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 @ 7:57 PM
Ignite Modification Date: 2025-12-25 @ 5:31 PM
NCT ID: NCT02175004
Description: SS included all enrolled participants who received at least 1 injection of inotersen in CS3.
Frequency Threshold: 5
Time Frame: From first dose of study drug up to 3 months post treatment period of 260 weeks (Up to approximately 272 weeks)
Study: NCT02175004
Study Brief: Extension Study Assessing Long Term Safety and Efficacy of IONIS-TTR Rx in Familial Amyloid Polyneuropathy (FAP)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Previous Placebo-Inotersen 300 mg Participants received SC doses of 300 mg inotersen once weekly for up to 260 weeks. Participants who received inotersen-matching placebo in ISIS 420915-CS2 study were included in this group. 2 None 18 50 50 50 View
Previous Inotersen-Inotersen 300 mg Participants received SC doses of 300 mg inotersen once weekly for up to 260 weeks. Participants who received inotersen in ISIS 420915-CS2 study were included in this group. 15 None 46 85 80 85 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 19.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 19.1 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders 19.1 View
Umbilical hernia, obstructive SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Wrist fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 19.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 19.1 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders 19.1 View
Cardiac failure acute SYSTEMATIC_ASSESSMENT Cardiac disorders 19.1 View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders 19.1 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders 19.1 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders 19.1 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders 19.1 View
Cardiac tamponade SYSTEMATIC_ASSESSMENT Cardiac disorders 19.1 View
Ventricular fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders 19.1 View
Atrioventricular block complete SYSTEMATIC_ASSESSMENT Cardiac disorders 19.1 View
Corneal perforation SYSTEMATIC_ASSESSMENT Eye disorders 19.1 View
Vitreous floaters SYSTEMATIC_ASSESSMENT Eye disorders 19.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
Peritoneal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
Oesophageal hypomotility SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders 19.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders 19.1 View
Generalised oedema SYSTEMATIC_ASSESSMENT General disorders 19.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders 19.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders 19.1 View
Autoimmune hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders 19.1 View
Biliary cirrhosis primary SYSTEMATIC_ASSESSMENT Hepatobiliary disorders 19.1 View
Liver disorder SYSTEMATIC_ASSESSMENT Hepatobiliary disorders 19.1 View
Jaundice cholestatic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders 19.1 View
Anti-neutrophil cytoplasmic antibody positive vasculitis SYSTEMATIC_ASSESSMENT Immune system disorders 19.1 View
Amyloidosis SYSTEMATIC_ASSESSMENT Immune system disorders 19.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Bacterial toxaemia SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Cellulitis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Cholecystitis infective SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Corona virus infection SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Endocarditis SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Localised infection SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Measles SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Osteomyelitis chronic SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Pneumococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Pneumonia pseudomonal SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Pneumonia viral SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Pyelonephritis acute SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Systemic infection SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Appendicitis perforated SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Escherichia pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Orchitis SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Subarachnoid haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 19.1 View
Facial bones fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 19.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 19.1 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 19.1 View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 19.1 View
Spleen contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 19.1 View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 19.1 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 19.1 View
Ligament sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 19.1 View
Toxicity to various agents SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 19.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 19.1 View
Fluid retention SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 19.1 View
Malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 19.1 View
Lumbar spinal stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 19.1 View
Small cell lung cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 19.1 View
Cholangiocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 19.1 View
Meningioma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 19.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders 19.1 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders 19.1 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders 19.1 View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders 19.1 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders 19.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders 19.1 View
Haemorrhage intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders 19.1 View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders 19.1 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders 19.1 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders 19.1 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders 19.1 View
Calculus bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders 19.1 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders 19.1 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders 19.1 View
Ovarian mass SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders 19.1 View
Acute pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 19.1 View
Asphyxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 19.1 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 19.1 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 19.1 View
Decubitus ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 19.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders 19.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders 19.1 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders 19.1 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders 19.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders 19.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 19.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders 19.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 19.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders 19.1 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders 19.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders 19.1 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders 19.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders 19.1 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 19.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 19.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 19.1 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders 19.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders 19.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders 19.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 19.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 19.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders 19.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 19.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders 19.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Injection site pruritus SYSTEMATIC_ASSESSMENT General disorders 19.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations 19.1 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders 19.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 19.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders 19.1 View
Muscle atrophy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 19.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders 19.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders 19.1 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders 19.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 19.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 19.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders 19.1 View
Balance disorder SYSTEMATIC_ASSESSMENT Nervous system disorders 19.1 View
Injection site rash SYSTEMATIC_ASSESSMENT General disorders 19.1 View
Oedema SYSTEMATIC_ASSESSMENT General disorders 19.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations 19.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders 19.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders 19.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 19.1 View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders 19.1 View
Glomerular filtration rate decreased SYSTEMATIC_ASSESSMENT Investigations 19.1 View
Injection site bruising SYSTEMATIC_ASSESSMENT General disorders 19.1 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders 19.1 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders 19.1 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 19.1 View
Wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 19.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations 19.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 19.1 View