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: 2025-12-25 @ 3:03 AM
Ignite Modification Date: 2025-12-26 @ 1:43 AM
NCT ID: NCT02162433
Description: None
Frequency Threshold: 0
Time Frame: 24 hours post-op
Study: NCT02162433
Study Brief: The Effect of Dexmedetomidine on Airway Complications After Deep or Awake Extubation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
1. Awake Extubation/Dexmedetomidine Awake extubation receiving dexmedetomidine. Dexmedetomidine: to arms 1,3 0 None 0 22 13 22 View
2. Awake Extubation/Placebo Awake extubation receiving placebo (normal saline). Normal Saline: to arms 2,4. Serves as the placebo. 0 None 0 21 15 21 View
3.Deep Extubation/Dexmedetomidine Deep extubation receiving dexmedetomidine. Dexmedetomidine: to arms 1,3 0 None 0 21 13 21 View
4. Deep Extubation/Placebo Deep extubation receiving placebo (normal saline). Normal Saline: to arms 2,4. Serves as the placebo. 0 None 0 22 17 22 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Post-extubation persistent cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
PACU persistent cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Post-extubation low SaO2 NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
PACU low SaO2 NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Laryngospasm NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nausea/Vomiting NON_SYSTEMATIC_ASSESSMENT General disorders None View
Post-Extubation Stridor NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
PACU stridor NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Post-Extubation Croup NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
PACU Croup NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Post-Extubation Breath Holding NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
PACU Breath Holding NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tonsil Bleed NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View