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 @ 7:42 PM
Ignite Modification Date: 2025-12-25 @ 5:21 PM
NCT ID: NCT02456103
Description: Adverse events collected from participants who received at least 1 dose of ataluren (As-Treated Population).
Frequency Threshold: 5
Time Frame: Baseline up to Week 100
Study: NCT02456103
Study Brief: Extension Study of Ataluren in Participants With Nonsense Mutation Cystic Fibrosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ataluren Participants were administered ataluren orally at a dose of 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening for up to 96 weeks. 1 None 89 245 191 245 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bronchopulmonary aspergillosis allergic SYSTEMATIC_ASSESSMENT Infections and infestations 17.0 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations 17.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations 17.0 View
Infective pulmonary exacerbation of cystic fibrosis SYSTEMATIC_ASSESSMENT Infections and infestations 17.0 View
Mycobacterium abscessus infection SYSTEMATIC_ASSESSMENT Infections and infestations 17.0 View
Peritonitis SYSTEMATIC_ASSESSMENT Infections and infestations 17.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations 17.0 View
Pseudomonas infection SYSTEMATIC_ASSESSMENT Infections and infestations 17.0 View
Respiratory syncytial virus infection SYSTEMATIC_ASSESSMENT Infections and infestations 17.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations 17.0 View
Viral pericarditis SYSTEMATIC_ASSESSMENT Infections and infestations 17.0 View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 17.0 View
Distal intestinal obstruction syndrome SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 17.0 View
Duodenal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 17.0 View
Enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 17.0 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 17.0 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 17.0 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 17.0 View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 17.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 17.0 View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 17.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 17.0 View
Forced expiratory volume decreased SYSTEMATIC_ASSESSMENT Investigations 17.0 View
Protein urine present SYSTEMATIC_ASSESSMENT Investigations 17.0 View
Pseudomonas test positive SYSTEMATIC_ASSESSMENT Investigations 17.0 View
Pulmonary function test decreased SYSTEMATIC_ASSESSMENT Investigations 17.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders 17.0 View
Renal colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders 17.0 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders 17.0 View
Cystic fibrosis lung SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders 17.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 17.0 View
Squamous cell carcinoma of the cervix SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 17.0 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders 17.0 View
Pregnancy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions 17.0 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations 17.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Infective pulmonary exacerbation of cystic fibrosis SYSTEMATIC_ASSESSMENT Infections and infestations 17.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations 17.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations 17.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 17.0 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 17.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 17.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 17.0 View
Forced expiratory volume decreased SYSTEMATIC_ASSESSMENT Investigations 17.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders 17.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 17.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders 17.0 View