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 @ 5:17 PM
Ignite Modification Date: 2025-12-25 @ 2:54 PM
NCT ID: NCT00875550
Description: None
Frequency Threshold: 1.1
Time Frame: None
Study: NCT00875550
Study Brief: Study Evaluating Safety and Efficacy of Dexmedetomidine (DEX) in Intubated and Mechanically Ventilated Pediatric Intensive Care Unit (PICU) Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dexmedetomidine Low Dose Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr) Midazolam: Rescue medication for sedation according to UMSS scores Fentanyl: Rescue medication for pain based on UMSS scores Morphine: Rescue medication for pain based on UMSS scores. None None 1 89 48 89 View
Dexmedetomidine High Dose Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr) Midazolam: Rescue medication for sedation according to UMSS scores Fentanyl: Rescue medication for pain based on UMSS scores Morphine: Rescue medication for pain based on UMSS scores. None None 1 86 43 86 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Apnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Drug withdrawal syndrome SYSTEMATIC_ASSESSMENT General disorders None View
General symptom SYSTEMATIC_ASSESSMENT General disorders None View
Inflammation SYSTEMATIC_ASSESSMENT General disorders None View
Infusion site extravasation SYSTEMATIC_ASSESSMENT General disorders None View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders None View
Device electrical finding SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Endotracheal intubation complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Activated partial thromboplastin time prolonged SYSTEMATIC_ASSESSMENT Investigations None View
Alanine aminotransferase abnormal SYSTEMATIC_ASSESSMENT Investigations None View
Base excess decreased SYSTEMATIC_ASSESSMENT Investigations None View
Blood albumin abnormal SYSTEMATIC_ASSESSMENT Investigations None View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood cortisol increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood culture positive SYSTEMATIC_ASSESSMENT Investigations None View
Blood fibrinogen decreased SYSTEMATIC_ASSESSMENT Investigations None View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood magnesium abnormal SYSTEMATIC_ASSESSMENT Investigations None View
Blood magnesium decreased SYSTEMATIC_ASSESSMENT Investigations None View
Blood pH decreased SYSTEMATIC_ASSESSMENT Investigations None View
Blood phosphorus decreased SYSTEMATIC_ASSESSMENT Investigations None View
Blood potassium abnormal SYSTEMATIC_ASSESSMENT Investigations None View
Blood pressure diastolic decreased SYSTEMATIC_ASSESSMENT Investigations None View
Carbon dioxide decreased SYSTEMATIC_ASSESSMENT Investigations None View
Central venous pressure decreased SYSTEMATIC_ASSESSMENT Investigations None View
Culture positive SYSTEMATIC_ASSESSMENT Investigations None View
Culture urine positive SYSTEMATIC_ASSESSMENT Investigations None View
Electrocardiogram SYSTEMATIC_ASSESSMENT Investigations None View
Electrocardiogram ST segment elevation SYSTEMATIC_ASSESSMENT Investigations None View
Haematocrit decreased SYSTEMATIC_ASSESSMENT Investigations None View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations None View
Heart rate decreased SYSTEMATIC_ASSESSMENT Investigations None View
Heart rate irregular SYSTEMATIC_ASSESSMENT Investigations None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Platelet count increased SYSTEMATIC_ASSESSMENT Investigations None View
Red blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Respiratory rate decreased SYSTEMATIC_ASSESSMENT Investigations None View
Sputum culture positive SYSTEMATIC_ASSESSMENT Investigations None View
Urine output decreased SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations None View
Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperammonaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Crying SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Status epilepticus SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bradypnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Haemothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal ulcer SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumomediastinum SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory acidosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory tract inflammation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Stridor SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tachypnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dermatitis diaper SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Subcutaneous emphysema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
PCO2 increased SYSTEMATIC_ASSESSMENT Investigations None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Nodal rhythm SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Parainfluenzae virus infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oxygen saturation decreased SYSTEMATIC_ASSESSMENT Investigations None View