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 @ 1:20 PM
Ignite Modification Date: 2025-12-25 @ 12:26 PM
NCT ID: NCT01830595
Description: None
Frequency Threshold: 0
Time Frame: 8 months
Study: NCT01830595
Study Brief: Lactoferrin Treatment in HIV Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Matched placebo will be administered by mouth twice daily Placebo 0 None 5 54 10 54 View
Recombinant Lactoferrin Recombinant lactoferrin will be administered by mouth twice daily Recombinant Lactoferrin 0 None 1 54 10 54 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization due to altered mental status NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hospitalization due to chest pain NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hospitalization due to COPD NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
hospitalization for confusion, disorientation, shakiness, unsteady gait and vomiting NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hospitalization for drug use NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hospitalized for syncope episode NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Bone NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
tinnitus NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Upper Respiratory infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Elevated CK SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Elevated AST SYSTEMATIC_ASSESSMENT General disorders None View
Skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fatigue, cough and sore throat NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bone spur on spine NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
surgery on rotator cuff NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
torn rotator cuff NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
right leg pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
nausea NON_SYSTEMATIC_ASSESSMENT General disorders None View
abdominal pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cough and respiratory congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sinus Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinus pain and congestion NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cough, congestion, sinus pressure, fatigue NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View