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: 2025-12-24 @ 9:13 PM
Ignite Modification Date: 2025-12-25 @ 7:03 PM
NCT ID: NCT00104104
Description: Because of GCP violations at Site 74, post-baseline data from that site are excluded from analyses, leaving 85 patients in the 15-minute infusion group and 84 patients in the 30-minute infusion group.
Frequency Threshold: 5
Time Frame: None
Study: NCT00104104
Study Brief: A Multiple Myeloma Trial in Patients With Bone Metastases
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
15 - Minute Infusion Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks. None None 30 85 74 85 View
30 - Minute Infusion Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks. None None 35 84 76 84 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.X View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.X View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.X View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.X View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.X View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.X View
Arteriosclerosis coronary artery SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.X View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.X View
Atrioventricular block first degree SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.X View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.X View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.X View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.X View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.X View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.X View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.X View
Left ventricular hypertrophy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.X View
Mitral valve disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.X View
Mitral valve stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.X View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.X View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.X View
Right atrial dilatation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.X View
Sinus arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.X View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.X View
Subendocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.X View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.X View
Adrenocortical insufficiency acute SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 10.X View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Diverticular perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Faecal incontinence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Suprapubic pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.X View
Jaundice cholestatic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.X View
Liver disorder SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.X View
Anaphylactic reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 10.X View
Abdominal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Meningitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Staphylococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.X View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.X View
Fractured sacrum SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.X View
Ilium fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.X View
Spinal compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.X View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.X View
Blood calcium abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.X View
Blood creatinine abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.X View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.X View
Blood potassium abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.X View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.X View
Blood urea abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.X View
Brain natriuretic peptide increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.X View
Ejection fraction abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.X View
Electrocardiogram ST segment elevation SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.X View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.X View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.X View
Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Diabetic ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Electrolyte imbalance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Hypovolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Groin pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Osteolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Osteonecrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Acute leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.X View
Pancreatic carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.X View
Brain oedema SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Carotid artery stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Cerebral ischaemia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Hydrocephalus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Metabolic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.X View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.X View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.X View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.X View
Acute prerenal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.X View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.X View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.X View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.X View
Renal failure chronic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.X View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Lung infiltration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Orthopnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Pleuritic pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Pulmonary hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Pulmonary mass SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Respiratory arrest SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.X View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.X View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.X View
Jugular vein distension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.X View
Jugular vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.X View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.X View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.X View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.X View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.X View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.X View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Pain in jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.X View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.X View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.X View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.X View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.X View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.X View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.X View