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 @ 3:29 AM
Ignite Modification Date: 2025-12-26 @ 2:10 AM
NCT ID: NCT00666705
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00666705
Study Brief: A Study To Evaluate An Interaction Between Maraviroc And Raltegravir In Healthy Subjects
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 + Raltegravir On Study Days 12-14: Raltegravir 400 milligrams (mg) every 12 hours, maraviroc 300 mg every 12 hours (AM doses only on Day 14) None None 0 17 4 None View
Maraviroc 300 milligrams (mg) every 12 hours on Study Days 6-11 None None 0 18 4 None View
Raltegravir 400 milligrams (mg) every 12 hours on Study Days 1-3 Followed by washout on Study Days 4-5 None None 0 18 3 None View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v11.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v11.1 View
Folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v11.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v11.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v11.1 View
Peripheral neurophathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v11.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v11.1 View