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 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
NCT ID:
NCT04442269
Description:
None
Frequency Threshold:
5
Time Frame:
From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Study:
NCT04442269
Study Brief:
Investigating Treatment With Dupilumab in Patients With Allergic Bronchopulmonary Aspergillosis (ABPA) (LIBERTY ABPA AIRED)
Event Groups(If Any):
Event Groups
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Pneumonia bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | View |
| Respiratory disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | View |
| Nephrotic syndrome | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (26.1) | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (26.1) | View |
| Pelvic fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Oesophageal carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | View |
| Abortion spontaneous | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (26.1) | View |
| Bronchopulmonary aspergillosis allergic | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | View |
| Trisomy 16 | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (26.1) | View |
| Pancreatic carcinoma metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Acute sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Bronchopulmonary aspergillosis allergic | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Tooth infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Respiratory tract infection bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (26.1) | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (26.1) | View |
| Injection site swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (26.1) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (26.1) | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (26.1) | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (26.1) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (26.1) | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | View |
| Respiratory disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.1) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.1) | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.1) | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.1) | View |
| Blepharitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.1) | View |