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 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
NCT ID:
NCT02544451
Description:
Only serious adverse events were collected for the observational cohort. Non-serious AEs were not collected and are not reported for the observational cohort. Adverse events reported based on MedDRA version 21.0 for Treatment Period 1 and MedDRA version 22.1 for Treatment Period 2.
Frequency Threshold:
5
Time Frame:
Treatment Period 1: Day 1 up to Week 100, Treatment Period 2: Day 1 up to Week 168
Study:
NCT02544451
Study Brief:
Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Treatment Period 1: LUM/IVA to LUM/IVA | Participants received LUM/IVA in parent studies (109, 011B) and continued to receive LUM/IVA for 96 weeks in the current study. | 0 | None | 43 | 143 | 141 | 143 | View |
| Treatment Period 1: PBO to LUM/IVA | Participants received PBO in parent study (109) and then received LUM/IVA for 96 weeks in the current study. | 0 | None | 29 | 96 | 93 | 96 | View |
| Treatment Period 1: Observational Cohort | Participants completed a parent study (109, 011B) but were not eligible or elected to not receive LUM/IVA for 96 weeks in the current study. | 0 | None | 1 | 6 | 0 | 0 | View |
| Treatment Period 2: LUM/IVA | Eligible subjects from Treatment Period 1 received LUM/IVA for up to approximately 168 weeks. | 0 | None | 0 | 10 | 9 | 10 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Bronchopulmonary aspergillosis allergic | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.0, 22.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.0, 22.1 | View |
| Infective pulmonary exacerbation of cystic fibrosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.0, 22.1 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.0, 22.1 | View |
| Atypical mycobacterial lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.0, 22.1 | View |
| Gastroenteritis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.0, 22.1 | View |
| Lower respiratory tract infection bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.0, 22.1 | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.0, 22.1 | View |
| Pulmonary function test decreased | SYSTEMATIC_ASSESSMENT | Investigations | 21.0, 22.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 21.0, 22.1 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 21.0, 22.1 | View |
| Pseudomonas test positive | SYSTEMATIC_ASSESSMENT | Investigations | 21.0, 22.1 | View |
| Atypical mycobacterium test positive | SYSTEMATIC_ASSESSMENT | Investigations | 21.0, 22.1 | View |
| Oxygen saturation decreased | SYSTEMATIC_ASSESSMENT | Investigations | 21.0, 22.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.0, 22.1 | View |
| Distal intestinal obstruction syndrome | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.0, 22.1 | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.0, 22.1 | View |
| Pleuritic pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.0, 22.1 | View |
| Sinus disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.0, 22.1 | View |
| Cystic fibrosis hepatic disease | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | 21.0, 22.1 | View |
| Cystic fibrosis lung | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | 21.0, 22.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 21.0, 22.1 | View |
| Intentional overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 21.0, 22.1 | View |
| Diabetic ketoacidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 21.0, 22.1 | View |
| Lymphadenitis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 21.0, 22.1 | View |
| Autoimmune hepatitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 21.0, 22.1 | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 21.0, 22.1 | View |
| Oesophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.0, 22.1 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 21.0, 22.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Infective pulmonary exacerbation of cystic fibrosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.0, 22.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.0, 22.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.0, 22.1 | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.0, 22.1 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.0, 22.1 | View |
| Otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.0, 22.1 | View |
| Pharyngitis streptococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.0, 22.1 | View |
| Bacterial disease carrier | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.0, 22.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.0, 22.1 | View |
| Ear infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.0, 22.1 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.0, 22.1 | View |
| Upper respiratory tract infection bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.0, 22.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.0, 22.1 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.0, 22.1 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.0, 22.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.0, 22.1 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.0, 22.1 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.0, 22.1 | View |
| Sputum increased | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.0, 22.1 | View |
| Sinus congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.0, 22.1 | View |
| Nasal polyps | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.0, 22.1 | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.0, 22.1 | View |
| Respiration abnormal | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.0, 22.1 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.0, 22.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.0, 22.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.0, 22.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.0, 22.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.0, 22.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.0, 22.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.0, 22.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.0, 22.1 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.0, 22.1 | View |
| Bacterial test positive | SYSTEMATIC_ASSESSMENT | Investigations | 21.0, 22.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 21.0, 22.1 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 21.0, 22.1 | View |
| Pseudomonas test positive | SYSTEMATIC_ASSESSMENT | Investigations | 21.0, 22.1 | View |
| Pulmonary function test decreased | SYSTEMATIC_ASSESSMENT | Investigations | 21.0, 22.1 | View |
| Activated partial thromboplastin time prolonged | SYSTEMATIC_ASSESSMENT | Investigations | 21.0, 22.1 | View |
| Forced expiratory volume decreased | SYSTEMATIC_ASSESSMENT | Investigations | 21.0, 22.1 | View |
| International normalised ratio increased | SYSTEMATIC_ASSESSMENT | Investigations | 21.0, 22.1 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | 21.0, 22.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 21.0, 22.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | 21.0, 22.1 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | 21.0, 22.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 21.0, 22.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 21.0, 22.1 | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | 21.0, 22.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 21.0, 22.1 | View |
| Seasonal allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | 21.0, 22.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 21.0, 22.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 21.0, 22.1 | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 21.0, 22.1 | View |
| Pulmonary imaging procedure abnormal | SYSTEMATIC_ASSESSMENT | Investigations | 21.0, 22.1 | View |
| Bronchiectasis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.0, 22.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.0, 22.1 | View |
| Lower respiratory tract congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.0, 22.1 | View |
| Paranasal sinus hypersecretion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.0, 22.1 | View |
| Rales | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.0, 22.1 | View |
| Eyelid oedema | SYSTEMATIC_ASSESSMENT | Eye disorders | 21.0, 22.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.0, 22.1 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 21.0, 22.1 | View |
| Hepatomegaly | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 21.0, 22.1 | View |
| Glucose tolerance impaired | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 21.0, 22.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.0, 22.1 | View |
| Oral fungal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.0, 22.1 | View |
| Respiratory tract infection bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | 21.0, 22.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.0, 22.1 | View |
| Wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.0, 22.1 | View |
| Prothrombin time prolonged | SYSTEMATIC_ASSESSMENT | Investigations | 21.0, 22.1 | View |
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 21.0, 22.1 | View |