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Comparison · NCT01028677-sae

Intranasal Spray With Oxytocin vs Intranasal Spray Without Oxytocin: 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. Intranasal Spray With Oxytocin vs Intranasal Spray Without Oxytocin: serious adverse events. Trial comparisons, record NCT01028677-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01028677-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 1000.278wilson
Risk in group 200.00000000000000005550.354wilson
Risk difference, group 1 minus group 20-0.3540.278newcombe 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

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Intranasal Spray With OxytocinTwice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks~intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks010EG000
Group 2Intranasal Spray Without Oxytocin
Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.~nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks
07EG001

Harm

What it counts
Total, serious adverse events
Time frame

Source ClinicalTrials.gov

Trial

Title
Oxytocin Treatment of Schizophrenia
NCT number
NCT01028677
Phases
NA
Conditions
Paranoia, Schizophrenia, Schizoaffective Disorder
Interventions
intranasal spray with oxytocin, nasal spray without oxytocin
Lead sponsor
University of North Carolina, Chapel Hill
Results first posted
2017-04-18

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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