Adverse Events Module

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 @ 4:09 AM
Ignite Modification Date: 2025-12-26 @ 3:07 AM
NCT ID: NCT00321620
Description: The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One subject who was randomized to zoledronic acid and received denosumab as the 1st investigational product was analyzed on the denosumab arm for safety analyses.
Frequency Threshold: 5
Time Frame: up to 3 years 5 months
Study: NCT00321620
Study Brief: Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Men With Hormone-refractory Prostate Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Zoledronic Acid 4 mg Q4W None None None 568 945 853 945 View
Denosumab 120 mg Q4W None None None 594 943 844 943 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Anal fissure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Anal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Colitis ulcerative SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Colonic obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Enterovesical fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Faecal incontinence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Faecaloma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Faeces discoloured SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Gastric ulcer haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Gastric ulcer perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Gastritis erosive SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Gastrointestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Gingival bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Ileus paralytic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Intestinal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Lower gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Obstruction gastric SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Odynophagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Oesophageal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Peritonitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Proctalgia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Rectal stenosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Rectourethral fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Reflux gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Retroperitoneal haematoma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Retroperitoneal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Subileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Abasia SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Catheter related complication SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Catheter site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Drug intolerance SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Generalised oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Hernia SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Impaired healing SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Localised oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Performance status decreased SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Sudden death SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Suprapubic pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Terminal state SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Bile duct obstruction SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.1 View
Bile duct stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.1 View
Biliary tract disorder SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.1 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.1 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.1 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.1 View
Cholelithiasis obstructive SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.1 View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.1 View
Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.1 View
Hepatomegaly SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.1 View
Hepatorenal syndrome SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.1 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.1 View
Jaundice SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.1 View
Jaundice cholestatic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.1 View
Abscess intestinal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Alveolar osteitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Anal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Bronchopneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Central line infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Cholecystitis infective SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Clostridial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Dermo-hypodermitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Endotoxaemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Enterococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Erysipelas SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Fungal oesophagitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Gangrene SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Gastrointestinal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Infective exacerbation of chronic obstructive airways disease SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Kidney infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Lobar pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Ludwig angina SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Meningitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Necrotising fasciitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Neutropenic sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Oesophageal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Orchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Penile abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Peridiverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Perirectal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Pneumonia klebsiella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Post procedural sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Postoperative wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Pulmonary sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Pyelonephritis acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Pyelonephritis chronic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Renal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Scrotal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Staphylococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Tongue abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Cardiac pacemaker malfunction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Concussion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Cystitis radiation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Device failure SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Device malfunction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Drug toxicity SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Extradural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Gastroenteritis radiation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Ilium fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Joint dislocation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Kidney rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Lumbar vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Medical device discomfort SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Mouth injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Poisoning SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Post procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Renal haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Stent occlusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Sternal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Subdural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Tendon rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Thoracic vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Traumatic lung injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Aspiration bronchial SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Blood creatinine SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Blood pressure systolic abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Blood urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
General physical condition abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Glomerular filtration rate SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
International normalised ratio decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Liver function test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Occult blood positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Prostatic specific antigen increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Prothrombin time prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Urine output decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Cachexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
Electrolyte imbalance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
Failure to thrive SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
Feeding disorder SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
Fluid overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
Hypercreatininaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
Hypermetabolism SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
Hypernatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
Hyperosmolar state SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
Metabolic disorder SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
Polydipsia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Cervical spinal stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Groin pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Intervertebral disc disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Joint effusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Joint range of motion decreased SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Lumbar spinal stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Mobility decreased SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Muscle haemorrhage SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Myopathy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Neck mass SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Osteitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Osteochondrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Osteonecrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Osteoporosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Pathological fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Rhabdomyolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Sarcopenia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Spinal column stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Spinal disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Spondylolisthesis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Bile duct cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Bladder cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Bladder transitional cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Cancer pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Colon cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Gastric cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Lung adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Lung carcinoma cell type unspecified recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Malignant neoplasm progression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Meningioma benign SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Metastases to bladder SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Metastases to bone SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Metastases to bone marrow SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Metastases to central nervous system SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Metastases to liver SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Metastases to lung SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Metastases to lymph nodes SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Metastases to meninges SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Metastases to rectum SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Metastasis SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Metastatic neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Metastatic pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Nasal sinus cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Neoplasm progression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Neoplasm prostate SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Pancreatic carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Pancreatic carcinoma metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Paraneoplastic syndrome SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Pituitary tumour benign SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Prostate cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Rectal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Renal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Transitional cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Waldenstrom's macroglobulinaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View
Balance disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Brown-Sequard syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Cauda equina syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Cerebral artery embolism SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Cerebral haematoma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Cerebral ischaemia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Cerebrovascular disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Cervical cord compression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Cognitive disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Diabetic hyperglycaemic coma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Diplegia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Dysaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Embolic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Encephalitis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Epidural lipomatosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Facial palsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Facial paresis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Grand mal convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Haemorrhage intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Haemorrhagic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Hemiparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Hemiplegia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Hepatic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Hypertonia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Hypotonia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Intracranial pressure increased SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Mental impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Monoparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Myoclonus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Nerve root compression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Neurological decompensation SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Paraparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Paraplegia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Peripheral sensorimotor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Polyneuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Radicular syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Spinal cord compression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Spinal cord ischaemia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Subarachnoid haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Trigeminal neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Abnormal behaviour SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View
Disorientation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View
Emotional distress SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View
Hypochondriasis SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View
Sopor SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View
Anuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Azotaemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Bladder obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Bladder perforation SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Calculus bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Calculus ureteric SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Calculus urinary SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Faecaluria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Haemorrhage urinary tract SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Neurogenic bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Obstructive uropathy SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Oliguria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Polyuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Renal colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Renal cyst SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Renal disorder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Renal failure chronic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Renal pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Ureteric obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Urethral haemorrhage SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Urethral obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Urethral stenosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Urinary bladder haemorrhage SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Urinary tract disorder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Urinary tract obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Urine odour abnormal SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Benign prostatic hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.1 View
Genital pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.1 View
Oedema genital SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.1 View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.1 View
Penile pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.1 View
Perineal pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.1 View
Prostatic cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.1 View
Prostatic disorder SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.1 View
Prostatic haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.1 View
Prostatic obstruction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.1 View
Prostatitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.1 View
Prostatomegaly SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.1 View
Scrotal oedema SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.1 View
Scrotal pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.1 View
Acute pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Bronchopneumopathy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Chronic respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Emphysema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Haemothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Hydrothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Lung disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Lung infiltration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Orthopnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Pleural haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Pleurisy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Pulmonary hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Pulmonary thrombosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Respiratory acidosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Respiratory disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Respiratory tract congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Tachypnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Angioedema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.1 View
Decubitus ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.1 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.1 View
Hypoaesthesia facial SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.1 View
Periorbital oedema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.1 View
Purpura SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.1 View
Skin toxicity SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.1 View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.1 View
Stasis dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.1 View
Walking disability SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 12.1 View
Catheter placement SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.1 View
Ostectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.1 View
Spinal operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.1 View
Transurethral prostatectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.1 View
Ureteral stent insertion SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.1 View
Accelerated hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
Aortic dissection SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
Circulatory collapse SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
Extremity necrosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
Extrinsic vascular compression SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
Hypovolaemic shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
Pelvic venous thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
Shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
Thrombophlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
Venous thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
Venous thrombosis limb SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
Acute vestibular syndrome SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 12.1 View
Hypoacusis SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 12.1 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 12.1 View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 12.1 View
Blindness unilateral SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.1 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.1 View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.1 View
Retinal artery thrombosis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.1 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
Splenic infarction SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Atrioventricular block complete SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Bundle branch block right SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Cardiovascular insufficiency SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Ischaemic cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Left ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Sick sinus syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
Anaemia of malignant disease SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Arteriosclerosis coronary artery SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Atrial tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Cardiac asthma SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Cardiac failure acute SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Cardiogenic shock SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Cardiomegaly SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Cardiopulmonary failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Coronary artery stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Tachyarrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Ventricular fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.1 View
Visual impairment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.1 View
Coagulopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
Disseminated intravascular coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
Febrile bone marrow aplasia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
Haemorrhagic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
Heparin-induced thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
Hypercoagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
Normochromic normocytic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.1 View