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 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:57 PM
NCT ID:
NCT01308567
Description:
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug until 30 days after the last administration of study drug). Analysis was performed on safety population, which was randomized participants who received study drug and analyzed according to the treatment actually received.
Frequency Threshold:
5
Time Frame:
All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 83 months) regardless of seriousness or relationship to investigational product.
Study:
NCT01308567
Study Brief:
Cabazitaxel Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant 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 |
|---|---|---|---|---|---|---|---|---|
| Docetaxel 75 mg/m^2 | Docetaxel (TXT) 75 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal. | None | None | 126 | 387 | 353 | 387 | View |
| Cabazitaxel 20 mg/m^2 | Cabazitaxel 20 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal. | None | None | 127 | 369 | 323 | 369 | View |
| Cabazitaxel 25 mg/m^2 | Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal. | None | None | 188 | 391 | 354 | 391 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Cholecystitis infective | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Clostridium difficile colitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Clostridium difficile infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Post procedural cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Rectal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Squamous cell carcinoma of skin | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 21.0 | View |
| Transitional cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 21.0 | View |
| Tumour pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 21.0 | View |
| Urinary tract neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 21.0 | View |
| Transient ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 21.0 | View |
| Bronchospasm | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 21.0 | View |
| Gastrointestinal vascular malformation haemorrhagic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Disease progression | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 21.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 21.0 | View |
| General physical health deterioration | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 21.0 | View |
| Craniocerebral injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 21.0 | View |
| Cystitis radiation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 21.0 | View |
| Abscess intestinal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Abscess jaw | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Abscess oral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Anal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Appendicitis perforated | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Device related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Endocarditis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Erysipelas | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Gastrointestinal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Lung abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Mastoiditis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Neutropenic infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Neutropenic sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Peritonitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Staphylococcal osteomyelitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Staphylococcal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Tracheobronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Tuberculosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Adenocarcinoma of colon | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 21.0 | View |
| Cancer pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 21.0 | View |
| Colon cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 21.0 | View |
| Colorectal cancer metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 21.0 | View |
| Malignant neoplasm of ampulla of Vater | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 21.0 | View |
| Metastases to central nervous system | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 21.0 | View |
| Metastases to meninges | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 21.0 | View |
| Non-small cell lung cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 21.0 | View |
| Prostate cancer metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 21.0 | View |
| Renal cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 21.0 | View |
| Sebaceous carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 21.0 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 21.0 | View |
| Disseminated intravascular coagulation | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 21.0 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 21.0 | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 21.0 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 21.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 21.0 | View |
| Pancytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 21.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 21.0 | View |
| Anaphylactic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDra 21.0 | View |
| Cytokine release syndrome | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDra 21.0 | View |
| Drug hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDra 21.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 21.0 | View |
| Failure to thrive | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 21.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 21.0 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 21.0 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 21.0 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 21.0 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 21.0 | View |
| Metabolic acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 21.0 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDra 21.0 | View |
| Brain oedema | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 21.0 | View |
| Cerebellar haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 21.0 | View |
| Cerebral haematoma | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 21.0 | View |
| Cerebral infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 21.0 | View |
| Cerebral ischaemia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 21.0 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 21.0 | View |
| Coma | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 21.0 | View |
| Haemorrhagic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 21.0 | View |
| Ischaemic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 21.0 | View |
| Leukoencephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 21.0 | View |
| Movement disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 21.0 | View |
| Paraparesis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 21.0 | View |
| Peripheral motor neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 21.0 | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 21.0 | View |
| Spinal cord compression | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 21.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 21.0 | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 21.0 | View |
| Cataract subcapsular | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 21.0 | View |
| Macular fibrosis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 21.0 | View |
| Acute coronary syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 21.0 | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 21.0 | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 21.0 | View |
| Angina unstable | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 21.0 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 21.0 | View |
| Atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 21.0 | View |
| Bundle branch block left | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 21.0 | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 21.0 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 21.0 | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 21.0 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 21.0 | View |
| Aortic aneurysm | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 21.0 | View |
| Aortic dissection | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 21.0 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 21.0 | View |
| Embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 21.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 21.0 | View |
| Hypertensive crisis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 21.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 21.0 | View |
| Hypovolaemic shock | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 21.0 | View |
| Pelvic venous thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 21.0 | View |
| Peripheral arterial occlusive disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 21.0 | View |
| Peripheral ischaemia | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 21.0 | View |
| Shock | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 21.0 | View |
| Thrombophlebitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 21.0 | View |
| Aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 21.0 | View |
| Choking | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 21.0 | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 21.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 21.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 21.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 21.0 | View |
| Hydrothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 21.0 | View |
| Interstitial lung disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 21.0 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 21.0 | View |
| Pleurisy | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 21.0 | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 21.0 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 21.0 | View |
| Pulmonary congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 21.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 21.0 | View |
| Pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 21.0 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 21.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Anal incontinence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Barrett's oesophagus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Colitis ischaemic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Colitis ulcerative | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Diverticular perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Duodenal ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Duodenal ulcer haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Enterovesical fistula | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Gastric haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Gastric perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Gastric ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Gastric ulcer haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Gastrointestinal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Gastrointestinal ulcer haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Haematemesis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Haemorrhagic erosive gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Large intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Large intestine perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Large intestine polyp | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Mechanical ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Melaena | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Necrotising colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Oesophageal ulcer haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Pancreatitis acute | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Upper gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDra 21.0 | View |
| Cholecystitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDra 21.0 | View |
| Hepatic function abnormal | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDra 21.0 | View |
| Diabetic foot | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 21.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 21.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 21.0 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 21.0 | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 21.0 | View |
| Haemarthrosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 21.0 | View |
| Intervertebral disc degeneration | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 21.0 | View |
| Intervertebral disc protrusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 21.0 | View |
| Joint effusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 21.0 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 21.0 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 21.0 | View |
| Pathological fracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 21.0 | View |
| Spinal osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 21.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 21.0 | View |
| Bladder obstruction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 21.0 | View |
| Bladder perforation | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 21.0 | View |
| Calculus bladder | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 21.0 | View |
| Calculus urinary | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 21.0 | View |
| Cystitis glandularis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 21.0 | View |
| Cystitis haemorrhagic | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 21.0 | View |
| Cystitis noninfective | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 21.0 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 21.0 | View |
| Hydronephrosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 21.0 | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 21.0 | View |
| Renal colic | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 21.0 | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 21.0 | View |
| Renal impairment | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 21.0 | View |
| Ureteric obstruction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 21.0 | View |
| Ureteric stenosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 21.0 | View |
| Urethral stenosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 21.0 | View |
| Urethritis noninfective | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 21.0 | View |
| Urinary bladder haemorrhage | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 21.0 | View |
| Urinary bladder rupture | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 21.0 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 21.0 | View |
| Urinary tract obstruction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 21.0 | View |
| Urinary tract pain | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 21.0 | View |
| Pelvic pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDra 21.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 21.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 21.0 | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 21.0 | View |
| Infusion site extravasation | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 21.0 | View |
| Multiple organ dysfunction syndrome | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 21.0 | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 21.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 21.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 21.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 21.0 | View |
| Sudden cardiac death | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 21.0 | View |
| Sudden death | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 21.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 21.0 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 21.0 | View |
| Creatinine renal clearance decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 21.0 | View |
| Hepatic enzyme increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 21.0 | View |
| International normalised ratio increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 21.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 21.0 | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 21.0 | View |
| Accidental overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 21.0 | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 21.0 | View |
| Hand fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 21.0 | View |
| Hip fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 21.0 | View |
| Recall phenomenon | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 21.0 | View |
| Spinal compression fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 21.0 | View |
| Subarachnoid haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 21.0 | View |
| Toxicity to various agents | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 21.0 | View |
| Upper limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 21.0 | View |
| Wrong drug administered | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 21.0 | View |
| Device issue | SYSTEMATIC_ASSESSMENT | Product Issues | MedDra 21.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 21.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 21.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 21.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDra 21.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 21.0 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 21.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 21.0 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 21.0 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 21.0 | View |
| Lacrimation increased | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 21.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 21.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 21.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 21.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 21.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 21.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 21.0 | View |
| Nail disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 21.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 21.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 21.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 21.0 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 21.0 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 21.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 21.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 21.0 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 21.0 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 21.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 21.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 21.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 21.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 21.0 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 21.0 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 21.0 | View |
| Incorrect dose administered | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 21.0 | View |