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 @ 4:50 AM
Ignite Modification Date: 2025-12-26 @ 3:52 AM
NCT ID: NCT02246218
Description: TEAEs (defined as AEs with an onset date on or after the first dose of study medication until study discontinuation) are presented.
Frequency Threshold: 0
Time Frame: From the first dose of study treatment through 30 days after the final dose (mean [SD] duration of treatment was 9.13 [6.838] months for Cohort of 2 Months to <2 Years Participants and 10.67 [6.142] months for Cohort of 0 Months to <2 Months Participants).
Study: NCT02246218
Study Brief: A Study of the Safety, Efficacy and Pharmacokinetics of Glycerol Phenylbutyrate in Pediatric Subjects Under 2 Years of Age With Urea Cycle Disorders
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
RAVICTI: Age 2 Months to < 2 Years Participants age 2 months to \< 2 years received RAVICTI Oral Liquid administered just prior to breastfeeding or intake of formula or food. The recommended dosing regimen is 3-6 times per day depending on feeding schedule and at the discretion of the Investigator. 1 None 6 10 8 10 View
RAVICTI: Age 0 to <2 Months Participants age 0 to \< 2 months received RAVICTI Oral Liquid administered just prior to breastfeeding or intake of formula or food. The recommended dosing regimen is 3-6 times per day depending on feeding schedule and at the discretion of the Investigator. 0 None 11 16 16 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ammonia increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Cyanosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Apnoeic attack SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Status asthmaticus SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Pneumatosis intestinalis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Hyperammonaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Feeding disorder SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Croup infectious SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Peritonitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Rhinovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Medical device site infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Meningitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Respiratory syncytial virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Tracheitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Venous thrombosis limb SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 18.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Amino acid level increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Thrombocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Lymphocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Ocular hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.0 View
Excessive cerumen production SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.0 View
Red man syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Seborrhoeic dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Torticollis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Catheter site rash SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Device occlusion SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Drug withdrawal syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Medical device site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Stoma site reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Amino acid level decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Ammonia increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Carbon dioxide decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Anion gap increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Blood bicarbonate decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Blood urea decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Body height below normal SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Platelet count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Dacryostenosis congenital SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 18.0 View
Plagiocephaly SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 18.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Microcytic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Apnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Respiratory disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Tachypnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Use of accessory respiratory muscles SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Gross motor delay SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Eye discharge SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Teething SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Post-tussive vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Hepatic calcification SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.0 View
Vesicoureteric reflux SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Nail ridging SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Dermatitis diaper SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Hypophagia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Hyperammonaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Feeding disorder of infancy or early childhood SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Protein deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Croup infectious SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Respiratory syncytial virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Angular cheilitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Candida infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Gastrointestinal viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Otitis media acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Rhinovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View