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: 2025-12-25 @ 2:39 AM
Ignite Modification Date: 2025-12-26 @ 1:17 AM
NCT ID: NCT05085834
Description: None
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT05085834
Study Brief: Zinc Effect on Inflammation and Cardiovascular Risk in HIV
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Zinc Gluconate Patients received Zinc gluconate 45 mg capsules orally twice daily for 24 weeks. Zinc Gluconate: Two 45 mg capsules once daily 1 None 1 63 48 63 View
Placebo Patients received Zinc gluconate Placebo capsules orally twice daily for 24 weeks. Placebo: Two placebo capsules once daily 0 None 0 32 27 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal adhesions with intestinal torsion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abcess post root canal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
High Blood Pressure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Left groin hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain in right hip and Sciatica SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Peripheral Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Scrotal Abcess SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Worsening of depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomach Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
High ALT and/or AST SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
High Cholesterol SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
High Creatine Kinase SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
High Creatinine SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Low Hemoglobin SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Low Phosphorus SYSTEMATIC_ASSESSMENT General disorders None View
Low Sodium SYSTEMATIC_ASSESSMENT General disorders None View
High Sodium SYSTEMATIC_ASSESSMENT General disorders None View
High Alkaline Phosphatase SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
High Bilirubin SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
High Glucose SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
High LDL SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
High Triglycerides SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
High Uric Acid SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View