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 @ 5:18 AM
Ignite Modification Date: 2025-12-26 @ 4:26 AM
NCT ID: NCT00515827
Description: MedDRA 14
Frequency Threshold: 5
Time Frame: From study enrollment until study completion
Study: NCT00515827
Study Brief: Effect of Addition of Raltegravir (MK-0518) to PI- or NNRTI-Based ART Regimens in HIV Infected Subjects With Undetectable Viral Load
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Raltegravir Baseline to Week 12 for Arm A (Raltegravir then Placebo), and Week 12 to Week 24 for Arm B (Placebo then Raltegravir). None None 0 52 10 52 View
Placebo Week 12 to Week 24 for Arm A (Raltegravir then Placebo), and Baseline to Week 12 for Arm B (Placebo then Raltegravir). None None 0 52 16 52 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Blood BILirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 14 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 14 View
Blood bicarbonate abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 14 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14 View
dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14 View