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 @ 3:45 AM
Ignite Modification Date: 2025-12-26 @ 2:32 AM
NCT ID: NCT02163902
Description: All enrolled participants with a clearly identifiable actual treatment received from a previous ATX-101 study and at least 1 visit in the long-term follow-up (LTFU) study were included in the analysis population. All adverse events (AEs) and serious adverse events (SAEs) that were ongoing at the conclusion of the predecessor Studies ATX-101-11-22 and ATX-101-11-23 were followed until they resolved or were considered medically stable.
Frequency Threshold: 5
Time Frame: From the first exposure to study drug in predecessor study to up to 36 months after last treatment in predecessor study
Study: NCT02163902
Study Brief: Long-term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ATX-101 (Deoxycholic Acid) Injection This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 2 predecessor studies ATX-101-11-22 and ATX-101-11-23. 0 None 5 113 0 113 View
Placebo This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 2 predecessor studies ATX-101- 11-22 and ATX-101-11-23. 0 None 1 111 0 111 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Small cell lung cancer stage unspecified SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (14.1) View
Diverticulitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (14.1) View
Breast reconstruction SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (14.1) View
Ovarian cancer recurrent SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (14.1) View
Breast cancer in situ SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (14.1) View
Other Events(If Any):