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 @ 2:42 AM
Ignite Modification Date: 2025-12-26 @ 1:21 AM
NCT ID: NCT00748033
Description: In this study all adverse events will be judged as adverse device effect. Adverse events were not monitored during reference testing.
Frequency Threshold: 1
Time Frame: Each subjects visited the clinic during one day. The subjects were catheterized for 3 minutes with each catheter. All subjects were catheterized with 3 catheters each, except one subject, who discontinued after test catheter 1 and was therefore only catheterized twice. At least 2 hours elapsed between each catheterization.
Study: NCT00748033
Study Brief: A Study Evaluating a Urinary Catheter With Different Activation Times for the Wetting Solution, in Healthy Male Volunteers.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
LoFric POBE Hydro-Kit II, 5 Seconds All subjects were first catheterizised with the reference catheter LoFric PVC, Nelaton 40 cm, CH 12. After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 5 seconds then LoFric POBE Hydro-Kit II, activation time 24 hours. After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 2 hours then LoFric POBE Hydro-Kit II, activation time 5 seconds. 0 None 0 24 17 24 View
LoFric POBE Hydro-Kit II, 24 Hours All subjects were first catheterizised with the reference catheter LoFric PVC, Nelaton 40 cm, CH 12. After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 5 seconds then LoFric POBE Hydro-Kit II, activation time 24 hours. After randomisation one group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 2 hours then LoFric POBE Hydro-Kit II, activation time 5 seconds. 0 None 0 25 18 25 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Discomfort during insertion of test catheter SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Discomfort during withdrawal of test catheter SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Discomfort during micturition after test catheter SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hematuria after test catheter is removed SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View