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 @ 12:16 AM
Ignite Modification Date: 2025-12-25 @ 10:19 PM
NCT ID: NCT01969058
Description: Expedited adverse event (EAE) reporting followed the Division of AIDS (DAIDS) EAE Manual under the SAE Reporting Category and including fetal losses. Events were graded (1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death) according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, Clarification Aug 2009.
Frequency Threshold: 5
Time Frame: Adverse Events (AEs) reported from study enrollment until study completion at 28 weeks
Study: NCT01969058
Study Brief: Effect of Isotretinoin on Immune Activation Among HIV-1 Infected Subjects With Incomplete CD4+ T Cell Recovery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Isotretinoin Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks. 0 None 2 50 41 50 View
No Study Treatment No Isotretinoin treatment 0 None 0 26 18 26 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Meningitis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Blood bicarbonate decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Blood cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Blood glucose decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Blood potassium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Blood sodium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Lipase abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Low density lipoprotein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View