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 @ 2:00 AM
Ignite Modification Date: 2025-12-26 @ 12:23 AM
NCT ID: NCT01278394
Description: AEs were defined as any change (expected or unexpected) in a subject's medical health that occurred during the study. A serious AE was fatal, life-threatening, resulted in persistent or significant disability or incapacity, required or prolonged inpatient hospitalization, was a congenital anomaly, or another medically important condition.
Frequency Threshold: 0
Time Frame: Pre and post treatment to Day 360
Study: NCT01278394
Study Brief: Safety and Efficacy Study of Subjects With Onychomycosis of the Great Toenail
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AN2690 Solution, 5.0% AN2690 Solution, 5.0%: Once daily application for 360 days None None 1 29 16 29 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Uterine haemorrhage (unrelated) SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MeDRA 9.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MeDRA 9.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MeDRA 9.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MeDRA 9.0 View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MeDRA 9.0 View
Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 9.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 9.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 9.0 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 9.0 View
Tinea pedis SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 9.0 View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 9.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 9.0 View
Vaginal infection SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA 9.0 View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MeDRA 9.0 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MeDRA 9.0 View
Blood glucose abnormal SYSTEMATIC_ASSESSMENT Investigations MeDRA 9.0 View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MeDRA 9.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MeDRA 9.0 View
Polycystic ovaries SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MeDRA 9.0 View
Ingrowing nail SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MeDRA 9.0 View
Onychomadesis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MeDRA 9.0 View
Tooth extraction SYSTEMATIC_ASSESSMENT Surgical and medical procedures MeDRA 9.0 View