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 @ 4:14 AM
Ignite Modification Date: 2025-12-26 @ 3:13 AM
NCT ID: NCT03077620
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data was collected from when the participants were consented into the study until 48 hours after the lumbar catheter was removed (~3 months).
Study: NCT03077620
Study Brief: Sleep Quality and Amyloid-Beta Kinetics
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Poor Sleep Group Control Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit. Placebo: Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit. 0 None 0 13 10 13 View
Poor Sleep Group Treatment 1 10mg Suvorexant tablet h.s. for two consecutive nights Suvorexant: Participants will be given a sleep aid (10mg or 20mg suvorexant) at bedtime for two consecutive nights that they are spending in a research unit. 0 None 0 13 10 13 View
Poor Sleep Group Treatment 2 20mg Suvorexant tablet h.s. for two consecutive nights Suvorexant: Participants will be given a sleep aid (10mg or 20mg suvorexant) at bedtime for two consecutive nights that they are spending in a research unit. 0 None 0 12 10 12 View
Good Sleep Group Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit. Placebo: Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit. 0 None 0 6 4 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache requiring blood patch NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Presyncope with lumbar catheter placement NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Back/neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Urinary incontinence NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Rash, swelling, or bruising at lumbar catheter site NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Ringing in ears NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View