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 @ 12:49 PM
Ignite Modification Date:
2025-12-25 @ 12:15 PM
NCT ID:
NCT03298061
Description:
Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Frequency Threshold:
3
Time Frame:
Up to approximately 89 Months
Study:
NCT03298061
Study Brief:
Long-term Access Program (LAP) of Mepolizumab for Subjects Who Participated in Study MEA115921
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Mepolizumab 300 mg | Participants who participated in clinical study MEA115921, who required additional dose of \>=5 milligrams per day (mg/day) prednisolone for adequate control of their Eosinophilic Granulomatosis with Polyangiitis (EGPA) received 300 milligrams (mg) mepolizumab subcutaneous (SC) injection every 4 weeks. | 1 | None | 38 | 100 | 97 | 100 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | v25.1 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | v25.1 | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | v25.1 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | v25.1 | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | v25.1 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | v25.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | v25.1 | View |
| Anal incontinence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | v25.1 | View |
| Colitis ulcerative | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | v25.1 | View |
| Food poisoning | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | v25.1 | View |
| Rectal prolapse | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | v25.1 | View |
| Rectal ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | v25.1 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | v25.1 | View |
| Eosinophilic granulomatosis with polyangiitis | SYSTEMATIC_ASSESSMENT | Immune system disorders | v25.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Bursitis infective | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Chronic sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Coronavirus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Folliculitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Hepatitis E | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Pneumonia pneumococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Pneumonia staphylococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Respiratory syncytial virus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Salpingitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Abdominal injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | v25.1 | View |
| Humerus fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | v25.1 | View |
| Lower limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | v25.1 | View |
| Post procedural fever | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | v25.1 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | v25.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | v25.1 | View |
| Intervertebral disc protrusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | v25.1 | View |
| Colon cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v25.1 | View |
| Renal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v25.1 | View |
| Cervical cord compression | SYSTEMATIC_ASSESSMENT | Nervous system disorders | v25.1 | View |
| Transient ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | v25.1 | View |
| Stress | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | v25.1 | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | v25.1 | View |
| Renal colic | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | v25.1 | View |
| Ureterolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | v25.1 | View |
| Heavy menstrual bleeding | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | v25.1 | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | v25.1 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | v25.1 | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | v25.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | v25.1 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | v25.1 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | v25.1 | View |
| Respiratory distress | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | v25.1 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | v25.1 | View |
| Vocal cord dysfunction | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | v25.1 | View |
| Dermal cyst | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | v25.1 | View |
| Skin ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | v25.1 | View |
| Vasculitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | v25.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | v25.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | v25.1 | View |
| Eosinophilic granulomatosis with polyangiitis | SYSTEMATIC_ASSESSMENT | Immune system disorders | v25.1 | View |
| Acute sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Ear infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Herpes simplex | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Oral candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Tooth abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Arthropod bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | v25.1 | View |
| Bone contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | v25.1 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | v25.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | v25.1 | View |
| Foot fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | v25.1 | View |
| Hand fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | v25.1 | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | v25.1 | View |
| Rib fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | v25.1 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | v25.1 | View |
| Vitamin D deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | v25.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | v25.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | v25.1 | View |
| Bursitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | v25.1 | View |
| Intervertebral disc protrusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | v25.1 | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | v25.1 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | v25.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | v25.1 | View |
| Skin papilloma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v25.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | v25.1 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | v25.1 | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | v25.1 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | v25.1 | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | v25.1 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | v25.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | v25.1 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | v25.1 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | v25.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | v25.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | v25.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | v25.1 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | v25.1 | View |
| Nasal polyps | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | v25.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | v25.1 | View |
| Sinus congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | v25.1 | View |
| Wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | v25.1 | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | v25.1 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | v25.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | v25.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | v25.1 | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | v25.1 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | v25.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | v25.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | v25.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | v25.1 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | v25.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | v25.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | v25.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | v25.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | v25.1 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | v25.1 | View |
| Injection site haematoma | SYSTEMATIC_ASSESSMENT | General disorders | v25.1 | View |
| Injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | v25.1 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Pulpitis dental | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | v25.1 | View |
| Muscle strain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | v25.1 | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | v25.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | v25.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | v25.1 | View |