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: 2025-12-26 @ 11:11 PM
Ignite Modification Date: 2025-12-26 @ 11:11 PM
NCT ID: NCT03016312
Description: 4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment. The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively). 759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Frequency Threshold: 5
Time Frame: From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period.
Study: NCT03016312
Study Brief: A Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide in Participants With Metastatic Castration-Resistant Prostrate Cancer (mCRPC) After Failure of an Androgen Synthesis Inhibitor And Failure of, Ineligibility For, or Refusal of a Taxane Regimen
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Atezolizumab + Enzalutamide Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity. 219 None 139 374 339 374 View
Enzalutamide Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity. 191 None 87 376 309 376 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22.0 View
Disseminated intravascular coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22.0 View
Heparin-induced thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22.0 View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Autoimmune myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Cardiac disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Cardiopulmonary failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Cardiovascular insufficiency SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Left ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Ventricular fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Deafness unilateral SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 22.0 View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 22.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 22.0 View
Uveitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 22.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Diverticular perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Gastroduodenal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Complication of device insertion SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Necrosis SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22.0 View
Anaphylactic reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 22.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 22.0 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Encephalitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Infected cyst SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Neutropenic sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Nosocomial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Pneumonia legionella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Spinal cord infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Superinfection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Facial bones fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Jaw fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Lower limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Multiple injuries SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Troponin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.0 View
Failure to thrive SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.0 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Haemarthrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Myositis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Pathological fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Torticollis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Bladder cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22.0 View
Colon cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22.0 View
Renal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22.0 View
Tumour pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22.0 View
Tumour rupture SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22.0 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Cranial nerve palsies multiple SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
IIIrd nerve paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Lacunar infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Myasthenic syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Paraparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Spinal cord compression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Subarachnoid haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22.0 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22.0 View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22.0 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22.0 View
Urinary tract obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Hydrothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Hypercapnia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Pleuritic pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Respiratory arrest SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.0 View
Erythema multiforme SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.0 View
Stevens-Johnson syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.0 View
Bladder neoplasm surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 22.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22.0 View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22.0 View
Pelvic venous thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22.0 View
Peripheral artery thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22.0 View
Myelosuppression SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22.0 View
Papilloedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 22.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Unevaluable event SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Hypertransaminasaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22.0 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Postoperative abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Nephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 22.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.0 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View