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 @ 10:41 PM
Ignite Modification Date: 2025-12-25 @ 8:12 PM
NCT ID: NCT05485935
Description: None
Frequency Threshold: 0
Time Frame: The study consisted of four study visits in a clinic (V0-V3) and two 4-week test periods at home. Hence, the total study duration for the individual subject lasted approximately nine weeks.
Study: NCT05485935
Study Brief: A Confirmatory Study Confirming Performance of a New Intermittent Catheter
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Investigational Device As this study was a crossover study, each participant underwent catheterizations with both the investigational device and the comparator device. Safety population constitutes the full analysis set. 0 None 3 73 8 73 View
Comparator Device As this study was a crossover study, each participant underwent catheterizations with both the investigational device and the comparator device. Safety population constitutes the full analysis set. 1 None 0 73 8 73 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Urosepsis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
unbalanced type 2 diabetes NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Fever SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Urolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Epididymit SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Blood in urine SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Swollen foot SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Stinging in urethra SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Micturition SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Gout SYSTEMATIC_ASSESSMENT Infections and infestations None View
fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View