Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 3:03 PM
Ignite Modification Date: 2025-12-25 @ 1:26 PM
NCT ID: NCT06019559
Description: None
Frequency Threshold: 5
Time Frame: 15 weeks
Study: NCT06019559
Study Brief: A Study to Evaluate the Safety, Tolerability, and Weight Loss Efficacy of K-757 Alone and in Combination With K-833
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo to K-757 and K-833 Matching placebo to K-757 and matching placebo to K-833: Both administered orally 0 None 0 52 31 52 View
K-757 Alone K-757 120 mg BID and matching placebo to K-833. Both Administered orally 0 None 0 51 41 51 View
K-757+K-833 K-757 120 mg BID and K-833 100 mg BID. Both administered orally 0 None 0 52 42 52 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 26.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 26.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 26.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 26.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 26.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 26.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 26.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 26.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 26.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 26.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 26.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 26.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 26.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 26.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 26.0 View