Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 11:43 PM
Ignite Modification Date: 2025-12-25 @ 9:35 PM
NCT ID: NCT00477451
Description: Adverse events (AEs) were assessed predose and at 13 pre-specified time points as well as whenever spontaneously reported by the subjects or study staff
Frequency Threshold: 5
Time Frame: Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment
Study: NCT00477451
Study Brief: Staccato Alprazolam in Panic Attack
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
RCT Placebo Subjects received inhaled placebo after 0.5 mg/kg doxapram IV in the randomized controlled trial Inhaled placebo: Inhaled Staccato Alprazolam Placebo IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo 0 None 0 20 2 20 View
RCT Alprazolam 1 mg Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the randomized controlled trial Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo 0 None 0 20 11 20 View
Open Label Inhaled Alprazolam 1 mg Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the open label dose validation Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo 0 None 0 7 1 7 View
Initial Inhaled Alprazolam 2 mg Subjects received 2 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the initial open label dose assessment Inhaled alprazolam 2 mg: Inhaled Staccato Alprazolam 2 mg IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo 0 None 0 2 1 2 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dysgeusia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
HYPOAESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
SEDATION SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.0) View