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 @ 9:55 PM
Ignite Modification Date: 2025-12-25 @ 7:34 PM
NCT ID: NCT02945332
Description: This study did not involve high risk. Walking was supervised and took place in a local community center. Participants had the option to immediately stop walking if they felt uneasy during walking. If it became apparent that the extent of an adverse event was beyond the research team's ability to handle, 911 would have been dialed immediately. The IRB would have been notified if any adverse event occurred.
Frequency Threshold: 0
Time Frame: Adverse events were assessed every one month. There was no reported adverse event in the study.
Study: NCT02945332
Study Brief: Incentivizing Lifestyle Modification to Reduce Disease Burden
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Required Supervised Walking Device: Fitbit Flexes Required supervised walking: The intervention will include meeting at an agreed upon community center location and time convenient for both the participant and the researcher. During these meetings, the participants will engage in indoor walking under the supervision of the researcher. This is to ensure accurate walking distance recording and also to monitor the participants for any potential adverse events. The participants will have the option of walking as long or short as they please, so long that it is less than 20 miles per week. This is to protect the participants from exhaustion or overexertion. Overall activity of this group will be recorded using Fitbit Flexes, worn at all time for the duration of the study. Fitbit Flex 0 None 0 4 0 4 View
Non-required Supervised Walking Device: Fitbit Flexes Non-required supervised walking: The intervention will include meeting at an agreed upon community center location and time convenient for both the participant and the researcher. During these meetings, the participants will engage in indoor walking under the supervision of the researcher. This is to ensure accurate walking distance recording and also to monitor the participants for any potential adverse events. The participants will have the option of walking as long or short as they please, so long that it is less than 20 miles per week. This is to protect the participants from exhaustion or overexertion. Overall activity of this group will be recorded using Fitbit Flexes, worn at all time for the duration of the study. Fitbit Flex 0 None 0 4 0 4 View
Serious Events(If Any):
Other Events(If Any):