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 @ 4:49 PM
Ignite Modification Date: 2025-12-25 @ 2:34 PM
NCT ID: NCT01693250
Description: Any adverse event happened during the study period will be reported to UCSF Institutional Review Board. The IRB will review the adverse event report and determine if a) the risk-benefit ratio continues to be acceptable, b) the research protocol and informed consent document accurately and completely present risk information, c) current subjects should be advised of newly identified risks and d) the event meets the definition of an Unanticipated Problem involving risk to participants or others.
Frequency Threshold: 0
Time Frame: The study period is 6 months, therefore, adverse event data were collected over 6 months.
Study: NCT01693250
Study Brief: iStart Smart for Teens for Healthy Weight Management
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fitbit Ultra A total of 23 adolescents in the intervention group received a Fitbit Ultra and will download an app to their smartphone. Participants will be asked to wear the Fitbit device and use the app every day for three months. fitbit Ultra: Participants were asked to wear the Fitbit device and use the app every day for three months. The app functions will include tracking of PA and dietary intake progress, setting individualized and realistic goals, monitoring progress related to reaching the goals, providing tips of everyday activities, and having interactive games related to PA and healthy diet. 0 None 0 23 0 23 View
Pedometer A total of 17 adolescent included in the control group. After completion of the baseline assessments, adolescents in the control group were given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months. Pedometer: adolescents in the control group were given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months. 0 None 0 17 0 17 View
Serious Events(If Any):
Other Events(If Any):