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 @ 9:14 PM
Ignite Modification Date: 2025-12-25 @ 7:03 PM
NCT ID: NCT02909504
Description: None
Frequency Threshold: 4
Time Frame: 16 weeks
Study: NCT02909504
Study Brief: Gao NARASD Lithium Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Lithium Lithium: Eligible patients will receive lithium 300 mg twice daily and titrated in 300 mg increments every 7 days as tolerated to levels \> 0.6 mEq/L 0 None 0 24 20 24 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Stomach Upset NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Increased Daytime Sleepiness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Increased Thirst NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dry Mouth NON_SYSTEMATIC_ASSESSMENT General disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cognitive Impairment NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Blurred Vision NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Itching NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Decreased Sexual Interest NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Hair Loss NON_SYSTEMATIC_ASSESSMENT General disorders None View
Increased urination NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View