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 @ 5:04 PM
Ignite Modification Date: 2025-12-25 @ 2:44 PM
NCT ID: NCT02189850
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT02189850
Study Brief: Efficacy, Safety and Tolerability of a Bowel Cleansing Preparation (BLI800) in Pediatric Subjects Undergoing Colonoscopy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BLI800 - Dose 2 BLI800 oral solution BLI800 - Dose 2: BLI800 oral solution (4.5 oz) 0 None 0 13 12 13 View
BLI800 - Dose 1 BLI800 oral solution BLI800 - Dose 1: BLI800 oral solution (6 oz) 0 None 0 16 13 16 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal tenderness NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anal fissure NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anorectal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Eructation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastric ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rectal hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
Injection site pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Bacterial test NON_SYSTEMATIC_ASSESSMENT Investigations None View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Blood creatine phosphokinase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Liver function test abnormal NON_SYSTEMATIC_ASSESSMENT Investigations None View
Protein urine present NON_SYSTEMATIC_ASSESSMENT Investigations None View
Urinary casts NON_SYSTEMATIC_ASSESSMENT Investigations None View
Metabolic acidosis NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dysmenorrhea NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Helicobacter infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View