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 @ 6:50 PM
Ignite Modification Date: 2025-12-25 @ 4:22 PM
NCT ID: NCT01588457
Description: Adverse events were only collected for Lithium and Divalproex interventions. Adverse events were not tracked for monotherapy plus QTP or LTG (in Randomization 2 of the study).
Frequency Threshold: 0
Time Frame: None
Study: NCT01588457
Study Brief: Sequential Multiple Assignment Treatment for Bipolar Disorder
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Divalproex After a washout period of up to 1 week, subjects will be openly randomized to treatment Divalproex for 2 weeks. Subjects who become intolerant to or divalproex at any point will be crossed over to the other mood stabilizer (Lithium) and continued in the study. Adverse events were not collected for Randomization 2. None None 1 59 19 59 View
Lithium After a washout period of up to 1 week, subjects will be openly randomized to treatment Lithium for 2 weeks. Subjects who become intolerant to or Lithium at any point will be crossed over to the other mood stabilizer (Divalproex) and continued in the study. Adverse events were not collected for Randomization 2. None None 1 53 15 53 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neurological symptoms NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Shortness of Breath NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea and Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View