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 @ 10:56 PM
Ignite Modification Date: 2025-12-25 @ 8:24 PM
NCT ID: NCT05235269
Description: None
Frequency Threshold: 3
Time Frame: Time of informed consent until the end of the study (up to 14 weeks)
Study: NCT05235269
Study Brief: A Study to Evaluate Organ Level Uptake Repeatability of 124I AT-01 in Subjects With Systemic Amyloidosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
124I-AT-01 All participants received 1 mCi 124I-AT-01 on Day 1 and at Week 6 via IV infusion over 2-5 minutes or slow IV bolus at 1 mL/5 seconds. 1 None 1 33 13 33 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Thalamic infarction SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders None View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders None View
Vessel puncture site bruised SYSTEMATIC_ASSESSMENT General disorders None View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial thrombosis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiogenic shock SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acute pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dysponea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hyperparathyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Blood lactic acid increase SYSTEMATIC_ASSESSMENT Investigations None View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View