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 @ 4:27 AM
Ignite Modification Date: 2025-12-26 @ 3:30 AM
NCT ID: NCT00762320
Description: None
Frequency Threshold: 5
Time Frame: Adverse events were collected for 24 weeks after switch from liquid to low dose tablet formulation of Kaletra
Study: NCT00762320
Study Brief: Comparison of Liquid Kaletra and Low Dose Kaletra Tablets
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Low Dose Kaletra Patients will serve as their own controls as they are switched from liquid Kaletra to Low Dose Tablet Kaletra Low dose Kaletra tablets : Lopinavir/Ritonavir tablets 100mg/25mg None None 0 8 8 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
fever SYSTEMATIC_ASSESSMENT General disorders None View
ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
difficulty breathing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Increased MCV SYSTEMATIC_ASSESSMENT Investigations None View
Increased Cholesterol SYSTEMATIC_ASSESSMENT Investigations None View
increased amylase SYSTEMATIC_ASSESSMENT Investigations None View
decreased plt SYSTEMATIC_ASSESSMENT Investigations None View
Increased lymphocyte percent SYSTEMATIC_ASSESSMENT Investigations None View
Decreased Na+ SYSTEMATIC_ASSESSMENT Investigations None View
Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Throat Pain SYSTEMATIC_ASSESSMENT General disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
headache SYSTEMATIC_ASSESSMENT General disorders None View
nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
leg pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
leg fatigue SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Increased Triglycerides SYSTEMATIC_ASSESSMENT Investigations None View
Increased Monocytes SYSTEMATIC_ASSESSMENT Investigations None View
Increased WBC SYSTEMATIC_ASSESSMENT Investigations None View
decreased RBC SYSTEMATIC_ASSESSMENT Investigations None View
Increased eosinophils SYSTEMATIC_ASSESSMENT Investigations None View
decreased neutrophil percent SYSTEMATIC_ASSESSMENT Investigations None View
decreased ANC SYSTEMATIC_ASSESSMENT Investigations None View
increased HCT SYSTEMATIC_ASSESSMENT Investigations None View
decreased CO2 SYSTEMATIC_ASSESSMENT Investigations None View
increased CO2 SYSTEMATIC_ASSESSMENT Investigations None View
Increased Alk Phos SYSTEMATIC_ASSESSMENT Investigations None View
Increased K+ SYSTEMATIC_ASSESSMENT Investigations None View
decreased K+ SYSTEMATIC_ASSESSMENT Investigations None View
Increased Creatinine SYSTEMATIC_ASSESSMENT Investigations None View