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 @ 5:32 PM
Ignite Modification Date: 2025-12-25 @ 3:05 PM
NCT ID: NCT05214768
Description: All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.
Frequency Threshold: 5
Time Frame: All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.
Study: NCT05214768
Study Brief: A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Japanese Participants With Eosinophilic Gastroenteritis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Induction and Maintenance - CC-93538 360mg QW Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase. 0 None 0 20 16 20 View
Maintenance - CC-93538 360mg QW/Q2W Participants with Eosinophilic Gastroenteritis who were randomized to receive 360 mg CC-93538 once weekly in Induction Phase received CC-93538 360 mg SC once every other week for 32 weeks during Maintenance Phase. 0 None 1 12 9 12 View
Induction and Maintenance - Placebo Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase. 0 None 0 16 13 16 View
Open-label Long-term Extension Phase - CC-93538 360mg QW Participants with Eosinophilic Gastroenteritis earlier randomized to Induction and Maintenance phase received 360 mg CC-93538 subcutaneously (SC) once weekly in Open-Label Long-term Extension phase. 0 None 0 44 30 44 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Iron deficiency anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Conjunctivitis allergic SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Iritis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Anal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Anaphylactic reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 27.0 View
Contrast media allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 27.0 View
Food allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 27.0 View
Bacterial vaginosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Herpes simplex SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Hordeolum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Perineal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Periodontitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Ligament sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Tooth fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Eosinophil count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Costochondritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Psoriatic arthropathy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Rheumatoid arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Spinal osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Trigger finger SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Gastrointestinal tract adenoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.0 View
Essential tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Anxiety disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Intermenstrual bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 27.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Eosinophilic bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
NSAID exacerbated respiratory disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Dermal cyst SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Dermatitis atopic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Hand dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Miliaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Onycholysis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View