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 @ 2:06 AM
Ignite Modification Date: 2025-12-26 @ 12:32 AM
NCT ID: NCT04617860
Description: None
Frequency Threshold: 5
Time Frame: Day 1 to Study Termination (maximum of 12 monthly doses)
Study: NCT04617860
Study Brief: Open-label Extension Study to Evaluate the Safety and Tolerability of WVE-120102 in Patients With Huntington's Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
4 mg WVE-120102 Received 4 mg WVE-120102 at any point in the study 0 None 0 8 7 8 View
8 mg WVE-120102 Received 8 mg WVE-120102 at any point in the study 0 None 1 18 14 18 View
16 mg WVE-120102 Received 16 mg WVE-120102 at any point in the study 0 None 5 35 34 35 View
32 mg WVE-120102 Received 32 mg WVE-120102 at any point in the study 0 None 3 17 17 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 8.2 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 8.2 View
Meningitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 8.2 View
Meningitis asceptic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 8.2 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 8.2 View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 8.2 View
Nervous system disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 8.2 View
Aggression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 8.2 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 8.2 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 8.2 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 8.2 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 8.2 View
Paresthesia oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 8.2 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 8.2 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 8.2 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 8.2 View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders MedDRA 8.2 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 8.2 View
Injection site hypersensitivity SYSTEMATIC_ASSESSMENT General disorders MedDRA 8.2 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 8.2 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 8.2 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 8.2 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 8.2 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 8.2 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 8.2 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 8.2 View
Procedural headache SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 8.2 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 8.2 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 8.2 View
Post procedural discomfort SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 8.2 View
Procedural dizziness SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 8.2 View
Scapula fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 8.2 View
CSF protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 8.2 View
CSF lymphocyte count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 8.2 View
CSF test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 8.2 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 8.2 View
CSF white blood cell count SYSTEMATIC_ASSESSMENT Investigations MedDRA 8.2 View
Lymphocyte count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 8.2 View
Complement factor increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 8.2 View
Dermatologic examination abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 8.2 View
Neurological examination abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 8.2 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 8.2 View
Increased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 8.2 View
Polydipsia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 8.2 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 8.2 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 8.2 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 8.2 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 8.2 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 8.2 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 8.2 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 8.2 View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 8.2 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 8.2 View
Balance disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 8.2 View
Dyskinesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 8.2 View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 8.2 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 8.2 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 8.2 View
Disturbance in attention SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 8.2 View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 8.2 View
Hypotonia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 8.2 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 8.2 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 8.2 View
Apathy SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 8.2 View
Behavior disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 8.2 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 8.2 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 8.2 View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 8.2 View
Hallucination, visual SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 8.2 View
Paranoia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 8.2 View
Persecutory delusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 8.2 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 8.2 View
Breast tenderness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 8.2 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 8.2 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 8.2 View
Dysnpoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 8.2 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 8.2 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 8.2 View