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Comparison · NCT04754802-sae

PH94B 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. PH94B vs Placebo: serious adverse events. Trial comparisons, record NCT04754802-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04754802-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 100.000000000000000003470.0335wilson
Risk in group 200.000000000000000003470.0332wilson
Risk difference, group 1 minus group 20-0.03320.0335newcombe 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 1PH94B3.2 micrograms PH94B intranasal spray (100 microliters to each nostril) one time~PH94B Nasal Spray: Nasal spray delivered 20 minutes before the public speaking stressor0111EG000
Group 2PlaceboPlacebo intranasal spray (100 microliters to each nostril) one time~Placebo Nasal Spray: Nasal spray delivered 20 minutes before the public speaking stressor0112EG001

Harm

What it counts
Total, serious adverse events
Time frame

Source ClinicalTrials.gov

Trial

Title
PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge
NCT number
NCT04754802
Phases
PHASE3
Conditions
Social Anxiety Disorder
Interventions
PH94B Nasal Spray, Placebo Nasal Spray
Lead sponsor
VistaGen Therapeutics, Inc.
Results first posted
2025-09-12

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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