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 @ 9:15 PM
Ignite Modification Date: 2025-12-25 @ 7:04 PM
NCT ID: NCT04989504
Description: None
Frequency Threshold: 0
Time Frame: Up to 5 months
Study: NCT04989504
Study Brief: Testing the Application of Mepitel Film During Radiation Therapy to Reduce Radiation Related Redness and Peeling in Breast Cancer Patients Following Mastectomy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm I (Standard of Care) Questionnaire Administration: Ancillary studies 0 None 2 65 59 65 View
Arm II (Mepitel Film) Questionnaire Administration: Ancillary studies 0 None 7 143 133 143 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 5 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 5 View
Dermatitis radiation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE 5 View
Osteoporosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 5 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 5 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lymph node pain SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 5 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 5 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders CTCAE 5 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE 5 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE 5 View
Localized edema SYSTEMATIC_ASSESSMENT General disorders CTCAE 5 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders CTCAE 5 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE 5 View
Infections and infestations - Oth spec SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 5 View
Shingles SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 5 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 5 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 5 View
Dermatitis radiation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE 5 View
Seroma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE 5 View
Wound complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE 5 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5 View
Hyperlipidemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5 View
Fibrosis deep connective tissue SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5 View
Joint range of motion decreased SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5 View
Osteoporosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5 View
Superficial soft tissue fibrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5 View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 5 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 5 View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 5 View
Breast pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE 5 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Hoarseness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Postnasal drip SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 5 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 5 View
Erythema multiforme SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 5 View
Pain of skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 5 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 5 View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 5 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 5 View
Skin and subcut tissue disord - Oth spec SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 5 View
Skin hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 5 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 5 View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 5 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 5 View
Lymphedema SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 5 View
Vascular disorders - Other, specify SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 5 View