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 @ 3:28 AM
Ignite Modification Date: 2025-12-26 @ 2:09 AM
NCT ID: NCT04484805
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were monitored/collected during the experimental conditions. With each condition lasting about 1 month, each participant was monitored for adverse events for about 2 months. Adverse events were monitored/assessed at least every 2 weeks by phone call, with study staff checking in more frequently if participants reached out with questions. Participants were told to reach out to study staff immediately if adverse events did occur.
Study: NCT04484805
Study Brief: Socket Cooling Effectiveness Take Home Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ICE Unit The subject wears the experimental socket with an ICE Unit, which includes a TEC and will be actively cooling the leg whenever the device is powered on. An ambient temperature sensor and step counter is attached to the socket. The subject is only informed that each condition is a "different level of cooling" to reduce bias. This condition should last approximately one month. ICE Condition: Experimental socket integrated with a heat spreader. An ICE Unit (includes TEC) is attached to the socket. 0 None 0 12 0 12 View
Sham Unit The subject wears the experimental socket with a Sham Unit, which excludes a TEC and will not be actively cooling the leg when the device is powered on. An ambient temperature sensor and step counter is attached to the socket. The subject is only informed that each condition is a "different level of cooling" to reduce bias. This condition should last approximately one month. Sham Condition: Experimental socket integrated with a heat spreader. A Sham Unit (excludes TEC) is attached to the socket. 0 None 0 12 0 12 View
Serious Events(If Any):
Other Events(If Any):