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 @ 2:15 AM
Ignite Modification Date: 2025-12-26 @ 12:44 AM
NCT ID: NCT05114460
Description: An adverse event is any unwanted experience or event occurring during the trial. An adverse event will be defined as serious whenever the outcome is fatal or life-threatening, is significantly or permanently disabling or incapacitating, requires or prolongs inpatient hospitalization, results in permanent disability, results in a congenital anomaly, or is unusual and potentially serious.
Frequency Threshold: 5
Time Frame: All Study Participants, the 4-week Inpatient testing period.
Study: NCT05114460
Study Brief: Vaped Marijuana to Attenuate Naloxone-Precipitated Withdrawal
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
All Study Participants Adverse events were assessed were collected throughout the 4-week inpatient period. 0 None 0 2 0 2 View
Serious Events(If Any):
Other Events(If Any):