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 @ 12:00 PM
Ignite Modification Date: 2025-12-25 @ 11:57 AM
NCT ID: NCT00961961
Description: All events were noted during the first phase of the study.
Frequency Threshold: 0
Time Frame: 15 months
Study: NCT00961961
Study Brief: Prevention of Relapse & Recurrence of Bipolar Depression
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 Plus Placebo Phase I No one was on placebo in Phase I. 0 None 0 0 0 0 View
Lithium Plus Placebo Phase II These are the patients randomly assigned to switch to placebo from fluoxetine in Phase II. 0 None 0 22 0 22 View
Lithium Plus Fluoxetine Phase I This is the condition that all participants started in. They were given Lithium plus Fluoxetine and, if they responded, they were asked to accept random assignment to Phase II. 0 None 20 177 0 177 View
Lithium Plus Fluoxetine Phase II These are the patients randomly assigned to stay on the fluoxetine in Phase II. 0 None 0 29 0 29 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Suicide ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Acute mood disturbance NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Elevated Creatinine NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Unable to swallow pills NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hospitalized for dehydration NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hospitalized for overdose of benzodiazepines NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hospitalized for acute alcohol abuse NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hospitalized for acute substance abuse NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Lethargy, cognitive dulling NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Muscle stiffness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Skin rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Tremors NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):