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Comparison · NCT00844649-sae

Albumin-bound Paclitaxel (ABI-007)/Gemcitabine 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

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ConductScience Library. Albumin-bound Paclitaxel (ABI-007)/Gemcitabine vs Gemcitabine: serious adverse events. Trial comparisons, record NCT00844649-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00844649-sae

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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 10.5040.4560.551wilson
Risk in group 20.4280.380.477wilson
Risk difference, group 1 minus group 20.07570.007530.143newcombe hybrid score
Risk ratio, group 1 over group 21.181.021.36log
Odds ratio, group 1 over group 21.361.031.79log
Number needed to harm, for one more participant with a serious adverse event on Albumin-bound Paclitaxel (ABI-007)/Gemcitabine than on Gemcitabine13.27133from the risk difference interval

Groups2

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

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Albumin-bound Paclitaxel (ABI-007)/Gemcitabine
Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m\^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m\^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
212421EG000
Group 2Gemcitabine
Gemcitabine 1000 mg/m\^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
172402EG001

Harm

What it counts
Total, serious adverse events
Time frame
Day 1 up to 30 days after the last dose (a maximum of 666 days)

Source ClinicalTrials.gov

Trial

Title
Phase III Study of ABI-007(Albumin-bound Paclitaxel) Plus Gemcitabine Versus Gemcitabine in Metastatic Adenocarcinoma of the Pancreas
NCT number
NCT00844649
Phases
PHASE3
Conditions
Metastatic Pancreatic Cancer
Interventions
Albumin-bound paclitaxel (ABI-007), Gemcitabine
Lead sponsor
Celgene
Results first posted
2013-12-11

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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