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 @ 2:20 PM
Ignite Modification Date: 2025-12-25 @ 12:56 PM
NCT ID: NCT01058395
Description: Serious Adverse l event medical or laboratory related to the use of the medication.
Frequency Threshold: 0
Time Frame: 3 months
Study: NCT01058395
Study Brief: Safety and Feasibility of Minocycline in the Treatment of Traumatic Brain Injury (TBI)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
800 mg Loading Then 200 mg Q12 Minocycline 800 mg. loading followed by 200 mg. Q 12 hours. Minocycline: Minocycline 800 mg loading followed by 200 mg Q12 or Minocycline 800 mg loading followed by 400 mg Q12 will be delivered in an open-label study for seven days intravenously in one of two different dosing tiers to assess safety and toxicity per FDA recommendations. There will be tow different arms or groups differing by the amount of minocycline given over 7 days. 2 None 0 7 7 7 View
800 mg Loading Then 400 mg Q12 Minocycline 800 mg. loading followed by 400 mg. Q 12 hours. Minocycline: Minocycline 800 mg loading followed by 200 mg Q12 or Minocycline 800 mg loading followed by 400 mg Q12 will be delivered in an open-label study for seven days intravenously in one of two different dosing tiers to assess safety and toxicity per FDA recommendations. There will be tow different arms or groups differing by the amount of minocycline given over 7 days. 1 None 0 8 8 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Medical NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View