Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 4:59 PM
Ignite Modification Date: 2025-12-25 @ 2:40 PM
NCT ID: NCT00706550
Description: None
Frequency Threshold: 1
Time Frame: None
Study: NCT00706550
Study Brief: Immune Responses to Pneumococcal Vaccination Among HIV-infected 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
Arm 2: PV After >6 Months of Antiretroviral Therapy Arm 2 received PV after at least 6 months of antiretroviral treatment. PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine None None 8 64 1 64 View
Arm 1: PV Before Starting Antiretroviral Therapy Arm 1 received PV prior to starting antiretroviral treatment. PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine None None 6 43 2 43 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
CHF, arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Death SYSTEMATIC_ASSESSMENT General disorders None View
Dehydration, electrolite abnormalities SYSTEMATIC_ASSESSMENT General disorders None View
Elective surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Gastrointestinal infections and other disorders SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mental health related SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other infections SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Skin infection SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations None View