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 @ 3:52 AM
Ignite Modification Date: 2025-12-26 @ 2:40 AM
NCT ID: NCT00736502
Description: None
Frequency Threshold: 5
Time Frame: 48 weeks
Study: NCT00736502
Study Brief: PMS Assessing the Long-term Efficacy and Safety of Nevirapine Therapy (Combined With Other ARV Drugs) in HIV-1 Positive Patients in Daily Clinical Practice.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Nevirapine Patients treated with 200 mg Nevirapine twice daily (administered orally). None None 12 278 0 278 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Clostridia enteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Helicobacter phylori infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
porta catheter infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Staphylococcus sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Fracture of foot SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Hyperkaliemia SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Lymphoma of the brain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Diabetes insipitus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Pneumocystitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Enanthema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.1 View
Herpes eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.1 View
Fever SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
Shunt thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
Lymphadenopathy, generalised SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Cholecystitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Pregnancy SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Melena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Other Events(If Any):