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 @ 4:04 PM
Ignite Modification Date: 2025-12-25 @ 2:06 PM
NCT ID: NCT03336866
Description: None
Frequency Threshold: 0
Time Frame: 126 days
Study: NCT03336866
Study Brief: Study of Antibody for Methamphetamine Outpatient 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
All Subjects: Day 1-3 No Investigational Product administration; subjects were administered 30 mg METH and saline on Day 1 for drug discrimination. 0 None 0 77 69 77 View
Placebo: Day 4-126 Normal saline Placebo: Normal saline 0 None 0 20 20 20 View
IXT-m200, 6 mg/kg: Day 4-126 Single 6 mg/kg intravenous dose of IXT-m200 IXT-m200: IXT-m200 is an anti-methamphetamine monoclonal antibody 0 None 0 18 17 18 View
IXT-m200, 20 mg/kg: Day 4-126 Single 20 mg/kg intravenous dose of IXT-m200 0 None 0 18 18 18 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Atrioventricular block first degree NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Ventricular extrasystoles NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Ear pruritis NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Eye irritation NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Scleral haemorrhage NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Scleral disorder NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Vision blurred NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Visual impairment NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dental caries NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Food poisoning NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastroesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Submaxillary gland enlargement NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Injection site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Catheter site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Feeling hot NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Influenza like illness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Feeling abnormal NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Energy increased NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Feeling of relaxation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Infusion site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Catheter site inflammation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Catheter site nodule NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chest discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site erythema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Medical device site reaction NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Seasonal allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bacterial vaginosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Folliculitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Rash pustular NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Skin laceration NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Wound NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Animal bite NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Arthropod bite NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Arthropod sting NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Burns third degree NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Eye contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Fractured coccyx NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Periorbital haemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Thermal burn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Heart rate increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood creatine phosphokinase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Glycosylated haemoglobin increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscle tightness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal chest pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal stiffness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Lipoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Head discomfort NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hypoaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cognitive disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hyporeflexia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Presyncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Restless legs syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Sinus headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Vibratory sense increased NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Pregnancy NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
Euphoric mood NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Hypervigilance NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Bruxism NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Logorrhoea NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Mood altered NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Abnormal dreams NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Anhedonia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Depressed mood NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Disinhibition NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Disturbance in sexual arousal NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Restlessness NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Sleep terror NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Thinking abnormal NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Proteinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal disorder NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Vaginal discharge NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Hypopnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nasal disorder NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nasal dryness NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Respiratory tract congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Sinus congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Tachypnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Hyperhidrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatitis contact NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Blister NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Blister rupture NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Ecchymosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Macule NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Miliaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pruritus generalised NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash macular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin hyperpigmentation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin lesion NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Drug abuser NON_SYSTEMATIC_ASSESSMENT Social circumstances MedDRA View
Phlebitis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Thrombophlebitis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Haematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Vasculitis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Ear pain NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Thirst NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Electrocardiogram ST segment depression NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Electrocardiogram ST-T change NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Hepatic enzyme increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Disgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dysarthria NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hyperaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Migraine with aura NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Change in sustained attention NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Sputum increased NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Hot flush NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Flushing NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View