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Comparison · NCT03538431-sae

Buspirone vs Unmedicated: 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. Buspirone vs Unmedicated: serious adverse events. Trial comparisons, record NCT03538431-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03538431-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 1000.129wilson
Risk in group 2000.129wilson
Risk difference, group 1 minus group 20-0.1290.129newcombe 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 1BuspironeThese subjects received buspirone either before driving simulation visit 1 or before driving simulation 2.026EG000
Group 2UnmedicatedThese subjects received no medication either before driving simulation visit 1 or before driving simulation 2.026EG001

Harm

What it counts
Total, serious adverse events
Time frame
Adverse event data was collected for each participant between the date the participant enrolled in the study and the date the participant completed the study. The precise time frame of this window differed by participant depending on their availability to schedule the driving simulations. On average, adverse event data were collected over a period of 7.2 weeks.

Source ClinicalTrials.gov

Trial

Title
Improving Driving in Young People With Autism Spectrum Disorders
NCT number
NCT03538431
Phases
PHASE4
Conditions
Autism Spectrum Disorder
Interventions
Buspirone
Lead sponsor
Massachusetts General Hospital
Results first posted
2021-03-18

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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