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 @ 7:58 PM
Ignite Modification Date: 2025-12-25 @ 5:32 PM
NCT ID: NCT03728504
Description: None
Frequency Threshold: 0
Time Frame: 16 weeks
Study: NCT03728504
Study Brief: Study to Evaluate ASN002 in Subjects With Moderate To Severe Chronic Hand Eczema
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ASN002 40 mg 40 mg ASN002 ASN002: Daily dose of ASN002 for 32 weeks 0 None 0 33 19 33 View
ASN002 80 mg 80 mg ASN002 ASN002: Daily dose of ASN002 for 32 weeks 0 None 2 32 24 32 View
Placebo Oral Tablet Matching placebo for ASN002 doses Placebo Oral Tablet: Daily dose of Placebo Oral Tablet for 16 weeks 0 None 1 32 17 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Femur fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Alcoholism NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Abscess limb NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Burning sensation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Dermatitis contact NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Peripheral swelling NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Tooth fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 21.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Acute sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Ear Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Eyelid infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Fungal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Oral herpes NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Otitis media NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pilonidal cyst NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Postoperative wound infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Rash pustular NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Tooth infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Ageusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Hyperaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Neuralgia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Sciatica NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Dermatitis atopic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Eczema nummular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Granuloma annulare NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Hyperhidrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Rash generalized NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Skin burning sensation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Night sweats NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Face oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Thirst NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Corneal abrasion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Limb injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Thermal burn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Blood CPK increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood potassium increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood urine present NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Lymphocyte count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Neutrophil count increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Reticulocyte count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
C-reactive protein increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Bursitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Muscular weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Musculoskeletal stiffness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Rhinalgia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Sleep apnoea syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Seasonal allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 21.0 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Seborrhoeic keratosis NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.0 View
Proteinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Wisdom teeth removal NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 21.0 View