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 @ 4:44 PM
Ignite Modification Date: 2025-12-25 @ 2:31 PM
NCT ID: NCT01275066
Description: Treatment Emergent Events Only
Frequency Threshold: 5
Time Frame: Study Period, through 24 weeks
Study: NCT01275066
Study Brief: A Double-Blind Study to Evaluate the Efficacy and Safety of BMN 110 in Patients With Mucopolysaccharidosis IVA (Morquio A Syndrome)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week. None None 2 59 57 59 View
BMN110 2.0 mg/kg/Qow Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks. None None 4 59 59 59 View
BMN110 2.0 mg/kg/Week Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week. None None 9 58 56 58 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Infusion site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Anaphylactic reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 15.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 15.0 View
Deafness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 15.0 View
Dengue fever SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Cervical cord compression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Suture removal SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Mitral valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Pulmonary valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Corneal opacity SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.0 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Device occlusion SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Infusion site extravasation SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Infusion site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Puncture site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 15.0 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Ligament sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Blood pressure diastolic increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Blood pressure systolic increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Body temperature increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Oxygen saturation decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Respiratory rate increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Osteopenia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Hyperreflexia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Dysmenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Throat irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Tonsillar hypertrophy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Poor venous access SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Tricuspid valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 15.0 View