Adverse Events Module

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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 @ 3:25 AM
Ignite Modification Date: 2025-12-26 @ 2:05 AM
NCT ID: NCT02787005
Description: All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Frequency Threshold: 5
Time Frame: Up to ~52 months
Study: NCT02787005
Study Brief: Study of Pembrolizumab (MK-3475) in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)(MK-3475-199/KEYNOTE-199)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort 2- 1st Course Participants with PD-L1 negative, measurable disease received pembrolizumab 200 mg via IV infusion 63 None 28 67 62 67 View
Cohort 3 - First Course Participants with bone metastases and non-measurable disease received pembrolizumab 200 mg via IV infusion 57 None 25 58 57 58 View
Cohort 4 - First Course Participants with RECIST 1.1-measureable disease received pembrolizumab 200 mg via IV infusion 76 None 26 81 79 81 View
Cohort 5 - First Course Participants with bone metastases only or bone-predominant disease received pembrolizumab 200 mg via IV infusion 40 None 19 45 42 45 View
Cohort 1 - Second Course Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion. 0 None 0 1 1 1 View
Cohort 1 - First Course Participants with PD-L1-positive, measurable disease received pembrolizumab 200 mg via IV infusion 126 None 70 133 128 133 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Stress cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Cataract congenital SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 24.1 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.1 View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 24.1 View
Hypophysitis SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 24.1 View
Hypopituitarism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 24.1 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 24.1 View
Blindness SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Diarrhoea haemorrhagic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Faecaloma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Large intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Subileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Physical deconditioning SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Cholangitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.1 View
Hepatic pain SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.1 View
Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.1 View
Immune-mediated hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.1 View
Jaundice cholestatic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.1 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Candida infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Device related bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Endocarditis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Enterocolitis infectious SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Gastroenteritis norovirus SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Necrotising fasciitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Pelvic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Pyelonephritis acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Staphylococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Thrombophlebitis septic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Ureteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Vascular device infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Post procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Urinary tract stoma complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Clostridium test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Cachexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Diabetic ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Tumour lysis syndrome SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Type 1 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Myositis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Cancer pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 View
Malignant neoplasm progression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 View
Squamous cell carcinoma of skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 View
Tumour pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Coordination abnormal SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Haemorrhage intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Miller Fisher syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Myasthenia gravis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Seizure like phenomena SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Spinal cord compression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Subdural hygroma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Toxic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Disorientation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Bladder perforation SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Glomerulosclerosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Perinephric collection SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Urinary tract obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Benign prostatic hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 24.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Micturition urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Nocturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Swelling face SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Cancer pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View