Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 12:43 AM
Ignite Modification Date: 2025-12-25 @ 10:55 PM
NCT ID: NCT03899467
Description: An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.
Frequency Threshold: 5
Time Frame: Average of 24 weeks, up to a maximum of 30 weeks
Study: NCT03899467
Study Brief: The Safety and Tolerability of GT0918 in Subjects With mHSPC and mCRPC
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm 1: 400 mg /Day of GT0918 Group 1: Post enzalutamide failure Group 2: Post abiraterone failure GT0918: anti-tumor activity 0 None 6 31 28 31 View
Arm 2: 500 mg/Day of GT0918 Group 1: Post enzalutamide failure Group 2: Post abiraterone failure GT0918: anti-tumor activity 0 None 12 30 26 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Rhabdomyolysis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Metabolic encephalopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Visual impairment NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Muscular weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cardiac failure congestive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Drug-induced liver injury NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Diverticulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Neutropenic sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hepatic enzyme increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Suicide attempt NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pneumothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dry gangrene NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
COVID-19 pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Muscular weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hot flush NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin abrasion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Blood alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Blood lactate dehydrogenase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypersomnia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Memory impairment NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Confusional state NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hiccups NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Vision blurred NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gait disturbance NON_SYSTEMATIC_ASSESSMENT General disorders None View