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 @ 2:47 AM
Ignite Modification Date: 2025-12-26 @ 1:28 AM
NCT ID: NCT03137433
Description: None
Frequency Threshold: 0
Time Frame: 52 weeks
Study: NCT03137433
Study Brief: Weight Loss With Meal-Replacement Therapy in Teens
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Meal-Replacements Plus Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). This group will be provided additional information to go along with meal-replacements, which was a financial incentive for weight loss. Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity. 0 None 1 63 6 63 View
Meal-Replacements Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity. 0 None 3 63 9 63 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Exacerbation of Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Suicide attempt NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Overdose NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Acquired pneumonia and E-cigarette associated lung injury (EVALI) NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Self report of taking laxatives NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Self induced vomiting NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View