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Comparison · NCT01968187-deaths

Carbetocin (FE 992097) vs Placebo: deaths from any cause

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. Carbetocin (FE 992097) vs Placebo: deaths from any cause. Trial comparisons, record NCT01968187-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01968187-deaths

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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 1000.184wilson
Risk in group 2000.161wilson
Risk difference, group 1 minus group 20-0.1610.184newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to harmfrom the risk difference intervalthe two groups' risks are equal

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Carbetocin (FE 992097)
Each spray pump actuation delivered a 50 μL volume of solution containing 1.6 mg carbetocin (FE 992097); each dose consisted of 3 spray pump actuations in each nostril delivering a total of 9.6 mg carbetocin.~Parents were instructed to administer 3 intranasal spray actuations in each nostril 3 times daily before meals for 14 days.
017EG000
Group 2Placebo
Each spray pump actuation delivered a 50 μL volume of sterile sodium chloride solution 0.9%; each dose consisted of 3 spray pump actuations in each nostril.~Parents were instructed to administer 3 intranasal spray actuations in each nostril 3 times daily before meals for 14 days.
020EG001

Harm

What it counts
Total, all-cause mortality
Time frame
The adverse events (AEs) were recorded from signing of the informed consent until the Day 19 follow-up phone call.

Source ClinicalTrials.gov

Trial

Title
Treatment of Hyperphagia Behavioral Symptoms in Children and Adults Diagnosed With Prader-Willi Syndrome
NCT number
NCT01968187
Phases
PHASE2
Conditions
Hyperphagia in Prader-Willi Syndrome
Interventions
FE 992097, Placebo
Lead sponsor
Ferring Pharmaceuticals
Results first posted
2025-03-27

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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