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 @ 6:55 PM
Ignite Modification Date:
2025-12-25 @ 4:28 PM
NCT ID:
NCT00736957
Description:
None
Frequency Threshold:
0
Time Frame:
From signing of informed consent until study completion (up to 54 weeks)
Study:
NCT00736957
Study Brief:
A Long-term Efficacy and Safety Study of Tramadol Hydrochloride Plus Acetaminophen (JNS013) in Japanese Participants With Chronic Pain
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Tramadol Hydrochloride Plus Acetaminophen (JNS013) | Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours. | None | None | 24 | 190 | 189 | 190 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA/J V11.1 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA/J V11.1 | View |
| Pyelonephritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA/J V11.1 | View |
| Cerebral infarction | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA/J V11.1 | View |
| Diabetic autonomic nerve neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA/J V11.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA/J V11.1 | View |
| Loss of consciousness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA/J V11.1 | View |
| Sudden deafness | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA/J V11.1 | View |
| Prinzmetal's angina | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA/J V11.1 | View |
| Arteriosclerosis obliterans | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA/J V11.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Colon polyps | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Ileus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Melena | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Upper gastrointestinal tract hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA/J V11.1 | View |
| Lumbar spinal canal stenosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA/J V11.1 | View |
| Osteonecrosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA/J V11.1 | View |
| Rheumatoid arthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA/J V11.1 | View |
| Ossification of the spinal ligaments | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA/J V11.1 | View |
| Ureteral calculus | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA/J V11.1 | View |
| Dysuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA/J V11.1 | View |
| Ureteropathy | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA/J V11.1 | View |
| Fall/tumble | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA/J V11.1 | View |
| Open fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA/J V11.1 | View |
| Subdural hematoma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA/J V11.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA/J V11.1 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA/J V11.1 | View |
| Cystitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA/J V11.1 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA/J V11.1 | View |
| Oral herpes | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA/J V11.1 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA/J V11.1 | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA/J V11.1 | View |
| Tinea pedis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA/J V11.1 | View |
| Bronchiectasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA/J V11.1 | View |
| Furuncle | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA/J V11.1 | View |
| Gastrointestinal candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA/J V11.1 | View |
| Herpes zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA/J V11.1 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA/J V11.1 | View |
| Onychomycosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA/J V11.1 | View |
| Paronychia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA/J V11.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA/J V11.1 | View |
| Helicobacter infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA/J V11.1 | View |
| Tinea infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA/J V11.1 | View |
| Oral fungal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA/J V11.1 | View |
| Purulence | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA/J V11.1 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA/J V11.1 | View |
| Seasonal allergy | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA/J V11.1 | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA/J V11.1 | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA/J V11.1 | View |
| Hypoglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA/J V11.1 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA/J V11.1 | View |
| Diabetes mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA/J V11.1 | View |
| Hypercholesterolaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA/J V11.1 | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA/J V11.1 | View |
| Hypertriglyceridaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA/J V11.1 | View |
| Hyperuricaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA/J V11.1 | View |
| Hyperlipidaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA/J V11.1 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA/J V11.1 | View |
| Delusion | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA/J V11.1 | View |
| Depressed mood | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA/J V11.1 | View |
| Hallucination, auditory | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA/J V11.1 | View |
| Hallucination, visual | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA/J V11.1 | View |
| Listless | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA/J V11.1 | View |
| Sleep disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA/J V11.1 | View |
| Depressive symptom | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA/J V11.1 | View |
| Affect lability | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA/J V11.1 | View |
| Anxiety disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA/J V11.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA/J V11.1 | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA/J V11.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA/J V11.1 | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA/J V11.1 | View |
| Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA/J V11.1 | View |
| Cervicobrachial syndrome | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA/J V11.1 | View |
| Carpal tunnel syndrome | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA/J V11.1 | View |
| Cerebral infarction | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA/J V11.1 | View |
| Dizziness postural | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA/J V11.1 | View |
| Dyskinesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA/J V11.1 | View |
| Head discomfort | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA/J V11.1 | View |
| Hypertonia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA/J V11.1 | View |
| Intracranial aneurysm | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA/J V11.1 | View |
| IVth nerve paralysis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA/J V11.1 | View |
| Memory impairment | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA/J V11.1 | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA/J V11.1 | View |
| Parosmia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA/J V11.1 | View |
| Post herpetic neuralgia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA/J V11.1 | View |
| Sciatica | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA/J V11.1 | View |
| Occipital neuralgia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA/J V11.1 | View |
| Conjunctivitis allergic | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA/J V11.1 | View |
| Conjunctival haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA/J V11.1 | View |
| Diabetic retinopathy | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA/J V11.1 | View |
| Blepharitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA/J V11.1 | View |
| Cataract | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA/J V11.1 | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA/J V11.1 | View |
| Eye haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA/J V11.1 | View |
| Keratitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA/J V11.1 | View |
| Posterior capsule opacification | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA/J V11.1 | View |
| Vitreous detachment | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA/J V11.1 | View |
| Ear discomfort | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA/J V11.1 | View |
| Deafness neurosensory | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA/J V11.1 | View |
| Tinnitus | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA/J V11.1 | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA/J V11.1 | View |
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA/J V11.1 | View |
| Angina pectoris | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA/J V11.1 | View |
| Bundle branch block left | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA/J V11.1 | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA/J V11.1 | View |
| Ventricular extrasystoles | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA/J V11.1 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA/J V11.1 | View |
| Hot flush | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA/J V11.1 | View |
| Blood pressure fluctuation | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA/J V11.1 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA/J V11.1 | View |
| Arteriosclerosis obliterans | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA/J V11.1 | View |
| Upper respiratory tract inflammation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA/J V11.1 | View |
| Dysphonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA/J V11.1 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA/J V11.1 | View |
| Productive cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA/J V11.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA/J V11.1 | View |
| Hyperventilation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA/J V11.1 | View |
| Nasal congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA/J V11.1 | View |
| Rhinitis allergic | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA/J V11.1 | View |
| Nasal cyst | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA/J V11.1 | View |
| Sputum retention | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA/J V11.1 | View |
| Nasal mucosal disorder | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA/J V11.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Stomach discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Dry mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Reflux oesophagitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Abdominal distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Gastric ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Periodontitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Haemorrhoids | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Abdominal discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Anal fistula | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Cheilitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Colonic polyp | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Dental caries | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Gastrooesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Gastrointestinal disorder | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Gingivitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Glossitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Hiatus hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Inguinal hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Melanosis coli | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Oral discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Gastrointestinal hypermotility | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Gastric mucosal lesion | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Oral mucosa erosion | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Gastrointestinal sounds abnormal | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA/J V11.1 | View |
| Cholelithiasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA/J V11.1 | View |
| Hepatic function abnormal | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA/J V11.1 | View |
| Liver disorder | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA/J V11.1 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA/J V11.1 | View |
| Hyperhidrosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA/J V11.1 | View |
| Eczema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA/J V11.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA/J V11.1 | View |
| Dermatitis contact | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA/J V11.1 | View |
| Cold sweat | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA/J V11.1 | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA/J V11.1 | View |
| Dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA/J V11.1 | View |
| Pruritus generalised | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA/J V11.1 | View |
| Eczema asteatotic | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA/J V11.1 | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA/J V11.1 | View |
| Haemorrhage subcutaneous | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA/J V11.1 | View |
| Hyperkeratosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA/J V11.1 | View |
| Prurigo | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA/J V11.1 | View |
| Senile pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA/J V11.1 | View |
| Skin chapped | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA/J V11.1 | View |
| Skin erosion | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA/J V11.1 | View |
| Skin ulcer | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA/J V11.1 | View |
| Skin swelling | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA/J V11.1 | View |
| Diabetic bullosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA/J V11.1 | View |
| Skin mass | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA/J V11.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA/J V11.1 | View |
| Osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA/J V11.1 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA/J V11.1 | View |
| Muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA/J V11.1 | View |
| Spinal osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA/J V11.1 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA/J V11.1 | View |
| Periarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA/J V11.1 | View |
| Rheumatoid arthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA/J V11.1 | View |
| Intervertebral disc protrusion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA/J V11.1 | View |
| Arthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA/J V11.1 | View |
| Fasciitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA/J V11.1 | View |
| Flank pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA/J V11.1 | View |
| Lumbar spinal stenosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA/J V11.1 | View |
| Osteoporosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA/J V11.1 | View |
| Rotator cuff syndrome | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA/J V11.1 | View |
| Trigger finger | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA/J V11.1 | View |
| Upper extremity mass | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA/J V11.1 | View |
| Musculoskeletal discomfort | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA/J V11.1 | View |
| Spinal ligament ossification | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA/J V11.1 | View |
| Spondylolisthesis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA/J V11.1 | View |
| Dysuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA/J V11.1 | View |
| Haematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA/J V11.1 | View |
| Micturition disorder | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA/J V11.1 | View |
| Nephrolithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA/J V11.1 | View |
| Proteinuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA/J V11.1 | View |
| Urinary retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA/J V11.1 | View |
| Benign prostatic hyperplasia | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA/J V11.1 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA/J V11.1 | View |
| Feeling abnormal | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA/J V11.1 | View |
| Thirst | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA/J V11.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA/J V11.1 | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA/J V11.1 | View |
| Chest discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA/J V11.1 | View |
| Oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA/J V11.1 | View |
| Application site dermatitis | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA/J V11.1 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA/J V11.1 | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA/J V11.1 | View |
| Feeling cold | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA/J V11.1 | View |
| Injection site haematoma | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA/J V11.1 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA/J V11.1 | View |
| Peripheral coldness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA/J V11.1 | View |
| Vessel puncture site haematoma | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA/J V11.1 | View |
| Weight decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA/J V11.1 | View |
| Gamma-glutamyltransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA/J V11.1 | View |
| Blood creatine phosphokinase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA/J V11.1 | View |
| Blood triglycerides increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA/J V11.1 | View |
| Blood pressure increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA/J V11.1 | View |
| Blood urea increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA/J V11.1 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA/J V11.1 | View |
| Glucose urine present | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA/J V11.1 | View |
| Blood urine present | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA/J V11.1 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA/J V11.1 | View |
| Blood alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA/J V11.1 | View |
| Blood potassium increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA/J V11.1 | View |
| Liver function test abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA/J V11.1 | View |
| Eosinophil percentage increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA/J V11.1 | View |
| White blood cell count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA/J V11.1 | View |
| Haemoglobin decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA/J V11.1 | View |
| Weight increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA/J V11.1 | View |
| Protein urine present | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA/J V11.1 | View |
| Albumin urine present | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA/J V11.1 | View |
| Blood creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA/J V11.1 | View |
| Blood pressure systolic increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA/J V11.1 | View |
| C-reactive protein increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA/J V11.1 | View |
| Red blood cell count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA/J V11.1 | View |
| Platelet count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA/J V11.1 | View |
| Blood cholesterol increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA/J V11.1 | View |
| Blood glucose increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA/J V11.1 | View |
| Blood pressure diastolic decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA/J V11.1 | View |
| Blood uric acid increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA/J V11.1 | View |
| Monocyte count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA/J V11.1 | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA/J V11.1 | View |
| Neutrophil percentage decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA/J V11.1 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA/J V11.1 | View |
| Wound | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA/J V11.1 | View |
| Excoriation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA/J V11.1 | View |
| Thermal burn | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA/J V11.1 | View |
| Joint sprain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA/J V11.1 | View |
| Arthropod sting | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA/J V11.1 | View |
| Back injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA/J V11.1 | View |
| Burns second degree | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA/J V11.1 | View |
| Foot fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA/J V11.1 | View |
| Foreign body in eye | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA/J V11.1 | View |
| Hand fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA/J V11.1 | View |
| Rib fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA/J V11.1 | View |
| Spinal compression fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA/J V11.1 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA/J V11.1 | View |
| Procedural pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA/J V11.1 | View |
| Blood lactate dehydrogenase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA/J V11.1 | View |