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Comparison · NCT03229538-36f66a13

Methylprednisolone Arm vs Placebo Arm: Number of Participants With Mortality, Including In-hospital Mortality or Mortality After Hospital Discharge But Within 30 Days of the Last Dose of Study Drug

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. Methylprednisolone Arm vs Placebo Arm: Number of Participants With Mortality, Including In-hospital Mortality or Mortality After Hospital Discharge But Within 30 Days of the Last Dose of Study Drug. Trial comparisons, record NCT03229538-36f66a13. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03229538-36f66a13

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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 10.020.01150.0347wilson
Risk in group 20.02830.01770.0448wilson
Risk difference, group 1 minus group 2-0.00825-0.02690.0098newcombe hybrid score
Risk ratio, group 1 over group 20.7080.3411.47log
Odds ratio, group 1 over group 20.7020.3321.48log
Number needed to treat, for one fewer participant with the outcome on Methylprednisolone Arm than on Placebo Arm121from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Methylprednisolone ArmIV Methylprednisolone~Methylprednisolone: IV Steroid pre-operative and intra-operative12599OG000
Group 2Placebo ArmIV Isotonic Saline~Isotonic saline: Isotonic saline pre-operative and intra-operative17601OG001

Outcome

Type
SECONDARY
Title
Number of Participants With Mortality, Including In-hospital Mortality or Mortality After Hospital Discharge But Within 30 Days of the Last Dose of Study Drug
Description
Time frame
up to 30 days
Population

Source ClinicalTrials.gov

Trial

Title
STeroids to REduce Systemic Inflammation After Infant Heart Surgery
NCT number
NCT03229538
Phases
PHASE3
Conditions
Congenital Heart Disease in Children, Inflammatory Response
Interventions
Methylprednisolone, Isotonic saline
Lead sponsor
Kevin Hill
Results first posted
2023-05-10

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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