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 @ 1:04 AM
Ignite Modification Date: 2025-12-25 @ 11:17 PM
NCT ID: NCT02925793
Description: Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
Frequency Threshold: 0
Time Frame: Up to 10 weeks
Study: NCT02925793
Study Brief: Safety and Efficacy Study of Topically Applied DS107 Cream in Mild to Moderate Atopic Dermatitis Patients (AD)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Vehicle Cream Vehicle cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks Vehicle cream 0 None 1 106 38 106 View
1% DS107 Cream 1% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks DS107 0 None 1 110 48 110 View
5% DS107 Cream 5% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks DS107 0 None 0 111 40 111 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Conjunctivitis allergic SYSTEMATIC_ASSESSMENT Eye disorders None View
Dermatitis Atopic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Drug Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders None View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dermatitis Infected SYSTEMATIC_ASSESSMENT Infections and infestations None View
Folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fungal Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Furuncle SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis Viral SYSTEMATIC_ASSESSMENT Infections and infestations None View
Helicobacter Zoster SYSTEMATIC_ASSESSMENT Infections and infestations None View
Herpes Zoster SYSTEMATIC_ASSESSMENT Infections and infestations None View
Impetigo SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Otitis Media Acute SYSTEMATIC_ASSESSMENT Infections and infestations None View
Perineal Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin Bacterial Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Soft Tissue Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Staphylococcal Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tooth Abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Arthropod Bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cataract Operation Complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Heat Stroke SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Joint Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Ligament Sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Muscle Strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Procedural Pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Sunburn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Tooth Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Blood Creatine Phosphokinase SYSTEMATIC_ASSESSMENT Investigations None View
Blood Creatinine Increased SYSTEMATIC_ASSESSMENT Investigations None View
Hepatic Enzyme Increased SYSTEMATIC_ASSESSMENT Investigations None View
Diabetes Mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fibromyalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Intervertebral Disc Degeneration SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Joint Swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle Spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain In Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Adenoma Benign SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tension Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Oropharyngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinitis Allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis Atopic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis Contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Intertrigo SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash Erythematous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Scab SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin Burning Sensation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin Exfoliation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin Fissures SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin Tightness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Tonsillectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Tooth Extraction SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Monocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hiatus Hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Application Site Erythema SYSTEMATIC_ASSESSMENT General disorders None View
Application Site Inflammation SYSTEMATIC_ASSESSMENT General disorders None View
Application Site Pain SYSTEMATIC_ASSESSMENT General disorders None View
Application Site Pruritus SYSTEMATIC_ASSESSMENT General disorders None View
Application Site Reaction SYSTEMATIC_ASSESSMENT General disorders None View
Application Site Swelling SYSTEMATIC_ASSESSMENT General disorders None View
Influenza Like Illness SYSTEMATIC_ASSESSMENT General disorders None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Peripheral Swelling SYSTEMATIC_ASSESSMENT General disorders None View
Swelling SYSTEMATIC_ASSESSMENT General disorders None View
Xerosis SYSTEMATIC_ASSESSMENT General disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abdominal Discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cheilitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Colitis Ulcerative SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dental Caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View