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Comparison · NCT02509078-sae

Early Neuromuscular Blockade (NMB) vs Control: No Routine Early NMB: 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. Early Neuromuscular Blockade (NMB) vs Control: No Routine Early NMB: serious adverse events. Trial comparisons, record NCT02509078-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02509078-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 10.05590.03890.0796wilson
Risk in group 20.04160.02740.0627wilson
Risk difference, group 1 minus group 20.0143-0.01280.0419newcombe hybrid score
Risk ratio, group 1 over group 21.340.7742.33log
Odds ratio, group 1 over group 21.360.7642.44log
Number needed to harm, for one more participant with a serious adverse event on Early Neuromuscular Blockade (NMB) than on Control: No Routine Early NMB69.9from 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 1Early Neuromuscular Blockade (NMB)
Patients will receive cisastracurium besylate for the first 48 hours of the trial.~cisastracurium besylate: Patients randomized to the early neuromuscular blockade arm will receive a cisastracurium besylate bolus of 15 mg, followed by a continuous infusion of 37.5 mg/hour for 48 hours. Patients randomized to the control arm will receive no protocol specified neuromuscular blockade.
28501EG000
Group 2Control: No Routine Early NMBUse of non-study NMB will be discouraged. Patients randomized to the control arm will receive no protocol specified neuromuscular blockade.21505EG001

Harm

What it counts
Total, serious adverse events
Time frame
Subjects were assessed for occurrence of adverse events from time of randomization through study day 7 (five days after infusion of study drug) or ICU discharge, whichever occurred first.

Source ClinicalTrials.gov

Trial

Title
Reevaluation Of Systemic Early Neuromuscular Blockade
NCT number
NCT02509078
Phases
PHASE3
Conditions
Acute Respiratory Distress Syndrome
Interventions
Cisatracurium Besylate
Lead sponsor
Massachusetts General Hospital
Results first posted
2019-08-13

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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