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: 2025-12-26 @ 10:37 AM
Ignite Modification Date: 2025-12-26 @ 10:37 AM
NCT ID: NCT02199028
Description: Adverse events were recorded during weeks of infusion set wear. In the study a total of 117 weeks of infusion set wear were available for analysis including 58 hyaluronidase weeks and 59 control weeks.
Frequency Threshold: 0
Time Frame: Adverse events were recorded during subject's participation in the study (screening to final visit). Adverse events were followed from onset to resolution.
Study: NCT02199028
Study Brief: Hyaluronidase Effect on Infusion Set Life
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Hyaluronidase Week Infuse 1mL Hyaluronidase at time of infusion set placement and again on Day 3 Hyaluronidase: If assigned to hyaluronidase week, subjects will inject 1 milliliter (ml) Hylenex (150 units/ml) into the catheter hub prior to connecting the insulin infusion set. They will then give a catheter fixed prime of 0.7 cc to clear the infusion set of hyaluronidase. On the morning of day 3 during a Hyaluronidase week, a second dose of 1ml Hylenex (150 units/1ml) will be injected through the catheter hub prior to breakfast using the Duo Infusion Set Tubing. They will then reconnect their pump catheter and give a fixed prime of 0.7 cc to clear the infusion set of hyaluronidase. None None 0 30 16 30 View
Control Week Subjects will not receive Hyaluronidase during this week None None 0 30 17 30 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Infection at sensor site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders abscess View
Erythema >10 mm diameter SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Erythema View
Infection at infusion set site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders abscess View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Rash View