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 @ 2:24 AM
Ignite Modification Date: 2025-12-26 @ 12:57 AM
NCT ID: NCT04182334
Description: None
Frequency Threshold: 0
Time Frame: Participants were assessed for adverse events from the time of informed consent process completion until the end of study participation. This was approximately 1 year if the study was completed.
Study: NCT04182334
Study Brief: Decreasing Delirium Through Music in Critically Ill Older Adults
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Slow Tempo Music Slow-tempo 60-80 beats per minute relaxing music. The intervention includes two one-hour music listening sessions, once in the morning and once in the evening for up to seven days, delivered through noise-canceling headphones and iPad. Slow Tempo Music: For up to seven days, enrolled subjects will receive one-hour slow tempo music listening sessions twice daily through noise-cancelling headphones. 10 None 1 79 2 79 View
Attention Control One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days. Attention Control: Subjects will receive a noise cancellation headphone-applied condition identical to the music intervention experimental treatment in twice daily one hour-sessions for up to seven days. 10 None 0 80 2 80 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hallucination SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Ear/ earlobe skin breakdown SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View