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 @ 1:00 PM
Ignite Modification Date:
2025-12-25 @ 12:19 PM
NCT ID:
NCT02294461
Description:
Data reported for deaths are the number of participants who died regardless of time (could be beyond treatment emergent adverse event time frame).
Frequency Threshold:
5
Time Frame:
All cause mortality: From the date of randomization up to 123 months and 24 days AE: From first dose on Day 1 until 28 days after the last dose of study drug, or one day before the date of initiation of cytotoxic chemotherapy or an investigational agent for treatment of prostate cancer, whichever comes first, up to 123 months and 24 days
Study:
NCT02294461
Study Brief:
An Asian Study to Evaluate Efficacy and Safety of Oral Enzalutamide in Progressive Metastatic Prostate Cancer Participants
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Enzalutamide | Participants received 160 mg of enzalutamide orally once a day during double blind period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 29.4 months). Eligible participants who received enzalutamide during double blind and who provided consent to take part in open-label period continued to receive 160 mg of enzalutamide in open-label period orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 54.3 months). | 85 | None | 87 | 202 | 169 | 202 | View |
| Placebo | Participants received enzalutamide matching placebo orally once a day during DB period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 18.6 months). | 57 | None | 57 | 193 | 125 | 193 | View |
| Placebo Patients Crossover to Enzalutamide 160 mg | Eligible participants who received enzalutamide matching placebo during DB period and who provided consent to take part in OLP, received 160 mg of enzalutamide orally once a day during open-label period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 53.8 months). | 21 | None | 24 | 51 | 31 | 51 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.0 | View |
| Ischaemic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.0 | View |
| Loss of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.0 | View |
| Urinary bladder haemorrhage | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v23.0 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v23.0 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v23.0 | View |
| Blood loss anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v23.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v23.0 | View |
| Acute coronary syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.0 | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.0 | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.0 | View |
| Angina unstable | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.0 | View |
| Arteriosclerosis coronary artery | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.0 | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.0 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.0 | View |
| Cardiac failure acute | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.0 | View |
| Cardiopulmonary failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.0 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.0 | View |
| Supraventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v23.0 | View |
| Angle closure glaucoma | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.0 | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v23.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Chronic gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Duodenal ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Functional gastrointestinal disorder | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Gastric mucosal lesion | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Gastric ulcer haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Gastritis erosive | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Upper gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Chest discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Disease progression | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Hernia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Multiple organ dysfunction syndrome | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Bile duct stone | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v23.0 | View |
| Cholangitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v23.0 | View |
| Cholecystitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v23.0 | View |
| Cholecystitis chronic | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v23.0 | View |
| Hepatic cirrhosis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v23.0 | View |
| Hepatic function abnormal | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v23.0 | View |
| Arthritis infective | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Chronic sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Helicobacter infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Large intestine infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Subcutaneous abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v23.0 | View |
| Craniocerebral injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v23.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v23.0 | View |
| Femoral neck fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v23.0 | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v23.0 | View |
| Fibula fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v23.0 | View |
| Humerus fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v23.0 | View |
| Lumbar vertebral fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v23.0 | View |
| Rib fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v23.0 | View |
| Spinal compression fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v23.0 | View |
| Subdural haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v23.0 | View |
| Tibia fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v23.0 | View |
| Traumatic haemothorax | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v23.0 | View |
| Wrist fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v23.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.0 | View |
| Prostatic specific antigen increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.0 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.0 | View |
| Cachexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.0 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.0 | View |
| Hypophagia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.0 | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | View |
| Cervical spinal stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | View |
| Intervertebral disc protrusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | View |
| Lumbar spinal stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | View |
| Osteonecrosis of jaw | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | View |
| B-cell lymphoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | View |
| Gastric cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | View |
| Hepatic cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | View |
| Lung cancer metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | View |
| Lymphoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | View |
| Malignant neoplasm of thorax | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | View |
| Malignant neoplasm progression | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | View |
| Meningioma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | View |
| Metastases to bladder | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | View |
| Metastases to central nervous system | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | View |
| Metastases to rectum | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | View |
| Metastases to spine | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | View |
| Metastatic neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | View |
| Myelodysplastic syndrome | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | View |
| Prostate cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | View |
| Prostate cancer metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | View |
| Renal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | View |
| Schwannoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | View |
| Small cell lung cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | View |
| Spinal cord neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | View |
| Tumour associated fever | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | View |
| Brain oedema | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.0 | View |
| Cerebral infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.0 | View |
| Cerebral ischaemia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.0 | View |
| Cerebral thrombosis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.0 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.0 | View |
| Cerebrovascular insufficiency | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.0 | View |
| Cognitive disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.0 | View |
| Hydrocephalus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.0 | View |
| Myelopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.0 | View |
| Nerve compression | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.0 | View |
| Spinal cord compression | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.0 | View |
| Subarachnoid haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.0 | View |
| Organic brain syndrome | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v23.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v23.0 | View |
| Azotaemia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v23.0 | View |
| Calculus bladder | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v23.0 | View |
| Calculus urinary | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v23.0 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v23.0 | View |
| End stage renal disease | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v23.0 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v23.0 | View |
| Haemorrhage urinary tract | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v23.0 | View |
| Hydronephrosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v23.0 | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v23.0 | View |
| Ureteric rupture | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v23.0 | View |
| Ureterolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v23.0 | View |
| Urethral stenosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v23.0 | View |
| Urinary tract obstruction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v23.0 | View |
| Benign prostatic hyperplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v23.0 | View |
| Pelvic pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v23.0 | View |
| Prostatic haemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v23.0 | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | View |
| Bronchitis chronic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | View |
| Pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | View |
| Decubitus ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v23.0 | View |
| Bilateral orchidectomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA v23.0 | View |
| Chemotherapy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA v23.0 | View |
| Medical device change | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA v23.0 | View |
| Nephrostomy tube removal | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA v23.0 | View |
| Radiotherapy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA v23.0 | View |
| Spinal laminectomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA v23.0 | View |
| Tumour excision | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA v23.0 | View |
| Ureteral stent insertion | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA v23.0 | View |
| Ureteral stent removal | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA v23.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v23.0 | View |
| Hypertensive crisis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v23.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v23.0 | View |
| Malignant hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v23.0 | View |
| Venous thrombosis limb | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v23.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v23.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v23.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v23.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Periodontitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.0 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v23.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.0 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.0 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v23.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v23.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v23.0 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v23.0 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v23.0 | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v23.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v23.0 | View |