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 @ 1:14 PM
Ignite Modification Date: 2025-12-25 @ 12:24 PM
NCT ID: NCT04147195
Description: Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
Frequency Threshold: 5
Time Frame: Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 113 days.
Study: NCT04147195
Study Brief: Study of Various Treatments in Non-alcoholic Fatty Liver Disease (NAFLD) Patients Who Have Aspects of Non-alcoholic Steatohepatitis (NASH)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
LYS006 LYS006 20 mg was administered orally twice per day (b.i.d) for 12 weeks 0 None 0 20 9 20 View
LYS006 + LJN452 LYS006 20 mg was administered orally twice per day (b.i.d) in addition to LJN452 200ug administered orally once daily for 12 weeks 0 None 0 21 15 21 View
Total Total 0 None 0 41 24 41 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (24.1) View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (24.1) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (24.1) View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (24.1) View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (24.1) View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (24.1) View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (24.1) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (24.1) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (24.1) View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (24.1) View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (24.1) View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (24.1) View