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: 2025-12-26 @ 12:14 PM
Ignite Modification Date: 2025-12-26 @ 12:14 PM
NCT ID: NCT00839800
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00839800
Study Brief: Study to Investigate the Efficacy of Symbicort® SMART.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Symbicort SMART Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed None None 41 1049 279 1049 View
Symbicort+Terbutaline As Needed Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed None None 74 1042 293 1042 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Breast Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Bronchopneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
H1n1 Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Lower Respiratory Tract Infection Bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Otitis Media Chronic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Pneumonia Bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Septic Shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Tooth Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Varicella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Viral Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Traumatic Brain Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Foot Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Joint Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Lower Limb Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Muscle Strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Patella Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Sternal Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Type 2 Diabetes Mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Diabetes Mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Intervertebral Disc Protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Rheumatoid Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Uterine Leiomyoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Breast Cancer In Situ SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Intestinal Adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Metastatic Neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Rectal Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Abortion Spontaneous SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 13.1 View
Abortion Threatened SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 13.1 View
Premature Baby SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 13.1 View
Major Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Breast Calcifications SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.1 View
Dysfunctional Uterine Bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.1 View
Endometriosis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.1 View
Infertility Male SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.1 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Nasal Septum Deviation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Acute Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Angina Pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Angina Unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Coronary Artery Disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Cleft Lip SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 13.1 View
Meniere's Disease SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 13.1 View
Basedow's Disease SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 13.1 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Retinal Detachment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Abdominal Hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Acute Abdomen SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Anal Fissure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Colonic Polyp SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Gastric Polyps SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Hernia Obstructive SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.1 View
Hepatotoxicity SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.1 View
Drug Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 13.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Tracheobronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Upper Respiratory Tract Infection Bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Acute Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Viral Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View