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 @ 11:32 PM
Ignite Modification Date: 2025-12-25 @ 9:20 PM
NCT ID: NCT00135356
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00135356
Study Brief: Study of Reyataz in HIV-infected Patients With Lipodystrophy Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ATV/RTV Switch Arm None None None 11 131 94 131 View
PI/RTV Control Arm None None None 5 69 35 69 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
DRUG ABUSE SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
DRUG DEPENDENCE SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
JAUNDICE SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 11.0 View
HYPERBILIRUBINAEMIA SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 11.0 View
CONVULSION SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
CEREBROVASCULAR ACCIDENT SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
CALCULUS BLADDER SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
STEVENS-JOHNSON SYNDROME SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
BENIGN PROSTATIC HYPERPLASIA SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.0 View
JAW FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
DRUG TOXICITY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
INTERVERTEBRAL DISC PROTRUSION SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
PROSTATE CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.0 View
SQUAMOUS CELL CARCINOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.0 View
MYOCARDIAL INFARCTION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
PARALYSIS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
IRRITABLE BOWEL SYNDROME SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
NEUROSYPHILIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
BLOOD BILIRUBIN INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
JAUNDICE SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 11.0 View
HYPERBILIRUBINAEMIA SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 11.0 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
INFLUENZA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
SINUSITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
PHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
HYPERTRIGLYCERIDAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View