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: 2025-12-25 @ 5:05 AM
Ignite Modification Date: 2025-12-26 @ 4:08 AM
NCT ID: NCT06178718
Description: None
Frequency Threshold: 0
Time Frame: Up to 8 days after the first dosing.
Study: NCT06178718
Study Brief: A Phase 1 Study to Evaluate PK Profile and Food Effects on PK Parameters of TNP-2092 Capsules
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
TNP-2092 Capsules 400mg (Fasting ) Participants received oral dose of TNP-2092 capsules 400mg in fasting state. 0 None 0 16 2 16 View
TNP-2092 Capsules 800mg (Fasting) Participants received single oral dose of TNP-2092 capsules 800mg on Day 1 in fasting state. 0 None 0 8 1 8 View
TNP-2092 Capsules 1200mg (Fasting) Participants received single oral dose of TNP-2092 capsules 1200mg on Day 1 in fasting state. 0 None 0 8 1 8 View
TNP-2092 Capsules 100mg (Fasting) Participants received single oral dose of TNP-2092 capsules 100mg on Day 1 in fasting state. 0 None 0 8 0 8 View
TNP-2092 Capsules 200mg (Fasting) Participants received single oral dose of TNP-2092 capsules 200mg on Day 1 in fasting state. 0 None 0 8 1 8 View
Placebo (Fasting) Participants received TNP-2092 placebo capsules in fasting state. 0 None 0 10 1 10 View
TNP-2092 Capsules 400mg - (Fed) Participants received oral dose of TNP-2092 capsules 400mg in fed state. 0 None 0 16 2 16 View
Placebo (Fed) Participants received placebo in fed state, with 1 participant in each of the 400 mg groups A and B. 0 None 0 2 0 2 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood bilirubin unconjugated increased SYSTEMATIC_ASSESSMENT Investigations None View
Acarodermatitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Activated partial thromboplastin time prolonged SYSTEMATIC_ASSESSMENT Investigations None View