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 @ 3:00 AM
Ignite Modification Date: 2025-12-26 @ 1:40 AM
NCT ID: NCT03225833
Description: None
Frequency Threshold: 5
Time Frame: Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])
Study: NCT03225833
Study Brief: Safety and Tolerability of WVE-120101 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
WVE-120101 (32 mg) WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO) 0 None 4 10 9 10 View
WVE-120101 (8 mg) WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO) 0 None 0 9 9 9 View
WVE-120101 (16 mg) WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO) 0 None 0 8 7 8 View
Pooled Placebo Placebo: 0.9% Sodium Chloride 0 None 0 16 12 16 View
WVE-120101 (2 mg) WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO) 0 None 2 9 8 9 View
WVE-120101 (4 mg) WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO) 0 None 1 9 8 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 8.2 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 8.2 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 8.2 View
Disorientation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 8.2 View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 8.2 View
Adenocarcinoma of colon SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 8.2 View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders MedDRA 8.2 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 8.2 View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 8.2 View
Skull Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 8.2 View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 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
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 8.2 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 8.2 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 8.2 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 8.2 View
Puncture site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA 8.2 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 8.2 View
Vessel puncture site bruise SYSTEMATIC_ASSESSMENT General disorders MedDRA 8.2 View
Vessel puncture site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 8.2 View
Hyporeflexia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 8.2 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 8.2 View
Lumbosacral radiculopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 8.2 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 8.2 View
Pleocytosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 8.2 View
Post-traumatic headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 8.2 View
Radicular pain SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 8.2 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 8.2 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 8.2 View
Affect lability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 8.2 View
Bradyphrenia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 8.2 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 8.2 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 8.2 View
Depression suicidal SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 8.2 View
Emotional disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 8.2 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 8.2 View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 8.2 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 8.2 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 8.2 View
Ovarian cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 8.2 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 8.2 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 8.2 View
Rhinorrhea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 8.2 View
Rash vesicular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 8.2 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 8.2 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 8.2 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 8.2 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRa 8.2 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRa 8.2 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 8.2 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 8.2 View
Wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 8.2 View
Foot fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRa 8.2 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRa 8.2 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 8.2 View
Ear discomfort SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 8.2 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 8.2 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 8.2 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 8.2 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 8.2 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 8.2 View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders MedDRA 8.2 View
Administration site bruise SYSTEMATIC_ASSESSMENT General disorders MedDRA 8.2 View
Administration site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 8.2 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 8.2 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 8.2 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 8.2 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 8.2 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 8.2 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 8.2 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 8.2 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 8.2 View
Post lumbar puncture syndrome SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 8.2 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 8.2 View
Eye contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 8.2 View
Hand fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 8.2 View
Head injury 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 headache SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 8.2 View
Skull fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 8.2 View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 8.2 View
Post procedural contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 8.2 View
Procedural nausea SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 8.2 View
Procedural vomiting SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 8.2 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 8.2 View
CSF lymphocyte count increase SYSTEMATIC_ASSESSMENT Investigations MedDRA 8.2 View
CSF protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 8.2 View
CSF white blood cell count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 8.2 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 8.2 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 8.2 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 8.2 View
Neutrophil count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 8.2 View
Platelet count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 8.2 View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 8.2 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 8.2 View
Increased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 8.2 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 8.2 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 8.2 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 8.2 View
Limb discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 8.2 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 8.2 View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 8.2 View
Neck 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
Spinal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 8.2 View
Muscle spasms 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
Dysarthria 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
Chorea SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 8.2 View
Hyperreflexia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 8.2 View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 8.2 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 8.2 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 8.2 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 8.2 View
Sensory disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 8.2 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 8.2 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 8.2 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 8.2 View