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 @ 4:17 AM
Ignite Modification Date: 2025-12-26 @ 3:17 AM
NCT ID: NCT00979420
Description: None
Frequency Threshold: 5
Time Frame: 14 to 185 months
Study: NCT00979420
Study Brief: Non-interventional Observational Study With Viramune (Nevirapine) and Various Drug Combinations in the Antiretroviral Combination Treatment of HIV-infected Patients Who Have Already Been Treated for Approx. 10 Years With Viramune
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Viramune None None None 35 356 60 356 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Cardiac valve disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Congestive cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Coronary artery occlusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Coronary artery stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Subileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Umbilical hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Spinal cord injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Osteonecrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Colon cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Hemiparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Premature baby SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 13.1 View
Substance abuse SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Caesarean section SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 13.1 View
Venous thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Pneumonia pneumococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Syphilis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Rotator cuff syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Cerebral ischaemia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Grand mal convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Abortion SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 13.1 View
Abortion spontaneous SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 13.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View