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 @ 5:53 PM
Ignite Modification Date: 2025-12-25 @ 3:18 PM
NCT ID: NCT02358668
Description: None
Frequency Threshold: 5
Time Frame: 16 weeks
Study: NCT02358668
Study Brief: BTI320 (SUGARDOWN®) on Post-Prandial Hyperglycaemia in Subjects With Pre-Diabetes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BTI320 4 Grams three times daily, oral for 16 weeks BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar. None None 1 24 18 24 View
BTI320 8 Grams three times daily, oral for 16 weeks BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar. None None 0 24 16 24 View
BTI320 Matching Placebo 2 tablets three times daily, oral for 16 weeks BTI320 matching placebo: Placebo None None 0 12 7 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
High grade osteosarcoma at left distal femur SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dermatitis allergic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Frequent bowel movements SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Tooth fracture SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View