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 @ 2:16 AM
Ignite Modification Date: 2025-12-26 @ 12:46 AM
NCT ID: NCT03675360
Description: None
Frequency Threshold: 0
Time Frame: For each participant, adverse event data was collected over the 6-month intervention period.
Study: NCT03675360
Study Brief: Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Low-Carbohydrate Diet Behavioral modification to reduce carbohydrate consumption. Target \<40 g net carbohydrates per day for first 3 months; \<60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups. At baseline, participants will receive written information with standard physical activity recommendations. Low-Carbohydrate Diet: Behavioral modification to reduce carbohydrate consumption. Target \<40 g net carbohydrates per day for first 3 months; \<60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups. At baseline, participants will receive written information with standard physical activity recommendations. 0 None 4 75 2 75 View
Usual Diet No dietary intervention. At baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations. 0 None 3 75 2 75 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Emergency room visit SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hospitalization SYSTEMATIC_ASSESSMENT General disorders None View
Emergency Room Visit SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hospitalization SYSTEMATIC_ASSESSMENT Infections and infestations None View
Emergency Room Visit SYSTEMATIC_ASSESSMENT Vascular disorders None View
Surgery and hospitalization SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Surgery SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Surgery SYSTEMATIC_ASSESSMENT Eye disorders None View
Surgery SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View