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 @ 1:39 AM
Ignite Modification Date: 2025-12-25 @ 11:55 PM
NCT ID: NCT06076694
Description: None
Frequency Threshold: 0
Time Frame: From Day 1 to Day 44 ~ Day 50 after the first dose
Study: NCT06076694
Study Brief: Efficacy and Safety After Multiple Doses of TNP-2198 Capsules, Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules in Helicobacter Pylori Infected-positive Participants
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group C TNP-2198 capsule 600 mg + rabeprazole sodium enteric-coated tablets 20 mg; Three times daily (TID) for 14 days 0 None 0 10 7 10 View
Group A TNP-2198 capsules 400 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g; Twice daily (BID) for 14 days 0 None 0 20 16 20 View
Group B TNP-2198 capsules 600 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g; BID for 14 days 0 None 0 20 20 20 View
Group D TNP-2198 capsules 600 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1g; TID for 7 days 0 None 0 10 8 10 View
Control Group Rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g; BID for 14 days 0 None 0 20 14 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypertriglyceridemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Blood albumin decreased SYSTEMATIC_ASSESSMENT Investigations None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate Aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Creatinine renal clearance decreased SYSTEMATIC_ASSESSMENT Investigations None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View