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 @ 9:50 PM
Ignite Modification Date:
2025-12-25 @ 7:28 PM
NCT ID:
NCT00896532
Description:
The safety subset is based on actual treatment received. One participant randomized to placebo received 1 dose of romosozumab 70 mg in error was subsequently randomized to denosumab and then received romosozumab in the retreatment phase. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed a 5% threshold
Frequency Threshold:
5
Time Frame:
Adverse events are reported by treatment phase: Romosozumab treatment phase (Baseline [BL] to month 12 and 24); Denosumab extension phase (months 24 to 36); Romosozumab retreatment phase (months 36 to 48); Follow-on phase (months 48 to 72).
Study:
NCT00896532
Study Brief:
Romosozumab (AMG 785) in Postmenopausal Women With Low Bone Mineral Density
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Month 36-48: Romosozumab/Placebo/Romosozumab | Participants who received romosozumab at any dose during the first 24-month romosozumab treatment phase and placebo to denosumab during months 24 to 36 then received romosozumab 210 mg subcutaneously QM in the 12-month romosozumab retreatment phase (months 36 to 48). | None | None | 4 | 72 | 53 | 72 | View |
| Month 48-72: Placebo/Placebo/Romosozumab/Zoledronic Acid | Participants who received placebo in the 24-month romosozumab treatment phase, placebo to denosumab during months 24 to 36 and romosozumab 210 mg QM in months 36 to 48 then received a single dose of open-label zoledronic acid 5 mg intravenously at month 48. | None | None | 1 | 11 | 10 | 11 | View |
| Month 48-72: Placebo/Denosumab/Romosozumab/Zoledronic | Participants who received placebo in the 24-month romosozumab treatment phase, denosumab 60 mg Q6M from months 24 to 36 and romosozumab 210 mg QM from months 36 to 48 then received a single dose of open-label zoledronic acid 5 mg intravenously at month 48. | None | None | 1 | 12 | 8 | 12 | View |
| Month 48-72: Romosozumab/Placebo/Romosozumab/Zoledronic Acid | Participants who received romosozumab at any dose during the 24-month romosozumab treatment phase, placebo to denosumab during months 24 to 36 and romosozumab 210 mg QM in months 36 to 48 then received a single dose of open-label zoledronic acid 5 mg intravenously at month 48. | None | None | 9 | 56 | 44 | 56 | View |
| BL-Month 12: Placebo QM | Participants received placebo matching to romosozumab once a month (QM) administered subcutaneously for 12 months. | None | None | 3 | 30 | 25 | 30 | View |
| BL-Month 12: Placebo Q3M | Participants received placebo matching to romosozumab once every 3 months (Q3M) administered subcutaneously for 12 months. | None | None | 4 | 20 | 19 | 20 | View |
| BL-Month 12: Alendronate | Participants received open-label alendronate (ALN) 70 mg orally (PO) every week (QW) for 12 months. | None | None | 4 | 51 | 38 | 51 | View |
| BL-Month12: Teriparatide | Participants received open-label teriparatide 20 μg subcutaneously every day (QD) for 12 months. | None | None | 5 | 54 | 36 | 54 | View |
| BL-Month 12: Romosozumab 70 mg QM | Participants received double-blind romosozumab 70 mg subcutaneously every month for 12 months. | None | None | 5 | 50 | 46 | 50 | View |
| BL-Month 12: Romosozumab 140 mg Q3M | Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 12 months. | None | None | 3 | 52 | 40 | 52 | View |
| BL-Month 12: Romosozumab 140 mg QM | Participants received double-blind romosozumab 140 mg subcutaneously every month for 12 months. | None | None | 2 | 49 | 41 | 49 | View |
| BL-Month 12: Romosozumab 210 mg Q3M | Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 12 months. | None | None | 3 | 53 | 45 | 53 | View |
| BL-Month 12: Romosozumab 210 mg QM | Participants received double-blind romosozumab 210 mg QM subcutaneously for 12 months. | None | None | 6 | 51 | 40 | 51 | View |
| BL-Month 24: Placebo QM | Participants received placebo matching to romosozumab QM administered subcutaneously for 24 months. | None | None | 5 | 30 | 28 | 30 | View |
| BL-Month 24: Placebo Q3M | Participants received placebo matching to romosozumab Q3M administered subcutaneously for 24 months. | None | None | 4 | 20 | 20 | 20 | View |
| BL-Month 24: ALN/Romosozumab 140 mg QM | Participants received open-label alendronate (ALN) 70 mg PO QW for 12 months. At month 12 participants transitioned to receive romosozumab 140 mg subcutaneously every month for an additional 12 months (months 12 to 24). | None | None | 8 | 51 | 49 | 51 | View |
| BL-Month 24: Romosozumab 70 mg QM | Participants received double-blind romosozumab 70 mg subcutaneously every month for 24 months. | None | None | 9 | 50 | 48 | 50 | View |
| BL-Month 24: Romosozumab 140 mg Q3M | Participants received double-blind romosozumab 140 mg subcutaneously once every 3 months for 24 months. | None | None | 8 | 52 | 47 | 52 | View |
| BL-Month 24: Romosozumab 140 mg QM | Participants received double-blind romosozumab 140 mg subcutaneously every month for 24 months. | None | None | 8 | 49 | 46 | 49 | View |
| BL-Month 24: Romosozumab 210 mg Q3M | Participants received double-blind romosozumab 210 mg Q3M subcutaneously for 24 months. | None | None | 6 | 53 | 51 | 53 | View |
| BL-Month 24: Romosozumab 210 mg QM | Participants received double-blind romosozumab 210 mg QM subcutaneously for 24 months. | None | None | 7 | 51 | 47 | 51 | View |
| Month 24-36: Placebo/Placebo | Participants who received placebo in the 24-month romosozumab treatment phase then received placebo to denosumab subcutaneously once every 6 months for 12 months during the denosumab extension phase. | None | None | 2 | 18 | 15 | 18 | View |
| Month 24-36: Placebo/Denosumab | Participants who received placebo in the 24-month romosozumab treatment phase then received denosumab 60 mg subcutaneously once every 6 months for 12 months during the denosumab extension phase. | None | None | 1 | 17 | 15 | 17 | View |
| Month 24-36: ALN/Romosozumab/Placebo | Participants who received alendronate for the first 12 months and romosozumab 140 mg subcutaneously every month from months 12 to 24 received placebo to denosumab subcutaneously once every 6 months for 12 months during the denosumab extension phase. | None | None | 2 | 19 | 12 | 19 | View |
| Month 24-36: ALN/Romosozumab/Denosumab | Participants who received alendronate for the first 12 months, romosozumab 140 mg subcutaneously every month from months 12-24 received denosumab 60 mg subcutaneously once every 6 months for 12 months during the denosumab extension phase. | None | None | 0 | 19 | 15 | 19 | View |
| Month 24-36: Romosozumab/Placebo | Participants who received romosozumab at any dose for 24 months in the romosozumab treatment phase received placebo to denosumab subcutaneously once every 6 months for 12 months during the denosumab extension phase. | None | None | 3 | 90 | 57 | 90 | View |
| Month 24-36: Romosozumab/Denosumab | Participants who received romosozumab at any dose for 24 months in the romosozumab treatment phase received denosumab 60 mg subcutaneously once every 6 months for 12 months during the denosumab extension phase. | None | None | 8 | 89 | 59 | 89 | View |
| Month 36-48: Placebo/Placebo/Romosozumab | Participants who received placebo in the first 24-month romosozumab treatment phase and placebo to denosumab during months 24 to 36 then received romosozumab 210 mg subcutaneously QM in the 12-month romosozumab retreatment phase (months 36 to 48). | None | None | 0 | 12 | 12 | 12 | View |
| Month 36-48: Placebo/Denosumab/Romosozumab | Participants who received placebo in the first 24-month romosozumab treatment phase and denosumab 60 mg during months 24 to 36 then received romosozumab 210 mg subcutaneously QM in the 12-month romosozumab retreatment phase (months 36 to 48). | None | None | 1 | 15 | 11 | 15 | View |
| Month 36-48: Romosozumab/Denosumab/Romosozumab | Participants who received romosozumab at any dose during the first 24-month romosozumab treatment phase and denosumab 60 mg during months 24 to 36 then received romosozumab 210 mg subcutaneously QM in the 12-month romosozumab retreatment phase (months 36 to 48). | None | None | 3 | 68 | 55 | 68 | View |
| Month 48-72: Romosozumab/Denosumab/Romosozumab/No Intervention | Participants who received romosozumab at any dose during the first 24 month treatment phase, denosumab 60 mg during months 24 to 36 and romosozumab 210 mg QM in months 36 to 48 then received no intervention during the 24-month follow-on phase (months 48-72). | None | None | 8 | 51 | 34 | 51 | View |
| Month 48-72: Romosozumab/Placebo/Romosozumab/No | Participants who received romosozumab at any dose during the first 24 month treatment phase, placebo to denosumab during months 24 to 36 and romosozumab 210 mg QM in months 36 to 48 were assigned to the zoledronic acid treatment group, but received no intervention during the 24-month follow-on phase (months 48 to 72). | None | None | 0 | 3 | 1 | 3 | View |
| Month 48-72: Romosozumab/Denosumab/Romosozumab/Zoledronic Acid | Participants who received romosozumab at any dose during the 24-month romosozumab treatment phase, denosumab 60 mg Q6M during months 24 to 36 and romosozumab 210 mg QM in months 36 to 48 then received a single dose of open-label zoledronic acid 5 mg intravenously at month 48. | None | None | 1 | 8 | 7 | 8 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pancytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 18.1 | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.1 | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.1 | View |
| Angina unstable | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.1 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.1 | View |
| Atrioventricular block second degree | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.1 | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.1 | View |
| Cardiac tamponade | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.1 | View |
| Cardio-respiratory arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.1 | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.1 | View |
| Mitral valve stenosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.1 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.1 | View |
| Sinus node dysfunction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.1 | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.1 | View |
| Hyperparathyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 18.1 | View |
| Iridocyclitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Barrett's oesophagus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Colitis ischaemic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Diverticulum | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Gastric ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Gastrointestinal fistula | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Gastrointestinal necrosis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Irritable bowel syndrome | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Large intestine polyp | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Peritoneal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Bile duct stone | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 18.1 | View |
| Cholangitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 18.1 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 18.1 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 18.1 | View |
| Anaphylactic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 18.1 | View |
| Abscess intestinal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Appendicitis perforated | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Clostridium difficile colitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Escherichia sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Mycobacterium kansasii infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Pneumonia legionella | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Salpingitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Epicondylitis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Fibula fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Head injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Postoperative ileus | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Radius fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Tibia fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Ulna fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Central obesity | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.1 | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.1 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.1 | View |
| Ketoacidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Chondropathy | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Foot deformity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Intervertebral disc protrusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Rotator cuff syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Acute lymphocytic leukaemia | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | View |
| Anal cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | View |
| Breast cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | View |
| Colon adenoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | View |
| Colon cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | View |
| Invasive ductal breast carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | View |
| Leiomyoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | View |
| Lung neoplasm malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | View |
| Non-Hodgkin's lymphoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | View |
| Renal neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | View |
| Renal oncocytoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | View |
| Squamous cell carcinoma of lung | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | View |
| Thyroid cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | View |
| Uterine cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | View |
| Amnesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Cerebral haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Cerebral ischaemia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Coma | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Dementia Alzheimer's type | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Lacunar infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Loss of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Nerve compression | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Transient ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 18.1 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 18.1 | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 18.1 | View |
| Stress urinary incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 18.1 | View |
| Hysterocele | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 18.1 | View |
| Ovarian cyst | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 18.1 | View |
| Rectocele | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 18.1 | View |
| Uterine polyp | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 18.1 | View |
| Uterine prolapse | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 18.1 | View |
| Vaginal prolapse | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 18.1 | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | View |
| Respiratory distress | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | View |
| Arteriosclerosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.1 | View |
| Femoral artery occlusion | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Normochromic normocytic anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 18.1 | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.1 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.1 | View |
| Ventricular extrasystoles | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.1 | View |
| Deafness neurosensory | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 18.1 | View |
| Presbyacusis | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 18.1 | View |
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 18.1 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 18.1 | View |
| Vertigo positional | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 18.1 | View |
| Goitre | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 18.1 | View |
| Age-related macular degeneration | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.1 | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.1 | View |
| Dacryostenosis acquired | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.1 | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.1 | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.1 | View |
| Visual acuity reduced | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.1 | View |
| Vitreous floaters | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.1 | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Diaphragmatic hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Diverticulum | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Diverticulum intestinal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Haematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Haemorrhoids thrombosed | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Large intestine polyp | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Paraesthesia oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Facial pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Gait disturbance | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Injection site bruising | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Injection site haematoma | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Injection site pruritus | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Injection site urticaria | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Peripheral swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Drug-induced liver injury | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 18.1 | View |
| Drug hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 18.1 | View |
| Borrelia infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Erysipelas | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Erythema migrans | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Eye infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Gastroenteritis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Gingival abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Gingivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Helicobacter infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Herpes ophthalmic | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Hordeolum | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Laryngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Localised infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Mastitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Nail infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Onychomycosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Oral fungal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Periodontitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Pharyngitis streptococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Pneumonia viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Post procedural infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Pulpitis dental | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Tooth abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Tooth infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Tracheitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Vestibular neuronitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Viral sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Vulvovaginal mycotic infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Alcohol poisoning | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Arthropod bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Arthropod sting | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Chest injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Eye contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Foot fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Joint injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Ligament rupture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Post procedural contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Post procedural haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Post procedural haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Procedural pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Radius fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Rib fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Skin abrasion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Thermal burn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Tooth fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Wound | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Blood calcium increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.1 | View |
| Blood parathyroid hormone increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.1 | View |
| Blood potassium decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.1 | View |
| Blood urine present | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.1 | View |
| Cardiac murmur | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.1 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.1 | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.1 | View |
| Gout | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.1 | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.1 | View |
| Hypercholesterolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.1 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.1 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.1 | View |
| Insulin resistance | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.1 | View |
| Type 2 diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Bursitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Costochondritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Exostosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Intervertebral disc degeneration | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Knee deformity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Musculoskeletal stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Neck mass | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Synovial cyst | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Temporomandibular joint syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Tendon disorder | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Tendonitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Thoracic spine flattening | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Basal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | View |
| Benign neoplasm of thyroid gland | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | View |
| Haemangioma of liver | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | View |
| Lipoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | View |
| Carotid artery occlusion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Facial neuralgia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Nystagmus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Restless legs syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 18.1 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 18.1 | View |
| Disorientation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 18.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 18.1 | View |
| Hypercalciuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 18.1 | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 18.1 | View |
| Renal cyst | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 18.1 | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 18.1 | View |
| Renal impairment | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 18.1 | View |
| Breast calcifications | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 18.1 | View |
| Ovarian cyst | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 18.1 | View |
| Vulvovaginal dryness | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 18.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | View |
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | View |
| Cutaneous lupus erythematosus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.1 | View |
| Dermal cyst | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.1 | View |
| Dermatitis contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.1 | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.1 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.1 | View |
| Night sweats | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.1 | View |
| Petechiae | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.1 | View |
| Rash pruritic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.1 | View |
| Skin lesion | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.1 | View |
| Endodontic procedure | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 18.1 | View |
| Intraocular lens implant | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 18.1 | View |
| Tooth extraction | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 18.1 | View |
| Tooth repair | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 18.1 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.1 | View |
| Haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.1 | View |
| Hypertensive crisis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.1 | View |
| Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.1 | View |
| Peripheral venous disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.1 | View |
| Phlebitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.1 | View |
| Phlebitis superficial | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.1 | View |