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 @ 10:52 PM
Ignite Modification Date: 2025-12-25 @ 8:21 PM
NCT ID: NCT04212169
Description: None
Frequency Threshold: 5
Time Frame: 24 weeks
Study: NCT04212169
Study Brief: Efficacy and Safety of MEDI3506 in Adult Subjects With Atopic Dermatitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Pooled Placebo 0 None 2 56 29 56 View
MEDI3506 Dose 1 MEDI3506 Dose 1 was administered SC to participants once every 4 weeks for 16 weeks 0 None 0 19 11 19 View
MEDI3506 Dose 2 MEDI3506 Dose 2 was administered SC to participants once every 4 weeks for 16 weeks 0 None 2 18 14 18 View
MEDI3506 Dose 3 MEDI3506 Dose 3 was administered SC to participants once every 4 weeks for 16 weeks 0 None 1 55 25 55 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Food allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 25.0 View
Covid-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Dermatitis exfoliative generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View
Medical device removal SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 25.0 View
Venous thrombosis limb SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Otitis externa SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 25.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Liver function test increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Urine analysis abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Carpal tunnel syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25.0 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Dermatitis atopic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Aphthous ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Injection site bruising SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Acarodermatitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Dermatitis infected SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Eczema infected SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View