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 @ 3:21 AM
Ignite Modification Date: 2025-12-26 @ 1:59 AM
NCT ID: NCT06450405
Description: There was no adverse event collection timeframe because the two enrollees did not have any study visits. The study sponsor terminated the grant funding before any data, besides names and signatures on consent forms, were collected. There are no adverse event data to collect or to analyze.
Frequency Threshold: 0
Time Frame: There is no time frame because the study sponsor terminated the grant funding before any analyzable data were collected. The study sponsor terminated the grant funding days after the first two participants signed consent forms, but before any data, besides names and signatures on consent forms, were collected. There are no data to analyze. No data will be analyzed in the future.
Study: NCT06450405
Study Brief: Androgen Effects on the Reproductive Neuroendocrine Axis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CGF Control Group Cisgender females serving as a control group 0 None 0 0 0 0 View
TGM Initiating TRT Transgender men/non-binary/non-gender-conforming initiating testosterone replacement therapy Testosterone Cypionate 50 MG/ML Injectable Solution: Participants in the initiating group will receive weekly doses of testosterone for gender-affirming care. 0 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):