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Comparison · NCT02227992-3aeb425a

EVARREST Sealant Matrix vs SURGICEL Absorbable Hemostat (Control): Number of Participants With AEs That Were Potentially Related To Thrombotic 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. EVARREST Sealant Matrix vs SURGICEL Absorbable Hemostat (Control): Number of Participants With AEs That Were Potentially Related To Thrombotic Events. Trial comparisons, record NCT02227992-3aeb425a. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02227992-3aeb425a

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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 1000.161wilson
Risk in group 2000.161wilson
Risk difference, group 1 minus group 20-0.1610.161newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to treatfrom the risk difference intervalthe two groups' risks are equal

Groups2

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

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1EVARREST Sealant Matrix
Participants with mild or moderate target bleeding site (TBS) were treated with EVARREST which was applied immediately to the actively bleeding TBS. EVARREST Sealant Matrix/Fibrin Sealant Patch was a sterile bio-absorbable combination product consisting of two constituent parts a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
020OG000
Group 2SURGICEL Absorbable Hemostat (Control)
Participants with mild or moderate TBS were treated with SURGICEL which was applied immediately to the actively bleeding TBS. SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) was a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
020OG001

Outcome

Type
SECONDARY
Title
Number of Participants With AEs That Were Potentially Related To Thrombotic Events
Description
Number of participants with AEs that were potentially related to thrombotic events (sponsor assessment) were reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time frame
Up to 44 days post-surgery on Day 0
Population
The safety analysis set consists of all participants who received treatment.

Source ClinicalTrials.gov

Trial

Title
The EVARREST® Paediatric Mild/Moderate Liver and Soft Tissue Bleeding Study
NCT number
NCT02227992
Phases
PHASE3
Conditions
Hemorrhage, Soft Tissue Bleeding, Hepatic Parenchyma Bleeding
Interventions
EVARREST™ Sealant Matrix, SURGICEL®
Lead sponsor
Ethicon, Inc.
Results first posted
2023-09-08

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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