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 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
NCT ID:
NCT02080520
Description:
None
Frequency Threshold:
0
Time Frame:
Adverse event data were collected for up to 3 years for each participant.
Study:
NCT02080520
Study Brief:
Nattokinase Atherothrombotic Prevention Study
Event Groups(If Any):
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pancreatic cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 22.0 | View |
| Non-fatal myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.0 | View |
| Coronary artery bypass graft surgery | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDra 22.0 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 22.0 | View |
| Transient ischemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 22.0 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 22.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 22.0 | View |
| Breast ductal carcinoma in-situ | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 22.0 | View |
| Breast invasive ductal carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 22.0 | View |
| Colon cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 22.0 | View |
| Follicular lymphoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 22.0 | View |
| Lung adenocarcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 22.0 | View |
| Papillary thyroid cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 22.0 | View |
| Prostate cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 22.0 | View |
| Rectal cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 22.0 | View |
| Knee arthroplasty | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDra 22.0 | View |
| Radical prostatectomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDra 22.0 | View |
| Hip arthroplasty | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDra 22.0 | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 22.0 | View |
| Hip fracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 22.0 | View |
| Perforated appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.0 | View |
| Diverticulosis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.0 | View |
| Carotid endarterectomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDra 22.0 | View |
| Cholangitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDra 22.0 | View |
| Benign tumor excision | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDra 22.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Increased tendency to bruise | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 22.0 | View |
| Thymic cyst | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 22.0 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.0 | View |
| Cardiomyopathy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.0 | View |
| Left ventricular failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.0 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.0 | View |
| Supraventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.0 | View |
| Ventricular extrasystoles | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 22.0 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDra 22.0 | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 22.0 | View |
| Retinal detachment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 22.0 | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 22.0 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.0 | View |
| Diverticulum | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.0 | View |
| Food poisoning | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.0 | View |
| Gingival bleeding | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.0 | View |
| Haematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.0 | View |
| Hiatus hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.0 | View |
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.0 | View |
| Colon polyps | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 22.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 22.0 | View |
| Peripheral swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 22.0 | View |
| Multiple allergies | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDra 22.0 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.0 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.0 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.0 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.0 | View |
| Pyelonephritis acute | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.0 | View |
| Tooth infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 22.0 | View |
| Animal bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.0 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.0 | View |
| Dermatitis contact | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.0 | View |
| Foot fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.0 | View |
| Forearm fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.0 | View |
| Head injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.0 | View |
| Humerus fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.0 | View |
| Laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.0 | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.0 | View |
| Radius fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.0 | View |
| Spinal compression fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 22.0 | View |
| Angiogram | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 22.0 | View |
| Arteriogram coronary | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 22.0 | View |
| Arthroscopy | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 22.0 | View |
| Biopsy | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 22.0 | View |
| Biopsy breast | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 22.0 | View |
| Biopsy colon | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 22.0 | View |
| Biopsy prostate | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 22.0 | View |
| Biopsy skin | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 22.0 | View |
| Biopsy thyroid gland | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 22.0 | View |
| Colonoscopy | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 22.0 | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 22.0 | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 22.0 | View |
| Joint swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 22.0 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 22.0 | View |
| Musculoskeletal stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 22.0 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 22.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 22.0 | View |
| Psoriatic arthropathy | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 22.0 | View |
| Rotator cuff syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 22.0 | View |
| Trigger finger | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 22.0 | View |
| Adenoma benign | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 22.0 | View |
| Basal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 22.0 | View |
| Benign breast neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 22.0 | View |
| Neoplasm malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 22.0 | View |
| Osteochondroma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 22.0 | View |
| Squamous cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 22.0 | View |
| Squamous cell carcinoma of skin | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 22.0 | View |
| Cognitive disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 22.0 | View |
| Dementia Alzheimer's type | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 22.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 22.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 22.0 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 22.0 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 22.0 | View |
| Parkinson's disease | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 22.0 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDra 22.0 | View |
| Libido decreased | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDra 22.0 | View |
| Ureterolithiasis and Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 22.0 | View |
| Breast cyst | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDra 22.0 | View |
| Breast tenderness | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDra 22.0 | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDra 22.0 | View |
| Vaginal haemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDra 22.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 22.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 22.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 22.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 22.0 | View |
| Respiratory tract congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 22.0 | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 22.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 22.0 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 22.0 | View |
| Swelling face | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 22.0 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 22.0 | View |
| Apicoectomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDra 22.0 | View |
| Appendicectomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDra 22.0 | View |
| Breast prosthesis implantation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDra 22.0 | View |
| Bunion and toe operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDra 22.0 | View |
| Bunion operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDra 22.0 | View |
| Cardiac ablation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDra 22.0 | View |
| Cardiac pacemaker insertion | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDra 22.0 | View |
| Cataract operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDra 22.0 | View |
| Dental implantation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDra 22.0 | View |
| Dupuytren's contracture operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDra 22.0 | View |
| Eyelid operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDra 22.0 | View |
| Femoral hernia repair | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDra 22.0 | View |
| Haemorrhoid operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDra 22.0 | View |
| Hip arthroplasty | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDra 22.0 | View |
| Inguinal hernia repair | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDra 22.0 | View |
| Knee arthroplasty | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDra 22.0 | View |
| Knee operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDra 22.0 | View |
| Large intestinal polypectomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDra 22.0 | View |
| Meniscus operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDra 22.0 | View |
| Oesophagogastric fundoplasty | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDra 22.0 | View |
| Prostatic radiotherapies | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDra 22.0 | View |
| Rotator cuff repair | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDra 22.0 | View |
| Shoulder arthroplasty | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDra 22.0 | View |
| Spinal laminectomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDra 22.0 | View |
| Surgery, hernia | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDra 22.0 | View |
| Suture insertion | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDra 22.0 | View |
| Tendon sheath incision | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDra 22.0 | View |
| Thyroidectomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDra 22.0 | View |
| Trapeziectomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDra 22.0 | View |
| Vitrectomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDra 22.0 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 22.0 | View |
| Haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 22.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 22.0 | View |