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 @ 11:41 PM
Ignite Modification Date: 2025-12-25 @ 9:32 PM
NCT ID: NCT01140451
Description: The Study 009e As-Treated Population: participants who received at least 1 dose of study drug.
Frequency Threshold: 5
Time Frame: Baseline (Week 1 [Total Study Week 48]) up to 4 Weeks Post-Treatment (Week 100 [Total Study Week 148]) or PD (whichever occurred first)
Study: NCT01140451
Study Brief: Extension Study of Ataluren (PTC124) in 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/Ataluren Participants who received double-blind ataluren during Study 009 continued to receive open-label ataluren taken 3 times per day (TID): 10 milligram (mg)/kilogram (kg) of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total dose 40 mg/kg/day), for up to 96 weeks. Participants were followed for 4 weeks after treatment. None None 48 95 95 95 View
Placebo/Ataluren Participants who received double-blind placebo during Study 009 received open-label ataluren TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total dose 40 mg/kg/day), for up to 96 weeks. Participants were followed for 4 weeks after treatment. None None 57 96 94 96 View
Overall Population Participants who received double-blind ataluren or placebo during Study 009 received open-label ataluren TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total dose 40 mg/kg/day), for up to 96 weeks. Participants were followed for 4 weeks after treatment. None None 105 191 189 191 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 16 View
Cystic fibrosis related diabetes SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 16 View
Distal intestinal obstruction syndrome SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Annual fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Crohn's disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Erosive oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Intussusception SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 16 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 16 View
Jaundice SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 16 View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Mycobacterium abscessus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Anal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Bronchopulmonary aspergillosis allergic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Burkholderia cepacia infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Catheter sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Lobar pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Lung infection pseudomonal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Parainfluenzae virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Respiratory tract infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Viral pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16 View
Bile duct cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16 View
Cauda equina syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16 View
Dysaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16 View
Serotonin syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16 View
Calculus ureteric SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16 View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16 View
Hypercreatininaemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16 View
Nephritis interstitial SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16 View
Cystic fibrosis lung SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16 View
Nasal polyps SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16 View
Axillary vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 16 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 16 View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 16 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Respiratory tract infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Lung infection pseudomonal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Bronchopulmonary aspergillosis allergic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Bronchopulmonary aspergillosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Respiratory tract infection fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Oral fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Pulmonary function test decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16 View
Abnormal loss of weight SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16 View
Hypercreatininaemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16 View
Cystic fibrosis lung SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16 View
Rales SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16 View
Nasal polyps SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16 View
Respiratory tract congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 16 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 16 View