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 @ 4:35 AM
Ignite Modification Date: 2025-12-26 @ 3:37 AM
NCT ID: NCT05627518
Description: None
Frequency Threshold: 1.40
Time Frame: Baseline to Visit 5, 1 month
Study: NCT05627518
Study Brief: Relative Bioavailability of Linaprazan for the Test Formulation vs. Reference Formulation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Reference Formulation (Treatment A) 100 mg linaprazan glurate reference formulation (4x25 mg), fasting conditions Linaprazan glurate: 100 mg 0 None 0 51 17 51 View
Test Formulation (Treatment B) 100 mg linaprazan glurate reference formulation (1x100 mg), fasting conditions Linaprazan glurate: 100 mg 0 None 1 53 12 53 View
Test Formulation (Treatment C) 100 mg linaprazan glurate test formulation (1x100 mg), fed conditions Linaprazan glurate: 100 mg 0 None 0 50 14 50 View
Reference 25 mg linaprazan glurate reference formulation fasting conditions 0 None 0 13 4 13 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Skin Bacterial Infection SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Blood pressure diastolic inceased SYSTEMATIC_ASSESSMENT Investigations None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Papula SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Vascular disorders SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Skin and subcutaneous tissue disorders SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Cardiac disorders SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Liver disorder SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders None View