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:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-26 @ 12:39 AM
NCT ID:
NCT03472560
Description:
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE.
Frequency Threshold:
5
Time Frame:
From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment or start of new anti-cancer treatment -1 day (maximum up to 56 months)
Study:
NCT03472560
Study Brief:
A Study of Avelumab in Combination With Axitinib In Non-Small Cell Lung Cancer (NSCLC) or Urothelial Cancer (Javelin Medley VEGF)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| NSCLC Avelumab + Axitinib | Participants received avelumab 800 milligrams (mg) intravenous dose every two weeks, (Day 1 and 15) of each 28-day cycle in combination with axitinib 5 mg twice daily dose on a continuous dosing schedule. | 27 | None | 21 | 41 | 41 | 41 | View |
| UC Avelumab + Axitinib | Participants received avelumab 800 mg intravenous dose every two weeks, (Day 1 and 15) of each 28-day cycle in combination with axitinib 5 mg twice daily dose on a continuous dosing schedule. | 11 | None | 11 | 20 | 17 | 20 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cardiac dysfunction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v25.1 | View |
| Cushing's syndrome | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA v25.1 | View |
| Inappropriate antidiuretic hormone secretion | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA v25.1 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Death | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Disease progression | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Gastric perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Jejunal perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Pancreatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Hepatitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v25.1 | View |
| Hepatitis acute | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v25.1 | View |
| Hepatobiliary disease | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v25.1 | View |
| Anal abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Atypical pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| COVID-19 pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Infectious pleural effusion | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Kidney infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Femur fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v25.1 | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v25.1 | View |
| Diabetic ketoacidosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v25.1 | View |
| Hypoalbuminaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v25.1 | View |
| Lung neoplasm malignant | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.1 | View |
| Cerebral infarction | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Haemorrhage intracranial | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Hemiparesis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Intracranial haematoma | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Haematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v25.1 | View |
| Urinary bladder haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v25.1 | View |
| Chronic obstructive pulmonary disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
| Pulmonary embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v25.1 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v25.1 | View |
| Blindness unilateral | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v25.1 | View |
| Colitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Liver function test increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.1 | View |
| Delirium | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v25.1 | View |
| Acute pulmonary oedema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v25.1 | View |
| Adrenal insufficiency | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA v25.1 | View |
| Hypothyroidism | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA v25.1 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| General physical health deterioration | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Mucosal inflammation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Non-cardiac chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Infusion related reaction | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v25.1 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.1 | View |
| Amylase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.1 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.1 | View |
| Blood alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.1 | View |
| Blood bilirubin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.1 | View |
| Blood corticotrophin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.1 | View |
| Blood creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.1 | View |
| Blood thyroid stimulating hormone increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.1 | View |
| Blood triglycerides increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.1 | View |
| C-reactive protein increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.1 | View |
| Gamma-glutamyltransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.1 | View |
| Lipase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.1 | View |
| Weight decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.1 | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v25.1 | View |
| Hyperkalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v25.1 | View |
| Hypermagnesaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v25.1 | View |
| Hypertriglyceridaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v25.1 | View |
| Hypoalbuminaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v25.1 | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v25.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v25.1 | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v25.1 | View |
| Haematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v25.1 | View |
| Proteinuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v25.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
| Dysphonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v25.1 | View |
| Palmar-plantar erythrodysaesthesia syndrome | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v25.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v25.1 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v25.1 | View |
| Hypertensive crisis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v25.1 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v25.1 | View |