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 @ 3:00 AM
Ignite Modification Date: 2025-12-26 @ 1:41 AM
NCT ID: NCT03003533
Description: The Full Analysis Set included all participants who received the infusion of SPK-8011.
Frequency Threshold: 0
Time Frame: From date of first dose up to Week 52
Study: NCT03003533
Study Brief: A Gene Transfer Study for Hemophilia A
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SPK-8011 5x10^11 vg/kg Participants received a single intravenous infusion of SPK-8011 5x10\^11 vg/kg. 0 None 0 2 2 2 View
SPK-8011 1x10^12 vg/kg Participants received a single intravenous infusion of SPK-8011 1x10\^12 vg/kg. 0 None 1 3 3 3 View
SPK-8011 2x10^12 vg/kg Participants received a single intravenous infusion of SPK-8011 2x10\^12 vg/kg. 0 None 1 9 9 9 View
SPK-8011 1.5x10^12 vg/kg Participants received a single intravenous infusion of SPK-8011 1.5x10\^12 vg/kg. 0 None 3 11 11 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24.0 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Transaminases Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Rhabdomyolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Tooth Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Viral Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Anaemia Postoperative SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Animal Bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Chemical Burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Pharyngeal Swelling SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Dermatitis Acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Dermatitis Contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Ingrowing Nail SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Hot Flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Hunger SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Influenza Like Illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Hiatus Hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Intestinal Mass SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Face Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Feeling Hot SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Feeling Jittery SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Generalised Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
Hand Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Morton's Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Iron Deficiency Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Normocytic Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Adrenal Insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 24.0 View
Asthenopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View
Scleral Hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View
Vision Blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View
Abdominal Distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Aphthous Ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Dental Caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Gastrooesophageal Reflux Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Gingival Discolouration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Salivary Gland Mass SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Hepatic Steatosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
Hyperplastic Cholecystopathy SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
Allergy To Arthropod Sting SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24.0 View
Covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Dermatitis Infected SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Herpes Dermatitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Herpes Zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Lower Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Nail Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Otitis Media Acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Pulpitis Dental SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Joint Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Ligament Sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Limb Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Muscle Strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Procedural Pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Scratch SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Skin Abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Skin Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood Creatinine Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Glycosylated Haemoglobin Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Sars-Cov-2 Test Positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Transaminases Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Weight Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
White Blood Cell Count Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Decreased Appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Iron Deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Exostosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Joint Swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Muscle Spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Musculoskeletal Chest Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Neck Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Osteoporosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Pain In Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Plantar Fasciitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Seronegative Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Synovial Cyst SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Synovitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Psychomotor Hyperactivity SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Attention Deficit Hyperactivity Disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Depressed Mood SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Nocturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Renal Colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Renal Cyst SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Testicular Disorder SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Oropharyngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View