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 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
NCT ID:
NCT00546351
Description:
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
Frequency Threshold:
5
Time Frame:
Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Study:
NCT00546351
Study Brief:
Study Evaluating Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy.
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Lacosamide | 50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years. | None | None | 132 | 621 | 169 | 621 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (9.1) | View |
| Angina pectoris | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| Coronary artery disease | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| Myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| Bundle branch block right | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| Bundle branch block left | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| Acute myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| Myocardial ischaemia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| Cardiac failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| Hypertensive cardiomyopathy | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| Cardiac arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| Angina unstable | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| Ventricular fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| Cardiogenic shock | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| Cardiac failure congestive | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (9.1) | View |
| Spondylolisthesis | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (9.1) | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (9.1) | View |
| Tympanic membrane perforation | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (9.1) | View |
| Goitre | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (9.1) | View |
| Cataract | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (9.1) | View |
| Retinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (9.1) | View |
| Retinal detachment | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (9.1) | View |
| Blindness unilateral | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (9.1) | View |
| Vitreous haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (9.1) | View |
| Eye haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (9.1) | View |
| Pancreatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| Umbilical hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| Reflux oesophagitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| Gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| Gastroduodenitis haemorrhagic | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| Diverticular perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.1) | View |
| Systemic inflammatory response syndrome | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.1) | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.1) | View |
| Perforated ulcer | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.1) | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.1) | View |
| Cholecystitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (9.1) | View |
| Cholecystitis acute | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (9.1) | View |
| Hypersensitivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (9.1) | View |
| Pyelonephritis acute | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| Gangrene | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| Superinfection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| Chronic sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| Bronchitis fungal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| Tubo-ovarian abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| Erysipelas | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| Bronchopneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| Bronchitis bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| Lung infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| Localised infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| Abscess limb | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| Accidental overdose | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| Patella fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| Forearm fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| Ulna fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| Lower limb fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| Hand fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| Epicondylitis | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| Traumatic brain injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| Radius fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (9.1) | View |
| Gamma-glutamyltransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (9.1) | View |
| QRS axis abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (9.1) | View |
| Electrocardiogram QT prolonged | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (9.1) | View |
| Diabetes mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (9.1) | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (9.1) | View |
| Ketoacidosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (9.1) | View |
| Hypoglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (9.1) | View |
| Gout | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (9.1) | View |
| Diabetes mellitus inadequate control | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (9.1) | View |
| Osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | View |
| Spinal osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | View |
| Polyarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | View |
| Fistula | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | View |
| Toe deformity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | View |
| Arthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | View |
| Uterine cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | View |
| Breast cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | View |
| Pleural mesothelioma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | View |
| Lipoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | View |
| Thyroid adenoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | View |
| Rectal cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | View |
| Ovarian adenoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | View |
| Malignant melanoma in situ | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | View |
| Lymphoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | View |
| Epithelioma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | View |
| Oropharyngeal cancer stage unspecified | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | View |
| Ovarian cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | View |
| Benign breast neoplasm | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | View |
| Loss of consciousness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| Presyncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| Diabetic neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| Carpal tunnel syndrome | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| Ischaemic stroke | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| Encephalopathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| Transient ischaemic attack | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| Drop attacks | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| Carotid artery stenosis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| Facial paresis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| Cerebral ischaemia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| Apallic syndrome | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| Cerebrovascular accident | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| Brain stem syndrome | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| Psychosomatic disease | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (9.1) | View |
| Renal colic | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (9.1) | View |
| Proteinuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (9.1) | View |
| Nephropathy | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (9.1) | View |
| Benign prostatic hyperplasia | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (9.1) | View |
| Ovarian cyst | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (9.1) | View |
| Postmenopausal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (9.1) | View |
| Sleep apnoea syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| Pulmonary fibrosis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| Nasal polyps | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| Chronic obstructive pulmonary disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| Snoring | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| Pulmonary congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| Asthma | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| Respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| Haemoptysis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | View |
| Skin ulcer | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (9.1) | View |
| Neuropathic ulcer | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (9.1) | View |
| Hyperkeratosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (9.1) | View |
| Knee operation | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (9.1) | View |
| Coronary arterial stent insertion | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (9.1) | View |
| Transurethral prostatectomy | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (9.1) | View |
| Vitrectomy | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (9.1) | View |
| Coronary artery bypass | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (9.1) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (9.1) | View |
| Peripheral arterial occlusive disease | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (9.1) | View |
| Intermittent claudication | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (9.1) | View |
| Circulatory collapse | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (9.1) | View |
| Hypertensive crisis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (9.1) | View |
| Venous thrombosis limb | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (9.1) | View |
| Arterial haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (9.1) | View |
| Femoral artery occlusion | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (9.1) | View |
| Femoral arterial stenosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (9.1) | View |
| Diabetic macroangiopathy | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (9.1) | View |
| Deep vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (9.1) | View |
| Arterial stenosis limb | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (9.1) | View |
| Arterial stenosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (9.1) | View |
| Thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (9.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (9.1) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (9.1) | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.1) | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.1) | View |