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: 2025-12-25 @ 4:58 AM
Ignite Modification Date: 2025-12-26 @ 3:58 AM
NCT ID: NCT03849118
Description: None
Frequency Threshold: 2
Time Frame: 3 years
Study: NCT03849118
Study Brief: 89Zr-TLX250 for PET/CT Imaging of ccRCC- ZIRCON Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Adverse Events Information The safety analysis set (SAF) consisted of all patients who received 89Zr-TLX250. 2 None 26 300 86 300 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25.1 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.1 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Hemoperitoneum SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Intestinal Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Retroperitoneal Effusion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
Multiple organ dysfunctional syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
Ischemic Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25.1 View
Hematoma Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Klebsiella Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View
Arterial Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
Post procedural bile leak SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
Post procedural complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
Post procedural hematuria SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
Post procedural hemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
Post procedural hypotension SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
Procedural pneumothorax SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.1 View
Hypovolemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.1 View
Hematoma muscle SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.1 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.1 View
Renal Impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.1 View
Subcapsular renal hematoma SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.1 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.1 View
Urinoma SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25.1 View
Acute pulmonary edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.1 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.1 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.1 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.1 View
Subcutaneous emphysema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.1 View
Arteriosclerosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.1 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.1 View