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 @ 12:43 AM
Ignite Modification Date: 2025-12-25 @ 10:55 PM
NCT ID: NCT01082367
Description: None
Frequency Threshold: 3
Time Frame: None
Study: NCT01082367
Study Brief: Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DB TOBI DB TOBI None None 0 32 12 32 View
DB Placebo DB Placebo None None 1 38 18 38 View
OL TOBI (Core) OL TOBI (core) None None 0 22 10 22 View
OL TOBI (Follow-up) OL TOBI (follow-up) None None 0 10 2 10 View
Off-treatment (Follow-up) Off-treatment (follow-up) None None 4 29 23 29 View
Off-treatment (Core) Off-treatment (core) None None 2 50 13 50 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Glucose-6-phosphate dehydrogenase deficiency SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Croup infectious SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lower respiratory tract infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Haemolytic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Bacterial disease carrier SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchopneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Infective pulmonary exacerbation of cystic fibrosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pseudomonas infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Stridor SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Eye discharge SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Faeces soft SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Oral mucosal eruption SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Teething SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Food allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Eye infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lobar pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lower respiratory tract infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Perineal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pseudomonas infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory tract infection viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Varicella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Foreign body SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Upper limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Acinetobacter test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Aspergillus test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Pseudomonas test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Streptococcus test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Bruxism SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Catarrh SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Increased bronchial secretion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nasal dryness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Snoring SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View