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 @ 2:44 AM
Ignite Modification Date:
2025-12-26 @ 1:23 AM
NCT ID:
NCT02300233
Description:
The safety set included all randomized participants who received at least one dose of study drug.
Frequency Threshold:
5
Time Frame:
Up to approximately 39 weeks.
Study:
NCT02300233
Study Brief:
The COMPASS Study: A Study of Volanesorsen (Formally ISIS-APOCIIIRx) in Patients With Hypertriglyceridemia
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Volanesorsen 300 mg Biweekly, Post Week 13 | Volanesorsen 300 mg administered subcutaneously once-weekly for 13 weeks, then bi-weekly for 13 weeks. | 0 | None | 6 | 50 | 49 | 50 | View |
| Placebo | Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks. | 0 | None | 4 | 38 | 31 | 38 | View |
| Volanesorsen 300 mg Weekly | Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks. | 0 | None | 2 | 25 | 24 | 25 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (19.1) | View |
| Ileus paralytic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| Pancreatitis acute | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| Pancreatitis relapsing | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (19.1) | View |
| Serum sickness | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (19.1) | View |
| Pancreas infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| Ulna fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| Carotid artery stenosis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| Hemiparesis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| Hypertensive crisis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| Peripheral arterial occlusive disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| Injection site pruritus | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| Injection site discolouration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| Red blood cell sedimentation rate increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| C-reactive protein increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| Low density lipoprotein increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| Hepatic enzyme increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.1) | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.1) | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| Gout | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| Type 2 diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| Actinic keratosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.1) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| Albuminuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.1) | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (19.1) | View |
| Hepatic pain | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (19.1) | View |
| Injection site induration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| Injection site discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| Injection site bruising | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| Injection site rash | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| Injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| Injection site warmth | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| Injection site haemorrhage | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| Injection site hypoaesthesia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| Injection site inflammation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| Injection site mass | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| Injection site oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| Injection site swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |