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 @ 5:49 PM
Ignite Modification Date: 2025-12-25 @ 3:15 PM
NCT ID: NCT04073368
Description: None
Frequency Threshold: 0
Time Frame: From the time of informed consent up to first administration of study product on Day 1, any untoward medical occurrence considered related to study procedures will be recorded as an AE. Adverse events that occur from the first administration of study product on Day 1 through the Follow-up Visit / Week 18 will be considered treatment-emergent AEs
Study: NCT04073368
Study Brief: Study of the Safety and Tolerability of AXA1125 and AXA1957 in Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AXA1957 High Dose AXA1957 20.3g AXA1957: Amino acids, food study 0 None 1 32 10 32 View
AXA1957 Low Dose AXA1957 13.5g AXA1957: Amino acids, food study 0 None 0 26 8 26 View
AXA1125 AXA1125 24g AXA1125: Amino acids, food study 0 None 1 29 13 29 View
Placebo Placebo 24g Placebo: Amino acids, food study 0 None 0 15 2 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
laryngeal squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View