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 @ 6:50 PM
Ignite Modification Date: 2025-12-25 @ 4:22 PM
NCT ID: NCT00361257
Description: None
Frequency Threshold: 5
Time Frame: Up to 48 weeks since the randomization.
Study: NCT00361257
Study Brief: Minocycline for the Treatment of Decreased Mental Function in HIV-Infected Adults
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Matching Placebo Placebo taken orally every 12 hours None None 3 55 34 55 View
Minocycline 100 mg orally every 12 hours None None 7 52 18 52 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Blood amylase increased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Vocal cord paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Tooth infection SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Suicidal attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Hypertension SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Blood triglycerides increased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Diarrhea/Loose SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Headache SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Sob SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View