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 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
NCT ID:
NCT03822351
Description:
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
Frequency Threshold:
5
Time Frame:
AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Study:
NCT03822351
Study Brief:
Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLC
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Durvalumab Monotherapy | Description (Arm-group) | 27 | None | 23 | 66 | 61 | 66 | View |
| Durvalumab + Oleclumab | Description (Arm-group) | 23 | None | 20 | 59 | 52 | 59 | View |
| Durvalumab + Monalizumab | Description (Arm-group) | 24 | None | 17 | 61 | 58 | 61 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Periorbital infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Pneumonia bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Spinal cord infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| Radiation pneumonitis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.0 | View |
| Radius fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.0 | View |
| Spinal fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.0 | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| Pericarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Sinus arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Type 1 diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Myopathy | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Myositis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Meningioma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | View |
| Oesophageal adenocarcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | View |
| Rectal adenocarcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | View |
| Transitional cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | View |
| Brain oedema | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Transient ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.0 | View |
| Glomerulonephritis membranous | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.0 | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Bronchostenosis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Oesophagobronchial fistula | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Pulmonary valve stenosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| Anoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Sudden death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Drug-induced liver injury | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.0 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Device related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Enterocolitis infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Infected dermal cyst | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Visual acuity reduced | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.0 | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 26.0 | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Pleuritic pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Hyperthyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 26.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.0 | View |
| Radiation pneumonitis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Amylase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.0 | View |
| Dysphonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |