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 @ 3:52 PM
Ignite Modification Date:
2025-12-25 @ 1:58 PM
NCT ID:
NCT00731692
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00731692
Study Brief:
This Was an Open-label, Single-arm Extension Study (CFTY720D2306E1) to a Double-blind, Randomized Multicenter, Placebo-controlled, Parallel-group Core Study (CFTY720D2306) in PPMS.
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Core: FTY720 1.25 mg | Patients who received FTY720 1.25 mg during core | None | None | 38 | 147 | 132 | 147 | View |
| Core: FTY720 0.5 mg | Patients who received FTY720 0.5 mg during core | None | None | 84 | 336 | 278 | 336 | View |
| Core: Placebo | Patients who received Placebo during core | None | None | 117 | 487 | 406 | 487 | View |
| Extension: FTY1.25-0.5 | Patients who received FTY20 1.25 mg in core and received 0.5 mg of FTY during Extension | None | None | 7 | 74 | 43 | 74 | View |
| Extension: FTY0.5-0.5 | Patients who received FTY20 0.5 mg in core and received 0.5 mg of FTY during Extension | None | None | 10 | 196 | 70 | 196 | View |
| Extension: Placebo-FTY0.5 | Patients who received Placebo in core and received 0.5 mg of FTY during Extension | None | None | 37 | 301 | 138 | 301 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia macrocytic | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 18.0 | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 18.0 | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.0 | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.0 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.0 | View |
| Atrioventricular block | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.0 | View |
| Atrioventricular block complete | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.0 | View |
| Atrioventricular block first degree | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.0 | View |
| Atrioventricular block second degree | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.0 | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.0 | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.0 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.0 | View |
| Myocardial ischaemia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.0 | View |
| Pericarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.0 | View |
| Sinus bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.0 | View |
| Tachycardia paroxysmal | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.0 | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 18.0 | View |
| Amblyopia strabismic | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.0 | View |
| Angle closure glaucoma | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.0 | View |
| Cataract cortical | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.0 | View |
| Chorioretinopathy | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.0 | View |
| Cystoid macular oedema | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.0 | View |
| Diplopia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.0 | View |
| Intraocular haematoma | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.0 | View |
| Macular oedema | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.0 | View |
| Myopia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.0 | View |
| Optic atrophy | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.0 | View |
| Retinal detachment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.0 | View |
| Retinal tear | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Abdominal pain lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Anal polyp | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Colitis ulcerative | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Faecaloma | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Gastric ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Obstruction gastric | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Pancreatitis acute | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Upper gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Chest discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Device dislocation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Device occlusion | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Drug ineffective | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Gait disturbance | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| General physical health deterioration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 18.0 | View |
| Cholecystitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 18.0 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 18.0 | View |
| Cholelithiasis obstructive | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 18.0 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Bacterial infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Blister infected | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Bronchitis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Bronchopneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Bursitis infective | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Dengue fever | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Enterocolitis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Epididymitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| H1N1 influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Herpes zoster infection neurological | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Herpes zoster meningomyelitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Incision site infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Infectious pleural effusion | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Meningitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Myelitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Ophthalmic herpes simplex | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Peritonitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Pulmonary sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Pyelonephritis acute | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Serratia sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Subcutaneous abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Systemic mycosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Tracheobronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Urinary tract infection bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Accidental overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Alcohol poisoning | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Ankle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Clavicle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Concussion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Facial bones fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Femoral neck fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Fibula fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Foot fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Fracture displacement | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Hand fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Head injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Hip fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Humerus fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Joint dislocation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Limb traumatic amputation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Lumbar vertebral fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Meniscus injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Pneumothorax traumatic | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Post procedural complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Post procedural haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Post procedural haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Radius fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Rib fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Road traffic accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Skull fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Subdural haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Thermal burn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Tibia fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Traumatic renal injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Upper limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Wound | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Wound dehiscence | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Wrist fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| Blood pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| Foetal heart rate abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| International normalised ratio decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| Troponin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.0 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.0 | View |
| Polydipsia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Bone swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Bursitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Intervertebral disc disorder | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Joint swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Mobility decreased | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Osteopenia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Rhabdomyolysis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Sjogren's syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Spinal column stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Tendon disorder | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Basal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Breast cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Dysplastic naevus | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Fibrous histiocytoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Invasive ductal breast carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Invasive lobular breast carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Lung neoplasm malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Lymphocytic leukaemia | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Malignant melanoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Malignant melanoma in situ | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Medullary thyroid cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Melanocytic naevus | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Metastases to bone | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Metastases to central nervous system | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Metastases to kidney | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Metastases to liver | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Non-Hodgkin's lymphoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Osteoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Ovarian cancer metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Prostate cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Small cell lung cancer metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Squamous cell carcinoma of skin | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Uterine leiomyoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Aphasia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Arachnoiditis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Brain oedema | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Central nervous system lesion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Cerebrovascular disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Generalised tonic-clonic seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Monoparesis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Multiple sclerosis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Multiple sclerosis relapse | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Muscle spasticity | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Myelitis transverse | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Neuralgia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Nystagmus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Optic neuritis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Paraparesis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Peroneal nerve palsy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Primary progressive multiple sclerosis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Progressive multiple sclerosis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Quadriparesis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Status epilepticus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Transient ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Trigeminal neuralgia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Uhthoff's phenomenon | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| VIIth nerve paralysis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Adjustment disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 18.0 | View |
| Aggression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 18.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 18.0 | View |
| Depressive symptom | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 18.0 | View |
| Mania | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 18.0 | View |
| Mood swings | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 18.0 | View |
| Panic attack | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 18.0 | View |
| Psychotic disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 18.0 | View |
| Suicidal ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 18.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 18.0 | View |
| Bladder neck sclerosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 18.0 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 18.0 | View |
| Nephrogenic diabetes insipidus | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 18.0 | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 18.0 | View |
| Neurogenic bladder | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 18.0 | View |
| Polyuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 18.0 | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 18.0 | View |
| Urethral obstruction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 18.0 | View |
| Urinary incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 18.0 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 18.0 | View |
| Adenomyosis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 18.0 | View |
| Adnexal torsion | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 18.0 | View |
| Benign prostatic hyperplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 18.0 | View |
| Breast mass | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 18.0 | View |
| Endometriosis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 18.0 | View |
| Prostatitis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 18.0 | View |
| Prostatomegaly | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 18.0 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Bronchopneumopathy | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Haemothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Nasal obstruction | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Respiratory arrest | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Sleep apnoea syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Actinic keratosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Decubitus ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Jessner's lymphocytic infiltration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Lentigo | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Activities of daily living impaired | SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA 18.0 | View |
| Poor personal hygiene | SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA 18.0 | View |
| Aneurysm | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.0 | View |
| Arterial spasm | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.0 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.0 | View |
| Femoral artery occlusion | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.0 | View |
| Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.0 | View |
| Peripheral venous disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.0 | View |
| Raynaud's phenomenon | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.0 | View |
| Venous thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 18.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Gait disturbance | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| Blood cholesterol increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| Hypercholesterolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Melanocytic naevus | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Seborrhoeic keratosis | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 18.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 18.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.0 | View |