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Comparison · NCT02474407-sae

Diazepam Nasal Spray vs Diazepam Rectal Gel: 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. Diazepam Nasal Spray vs Diazepam Rectal Gel: serious adverse events. Trial comparisons, record NCT02474407-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02474407-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 1000.0469wilson
Risk in group 2000.0469wilson
Risk difference, group 1 minus group 20-0.04690.0469newcombe 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 1Diazepam Nasal SprayOne dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.~Diazepam Nasal Spray078EG000
Group 2Diazepam Rectal GelA single rectal dose of diazepam will be administered to subjects according to the Diastat prescribing information.~Diazepam Rectal Gel078EG001

Harm

What it counts
Total, serious adverse events
Time frame
31 Days

Source ClinicalTrials.gov

Trial

Title
Bioavailability, Safety and Tolerability of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat®)
NCT number
NCT02474407
Phases
PHASE2
Conditions
Refractory Epilepsy
Interventions
diazepam nasal spray, diazepam rectal gel
Lead sponsor
Acorda Therapeutics
Results first posted
2018-10-16

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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