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 @ 1:56 PM
Ignite Modification Date: 2025-12-25 @ 12:44 PM
NCT ID: NCT00850395
Description: The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Frequency Threshold: 5
Time Frame: None
Study: NCT00850395
Study Brief: Non-Interventional Study Of Celsentri® In Treatment Experienced Patients With CCR5-Tropic HIV-Infection
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Maraviroc Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation. None None 3 79 4 79 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ichthyosis NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 14.1 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Hodgkin's disease NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.1 View
Suicide attempt NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Respiratory arrest NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View