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 @ 12:00 PM
Ignite Modification Date: 2025-12-25 @ 11:57 AM
NCT ID: NCT02073461
Description: None
Frequency Threshold: 1
Time Frame: 12 weeks
Study: NCT02073461
Study Brief: Efficacy and Safety Study of 2 Different Concentrations of CD1579 Gels Versus Vehicle in the Treatment of Acne Vulgaris.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CD1579 2.5% Benzoyl Peroxide 2.5% CD1579 2.5% None None 0 79 34 79 View
CD1579 5% Benzoyl Peroxide 5% CD1579 5% None None 0 78 31 78 View
Vehicle Vehicle Vehicle None None 1 79 26 79 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Compression fracture None Injury, poisoning and procedural complications MedDRA 15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ear pruritus None Ear and labyrinth disorders MedDRA 15.0 View
Erythema of eyelid None Eye disorders MedDRA 15.0 View
Conjunctivitis allergic None Eye disorders MedDRA 15.0 View
Abdominal pain None Gastrointestinal disorders MedDRA 15.0 View
Abdominal pain upper None Gastrointestinal disorders MedDRA 15.0 View
Diarrhoea None Gastrointestinal disorders MedDRA 15.0 View
Toothache None Gastrointestinal disorders MedDRA 15.0 View
Vomiting None Gastrointestinal disorders MedDRA 15.0 View
Vessel puncture site haematoma None General disorders MedDRA 15.0 View
Hyperbilirubinaemia None Hepatobiliary disorders MedDRA 15.0 View
Seasonal allergy None Immune system disorders MedDRA 15.0 View
Allergy to arthropod sting None Immune system disorders MedDRA 15.0 View
Nasopharyngitis None Infections and infestations MedDRA 15.0 View
Oral herpes None Infections and infestations MedDRA 15.0 View
Otitis externa None Infections and infestations MedDRA 15.0 View
Tinea pedis None Infections and infestations MedDRA 15.0 View
Acute tonsillitis None Infections and infestations MedDRA 15.0 View
Herpes simplex None Infections and infestations MedDRA 15.0 View
Influenza None Infections and infestations MedDRA 15.0 View
Laryngitis None Infections and infestations MedDRA 15.0 View
Pharyngitis None Infections and infestations MedDRA 15.0 View
Tinea versicolour None Infections and infestations MedDRA 15.0 View
Contusion None Injury, poisoning and procedural complications MedDRA 15.0 View
Excoriation None Injury, poisoning and procedural complications MedDRA 15.0 View
Hand fracture None Injury, poisoning and procedural complications MedDRA 15.0 View
Ligament sprain None Injury, poisoning and procedural complications MedDRA 15.0 View
Post-traumatic neck syndrome None Injury, poisoning and procedural complications MedDRA 15.0 View
Radius fracture None Injury, poisoning and procedural complications MedDRA 15.0 View
Arthropod bite None Injury, poisoning and procedural complications MedDRA 15.0 View
Thermal burn None Injury, poisoning and procedural complications MedDRA 15.0 View
Protein urine present None Investigations MedDRA 15.0 View
Back pain None Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Synovial cyst None Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Headache None Nervous system disorders MedDRA 15.0 View
Dysmenorrhoea None Reproductive system and breast disorders MedDRA 15.0 View
Premenstrual syndrome None Reproductive system and breast disorders MedDRA 15.0 View
Rhinitis allergic None Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Upper respiratory tract inflammation None Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Skin irritation None Skin and subcutaneous tissue disorders MedDRA 15.0 View
Drug eruption None Skin and subcutaneous tissue disorders MedDRA 15.0 View
Eczema None Skin and subcutaneous tissue disorders MedDRA 15.0 View
Urticaria None Skin and subcutaneous tissue disorders MedDRA 15.0 View
Dermatitis allergic None Skin and subcutaneous tissue disorders MedDRA 15.0 View
Dermatitis contact None Skin and subcutaneous tissue disorders MedDRA 15.0 View
Dry skin None Skin and subcutaneous tissue disorders MedDRA 15.0 View
Eczema asteatotic None Skin and subcutaneous tissue disorders MedDRA 15.0 View
Urticaria chronic None Skin and subcutaneous tissue disorders MedDRA 15.0 View