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 @ 4:53 AM
Ignite Modification Date: 2025-12-26 @ 3:53 AM
NCT ID: NCT04417218
Description: None
Frequency Threshold: 0
Time Frame: Adverse events data were collected over the 4 week study period.
Study: NCT04417218
Study Brief: Determinants of Alpha-aminoadipic Acid (2-AAA) and Relationship to Diabetes: Study 2
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Normal Lysine Diet Participants will complete two one-week dietary interventions, in a randomized order. For the normal lysine diet, participants will be asked to adhere to a specific diet for 1 week. Each study subject will receive 3 meals and 1-2 snacks per day during the study period. Controlled Diet: Individuals will be instructed to consume specific foods, to adhere to a controlled lysine diet. 0 None 0 47 2 47 View
High Lysine Diet Participants will complete two one-week dietary interventions, in a randomized order. For the high lysine diet, participants will be asked to consume the same foods as in the normal lysine diet, but with the addition of lysine supplements (5g/day). Lysine: Lysine is an essential amino acid which is acquired from dietary sources. Controlled Diet: Individuals will be instructed to consume specific foods, to adhere to a controlled lysine diet. 0 None 0 46 7 46 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bloating NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Changes in mood NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Change in mood NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Bruising NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View