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 @ 11:50 PM
Ignite Modification Date: 2025-12-25 @ 9:45 PM
NCT ID: NCT00307151
Description: Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and \>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.
Frequency Threshold: 5
Time Frame: From study enrollment until study completion
Study: NCT00307151
Study Brief: Antiviral Responses to NNRTI-Based vs. PI-Based ARV Therapy in HIV Infected Infants Who Have or Have Not Received Single Dose NVP for Prevention of Mother-to-Child Transmission of 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
Coh I: NVP Cohort II: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen. 6 None 23 82 81 82 View
Coh I: LPV/r Cohort II: Previously received SD NVP. Randomly assigned to receive a PI-based regimen. 3 None 19 82 82 82 View
Coh II: NVP Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen. 10 None 65 147 146 147 View
Coh II: LPV/r Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen. 6 None 47 140 140 140 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View
Immunosuppression SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 19.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Hepatitis A SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Malaria SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Measles SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Meningitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Alanine aminotransferase abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Blood cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Neutrophil count SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Lactic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Hypocalcaemic seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Breath holding SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View
Otorrhoea SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 19.1 View
Eye discharge SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.1 View
Eye pruritus SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.1 View
Ocular hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Aphthous ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Acarodermatitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Body tinea SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Impetigo SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Malaria SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Measles SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Molluscum contagiosum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Otitis externa SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Otitis media acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Parotitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Persistent generalised lymphadenopathy SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Plasmodium falciparum infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Pulmonary tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Purulent discharge SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Tinea capitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Tinea infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Varicella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Alanine aminotransferase SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Aspartate aminotransferase SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Blood cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Blood triglycerides increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Failure to thrive SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Kwashiorkor SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Pharyngeal erythema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Pharyngeal inflammation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Tonsillar hypertrophy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Dermatitis allergic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Papule SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Rash generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Rash papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Seborrhoeic dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Skin plaque SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Skin reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Swelling face SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Pallor SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Tinea faciei SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Bronchial hyperreactivity SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Iron deficiency anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.1 View