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 @ 4:26 AM
Ignite Modification Date: 2025-12-26 @ 3:29 AM
NCT ID: NCT00252720
Description: Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
Frequency Threshold: 5
Time Frame: During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment.
Study: NCT00252720
Study Brief: DIabetic Retinopathy Candesartan Trials.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Candesartan Candesartan cilexetil 32 mg once daily None None 173 951 92 951 View
Placebo Placebo Comparator None None 161 951 32 951 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Idiopathic Thrombocytopenic Purpura SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Iron Deficiency Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Thrombocytopenic Purpura SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Acute Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Angina Pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Cardiovascular Disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Heart Disease Congenital SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 11.0 View
Hepato-Lenticular Degeneration SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 11.0 View
Ear Congestion SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 11.0 View
Sudden Hearing Loss SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 11.0 View
Vestibular Neuronitis SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 11.0 View
Addison's Disease SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 11.0 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Diabetic Blindness SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Eye Haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Inguinal Hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Abdominal Adhesions SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Abdominal Pain Lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Anal Fissure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Change Of Bowel Habit SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Coeliac Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Duodenal Ulcer Perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Food Poisoning SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Gastric Ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Gastrointestinal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Gingival Disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Hiatus Hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Irritable Bowel Syndrome SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Pancreatitis Acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Rectal Polyp SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Foreign Body Reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Macrosomia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Organ Failure SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 11.0 View
Hepatitis Acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 11.0 View
Hepatitis Toxic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 11.0 View
Sarcoidosis SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 11.0 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Pyelonephritis Acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Hepatitis B SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Localised Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Pilonidal Cyst SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Postoperative Wound Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Viral Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Abdominal Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Abdominal Wall Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Abscess Limb SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Acute Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Adnexitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Bronchopneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Carbuncle SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Corneal Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Empyema SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Encephalitis Viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Gastrointestinal Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Groin Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Hepatitis A SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Hepatitis C SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Herpes Zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Infected Cyst SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Liver Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Lower Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Oophoritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Pelvic Inflammatory Disease SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Perianal Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Perineal Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Peritonsillar Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Pulmonary Tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Pyelonephritis Chronic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Retroperitoneal Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Subcutaneous Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Viral Diarrhoea SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Viral Skin Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Wound Infection Staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Road Traffic Accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Meniscus Lesion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Multiple Injuries SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Hand Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Humerus Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Ligament Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Lower Limb Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Ankle Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Cartilage Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Cervical Vertebral Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Concussion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Epicondylitis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Femur Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Foot Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Frostbite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Gun Shot Wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Hip Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Injury Corneal SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Intentional Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Intervertebral Disc Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Joint Dislocation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Joint Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Ligament Rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Limb Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Multiple Fractures SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Patella Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Radius Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Skin Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Skull Fractured Base SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Sports Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Tendon Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Thermal Burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Tibia Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Hepatitis C Positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Tumour Marker Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Diabetic Ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Diabetes Mellitus Inadequate Control SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Hypoglycaemic Seizure SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Diabetic Foot SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Periarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Intervertebral Disc Protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Musculoskeletal Chest Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Dupuytren's Contracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Myopathy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Osteoarthropathy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Rotator Cuff Syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Spondylolisthesis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Tenosynovitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Trigger Finger SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Fibroadenoma Of Breast SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.0 View
Malignant Melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.0 View
Anaplastic Astrocytoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.0 View
Benign Colonic Neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.0 View
Fibroma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.0 View
Hepatic Adenoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.0 View
Lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.0 View
Ovarian Adenoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.0 View
Papillary Thyroid Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.0 View
Penile Wart SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.0 View
Hypoglycaemic Coma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Carpal Tunnel Syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Diabetic Coma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Diabetic Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Grand Mal Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Cerebral Haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Cerebrovascular Accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Diabetic Hyperosmolar Coma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Diabetic Ketoacidotic Hyperglycaemic Coma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Haemorrhagic Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Intra-Uterine Death SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 11.0 View
Polyhydramnios SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 11.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Major Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Suicide Attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Calculus Urinary SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Diabetic Nephropathy SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Ureteric Stenosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Adenomyosis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.0 View
Cervical Dysplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.0 View
Dysfunctional Uterine Bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.0 View
Endometriosis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.0 View
Menometrorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.0 View
Menorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.0 View
Ovarian Cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.0 View
Pelvic Pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.0 View
Pneumomediastinum SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Tonsillar Hypertrophy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Vocal Cord Polyp SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Angioedema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Dermal Cyst SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Erythema Nodosum SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Skin Ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Varicose Vein SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Accidental Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Uterine Leiomyoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.0 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Multiple Sclerosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Myelitis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Tension Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Abortion Spontaneous SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 11.0 View
Foetal Cardiac Disorder SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 11.0 View
Uterine Polyp SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.0 View
Varicocele SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.0 View
Bronchitis Chronic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Chronic Obstructive Pulmonary Disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Nasal Polyps SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Nasal Septum Deviation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Femoral Artery Occlusion SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View