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 @ 4:16 AM
Ignite Modification Date: 2025-12-26 @ 3:16 AM
NCT ID: NCT01880320
Description: None
Frequency Threshold: 1
Time Frame: None
Study: NCT01880320
Study Brief: Multi-center, Randomized, Double-blind Efficacy and Safety of CD0271 0.3%/CD1579 2.5 % Topical Gel in 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
CD0271 0.3% /CD1579 2.5% Gel Active arm CD0271 0.3% / CD1579 2.5% None None 0 217 34 217 View
CD0271 0.1% / CD1579 2.5% Comparator arm CD0271 0.1% / CD1579 2.5% None None 1 217 23 217 View
Topical Gel Vehicle Placebo arm Topical Gel Vehicle None None 0 69 13 69 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Generalized Anxiety Disorder None Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gastroenteritis None Infections and infestations None View
Ear infection None Infections and infestations None View
Pharyngitis None Infections and infestations None View
Skin irritation None Skin and subcutaneous tissue disorders None View
Dermatitis allergic None Skin and subcutaneous tissue disorders None View
Eczema None Skin and subcutaneous tissue disorders None View
Rash None Skin and subcutaneous tissue disorders None View
Urticaria None Skin and subcutaneous tissue disorders None View
Headache None Nervous system disorders None View
Dizziness None Nervous system disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Rhinitis seasonal None Nervous system disorders None View
Fatigue None General disorders None View
Pyrexia None General disorders None View
Motion sickness None Ear and labyrinth disorders None View
Hypokalemia None Metabolism and nutrition disorders None View
Nasopharyngitis None Infections and infestations None View
Upper respiratory tract infection None Infections and infestations None View
Infleunza None Infections and infestations None View