Adverse Events Module

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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 @ 5:47 PM
Ignite Modification Date: 2025-12-25 @ 3:14 PM
NCT ID: NCT04941768
Description: AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent and All-Cause Mortality data was assessed in all enrolled participants.
Frequency Threshold: 5
Time Frame: From index date up to 12 months after the index date
Study: NCT04941768
Study Brief: An Observational Study to Evaluate the Efficacy and Safety of Avelumab + Axitinib Combination in Participants With aRCC (AVION)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Avelumab + Axitinib Participants with advanced renal cell carcinoma (RCC) received 800 milligrams (mg) of Avelumab intravenously every 2 weeks (Q2W) in combination with 5 mg of Axitinib orally twice per day in accordance with the terms of marketing authorization for the first-line therapy as per the current clinical practice were observed for 24 months in this study. 24 None 38 104 80 104 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gait disturbance NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Hypothermia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Myositis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Osteolysis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Polymyalgia rheumatica NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Haemorrhage intracranial NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Hemiparesis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Monoparesis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Myocarditis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Autoimmune hepatitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
Cholecystitis acute NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
Immune-mediated hepatitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Eastern Cooperative Oncology Group performance status worsened NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
End stage renal disease NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Hypertensive crisis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hypothyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 24.0 View
Cataract NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View
Hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24.0 View
Hip fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Cancer pain NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
Prostatitis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.0 View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Ureteral stent insertion NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 24.0 View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Pneumothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Cardiac failure chronic NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Gallbladder abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Diarrhoea 3 ( 2.9) NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Diverticular perforation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Post procedural infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Subcutaneous abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Disease progression NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Palmar-plantar erythrodysaesthesia syndrome NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Hypothyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 24.0 View