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 @ 9:18 PM
Ignite Modification Date:
2025-12-25 @ 7:06 PM
NCT ID:
NCT01601704
Description:
Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.
Frequency Threshold:
0
Time Frame:
Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).
Study:
NCT01601704
Study Brief:
Cardiovascular Outcomes Study of Naltrexone SR/Bupropion SR in Overweight and Obese Subjects With Cardiovascular Risk Factors (The Light Study)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| NB32 | NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program. Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools. | None | None | 463 | 4455 | 1157 | 4455 | View |
| Placebo | Administered in addition to the weight management program. Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools. | None | None | 386 | 4450 | 282 | 4450 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | None | Blood and lymphatic system disorders | MedDRA 15.0 | View |
| Haemorrhagic anaemia | None | Blood and lymphatic system disorders | MedDRA 15.0 | View |
| Iron deficiency anaemia | None | Blood and lymphatic system disorders | MedDRA 15.0 | View |
| Lymphadenopathy | None | Blood and lymphatic system disorders | MedDRA 15.0 | View |
| Accelerated idioventricular rhythm | None | Cardiac disorders | MedDRA 15.0 | View |
| Acute coronary syndrome | None | Cardiac disorders | MedDRA 15.0 | View |
| Acute myocardial infarction | None | Cardiac disorders | MedDRA 15.0 | View |
| Angina pectoris | None | Cardiac disorders | MedDRA 15.0 | View |
| Angina unstable | None | Cardiac disorders | MedDRA 15.0 | View |
| Aortic valve disease | None | Cardiac disorders | MedDRA 15.0 | View |
| Arrhythmia | None | Cardiac disorders | MedDRA 15.0 | View |
| Arteriosclerosis coronary artery | None | Cardiac disorders | MedDRA 15.0 | View |
| Atrial fibrillation | None | Cardiac disorders | MedDRA 15.0 | View |
| Atrial flutter | None | Cardiac disorders | MedDRA 15.0 | View |
| Atrial tachycardia | None | Cardiac disorders | MedDRA 15.0 | View |
| Atrial thrombosis | None | Cardiac disorders | MedDRA 15.0 | View |
| Atrioventricular block | None | Cardiac disorders | MedDRA 15.0 | View |
| Atrioventricular block complete | None | Cardiac disorders | MedDRA 15.0 | View |
| Cardiac arrest | None | Cardiac disorders | MedDRA 15.0 | View |
| Cardiac failure | None | Cardiac disorders | MedDRA 15.0 | View |
| Cardiac failure acute | None | Cardiac disorders | MedDRA 15.0 | View |
| Chest pain | None | General disorders | MedDRA 15.0 | View |
| Cyst | None | General disorders | MedDRA 15.0 | View |
| Systemic inflammatory response syndrome | None | General disorders | MedDRA 15.0 | View |
| Unevaluable event | None | General disorders | MedDRA 15.0 | View |
| Bile duct stone | None | Hepatobiliary disorders | MedDRA 15.0 | View |
| Biliary colic | None | Hepatobiliary disorders | MedDRA 15.0 | View |
| Biliary dyskinesia | None | Hepatobiliary disorders | MedDRA 15.0 | View |
| Cholecystitis | None | Hepatobiliary disorders | MedDRA 15.0 | View |
| Cholecystitis acute | None | Hepatobiliary disorders | MedDRA 15.0 | View |
| Cholecystitis chronic | None | Hepatobiliary disorders | MedDRA 15.0 | View |
| Cholelithiasis | None | Hepatobiliary disorders | MedDRA 15.0 | View |
| Drug-induced liver injury | None | Hepatobiliary disorders | MedDRA 15.0 | View |
| Gallbladder disorder | None | Hepatobiliary disorders | MedDRA 15.0 | View |
| Gallbladder polyp | None | Hepatobiliary disorders | MedDRA 15.0 | View |
| Hepatic cyst | None | Hepatobiliary disorders | MedDRA 15.0 | View |
| Anaphylactic reaction | None | Immune system disorders | MedDRA 15.0 | View |
| Hypersensitivity | None | Immune system disorders | MedDRA 15.0 | View |
| Abdominal wall abscess | None | Infections and infestations | MedDRA 15.0 | View |
| Abscess | None | Infections and infestations | MedDRA 15.0 | View |
| Abscess limb | None | Infections and infestations | MedDRA 15.0 | View |
| Appendicitis | None | Infections and infestations | MedDRA 15.0 | View |
| Appendicitis perforated | None | Infections and infestations | MedDRA 15.0 | View |
| Arthritis bacterial | None | Infections and infestations | MedDRA 15.0 | View |
| Bronchitis | None | Infections and infestations | MedDRA 15.0 | View |
| Bursitis infective staphylococcal | None | Infections and infestations | MedDRA 15.0 | View |
| Cellulitis | None | Infections and infestations | MedDRA 15.0 | View |
| Cellulitis of male external genital organ | None | Infections and infestations | MedDRA 15.0 | View |
| Cellulitis staphylococcal | None | Infections and infestations | MedDRA 15.0 | View |
| Clostridium difficile colitis | None | Infections and infestations | MedDRA 15.0 | View |
| Clostridium difficile infection | None | Infections and infestations | MedDRA 15.0 | View |
| Colonic abscess | None | Infections and infestations | MedDRA 15.0 | View |
| Diverticulitis | None | Infections and infestations | MedDRA 15.0 | View |
| Escherichia bacteraemia | None | Infections and infestations | MedDRA 15.0 | View |
| Gastroenteritis | None | Infections and infestations | MedDRA 15.0 | View |
| Gastroenteritis bacterial | None | Infections and infestations | MedDRA 15.0 | View |
| Gastroenteritis viral | None | Infections and infestations | MedDRA 15.0 | View |
| Human ehrlichiosis | None | Infections and infestations | MedDRA 15.0 | View |
| Infected bites | None | Infections and infestations | MedDRA 15.0 | View |
| Infection | None | Infections and infestations | MedDRA 15.0 | View |
| Influenza | None | Infections and infestations | MedDRA 15.0 | View |
| Intervertebral discitis | None | Infections and infestations | MedDRA 15.0 | View |
| Lobar pneumonia | None | Infections and infestations | MedDRA 15.0 | View |
| Lung infection | None | Infections and infestations | MedDRA 15.0 | View |
| Osteomyelitis | None | Infections and infestations | MedDRA 15.0 | View |
| Perirectal abscess | None | Infections and infestations | MedDRA 15.0 | View |
| Pharyngeal abscess | None | Infections and infestations | MedDRA 15.0 | View |
| Pneumonia | None | Infections and infestations | MedDRA 15.0 | View |
| Pneumonia staphylococcal | None | Infections and infestations | MedDRA 15.0 | View |
| Pyelonephritis | None | Infections and infestations | MedDRA 15.0 | View |
| Sepsis | None | Infections and infestations | MedDRA 15.0 | View |
| Septic shock | None | Infections and infestations | MedDRA 15.0 | View |
| Staphylococcal infection | None | Infections and infestations | MedDRA 15.0 | View |
| Upper respiratory tract infection | None | Infections and infestations | MedDRA 15.0 | View |
| Urinary tract infection | None | Infections and infestations | MedDRA 15.0 | View |
| Urinary tract infection bacterial | None | Infections and infestations | MedDRA 15.0 | View |
| Urosepsis | None | Infections and infestations | MedDRA 15.0 | View |
| Wound abscess | None | Infections and infestations | MedDRA 15.0 | View |
| Acetabulum fracture | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Ankle fracture | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Cervical vertebral fracture | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Concussion | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Craniocerebral injury | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Cystitis radiation | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Fall | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Femoral neck fracture | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Femur fracture | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Gastrointestinal stoma complication | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Gun shot wound | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Head injury | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Hip fracture | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Humerus fracture | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Incisional hernia | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Joint dislocation | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Joint injury | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Lower limb fracture | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Meniscus injury | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Multiple injuries | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Postoperative ileus | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Postoperative respiratory failure | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Procedural pain | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Radius fracture | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Rib fracture | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Road traffic accident | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Skull fracture | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Spinal column injury | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Spinal cord injury | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Spinal fracture | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Subdural haematoma | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Tendon rupture | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Thermal burn | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Ulna fracture | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Upper limb fracture | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Wound dehiscence | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Wrist fracture | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Anticoagulation drug level below therapeutic | None | Investigations | MedDRA 15.0 | View |
| Blood potassium decreased | None | Investigations | MedDRA 15.0 | View |
| Blood potassium increased | None | Investigations | MedDRA 15.0 | View |
| Blood pressure increased | None | Investigations | MedDRA 15.0 | View |
| Thyroid function test abnormal | None | Investigations | MedDRA 15.0 | View |
| Troponin increased | None | Investigations | MedDRA 15.0 | View |
| Alkalosis hypochloraemic | None | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Dehydration | None | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Diabetes mellitus inadequate control | None | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Fluid overload | None | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Hyperglycaemia | None | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Hypoglycaemia | None | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Hypokalaemia | None | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Hyponatraemia | None | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Metabolic acidosis | None | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Obesity | None | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Arthralgia | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Arthritis | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Back pain | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Bursitis | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Cervical spinal stenosis | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Exostosis | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Intervertebral disc compression | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Intervertebral disc degeneration | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Intervertebral disc disorder | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Intervertebral disc protrusion | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Lumbar spinal stenosis | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Musculoskeletal chest pain | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Musculoskeletal pain | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Neck pain | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Osteoarthritis | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Osteoarthropathy | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Osteonecrosis | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Pain in extremity | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Resorption bone increased | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Rheumatoid arthritis | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Rotator cuff syndrome | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Spinal column stenosis | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Spinal ligament ossification | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Spinal osteoarthritis | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Spondylolisthesis | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Synovial cyst | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Vertebral osteophyte | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Acute myeloid leukaemia | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Adenocarcinoma gastric | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Adenocarcinoma pancreas | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Adenoma benign | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| B-cell lymphoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| B-cell unclassifiable lymphoma high grade | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Basal cell carcinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Benign lung neoplasm | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Bladder cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Bladder transitional cell carcinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Bowen's disease | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Breast cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Cholangiocarcinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Clear cell renal cell carcinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Colon adenoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Colon cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Colon cancer metastatic | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Endometrial adenocarcinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Endometrial cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Glioblastoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Glioblastoma multiforme | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Invasive ductal breast carcinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Leukaemia | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Lung adenocarcinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Lung neoplasm malignant | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Malignant melanoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Malignant melanoma in situ | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Mesothelioma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Metastases to liver | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Metastases to spleen | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Metastatic neoplasm | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Metastatic squamous cell carcinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Non-Hodgkin's lymphoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Oesophageal adenocarcinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Oesophageal cancer metastatic | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Ovarian cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Ovarian granulosa cell tumour | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Pancreatic carcinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Phaeochromocytoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Prostate cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Prostate cancer stage II | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Renal cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Renal cell carcinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Squamous cell carcinoma of skin | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Thymoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Thyroid neoplasm | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Tongue neoplasm malignant stage unspecified | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Tonsil cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Uterine cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Uterine leiomyoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Aphasia | None | Nervous system disorders | MedDRA 15.0 | View |
| Brain stem stroke | None | Nervous system disorders | MedDRA 15.0 | View |
| Carotid artery disease | None | Nervous system disorders | MedDRA 15.0 | View |
| Carotid artery occlusion | None | Nervous system disorders | MedDRA 15.0 | View |
| Carotid artery stenosis | None | Nervous system disorders | MedDRA 15.0 | View |
| Cerebellar haemorrhage | None | Nervous system disorders | MedDRA 15.0 | View |
| Cerebral infarction | None | Nervous system disorders | MedDRA 15.0 | View |
| Cerebrovascular accident | None | Nervous system disorders | MedDRA 15.0 | View |
| Complicated migraine | None | Nervous system disorders | MedDRA 15.0 | View |
| Convulsion | None | Nervous system disorders | MedDRA 15.0 | View |
| Dementia with Lewy bodies | None | Nervous system disorders | MedDRA 15.0 | View |
| Diabetic hyperosmolar coma | None | Nervous system disorders | MedDRA 15.0 | View |
| Dizziness | None | Nervous system disorders | MedDRA 15.0 | View |
| Encephalopathy | None | Nervous system disorders | MedDRA 15.0 | View |
| Haemorrhage intracranial | None | Nervous system disorders | MedDRA 15.0 | View |
| Headache | None | Nervous system disorders | MedDRA 15.0 | View |
| Hemiparesis | None | Nervous system disorders | MedDRA 15.0 | View |
| Hydrocephalus | None | Nervous system disorders | MedDRA 15.0 | View |
| Hypoaesthesia | None | Nervous system disorders | MedDRA 15.0 | View |
| Ischaemic stroke | None | Nervous system disorders | MedDRA 15.0 | View |
| Lacunar infarction | None | Nervous system disorders | MedDRA 15.0 | View |
| Lumbar radiculopathy | None | Nervous system disorders | MedDRA 15.0 | View |
| Metabolic encephalopathy | None | Nervous system disorders | MedDRA 15.0 | View |
| Nerve root compression | None | Nervous system disorders | MedDRA 15.0 | View |
| Normal pressure hydrocephalus | None | Nervous system disorders | MedDRA 15.0 | View |
| Paraesthesia | None | Nervous system disorders | MedDRA 15.0 | View |
| Presyncope | None | Nervous system disorders | MedDRA 15.0 | View |
| Spondylitic myelopathy | None | Nervous system disorders | MedDRA 15.0 | View |
| Subarachnoid haemorrhage | None | Nervous system disorders | MedDRA 15.0 | View |
| Syncope | None | Nervous system disorders | MedDRA 15.0 | View |
| Transient ischaemic attack | None | Nervous system disorders | MedDRA 15.0 | View |
| VIIth nerve paralysis | None | Nervous system disorders | MedDRA 15.0 | View |
| Alcohol withdrawal syndrome | None | Psychiatric disorders | MedDRA 15.0 | View |
| Bipolar disorder | None | Psychiatric disorders | MedDRA 15.0 | View |
| Delirium | None | Psychiatric disorders | MedDRA 15.0 | View |
| Depression | None | Psychiatric disorders | MedDRA 15.0 | View |
| Hallucination | None | Psychiatric disorders | MedDRA 15.0 | View |
| Major depression | None | Psychiatric disorders | MedDRA 15.0 | View |
| Mental status changes | None | Psychiatric disorders | MedDRA 15.0 | View |
| Suicidal ideation | None | Psychiatric disorders | MedDRA 15.0 | View |
| Acute prerenal failure | None | Renal and urinary disorders | MedDRA 15.0 | View |
| Haematuria | None | Renal and urinary disorders | MedDRA 15.0 | View |
| Nephrolithiasis | None | Renal and urinary disorders | MedDRA 15.0 | View |
| Nephrosclerosis | None | Renal and urinary disorders | MedDRA 15.0 | View |
| Obstructive uropathy | None | Renal and urinary disorders | MedDRA 15.0 | View |
| Renal failure | None | Renal and urinary disorders | MedDRA 15.0 | View |
| Renal failure acute | None | Renal and urinary disorders | MedDRA 15.0 | View |
| Renal failure chronic | None | Renal and urinary disorders | MedDRA 15.0 | View |
| Urinary retention | None | Renal and urinary disorders | MedDRA 15.0 | View |
| Benign prostatic hyperplasia | None | Reproductive system and breast disorders | MedDRA 15.0 | View |
| Cystocele | None | Reproductive system and breast disorders | MedDRA 15.0 | View |
| Endometrial hyperplasia | None | Reproductive system and breast disorders | MedDRA 15.0 | View |
| Ovarian mass | None | Reproductive system and breast disorders | MedDRA 15.0 | View |
| Pelvic prolapse | None | Reproductive system and breast disorders | MedDRA 15.0 | View |
| Rectocele | None | Reproductive system and breast disorders | MedDRA 15.0 | View |
| Uterine prolapse | None | Reproductive system and breast disorders | MedDRA 15.0 | View |
| Uterovaginal prolapse | None | Reproductive system and breast disorders | MedDRA 15.0 | View |
| Acute pulmonary oedema | None | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Acute respiratory failure | None | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Asthma | None | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Bronchospasm | None | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Chronic obstructive pulmonary disease | None | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Dyspnoea | None | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Dyspnoea exertional | None | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Hypoxia | None | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Pleural effusion | None | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Pleurisy | None | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Pleuritic pain | None | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Pneumothorax | None | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Pulmonary embolism | None | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Pulmonary haemorrhage | None | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Pulmonary hypertension | None | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Pulmonary thrombosis | None | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Respiratory distress | None | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Respiratory failure | None | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Angioedema | None | Skin and subcutaneous tissue disorders | MedDRA 15.0 | View |
| Skin ulcer | None | Skin and subcutaneous tissue disorders | MedDRA 15.0 | View |
| Subcutaneous emphysema | None | Skin and subcutaneous tissue disorders | MedDRA 15.0 | View |
| Gastrectomy | None | Surgical and medical procedures | MedDRA 15.0 | View |
| Hip surgery | None | Surgical and medical procedures | MedDRA 15.0 | View |
| Accelerated hypertension | None | Vascular disorders | MedDRA 15.0 | View |
| Aortic aneurysm | None | Vascular disorders | MedDRA 15.0 | View |
| Aortic stenosis | None | Vascular disorders | MedDRA 15.0 | View |
| Arterial occlusive disease | None | Vascular disorders | MedDRA 15.0 | View |
| Deep vein thrombosis | None | Vascular disorders | MedDRA 15.0 | View |
| Haematoma | None | Vascular disorders | MedDRA 15.0 | View |
| Hypertensive crisis | None | Vascular disorders | MedDRA 15.0 | View |
| Hypotension | None | Vascular disorders | MedDRA 15.0 | View |
| Iliac artery occlusion | None | Vascular disorders | MedDRA 15.0 | View |
| Orthostatic hypotension | None | Vascular disorders | MedDRA 15.0 | View |
| Peripheral artery thrombosis | None | Vascular disorders | MedDRA 15.0 | View |
| Peripheral ischaemia | None | Vascular disorders | MedDRA 15.0 | View |
| Peripheral vascular disorder | None | Vascular disorders | MedDRA 15.0 | View |
| Subclavian artery stenosis | None | Vascular disorders | MedDRA 15.0 | View |
| Cardiac failure congestive | None | Cardiac disorders | MedDRA 15.0 | View |
| Cardio-respiratory arrest | None | Cardiac disorders | MedDRA 15.0 | View |
| Chronotropic incompetence | None | Cardiac disorders | MedDRA 15.0 | View |
| Congestive cardiomyopathy | None | Cardiac disorders | MedDRA 15.0 | View |
| Coronary artery disease | None | Cardiac disorders | MedDRA 15.0 | View |
| Coronary artery occlusion | None | Cardiac disorders | MedDRA 15.0 | View |
| Coronary artery stenosis | None | Cardiac disorders | MedDRA 15.0 | View |
| Ischaemic cardiomyopathy | None | Cardiac disorders | MedDRA 15.0 | View |
| Myocardial infarction | None | Cardiac disorders | MedDRA 15.0 | View |
| Myocardial ischaemia | None | Cardiac disorders | MedDRA 15.0 | View |
| Palpitations | None | Cardiac disorders | MedDRA 15.0 | View |
| Pericardial effusion | None | Cardiac disorders | MedDRA 15.0 | View |
| Sick sinus syndrome | None | Cardiac disorders | MedDRA 15.0 | View |
| Supraventricular tachycardia | None | Cardiac disorders | MedDRA 15.0 | View |
| Tachycardia | None | Cardiac disorders | MedDRA 15.0 | View |
| Ventricular fibrillation | None | Cardiac disorders | MedDRA 15.0 | View |
| Ventricular tachycardia | None | Cardiac disorders | MedDRA 15.0 | View |
| Haemorrhagic arteriovenous malformation | None | Congenital, familial and genetic disorders | MedDRA 15.0 | View |
| Porphyria acute | None | Congenital, familial and genetic disorders | MedDRA 15.0 | View |
| Vertigo | None | Ear and labyrinth disorders | MedDRA 15.0 | View |
| Adrenal insufficiency | None | Endocrine disorders | MedDRA 15.0 | View |
| Goitre | None | Endocrine disorders | MedDRA 15.0 | View |
| Hyperparathyroidism | None | Endocrine disorders | MedDRA 15.0 | View |
| Abdominal adhesions | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Abdominal hernia | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Abdominal hernia obstructive | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Abdominal pain | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Abdominal pain lower | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Abdominal pain upper | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Abdominal strangulated hernia | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Colitis | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Colitis ischaemic | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Constipation | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Crohn's disease | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Diverticulum intestinal haemorrhagic | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Duodenal ulcer haemorrhage | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Duodenitis | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Enteritis | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Gastric ulcer haemorrhage | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Gastritis | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Gastrointestinal haemorrhage | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Gastrointestinal ulcer | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Gastrointestinal ulcer haemorrhage | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Gastrooesophageal reflux disease | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Haematochezia | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Hiatus hernia | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Hiatus hernia, obstructive | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Impaired gastric emptying | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Inguinal hernia | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Intestinal perforation | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Large intestine polyp | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Lower gastrointestinal haemorrhage | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Nausea | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Obstruction gastric | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Oesophageal spasm | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Oesophagitis | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Oesophagitis haemorrhagic | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Pancreatitis | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Pancreatitis acute | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Peptic ulcer | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Retroperitoneal haemorrhage | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Small intestinal obstruction | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Umbilical hernia | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Umbilical hernia, obstructive | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Upper gastrointestinal haemorrhage | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Asthenia | None | General disorders | MedDRA 15.0 | View |
| Chest discomfort | None | General disorders | MedDRA 15.0 | View |
| Death | None | General disorders | MedDRA 15.0 | View |
| Device dislocation | None | General disorders | MedDRA 15.0 | View |
| Device malfunction | None | General disorders | MedDRA 15.0 | View |
| Fat tissue increased | None | General disorders | MedDRA 15.0 | View |
| Ischaemic ulcer | None | General disorders | MedDRA 15.0 | View |
| Non-cardiac chest pain | None | General disorders | MedDRA 15.0 | View |
| Pyrexia | None | General disorders | MedDRA 15.0 | View |
| Sudden cardiac death | None | General disorders | MedDRA 15.0 | View |
| Surgical failure | None | General disorders | MedDRA 15.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Angina pectoris | None | Cardiac disorders | MedDRA 15.0 | View |
| Atrial fibrillation | None | Cardiac disorders | MedDRA 15.0 | View |
| Bradycardia | None | Cardiac disorders | MedDRA 15.0 | View |
| Cardiac discomfort | None | Cardiac disorders | MedDRA 15.0 | View |
| Cardiac failure congestive | None | Cardiac disorders | MedDRA 15.0 | View |
| Cardiac flutter | None | Cardiac disorders | MedDRA 15.0 | View |
| Extrasystoles | None | Cardiac disorders | MedDRA 15.0 | View |
| Palpitations | None | Cardiac disorders | MedDRA 15.0 | View |
| Tachycardia | None | Cardiac disorders | MedDRA 15.0 | View |
| Hearing impaired | None | Ear and labyrinth disorders | MedDRA 15.0 | View |
| Tinnitus | None | Ear and labyrinth disorders | MedDRA 15.0 | View |
| Vertigo | None | Ear and labyrinth disorders | MedDRA 15.0 | View |
| Vertigo positional | None | Ear and labyrinth disorders | MedDRA 15.0 | View |
| Blepharospasm | None | Eye disorders | MedDRA 15.0 | View |
| Diplopia | None | Eye disorders | MedDRA 15.0 | View |
| Vision blurred | None | Eye disorders | MedDRA 15.0 | View |
| Visual acuity reduced | None | Eye disorders | MedDRA 15.0 | View |
| Abdominal discomfort | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Abdominal distension | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Abdominal pain | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Abdominal pain lower | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Abdominal pain upper | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Bowel movement irregularity | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Coeliac disease | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Colitis | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Constipation | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Diarrhoea | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Diverticulum | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Dry mouth | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Dyspepsia | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Dysphagia | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Epigastric discomfort | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Eructation | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Faecal incontinence | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Flatulence | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Frequent bowel movements | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Gastritis | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Gastrointestinal hypermotility | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Gastrooesophageal reflux disease | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Haematemesis | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Haematochezia | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Haemorrhoids | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Hypoaesthesia oral | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Intestinal obstruction | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Irritable bowel syndrome | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Lip swelling | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Nausea | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Oesophageal rupture | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Pancreatitis | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Retching | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Stomatitis | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Upper gastrointestinal haemorrhage | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Vomiting projectile | None | Gastrointestinal disorders | MedDRA 15.0 | View |
| Asthenia | None | General disorders | MedDRA 15.0 | View |
| Chest discomfort | None | General disorders | MedDRA 15.0 | View |
| Chest pain | None | General disorders | MedDRA 15.0 | View |
| Drug intolerance | None | General disorders | MedDRA 15.0 | View |
| Fatigue | None | General disorders | MedDRA 15.0 | View |
| Feeling abnormal | None | General disorders | MedDRA 15.0 | View |
| Feeling cold | None | General disorders | MedDRA 15.0 | View |
| Feeling jittery | None | General disorders | MedDRA 15.0 | View |
| Feeling of body temperature change | None | General disorders | MedDRA 15.0 | View |
| Gait disturbance | None | General disorders | MedDRA 15.0 | View |
| Generalised oedema | None | General disorders | MedDRA 15.0 | View |
| Influenza like illness | None | General disorders | MedDRA 15.0 | View |
| Local swelling | None | General disorders | MedDRA 15.0 | View |
| Mucosal dryness | None | General disorders | MedDRA 15.0 | View |
| Non-cardiac chest pain | None | General disorders | MedDRA 15.0 | View |
| Oedema peripheral | None | General disorders | MedDRA 15.0 | View |
| Pain | None | General disorders | MedDRA 15.0 | View |
| Cholelithiasis | None | Hepatobiliary disorders | MedDRA 15.0 | View |
| Hepatic cirrhosis | None | Hepatobiliary disorders | MedDRA 15.0 | View |
| Drug hypersensitivity | None | Immune system disorders | MedDRA 15.0 | View |
| Hypersensitivity | None | Immune system disorders | MedDRA 15.0 | View |
| Acute sinusitis | None | Infections and infestations | MedDRA 15.0 | View |
| Bronchitis | None | Infections and infestations | MedDRA 15.0 | View |
| Bronchopneumonia | None | Infections and infestations | MedDRA 15.0 | View |
| Diverticulitis | None | Infections and infestations | MedDRA 15.0 | View |
| Gastroenteritis | None | Infections and infestations | MedDRA 15.0 | View |
| Helicobacter infection | None | Infections and infestations | MedDRA 15.0 | View |
| Impetigo | None | Infections and infestations | MedDRA 15.0 | View |
| Influenza | None | Infections and infestations | MedDRA 15.0 | View |
| Pharyngitis streptococcal | None | Infections and infestations | MedDRA 15.0 | View |
| Pneumonia | None | Infections and infestations | MedDRA 15.0 | View |
| Sinusitis | None | Infections and infestations | MedDRA 15.0 | View |
| Upper respiratory tract infection | None | Infections and infestations | MedDRA 15.0 | View |
| Urinary tract infection | None | Infections and infestations | MedDRA 15.0 | View |
| Viral infection | None | Infections and infestations | MedDRA 15.0 | View |
| Ankle fracture | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Foot fracture | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Humerus fracture | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Joint injury | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Ligament rupture | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Lower limb fracture | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Meniscus injury | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Muscle injury | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Muscle strain | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Procedural pain | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Rib fracture | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Tendon injury | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Tendon rupture | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Upper limb fracture | None | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Alanine aminotransferase increased | None | Investigations | MedDRA 15.0 | View |
| Aspartate aminotransferase increased | None | Investigations | MedDRA 15.0 | View |
| Blood creatinine increased | None | Investigations | MedDRA 15.0 | View |
| Blood glucose decreased | None | Investigations | MedDRA 15.0 | View |
| Blood glucose increased | None | Investigations | MedDRA 15.0 | View |
| Blood pressure increased | None | Investigations | MedDRA 15.0 | View |
| Blood pressure systolic increased | None | Investigations | MedDRA 15.0 | View |
| Grip strength decreased | None | Investigations | MedDRA 15.0 | View |
| Heart rate increased | None | Investigations | MedDRA 15.0 | View |
| Hepatic enzyme increased | None | Investigations | MedDRA 15.0 | View |
| International normalised ratio increased | None | Investigations | MedDRA 15.0 | View |
| Prostatic specific antigen increased | None | Investigations | MedDRA 15.0 | View |
| Weight increased | None | Investigations | MedDRA 15.0 | View |
| Decreased appetite | None | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Diabetes mellitus | None | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Gout | None | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Hyperphagia | None | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Hypoglycaemia | None | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Increased appetite | None | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Arthralgia | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Arthritis | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Back pain | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Intervertebral disc degeneration | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Intervertebral disc protrusion | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Muscle spasms | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Muscle twitching | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Muscular weakness | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Musculoskeletal chest pain | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Musculoskeletal pain | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Musculoskeletal stiffness | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Myalgia | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Neck pain | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Osteoporosis | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Pain in extremity | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Polymyalgia rheumatica | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Rotator cuff syndrome | None | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Benign breast neoplasm | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Breast cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Malignant melanoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Altered state of consciousness | None | Nervous system disorders | MedDRA 15.0 | View |
| Amnesia | None | Nervous system disorders | MedDRA 15.0 | View |
| Balance disorder | None | Nervous system disorders | MedDRA 15.0 | View |
| Burning sensation | None | Nervous system disorders | MedDRA 15.0 | View |
| Carpal tunnel syndrome | None | Nervous system disorders | MedDRA 15.0 | View |
| Disturbance in attention | None | Nervous system disorders | MedDRA 15.0 | View |
| Dizziness | None | Nervous system disorders | MedDRA 15.0 | View |
| Dizziness postural | None | Nervous system disorders | MedDRA 15.0 | View |
| Dysgeusia | None | Nervous system disorders | MedDRA 15.0 | View |
| Dysgraphia | None | Nervous system disorders | MedDRA 15.0 | View |
| Dyskinesia | None | Nervous system disorders | MedDRA 15.0 | View |
| Essential tremor | None | Nervous system disorders | MedDRA 15.0 | View |
| Headache | None | Nervous system disorders | MedDRA 15.0 | View |
| Hypoaesthesia | None | Nervous system disorders | MedDRA 15.0 | View |
| Lethargy | None | Nervous system disorders | MedDRA 15.0 | View |
| Memory impairment | None | Nervous system disorders | MedDRA 15.0 | View |
| Migraine | None | Nervous system disorders | MedDRA 15.0 | View |
| Multiple sclerosis | None | Nervous system disorders | MedDRA 15.0 | View |
| Muscle contractions involuntary | None | Nervous system disorders | MedDRA 15.0 | View |
| Nerve compression | None | Nervous system disorders | MedDRA 15.0 | View |
| Neurodegenerative disorder | None | Nervous system disorders | MedDRA 15.0 | View |
| Paraesthesia | None | Nervous system disorders | MedDRA 15.0 | View |
| Parkinson's disease | None | Nervous system disorders | MedDRA 15.0 | View |
| Restless legs syndrome | None | Nervous system disorders | MedDRA 15.0 | View |
| Sciatica | None | Nervous system disorders | MedDRA 15.0 | View |
| Somnolence | None | Nervous system disorders | MedDRA 15.0 | View |
| Spinal meningeal cyst | None | Nervous system disorders | MedDRA 15.0 | View |
| Tremor | None | Nervous system disorders | MedDRA 15.0 | View |
| VIIth nerve paralysis | None | Nervous system disorders | MedDRA 15.0 | View |
| Abnormal behaviour | None | Psychiatric disorders | MedDRA 15.0 | View |
| Abnormal dreams | None | Psychiatric disorders | MedDRA 15.0 | View |
| Affect lability | None | Psychiatric disorders | MedDRA 15.0 | View |
| Agitation | None | Psychiatric disorders | MedDRA 15.0 | View |
| Anger | None | Psychiatric disorders | MedDRA 15.0 | View |
| Anxiety | None | Psychiatric disorders | MedDRA 15.0 | View |
| Apathy | None | Psychiatric disorders | MedDRA 15.0 | View |
| Aversion | None | Psychiatric disorders | MedDRA 15.0 | View |
| Bruxism | None | Psychiatric disorders | MedDRA 15.0 | View |
| Confusional state | None | Psychiatric disorders | MedDRA 15.0 | View |
| Depression | None | Psychiatric disorders | MedDRA 15.0 | View |
| Disorientation | None | Psychiatric disorders | MedDRA 15.0 | View |
| Fear | None | Psychiatric disorders | MedDRA 15.0 | View |
| Hallucination | None | Psychiatric disorders | MedDRA 15.0 | View |
| Hallucination, auditory | None | Psychiatric disorders | MedDRA 15.0 | View |
| Hallucination, visual | None | Psychiatric disorders | MedDRA 15.0 | View |
| Insomnia | None | Psychiatric disorders | MedDRA 15.0 | View |
| Irritability | None | Psychiatric disorders | MedDRA 15.0 | View |
| Libido decreased | None | Psychiatric disorders | MedDRA 15.0 | View |
| Major depression | None | Psychiatric disorders | MedDRA 15.0 | View |
| Mental disorder | None | Psychiatric disorders | MedDRA 15.0 | View |
| Middle insomnia | None | Psychiatric disorders | MedDRA 15.0 | View |
| Mood altered | None | Psychiatric disorders | MedDRA 15.0 | View |
| Mood swings | None | Psychiatric disorders | MedDRA 15.0 | View |
| Nervousness | None | Psychiatric disorders | MedDRA 15.0 | View |
| Nightmare | None | Psychiatric disorders | MedDRA 15.0 | View |
| Obsessive-compulsive disorder | None | Psychiatric disorders | MedDRA 15.0 | View |
| Panic attack | None | Psychiatric disorders | MedDRA 15.0 | View |
| Paranoia | None | Psychiatric disorders | MedDRA 15.0 | View |
| Personality change | None | Psychiatric disorders | MedDRA 15.0 | View |
| Psychomotor retardation | None | Psychiatric disorders | MedDRA 15.0 | View |
| Restlessness | None | Psychiatric disorders | MedDRA 15.0 | View |
| Sleep disorder | None | Psychiatric disorders | MedDRA 15.0 | View |
| Sleep talking | None | Psychiatric disorders | MedDRA 15.0 | View |
| Sleep terror | None | Psychiatric disorders | MedDRA 15.0 | View |
| Suicidal ideation | None | Psychiatric disorders | MedDRA 15.0 | View |
| Dysuria | None | Renal and urinary disorders | MedDRA 15.0 | View |
| Glomerulosclerosis | None | Renal and urinary disorders | MedDRA 15.0 | View |
| Haematuria | None | Renal and urinary disorders | MedDRA 15.0 | View |
| Nephrolithiasis | None | Renal and urinary disorders | MedDRA 15.0 | View |
| Pollakiuria | None | Renal and urinary disorders | MedDRA 15.0 | View |
| Renal colic | None | Renal and urinary disorders | MedDRA 15.0 | View |
| Renal failure chronic | None | Renal and urinary disorders | MedDRA 15.0 | View |
| Renal impairment | None | Renal and urinary disorders | MedDRA 15.0 | View |
| Urinary hesitation | None | Renal and urinary disorders | MedDRA 15.0 | View |
| Benign prostatic hyperplasia | None | Reproductive system and breast disorders | MedDRA 15.0 | View |
| Ejaculation disorder | None | Reproductive system and breast disorders | MedDRA 15.0 | View |
| Erectile dysfunction | None | Reproductive system and breast disorders | MedDRA 15.0 | View |
| Vaginal prolapse | None | Reproductive system and breast disorders | MedDRA 15.0 | View |
| Asthma | None | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Choking sensation | None | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Dysphonia | None | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Dyspnoea | None | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Dyspnoea exertional | None | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Epistaxis | None | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Nasal discomfort | None | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Oropharyngeal pain | None | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Paranasal sinus hypersecretion | None | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Pleural effusion | None | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Pleurisy | None | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Pulmonary fibrosis | None | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Sinus congestion | None | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Wheezing | None | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Alopecia | None | Skin and subcutaneous tissue disorders | MedDRA 15.0 | View |
| Angioedema | None | Skin and subcutaneous tissue disorders | MedDRA 15.0 | View |
| Dermatitis | None | Skin and subcutaneous tissue disorders | MedDRA 15.0 | View |
| Dermatitis contact | None | Skin and subcutaneous tissue disorders | MedDRA 15.0 | View |
| Drug eruption | None | Skin and subcutaneous tissue disorders | MedDRA 15.0 | View |
| Hyperhidrosis | None | Skin and subcutaneous tissue disorders | MedDRA 15.0 | View |
| Night sweats | None | Skin and subcutaneous tissue disorders | MedDRA 15.0 | View |
| Pruritus | None | Skin and subcutaneous tissue disorders | MedDRA 15.0 | View |
| Pruritus generalised | None | Skin and subcutaneous tissue disorders | MedDRA 15.0 | View |
| Rash | None | Skin and subcutaneous tissue disorders | MedDRA 15.0 | View |
| Skin irritation | None | Skin and subcutaneous tissue disorders | MedDRA 15.0 | View |
| Skin reaction | None | Skin and subcutaneous tissue disorders | MedDRA 15.0 | View |
| Swelling face | None | Skin and subcutaneous tissue disorders | MedDRA 15.0 | View |
| Urticaria | None | Skin and subcutaneous tissue disorders | MedDRA 15.0 | View |
| Cardioversion | None | Surgical and medical procedures | MedDRA 15.0 | View |
| Knee arthroplasty | None | Surgical and medical procedures | MedDRA 15.0 | View |
| Flushing | None | Vascular disorders | MedDRA 15.0 | View |
| Hot flush | None | Vascular disorders | MedDRA 15.0 | View |
| Hypertension | None | Vascular disorders | MedDRA 15.0 | View |
| Hypotension | None | Vascular disorders | MedDRA 15.0 | View |
| Labile blood pressure | None | Vascular disorders | MedDRA 15.0 | View |