Adverse Events Module

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 @ 3:38 AM
Ignite Modification Date: 2025-12-26 @ 2:22 AM
NCT ID: NCT00925002
Description: Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Frequency Threshold: 4
Time Frame: From Baseline (i.e., Day 0 of B3461023) up to 10 years
Study: NCT00925002
Study Brief: Safety And Efficacy Evaluation Of Fx-1006A In Subjects With Transthyretin Amyloidosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Val30Met: Tafamidis Then Tafamidis Val30Met participants who received tafamidis in study B3461020 (Fx-005), continued the same in study B3461021 (Fx-006), received tafamidis 20 milligrams (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries. 3 None 6 38 34 38 View
Val30Met: Placebo Then Tafamidis Val30Met participants who received placebo in study B3461020 (Fx-005) and assigned to receive tafamidis in study B3461021 (Fx-006) and study B3461023 (Fx1A-303), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries. 1 None 9 37 32 37 View
NonVal30Met: Tafamidis NonVal30Met participants who received tafamidis in study B3461022 (Fx1A-201), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries. 7 None 10 18 18 18 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Angina Unstable NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Cardiac Amyloidosis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Cardiac Arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Cardiac Failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Cardiac Failure Acute NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Pericardial Effusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Ventricular Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 23.0 View
Hyperthyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.0 View
Ascites NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Ileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Vomitting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Chest Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Disease Progression NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Oedema Peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Cholangitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Cholecystitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Hepatomegaly NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Amyloidosis NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 23.0 View
Device Related Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Endocarditis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Osteomyelitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Concussion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Lower Limb Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Tibia Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Wound NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Wrist Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Alanine Aminotransferase Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Aspartate Aminotransferase Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Gamma-Glutamyltransferase Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Weight Decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Decreased Appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypoalbuminaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypovolaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Vitamin D Deficiency NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Muscular Weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Synovial Cyst NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Central Nervous System Lymphoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Lymphoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Dementia Alzheimer's Type NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Epilepsy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Transient Ischaemic Attack NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Confusional State NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Nephrolithiasis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Renal Failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Renal Impairment NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Cervical Dysplasia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 23.0 View
Pleural Effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Heart Transplant NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 23.0 View
Deep Vein Thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Orthostatic Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bundle Branch Block Bilateral NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Cardiac Failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Cardiomyopathy NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Mitral Valve Incompetence NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Deafness NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 23.0 View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 23.0 View
Vertigo Positional NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 23.0 View
Cataract NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Dry Eye NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Eye Pruritus NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Vision Blurred NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Abdominal Distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Abdominal Pain Lower NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Abdominal Pain Upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Dental Caries NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Dry Mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Gastrointestinal Disorder NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Gastrointestinal Motility Disorder NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Haemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Inguinal Hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Odynophagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Vomitting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Chest Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Early Satiety NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Exercise Tolerance Decreased NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Gait Disturbance NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Implant Site Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Oedema Peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Cholelithiasis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Burn Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Diverticulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Ear Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Gastroenteritis Viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Gingivitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Hordeolum NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Infected Skin Ulcer NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Onychomycosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pneumonia Streptococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pyelonephritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Respiratory Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Skin Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Tooth Abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Tracheobronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Upper Respiratory Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Vaginal Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Vulvovaginal Mycotic Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Wound Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Burns Second Degree NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Head Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Joint Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Limb Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Medication Error NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Muscle Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Procedural Pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Skin Abrasion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Skin Laceration NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Thermal Burn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Tooth Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Traumatic Ulcer NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Wound NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Blood Cholesterol Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Blood Thyroid Stimulating Hormone Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Haemoglobin Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Hepatic Enzyme Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Weight Decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Decreased Appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Fluid Overload NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Vitamin B12 Deficiency NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Vitamin D Deficiency NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Foot Deformity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Muscle Atrophy NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Muscle Spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Muscular Weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Musculoskeletal Chest Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Musculoskeletal Stiffness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Neck Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Pain in Extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Tendonitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Amnesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Balance Disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Burning Sensation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Carotid Artery Stenosis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Fine Motor Skill Dysfunction NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Hypoaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Memory Impairment NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Neuralgia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Neuropathy Peripheral NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Presyncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Sciatica NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Dysuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Nephrolithiasis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Renal Failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Urinary Retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Benign Prostatic Hyperplasia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 23.0 View
Erectile Dysfunction NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 23.0 View
Vulvovaginal Pruritus NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 23.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Dysphonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Blister NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Decubitus Ulcer NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Hyperhidrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Night Sweats NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Purpura NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Skin Lesion NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Skin Ulcer NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Walking Disability NON_SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 23.0 View
Carpal Tunnel Decompression NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 23.0 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Orthostatic Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Peripheral Vascular Disorder NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Arrhythmia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Atrial Fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View