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 @ 4:53 AM
Ignite Modification Date: 2025-12-26 @ 3:54 AM
NCT ID: NCT03570918
Description: None
Frequency Threshold: 0
Time Frame: up to 19 weeks
Study: NCT03570918
Study Brief: MGD014 in HIV-Infected Individuals on Suppressive Antiretroviral Therapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MGD014 0.1 mcg/kg Single infusion of MGD014 0 None 0 1 1 1 View
MGD014 0.3 mcg/kg Single infusion of MGD014 0 None 0 1 1 1 View
MGD014 1.0 mcg/kg Single infusion of MGD014 0 None 0 4 4 4 View
MGD014 3.0 mcg/kg Single infusion of MGD014 0 None 0 3 3 3 View
MGD014 10.0 mcg/kg Single infusion of MGD014 0 None 0 3 2 3 View
MGD014 30 mcg/kg Single infusion of MGD014 0 None 0 3 2 3 View
MGD014 100 mcg/kg Single infusion of MGD014 0 None 0 3 2 3 View
MGD014 300 mcg/kg Single infusion of MGD014 0 None 0 3 3 3 View
Multiple Dose MGD014 300 mcg/kg Infusion every 2 weeks for 3 infusions. 0 None 0 3 2 3 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lymph node pain SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Cerumen impaction SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Application site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Vessel puncture site bruise SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Vessel puncture site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Infusion site bruising SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Feeling hot SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Vessel puncture site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Skin abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Eye contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Electrocardiogram QT prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Electrocardiogram abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Glomerular filtration rate decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Sensory disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Emotional distress SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Abnormal dreams SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Nightmare SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Papule SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Skin irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Peripheral coldness SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View