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 @ 6:50 PM
Ignite Modification Date: 2025-12-25 @ 4:23 PM
NCT ID: NCT03938857
Description: No participants were enrolled in the Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) group.
Frequency Threshold: 0
Time Frame: Up to 28 days or until discharge from the ICU (whichever is first)
Study: NCT03938857
Study Brief: DOSE Trial of Opioid Sparing Effect
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr) Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr) 0 None 2 12 9 12 View
Fen. SOC+Saline Placebo (Bolus+Infusion) Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion) Fentanyl: Fentanyl standard of care 0 None 0 6 4 6 View
Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr) Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr) 0 None 1 12 8 12 View
Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion) Fentanyl: Fentanyl standard of care Dexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr) 0 None 0 0 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
General signs and symptoms NEC NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA High Level View
Colitis (excl infective) NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA High Level View
Seizures and seizure disorder NEC NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA High Level View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Encephalopathies NEC NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA High Level View
Anaesthetic and allied procedural complications NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA High Level View
Anxiety symptoms NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA High Level View
Bladder and urethral symptoms NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA High Level View
Colitis (excl infective) NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA High Level View
Conditions associated with abnormal gas exchange NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA High Level View
Febrile disorders NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA High Level View
General signs and symptoms NEC NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA High Level View
Heart rate and pulse investigations NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA High Level View
Hepatic failure and associated disorders NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA High Level View
Laryngeal spasm, oedema and obstruction NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA High Level View
Magnesium metabolism disorders NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA High Level View
Nausea and vomiting symptoms NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA High Level View
Parainfluenzae viral infections NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA High Level View
Pneumothorax and pleural effusions NEC NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA High Level View
Protein metabolism disorders NEC NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA High Level View
Rate and rhythm disorders NEC NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA High Level View
Renal failure and impairment NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA High Level View
Respiratory tract and thoracic cavity procedural complications NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA High Level View
Seizures and seizure disorders NEC NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA High Level View
Stereotypies and automatisms NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA High Level View
Tremor (excl congenital) NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA High Level View
Vascular hypotensive disorders NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA High Level View