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 @ 4:47 PM
Ignite Modification Date: 2025-12-25 @ 2:33 PM
NCT ID: NCT02640950
Description: None
Frequency Threshold: 0
Time Frame: Six months
Study: NCT02640950
Study Brief: An Open Label Trial of TMS Therapy for 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
Patients With Bipolar (I or II) Depression Thirty-one adults (13M/18F; age: 42.2\[14.3\]) with bipolar (I or II) depression, per DSM-5 criteria, were recruited at Sheppard Pratt and Mayo Clinic between December 2015-February 2020 for TMS. Standardized treatment protocols employed 6 weeks of 10 Hz TMS to the left dorsolateral prefrontal cortex at 120% of motor threshold with 3,000 pulses per session in 4 second trains with intertrain intervals of 26 seconds. All patients were treated concurrently with a mood stabilizer. The primary outcome measure was the Montgomery-Asberg Depression Rating Scale (MADRS). Response and remission were defined as MADRS score reductions of ≥ 50% or score ≤10, respectively. We examined response, remission, and potential contributing factors with multivariate and logistic regression models. 0 None 0 31 1 31 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View