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 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
NCT ID:
NCT00141518
Description:
None
Frequency Threshold:
0
Time Frame:
Events presented are treatment-emergent (those with a start date beyond or equal to first day of study treatment but within 7 days [for adverse events] or 30 days [for serious adverse events] after last study drug intake). Treatment period was 36 months.
Study:
NCT00141518
Study Brief:
Long-term Study of Duodopa (Levodopa/Carbidopa) in Advanced Parkinson's: Health Outcomes & Net Economic Impact
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Duodopa Non-naïve < 2 Years | Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually. | None | None | 17 | 22 | 22 | 22 | View |
| Duodopa Naïve | Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually. | None | None | 24 | 36 | 29 | 36 | View |
| Duodopa Non-naïve ≥ 2 Years | Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually. | None | None | 14 | 18 | 17 | 18 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Lumbar vertebral fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Medical device complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Medical device pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Neck injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Patella fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Procedural complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Spinal compression fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Blood glucose increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Electrocardiogram rr interval prolonged | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | View |
| Bursitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | View |
| Lumbar spinal stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | View |
| Osteonecrosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | View |
| Spinal column stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | View |
| Cerebral infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Cognitive disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Dyskinesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Dystonia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Haemorrhage intracranial | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Hyperkinesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Loss of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| On and off phenomenon | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Parkinson's disease | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Aggression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 9.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 9.1 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 9.1 | View |
| Delusion | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 9.1 | View |
| Disorientation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 9.1 | View |
| Hallucination | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 9.1 | View |
| Psychotic disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 9.1 | View |
| Suicide attempt | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 9.1 | View |
| Cystocele | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 9.1 | View |
| Vaginal prolapse | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 9.1 | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | View |
| Pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | View |
| Decubitus ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 9.1 | View |
| Deep brain stimulation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 9.1 | View |
| Device therapy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 9.1 | View |
| Drug therapy changed | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 9.1 | View |
| Medical device change | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 9.1 | View |
| Medical device implantation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 9.1 | View |
| Medical device removal | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 9.1 | View |
| Pelvic floor repair | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 9.1 | View |
| Rehabilitation therapy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 9.1 | View |
| Therapy regimen changed | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 9.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 9.1 | View |
| Gait disturbance | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| General physical health deterioration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Therapeutic response decreased | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Arthritis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Device related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Ear infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Empyema | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Erysipelas | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Gastric ulcer helicobacter | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Cardiac procedure complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Compression fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Concussion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Device breakage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Device connection issue | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Device dislocation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Device occlusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Drug toxicity | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Feeding tube complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Hip fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Oesophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Peritonitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.1 | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 9.1 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 9.1 | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 9.1 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 9.1 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 9.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Duodenal ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Gastric ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Femoral neck fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Head injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.1 | View |
| Anaemia megaloblastic | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.1 | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.1 | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 9.1 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 9.1 | View |
| Atrioventricular block first degree | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 9.1 | View |
| Mitral valve incompetence | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 9.1 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 9.1 | View |
| Myocardial ischaemia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 9.1 | View |
| Ventricular extrasystoles | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 9.1 | View |
| Deafness unilateral | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 9.1 | View |
| Hyperthyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 9.1 | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 9.1 | View |
| Toxic nodular goitre | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 9.1 | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 9.1 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 9.1 | View |
| Glaucoma | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 9.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Oesophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Salivary hypersecretion | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.1 | View |
| Adverse drug reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Implant site inflammation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Implant site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.1 | View |
| Seasonal allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 9.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Device related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Erysipelas | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Gastrointestinal candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Infected skin ulcer | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Localised infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Oral candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Postoperative wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Tinea pedis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Tooth infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.1 | View |
| Animal bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Ankle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Device connection issue | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Device dislocation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Device occlusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Gastrointestinal stoma complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Hand fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Joint injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Lower limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Medical device pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Mouth injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Pelvic fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Post procedural fistula | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Procedural site reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Radius fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Rib fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Spinal compression fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Blood amino acid level increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Blood folate decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Blood homocysteine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Blood thyroid stimulating hormone decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Cerebrospinal fluid white blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Electrocardiogram abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Electrocardiogram ST-T change | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Residual urine volume | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.1 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Folate deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Hyperhomocysteinaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Hyperlipidaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Hypovitaminosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Vitamin B12 deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | View |
| Bursitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | View |
| Limb discomfort | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | View |
| Osteonecrosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | View |
| Osteoporosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | View |
| Spinal column stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | View |
| Tendonitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | View |
| Benign neoplasm of skin | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | View |
| Neoplasm skin | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | View |
| Cognitive disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Dementia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Dystonia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Parkinson's disease | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Polyneuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Transient ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.1 | View |
| Abnormal dreams | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 9.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 9.1 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 9.1 | View |
| Delusion | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 9.1 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 9.1 | View |
| Hallucination | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 9.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 9.1 | View |
| Hypertonic bladder | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 9.1 | View |
| Micturition urgency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 9.1 | View |
| Neurogenic bladder | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 9.1 | View |
| Nocturia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 9.1 | View |
| Polyuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 9.1 | View |
| Urinary incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 9.1 | View |
| Benign prostatic hyperplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 9.1 | View |
| Epididymitis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 9.1 | View |
| Erectile dysfunction | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 9.1 | View |
| Prostatism | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 9.1 | View |
| Sexual dysfunction | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 9.1 | View |
| Bronchial obstruction | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | View |
| Obstructive airways disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | View |
| Decubitus ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 9.1 | View |
| Excessive granulation tissue | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 9.1 | View |
| Rosacea | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 9.1 | View |
| Cardiac operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 9.1 | View |
| Cataract operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 9.1 | View |
| Eye operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 9.1 | View |
| Knee operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 9.1 | View |
| Medical device change | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 9.1 | View |
| Medical device removal | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 9.1 | View |
| Prostatic operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 9.1 | View |
| Shoulder operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 9.1 | View |
| Skin neoplasm excision | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 9.1 | View |
| Tendon operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 9.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 9.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 9.1 | View |
| Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 9.1 | View |