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 @ 10:47 PM
Ignite Modification Date: 2025-12-25 @ 8:17 PM
NCT ID: NCT02654769
Description: None
Frequency Threshold: 0
Time Frame: From the start of the study until Week 8 (end of study).
Study: NCT02654769
Study Brief: A Study of Equivalence of Generic Ingenol Mebutate Gel 0.05% and Picato Gel 0.05% in Subjects With Actinic Keratosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Generic Ingenol Mebutate Generic ingenol mebutate gel, 0.05% \[Test\] Generic Ingenol Mebutate: Generic formulated to have the same therapeutic effect of the brand 0 None 0 149 18 149 View
Active Comparator Picato® Picato® (ingenol mebutate) gel, 0.05% (Leo Pharma Inc.) \[Reference Listed Drug (RLD)\] Ingenol Mebutate (Picato®): Brand product 0 None 0 149 29 149 View
Vehicle Foam Vehicle gel of the test product Vehicle Foam: It does not contain active ingredient. A placebo to test the sensitivity of the active treatments. 0 None 0 143 17 143 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Benign neoplasm of skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Spider vein SYSTEMATIC_ASSESSMENT Vascular disorders None View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypoacusis SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Conjunctival irritation SYSTEMATIC_ASSESSMENT Eye disorders None View
Erythema of eyelid SYSTEMATIC_ASSESSMENT Eye disorders None View
Eyelid oedema SYSTEMATIC_ASSESSMENT Eye disorders None View
Gastrointestinal wall thickening SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Large intestine perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Application site erosion SYSTEMATIC_ASSESSMENT General disorders None View
Application site hypoaesthesia 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 scab SYSTEMATIC_ASSESSMENT General disorders None View
Application site vesicles SYSTEMATIC_ASSESSMENT General disorders None View
Death SYSTEMATIC_ASSESSMENT General disorders None View
Application site abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Application site cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations None View
Genital herpes simplex SYSTEMATIC_ASSESSMENT Infections and infestations None View
Staphyloccocall skin infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Joint injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Skin abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Blood triglycerides increased SYSTEMATIC_ASSESSMENT Investigations None View
Hyperlipidaemis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Vitamin D deficiency 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
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Haemangioma of skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Squamous cell carcinoma of skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Occipital neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Chronic obstructive pulmonary disease 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
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal 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
Photodermatosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View