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 @ 11:11 AM
Ignite Modification Date: 2025-12-26 @ 11:11 AM
NCT ID: NCT00993928
Description: Regardless of whether they completed study treatment or any endpoint, all patients that began intervention and were assessed for adverse events were included in the analysis.
Frequency Threshold: 0
Time Frame: Adverse events were monitored weekly from week 1 to week 7.
Study: NCT00993928
Study Brief: Home-Based Programs for Improving Sleep in Cancer Survivors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm A: Home-based Sleep Intervention With Device #1 Participants listen to a pre-recorded mp3 device #1 before retiring to sleep. Only patients in Arm A will have assigned bed and wake times based on their baseline diary. 0 None 1 44 22 44 View
Arm B: Home-based Sleep Intervention With Device #2 Participants will listen to a pre-recorded mp3 device #2 before retiring to sleep. At the end of the study, participants assigned to pre-recorded mp3 device #2 will be offered pre-recorded mp3 device #1 for their own use. 0 None 0 43 18 43 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12 View
Facial pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 12 View
Infections and infestations - Other, specify SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View
Periorbital infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12 View