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 @ 2:10 AM
Ignite Modification Date: 2025-12-26 @ 12:37 AM
NCT ID: NCT00071760
Description: All participants received FPV or FPV/RTV at any dose were included in the safety population.
Frequency Threshold: 0
Time Frame: All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks.
Study: NCT00071760
Study Brief: Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort 2, Arm A - 4 Weeks to <6 Months Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID. 1 None 13 29 24 29 View
Cohort 1, Arm A - 6 Months to <2 Years Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID. 2 None 12 30 28 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v25 View
Hydrocele SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v25 View
Iridocyclitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v25 View
Abdominal symptom SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25 View
Inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA v25 View
Hypertransaminasaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v25 View
Arthritis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Escherichia urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Mastoiditis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Meningitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Meningitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Otitis media chronic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Pneumonia viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Tracheobronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Greenstick fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v25 View
Herbal toxicity SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v25 View
Pneumonitis chemical SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v25 View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v25 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v25 View
Hypernatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v25 View
Kwashiorkor SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v25 View
Malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v25 View
Anogenital warts SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v25 View
Febrile convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v25 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v25 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v25 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Otitis media acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Failure to thrive SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v25 View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v25 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v25 View
Nasal disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v25 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v25 View
Otorrhoea SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA v25 View
Aphthous ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25 View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA v25 View
Abdominal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Acarodermatitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Fungal skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Helminthic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Impetigo SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Pulmonary tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Tinea capitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Tinea infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v25 View
Blood cholesterol SYSTEMATIC_ASSESSMENT Investigations MedDRA v25 View
Blood cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v25 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v25 View
Blood triglycerides increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v25 View
Cardiac murmur SYSTEMATIC_ASSESSMENT Investigations MedDRA v25 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v25 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v25 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v25 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v25 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v25 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v25 View
Dermatitis allergic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v25 View
Dermatitis diaper SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v25 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v25 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v25 View
Seborrhoeic dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v25 View
Herpes simplex SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Measles SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Molluscum contagiosum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Mumps SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Otitis externa SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Otitis media chronic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Varicella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Viral rash SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Bacterial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Bartholin's abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Candida infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Candida nappy rash SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Erythema infectiosum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Hand-foot-and-mouth disease SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Hordeolum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Oral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Post procedural infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Skin candida SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Staphylococcal skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Tinea cruris SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Tinea faciei SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Vulvovaginal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Body tinea SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Gingivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25 View
Cheilitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25 View
Teething SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25 View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v25 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v25 View
Night sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v25 View
Pityriasis alba SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v25 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v25 View
Rash pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v25 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v25 View
Sneezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v25 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v25 View
Bronchial hyperreactivity SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v25 View
Tonsillar hypertrophy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v25 View
Upper airway obstruction SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v25 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v25 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v25 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v25 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v25 View
Blood sodium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA v25 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA v25 View
Cachexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v25 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v25 View
Hyperlipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v25 View
Hypernatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v25 View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v25 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v25 View
Malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v25 View
Underweight SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v25 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v25 View
Thrombocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v25 View
Eosinophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v25 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v25 View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v25 View
Burns second degree SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v25 View
Eye injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v25 View
Joint injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v25 View
Lip injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v25 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v25 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v25 View
Ear pruritus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA v25 View
Excessive cerumen production SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA v25 View
Developmental delay SYSTEMATIC_ASSESSMENT General disorders MedDRA v25 View
Conjunctivitis allergic SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v25 View
Chalazion SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v25 View
Conjunctival hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v25 View
Eye allergy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v25 View
Strabismus SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v25 View
Febrile convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v25 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v25 View
Ichthyosis SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v25 View
Phimosis SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA v25 View
Hepatomegaly SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v25 View
Immunisation reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA v25 View
Anogenital warts SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v25 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v25 View
Educational problem SYSTEMATIC_ASSESSMENT Social circumstances MedDRA v25 View