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 @ 12:56 AM
Ignite Modification Date: 2025-12-25 @ 11:11 PM
NCT ID: NCT00337467
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00337467
Study Brief: Phase IIIb Study to Evaluate the Effectiveness and Safety of Atazanavir/Ritonavir as Single Enhanced Protease Inhibitor Therapy in Human Immunodeficiency Virus (HIV)-Infected Subjects Evidencing Virologic Suppression
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ATV/RTV Monotherapy ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack) None None 12 61 25 61 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
DYSTHYMIC DISORDER SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
PERIPHERAL ISCHAEMIA SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
SUICIDAL IDEATION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
PSYCHOTIC DISORDER SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
DEPRESSION SUICIDAL SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
ISCHAEMIC STROKE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
APPENDICITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
EYE INFECTION SYPHILITIC SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
TESTICULAR ATROPHY SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.0 View
ACCIDENT SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
MULTI-ORGAN FAILURE SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
BLADDER CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
DEPRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
TOOTH INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
HYPERCHOLESTEROLAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
HYPERTRIGLYCERIDAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View