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Comparison · NCT00811720-sae

Nalmefene 18.06 mg vs Placebo: 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. Nalmefene 18.06 mg vs Placebo: serious adverse events. Trial comparisons, record NCT00811720-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00811720-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 10.05630.03540.0883wilson
Risk in group 20.06080.03880.0941wilson
Risk difference, group 1 minus group 2-0.00452-0.04380.0343newcombe hybrid score
Risk ratio, group 1 over group 20.9260.4871.76log
Odds ratio, group 1 over group 20.9210.4651.82log
Number needed to treat, for one fewer participant with a serious adverse event on Nalmefene 18.06 mg than on Placebo221from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Nalmefene 18.06 mg17302EG001
Group 2Placebo18296EG000

Harm

What it counts
Total, serious adverse events
Time frame
Serious Adverse Events: 24 weeks, a 4-week run-out period, and a safety follow-up (visit/telephone call) scheduled for 4 weeks after completion of the study or after withdrawal from the study. Other Adverse Events: 24 weeks and a 4-week run-out period.

Source ClinicalTrials.gov

Trial

Title
Efficacy of Nalmefene in Patients With Alcohol Dependence
NCT number
NCT00811720
Phases
PHASE3
Conditions
Alcohol Dependence
Interventions
Placebo, Nalmefene
Lead sponsor
H. Lundbeck A/S
Results first posted
2013-07-09

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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