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 @ 4:11 AM
Ignite Modification Date: 2025-12-26 @ 3:10 AM
NCT ID: NCT03047720
Description: The number of participants in ARM 2 at risk all-cause mortality, SAEs, and other adverse events was zero because no patients advanced to that arm.
Frequency Threshold: 0
Time Frame: 6weeks
Study: NCT03047720
Study Brief: Scheduled Awakenings for the Treatment of Nocturnal Enuresis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
S1: Lully Device Plus Behavioral Modifications The S1 therapeutic phase of this study was: 6 weeks of behavioral modifications plus the Lully device The family received counseling on behavioral modifications during initial baseline phase to follow throughout S1. During this phase, a scheduled awakening was performed each night with the Lully pod following the scheduled awakening protocol using Lully Sleep Guardian. This was used to reliably produce a brief awakening by titrating the device to a minimal awakening stimulus during the first night of use. If the brief awakening could not be produced using the Lully pod, the parent was to gently awaken the child Participants were asked to enter responses daily into a Lully Study app. The questions the participant was prompted to answer were to serve to document occurrence of bedwetting and the degree of wetness. In addition, the family were asked to complete the KIDSCREEN 27 and the Vancouver questionnaire at defined intervals 0 None 0 12 0 12 View
S2: Behavioral Modifications Only The S2 therapeutic phase of this study : 6 weeks of behavioral modifications only without the device. The family received counseling on behavioral modifications during initial baseline phase to follow throughout S1. During this phase, participants were asked to enter responses daily into a Lully Study app. The questions the participant was prompted to answer were to serve to document occurrence of bedwetting and the degree of wetness. In addition, the family were asked to complete the KIDSCREEN 27 and the Vancouver questionnaire at defined intervals 0 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):