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 @ 5:03 AM
Ignite Modification Date: 2025-12-26 @ 4:05 AM
NCT ID: NCT00876018
Description: General Disorders adverse events (AEs) terms are not coded.
Frequency Threshold: 1
Time Frame: None
Study: NCT00876018
Study Brief: Nutrition, Physical Performance & Fitness in Indian School Children
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Experimental Group (Fortified Nutritional Supplement) Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays. 0 None 0 100 29 100 View
Control Group A (Unfortified Nutritional Powder) Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays. 0 None 0 100 25 100 View
Control Group B (No Intervention) Participants were not administered with any intervention. 0 None 0 100 8 100 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Skin allergy None General disorders None View
Abdominal pain None General disorders None View
Excessive tiredness after 20m shuttle None General disorders None View
Otitis media None General disorders None View
Abrasion during 20 m shuttle None General disorders None View
Felt dizzy after blood collection None General disorders None View
Fever None General disorders None View
Urinary tract infection None General disorders None View
Abrasion None General disorders None View
Fall/Fracture None General disorders None View
Chicken pox None General disorders None View
Leg wound None General disorders None View
Scabies None General disorders None View
Tooth ache None General disorders None View
Respiratory tract infection None General disorders None View
Ear/leg pain None General disorders None View
Perianal abscess None General disorders None View
Insect bite None Gastrointestinal disorders None View
Vomiting None General disorders None View
Loose stools None General disorders None View