Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 2:09 PM
Ignite Modification Date: 2025-12-25 @ 12:50 PM
NCT ID: NCT01746095
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01746095
Study Brief: Efficacy and Safety Study of AeroVanc for the Treatment of Persistent MRSA Lung Infection in Cystic Fibrosis Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AeroVanc 32 mg Vancomycin hydrochloride inhalation powder 32 mg BID 0 None 4 20 18 20 View
Placebo to 32 mg Placebo inhalation powder BID 0 None 2 20 18 20 View
AeroVanc 64 mg Vancomycin hydrochloride inhalation powder 64 mg BID 0 None 1 24 20 24 View
Placebo to 64 mg Placebo inhalation powder BID 0 None 4 23 19 23 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Infective pulmonary exacerbation of cystic fibrosis None Infections and infestations None View
Pneumonia None Infections and infestations None View
Pleural effusion None Respiratory, thoracic and mediastinal disorders None View
Hyperglycemia None Metabolism and nutrition disorders None View
Pain None General disorders None View
Infective exacerbation of bronchiectasis None Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Chest discomfort None General disorders None View
Muscle strain None Injury, poisoning and procedural complications None View
Dysuria None Renal and urinary disorders None View
Hematuria None Renal and urinary disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Respiratory tract congestion None Respiratory, thoracic and mediastinal disorders None View
Sputum increased None Respiratory, thoracic and mediastinal disorders None View
Dyspnoea exertional None Respiratory, thoracic and mediastinal disorders None View
Paranasal sinus hypersecretion None Respiratory, thoracic and mediastinal disorders None View
Increased viscosity of bronchial secretion None Respiratory, thoracic and mediastinal disorders None View
Dyspnoea None Respiratory, thoracic and mediastinal disorders None View
Haemoptysis None Respiratory, thoracic and mediastinal disorders None View
Fatigue None General disorders None View
Exercise tolerance decreased None General disorders None View
Infective pulmonary exacerbation of cystic fibrosis None Infections and infestations None View
Forced expiratory volume decreased None Investigations None View
Weight decreased None Investigations None View
Sinus headache None Nervous system disorders None View
Decreased appetite None Metabolism and nutrition disorders None View
Diarrhoea None Gastrointestinal disorders None View
Sputum discoloured None Respiratory, thoracic and mediastinal disorders None View
Wheezing None Respiratory, thoracic and mediastinal disorders None View
Bronchospasm None Respiratory, thoracic and mediastinal disorders None View
Oropharyngeal pain None Respiratory, thoracic and mediastinal disorders None View
Rales None Respiratory, thoracic and mediastinal disorders None View
Rhinorrhoea None Respiratory, thoracic and mediastinal disorders None View
Rhinitis allergic None Respiratory, thoracic and mediastinal disorders None View
Throat tightness None Respiratory, thoracic and mediastinal disorders None View
Malaise None General disorders None View
Pain None General disorders None View
Product taste abnormal None General disorders None View
Nasopharyngitis None Infections and infestations None View
Upper respiratory tract infection None Infections and infestations None View
Vulvovaginal mycotic infection None Infections and infestations None View
Blood potassium increased None Investigations None View
Peak expiratory flow rate decreased None Investigations None View
Pulmonary function test decreased None Investigations None View
Dysgeusia None Nervous system disorders None View
Headache None Nervous system disorders None View
Lethargy None Nervous system disorders None View
Abdominal pain upper None Gastrointestinal disorders None View
Constipation None Gastrointestinal disorders None View
Pruritus None Skin and subcutaneous tissue disorders None View
Jaw cyst None Musculoskeletal and connective tissue disorders None View