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 @ 1:41 AM
Ignite Modification Date: 2025-12-25 @ 11:57 PM
NCT ID: NCT00477594
Description: In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
Frequency Threshold: 0
Time Frame: Up to 3 years.
Study: NCT00477594
Study Brief: Open Label Extension of ISIS 301012 (Mipomersen) to Treat Familial Hypercholesterolemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Mipomersen 200 mg Per Week Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years. None None 4 16 16 16 View
Mipomersen 200 mg Every Other Week Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator's discretion after the first 52 weeks of the treatment period. None None 3 5 5 5 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Malignant melanoma in situ SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Grief reaction SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Mood altered SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Splenomegaly SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Cardiomegaly SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Arteriovenous malformation SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 13.1 View
Ear discomfort SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 13.1 View
Thyroid cyst SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 13.1 View
Arcus lipoides SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Conjunctival haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Hypoaesthesia oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Lip swelling SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Adverse drug reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Feeling jittery SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Injection site coldness SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Injection site discolouration SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Injection site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Injection site hypertrophy SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Injection site rash SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Injection site urticaria SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.1 View
Hepatic steatosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.1 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 13.1 View
Acarodermatitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Back injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Excoriation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Foot fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Joint injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Joint sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Post procedural discomfort SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Splinter SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Wrong technique in drug usage process SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Blood urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Protein urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Urine analysis abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Increased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Exostosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Rotator cuff syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Sensation of heaviness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Angiomyolipoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Nerve compression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Hypertonic bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Renal cyst SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Breast cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.1 View
Breast mass SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.1 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Emphysema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Increased upper airway secretion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Respiratory tract congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Throat irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Rash erythematous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Rash generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Skin irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Diverticulum intestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Injection site anaesthesia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Injection site haematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Injection site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Chromaturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View