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 @ 12:40 AM
Ignite Modification Date: 2025-12-25 @ 10:52 PM
NCT ID: NCT01615367
Description: None
Frequency Threshold: 0
Time Frame: 52 weeks
Study: NCT01615367
Study Brief: Nutrition, Exercise, and Wellness Treatment (NEW Tx) 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
NEW Tx 19 people were randomized to NEW Tx, a weekly individualized psychotherapy. Therapy is 20 weeks long. Nutrition, Exercise, and Wellness (NEW) psychotherapy: NEW Tx is a flexible modular treatment such that modules are selected based on the needs of the individual to increase its generalizability across patients, settings, and providers as well as its acceptability to patients. 0 None 0 19 5 19 View
Treatment as Usual (TAU) 19 people were randomized to TAU and will meet with their psychiatrist as often as clinically needed over the 20 week study duration. Typically consists of at least one FDA-approved mood stabilizer: Pharmacotherapy will be conducted by experts in BD treatment and will follow the empirically-supported treatment algorithm for BD that has been developed and recently revised. The foundation of TAU is to maintain treatment with at least one Food and Drug Administration approved mood stabilizer. For TAU, medication and dosage changes are allowed as needed as long as the change is recommended based on the guidelines and participants remain on a mood stabilizer. 0 None 0 19 3 19 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Medical Issues (Physical) SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Unrelated Life Events SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Worsening Psychiatric Illness SYSTEMATIC_ASSESSMENT General disorders None View