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Comparison · NCT02495285-2160655a

Gelofusine 4% vs Gelaspan 4%: Number of Participants With (Serious) Adverse Events / Reactions

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. Gelofusine 4% vs Gelaspan 4%: Number of Participants With (Serious) Adverse Events / Reactions. Trial comparisons, record NCT02495285-2160655a. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02495285-2160655a

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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 10.008260.001460.0453wilson
Risk in group 20.008330.003250.0212wilson
Risk difference, group 1 minus group 2-0.0000689-0.01460.0373newcombe hybrid score
Risk ratio, group 1 over group 20.9920.1128.79log
Odds ratio, group 1 over group 20.9920.118.95log
Number needed to treat, for one fewer participant with the outcome on Gelofusine 4% than on Gelaspan 4%14,500from 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 1Gelofusine 4%Children age ≤ 12 years~Gelofusine 4%1121OG000
Group 2Gelaspan 4%Children age ≤ 12 years~Gelaspan 4%4480OG001

Outcome

Type
SECONDARY
Title
Number of Participants With (Serious) Adverse Events / Reactions
Description
Time frame
Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions
Population

Source ClinicalTrials.gov

Trial

Title
Gelatines in Pediatric PatientS
NCT number
NCT02495285
Phases
Conditions
Treatment of Hypovolemia and Shock
Interventions
Gelofusine 4%, Gelaspan 4%
Lead sponsor
B. Braun Melsungen AG
Results first posted
2024-12-04

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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