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 @ 3:09 AM
Ignite Modification Date: 2025-12-26 @ 1:48 AM
NCT ID: NCT01458405
Description: Analysis was performed on safety population.
Frequency Threshold: 0
Time Frame: Phase 1 and 2: Adverse Events data was collected from first infusion up to 12 Month post-infusion in each Phase of the study (i.e., up to Month 12)
Study: NCT01458405
Study Brief: Allogeneic Heart Stem Cells to Achieve Myocardial Regeneration
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Phase 1: Safety Cohort:12.5 M CDCs Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized in safety cohort received a single infusion of CAP-1002 (12.5 M cells) suspended in cryopreservation solution on Day 0 and were followed up for 12 months post-infusion. 0 None 0 4 4 4 View
Phase 1: Safety Cohort: 25 M CDCs Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized in safety cohort received a single infusion of CAP-1002 (25 M cells) suspended in cryopreservation solution on Day 0 and were followed up for 12 months post-infusion. 0 None 0 10 10 10 View
Phase 2: Randomized Treatment Cohort: Placebo Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to placebo received an infusion of 11.1 mL of cryopreservation solution on Day 0 and were followed up for 12 months post-infusion. 0 None 15 44 24 44 View
Phase 2: Randomized Treatment Cohort: CAP-1002 Allogeneic Cardiosphere-Derived Cells Participants with recent MI (defined as index MI more than 4 weeks but within 90 days prior to infusion), and chronic MI (defined as index MI more than 90 days but less than 12 months prior to infusion), randomized to active treatment received a single infusion of CAP-1002 (25 M cells) suspended in cryopreservation solution on Day 0 and were followed up for 12 months post-infusion. 0 None 20 77 42 77 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Iron Deficiency Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Acute Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Angina Pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Cardiac Failure Acute SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Cardiac Failure Congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Cardiogenic Shock SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Mitral Valve Incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Erosive Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Gastrointestinal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pancreatitis Bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Vascular Pseudoaneurysm SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Ischaemic Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Implantable Defibrillator Insertion SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.1 View
Intermittent Claudication SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Peripheral Arterial Occlusive Disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Cardiac Failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Ventricular Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Non-Cardiac Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Angiogram SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Cervical Radiculopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Implantable Icd Insertion SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cardiac Failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Left Ventricular Dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Angina Pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Rectal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Chest Discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Catheter Site Related Reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Drug Intolerance SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Mucosal Inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Ear Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Furuncle SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Gastroenteritis Viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Implant Site Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Vulvovaginal Mycotic Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Brain Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Corneal Abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Foreign Body SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Wrist Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Troponin I Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Decreased Appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Musculoskeletal Chest Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Lipoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Dizziness Postural SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Renal Failure Acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Dyspnoea Exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Oropharyngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Orthopnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Productive Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Dermatitis Contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Anaemia Macrocytic SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Iron Deficiency Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Acute Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Angina Unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Anginal Equivalent SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Atrial Thrombosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Atrioventricular Block SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Atrioventricular Block First Degree SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Bradycardia And Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Bundle Branch Block Left SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Cardiac Aneurysm SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Cardiac Failure Acute SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Cardiac Failure Chronic SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Cardiac Failure Congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Cardiac Ventricular Thrombosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Coronary Artery Dissection SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Coronary Artery Thrombosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Intracardiac Thrombus SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Sinus Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Supraventricular Extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Supraventricular Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Ventricular Extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Ventricular Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Arteriovenous Malformation SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 18.1 View
Ear Pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.1 View
Mixed Deafness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.1 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.1 View
Vertigo Positional SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.1 View
Glaucoma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Hyphaema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Diverticulum SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Food Poisoning SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Gastrooesophageal Reflux Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Large Intestine Polyp SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Catheter Site Bruise SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Hernia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Non-Cardiac Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Peripheral Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Hepatic Lesion SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.1 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Hordeolum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Onychomycosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Oral Herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Otitis Media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Rash Pustular SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Tinea Pedis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Tooth Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Viral Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Joint Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Limb Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Procedural Hypotension SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Procedural Pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Vascular Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Ingrowing Nail SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Pruritus Generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Rash Maculo-Papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Implantable Defibrillator Insertion SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.1 View
Arteriovenous Fistula SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Hypertensive Crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Intermittent Claudication SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Orthostatic Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
ALT Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
AST Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood Creatinine Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood Glucose Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood Potassium Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood Uric Acid Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Cardiac Murmur SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
ECG PR Prolongation SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
ECG ST Segment Depression SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
ECG ST Segment Elevation SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Ejection Fraction Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Haematocrit Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Haemoglobin Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Liver Function Test Abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Mean Cell Haemoglobin Conc Dec SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Mean Cell Haemoglobin Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Red Blood Cells Urine SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Red Cell Distribution Width Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Transaminases Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Electrolyte Imbalance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Fluid Retention SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Costochondritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Dupuytrens Contracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Flank Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Muscle Spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Musculoskeletal Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Neck Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Pain In Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Pain In Jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Rotator Cuff Syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Spinal Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Tendonitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Adrenal Adenoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
Basal Cell Carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
Plasma Cell Myeloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
Skin Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
Diabetic Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Ischaemic Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Sensory Disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Alcohol Withdrawal Syndrome SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Libido Decreased SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Panic Attack SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Suicidal Ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Diabetic Nephropathy SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Erectile Dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 18.1 View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
COPD SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Sleep Apnoea Syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Tonsillar Hypertrophy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View