 GEM as an IV infusion. In Cycle 1 Week 1, PEGPH20 was given alone on Days 1 and 4 and NAB+GEM was given on Day 2 at approximately 24 hours after the first dose of PEGPH20. In Cycle 1 Weeks 2 and 3, PEGPH20 was given twice/week on Days 8, 11, 15, and 18 and NAB+GEM were given once/week at 2 to 4 hours after PEGPH20 administration on Days 8 and 15. In Cycle 2 onwards, PEGPH20, NAB, and GEM were given once/week on Days 1, 8, and 15. NAB+GEM were given 2 to 4 hours after the dose of PEGPH20. Each cycle was of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment was given). Treatment was continued until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg was given in each cycle within 2 hours prior to the beginning and 8 to 12 hours after the completion of each PEGPH20 infusion.
131166EG000
Group 2AG: Nab-paclitaxel + Gemcitabine
Participants received 125 mg/m\^2 NAB and 1000 mg/m\^2 GEM as an IV infusion once weekly on Days 1, 8, and 15 of each cycle. Each cycle was of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment was given). Treatment was continued until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg was given in each cycle within 2 hours prior to the beginning of each NAB infusion and 8 to 12 hours after the completion of GEM infusion.
87113EG001

Harm

What it counts
Total, all-cause mortality
Time frame
From first exposure to any study drug (PEGPH20, NAB, GEM) through 30 days after end of treatment visit (maximum exposure: 30.72 months for PAG and 20.27 months for AG)

Source ClinicalTrials.gov

Trial

Title
PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Participants With Stage IV Untreated Pancreatic Cancer
NCT number
NCT01839487
Phases
PHASE2
Conditions
Metastatic Pancreatic Cancer
Interventions
PEGPH20, Nab-paclitaxel, Gemcitabine, Dexamethasone, Enoxaparin
Lead sponsor
Halozyme Therapeutics
Results first posted
2020-07-20

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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