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 @ 12:36 AM
Ignite Modification Date: 2025-12-25 @ 10:44 PM
NCT ID: NCT00600067
Description: None
Frequency Threshold: 1
Time Frame: AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Study: NCT00600067
Study Brief: A VI-0521 Study to Evaluate the Long-term Safety and Efficacy in Type 2 Diabetic Adults
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 None None None 1 55 34 55 View
Active PHEN/TPM 15/92 None None 2 75 48 75 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (10.0) View
costochondritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (10.0) View
intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (10.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (10.0) View
hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (10.0) View
diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (10.0) View
cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.0) View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
hypoesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (10.0) View
arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (10.0) View
insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (10.0) View
anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (10.0) View
pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (10.0) View
hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (10.0) View
depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (10.0) View
hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (10.0) View