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 @ 6:32 PM
Ignite Modification Date: 2025-12-25 @ 4:02 PM
NCT ID: NCT01614457
Description: None
Frequency Threshold: 0
Time Frame: Baseline up to follow-up (3 to 4 weeks after last dose [last dose = Week 24])
Study: NCT01614457
Study Brief: Study of Ivacaftor in Subjects With Cystic Fibrosis (CF) Who Have the R117H-CF Transmembrane Conductance Regulator (CFTR) Mutation (KONDUCT)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Placebo matched to ivacaftor tablet orally twice daily for 24 weeks. None None 6 35 35 35 View
Ivacaftor Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks. None None 4 34 32 34 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Infective pulmonary exacerbation of cystic fibrosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Infective pulmonary exacerbation of cystic fibrosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Bacterial disease carrier SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Lip infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Oral fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Otitis externa SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Scarlet fever SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Varicella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Sputum increased SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Nasal oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Rales SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Upper-airway cough syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Nasal mucosal disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Paranasal sinus hypersecretion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Nasal turbinate abnormality SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Pleurisy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Pleuritic pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Respiration abnormal SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Respiratory tract congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Tonsillolith SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Abdominal tenderness SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Loose tooth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Palatal oedema SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Irritability SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Forced expiratory volume decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Blood potassium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Blood calcium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Liver function test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Platelet count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Pulmonary function test decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Urine leukocyte esterase positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
White blood cells urine positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Sinus headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Clubbing SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Exostosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Anal injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Animal bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Hand fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Ligament sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Periorbital haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Tendon rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Drug eruption SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Ingrowing nail SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Pruritus generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Rosacea SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Iron deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Attention deficit/hyperactivity disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Ear congestion SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 15.1 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 15.1 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 15.1 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View