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Comparison · NCT01565941-sae

Tight Glycemic Control 1 (TGC-1) vs Tight Glycemic Control 2 (TGC-2): 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. Tight Glycemic Control 1 (TGC-1) vs Tight Glycemic Control 2 (TGC-2): serious adverse events. Trial comparisons, record NCT01565941-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01565941-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 10.05160.03290.08wilson
Risk in group 20.02010.009750.0408wilson
Risk difference, group 1 minus group 20.03150.003580.0618newcombe hybrid score
Risk ratio, group 1 over group 22.571.096.08log
Odds ratio, group 1 over group 22.661.16.44log
Number needed to harm, for one more participant with a serious adverse event on Tight Glycemic Control 1 (TGC-1) than on Tight Glycemic Control 2 (TGC-2)31.716.2280from 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 1Tight Glycemic Control 1 (TGC-1)
Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-1 which will seek to maintain the subject's blood sugar between 80-110 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 80-110 mg/dL
18349EG000
Group 2Tight Glycemic Control 2 (TGC-2)
Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-2 which will seek to maintain the subject's blood sugar between 150-180 mg/dL. Intravenous insulin may be administered per insulin algorithm.~Insulin: IV insulin titration to target a blood glucose of 150-180 mg/dL
7349EG001

Harm

What it counts
Total, serious adverse events
Time frame
Entire course of protocol, up to 28 days

Source ClinicalTrials.gov

Trial

Title
Heart And Lung Failure - Pediatric INsulin Titration Trial
NCT number
NCT01565941
Phases
PHASE3
Conditions
Heart Failure, Respiratory Failure
Interventions
Insulin, Insulin
Lead sponsor
Boston Children's Hospital
Results first posted
2017-12-11

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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