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 @ 11:10 PM
Ignite Modification Date: 2025-12-25 @ 8:43 PM
NCT ID: NCT00274469
Description: First patient was enrolled on 6th Feb 2006. Non-serious AEs are reported from randomisation up to the data cut-off (DCO 10th Jan 2008) for the primary analysis (56 days after last injection and 30 days after last tablet). Serious AEs are reported from randomisation up to DCO for the 65% OS (15th July 2014). Note: All-Mortality is based on full population, while AEs and SAEs are based on safety population (1 less patient in Fulvestrant arm as it never received the randomised drug).
Frequency Threshold: 0
Time Frame: Non-serious adverse events = randomisation upto the point of data cut off for the primary efficacy analysis. Serious adverse events = randomisation up to the point of data cut off for the 65% overall survival analysis.
Study: NCT00274469
Study Brief: A Clinical Trial to Compare Efficacy and Tolerability of Faslodex With Arimidex in Patients With Advanced Breast Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fulvestrant 500 mg Fulvestrant 500 mg 63 None 24 101 71 101 View
Anastrozole 1 mg Anastrozole 1 mg 74 None 22 103 70 103 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ATRIAL FIBRILLATION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
CHRONIC OBSTRUCTIVE PULMONARY DISEASE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
CONFUSIONAL STATE SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
FALL SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
FEMUR FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
GASTRIC ULCER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
GASTROENTERITIS VIRAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
HUMERUS FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
LACRIMAL DISORDER SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 10.0 View
LYMPHADENOPATHY SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
NEURALGIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
OSTEOARTHRITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
PLEURITIC PAIN SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
RADIUS FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
TRANSIENT ISCHAEMIC ATTACK SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
FEBRILE NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
ARRHYTHMIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
CARDIAC FAILURE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
CARDIAC FAILURE CONGESTIVE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
CORONARY OSTIAL STENOSIS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
BLINDNESS SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
ANAL HAEMRROHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
SUBILEUS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ASTHENIA SYSTEMATIC_ASSESSMENT General disorders MedDRA View
DEATH SYSTEMATIC_ASSESSMENT General disorders MedDRA View
GENERAL PHYSICAL HEALTH DETERIORATION SYSTEMATIC_ASSESSMENT General disorders MedDRA View
ARTHRITIS BACTERIAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
EMPYEMA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
LOWER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
FEMORAL NECK FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
HIP FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
RIB FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
ROAD TRAFFIC ACCIDENT SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
CACHEXIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
DECREASED APPETITE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
DEHYDRATION SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
BONE PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
COLON CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
LUNG CANCERMETASTATIC SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
METASTASES TO THORAX SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
SARCOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
SQUAMOUS CELL CARCINOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
TUMOUR HAEMORRAGE SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
CEREBROVASCULAR ACCIDENT SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
SPINAL CORD COMPRESSION SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
PULMONARY EMBOLISM SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
ANGIOEDEMA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
CHOLECYSTECTOMY SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
FLATULENCE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
DYSGEUSIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
LETHARGY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
SOMNOLENCE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
CEREBRAL ISCHAEMIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
DIABETIC NEUROPATHY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
DISTURBANCE IN ATTENTION SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
MEMORY IMPAIRMENT SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
PARKINSON'S DISEASE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
PAROSMIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
VITH NERVE PARALYSIS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
LOWER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
CYSTITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
HERPES ZOSTER SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
ORAL CANDIDIASIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
SINUSITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
TONSILLITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
VIRAL UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
DYSPNOEA EXERTIONAL SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
ECZEMA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
SCAR SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
SUBCUTANEOUS NODULE SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
DEPRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
ANXIETY SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
DEPRESSED MOOD SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
CRYING SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
LIBIDO DECREASED SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
NEUROSIS SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
WEIGHT INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
ACCOMMODATION DISORDER SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
CONJUNCTIVAL DISORDER SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
DIPLOPIA SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
ERYTHEMA OF EYELID SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
EXOPHTHALMOS SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
EYE PAIN SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
EYELID PTOSIS SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
MYOPIA SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
VISUAL ACUITY REDUCED SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
VERTIGO SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
TINNITUS SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
EAR PAIN SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
DYSURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
GOITRE SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
MUSCULOSKELETAL PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
MUSCLE SPASMS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
JOINT STIFFNESS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
MUSCULOSKELETAL CHEST PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
OSTEOARTHRITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
BURSITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
GROIN PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
MUSCLE CONTRACTURE SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
SYMPATHETIC POSTERIOR CERVICAL SYNDROME SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
GASTRODUODENITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
NEURALGIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
ASTHENIA SYSTEMATIC_ASSESSMENT General disorders MedDRA View
GASTROINTESTINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
BONE PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
HOT FLUSH SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10. View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
INFLUENZA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
INJECTION SITE PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
MYALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
DYSPEPSIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ABDOMINAL PAIN UPPER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
HIATUS HERNIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
DRY MOUTH SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ANAL DISCOMFORT SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
DIVERTICULUM INTESTINAL SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
GASTROOESOPHAGEAL REFLUX DISEASE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
STOMATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ABDOMINAL DISTENSION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
ABDOMINAL PAIN LOWER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
HAEMATEMESIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
HAEMORRHOIDAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
HAEMORRHOIDS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
PROCTITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
RETCHING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
OEDEMA PERIPHERAL SYSTEMATIC_ASSESSMENT General disorders MedDRA View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA View
INFLUENZA LIKE ILLNESS SYSTEMATIC_ASSESSMENT General disorders MedDRA View
INJECTION SITE HAEMATOMA SYSTEMATIC_ASSESSMENT General disorders MedDRA View
INJECTION SITE HAEMORRHAGE SYSTEMATIC_ASSESSMENT General disorders MedDRA View
INJECTION SITE PRURITUS SYSTEMATIC_ASSESSMENT General disorders MedDRA View
APPLICATION SITE PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA View
GENERAL PHYSICAL HEALTH DETERIORATION SYSTEMATIC_ASSESSMENT General disorders MedDRA View
CHILLS SYSTEMATIC_ASSESSMENT General disorders MedDRA View
GAIT DISTURBANCE SYSTEMATIC_ASSESSMENT General disorders MedDRA View
INJECTION SITE NODULE SYSTEMATIC_ASSESSMENT General disorders MedDRA View
IRRITABILITY SYSTEMATIC_ASSESSMENT General disorders MedDRA View
NON-CARDIAC CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA View
WOUND INFECTION STAPHYLOCOCCAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
ACARIASIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
BACTERIAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
CANDIDIASIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
FUNGAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
IMPETIGO SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
OSTEOMYELITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
RHINITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
VIRAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
WOUND INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
DYSPHONIA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
PHARYNGOLARYNGEAL PAIN SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
EPISTAXIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
NASAL CONGESTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
ALLERGIC SINUSITIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
BRONCHOSPASM SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
LARYNGEAL DISORDER SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
LUNG INFILTRATION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
NASAL DRYNESS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
PLEURAL EFFUSION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
RALES SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
UPPER RESPIRATORY TRACT INFLAMMATION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
HAEMATOMA SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
HYPERAEMIA SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
PHLEBITIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
HYPOTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
ALOPECIA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
HYPERHIDROSIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
DERMATITIS CONTACT SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
PRURITUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
DRY SKIN SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
NIGHT SWEATS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
COLD SWEAT SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
DERMATITIS ALLERGIC SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
ANOREXIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
DECREASED APPETITE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
DIABETES MELLITUS SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
FLUID RETENTION SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
HYPERGLYCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
HYPERURICAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
HYPOALBUMINAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
HYPOCALCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
VITAMIN D DEFICIENCY SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
CONTUSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
THERMAL BURN SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
ANAEMIA POSTOPERATIVE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
CONTRAST MEDIA REACTION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
FALL SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
FEMUR FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
JOINT INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
LACERATION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
POST PROCEDURAL COMPLICATION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
PUBIC RAMI FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
RADIATION SKIN INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
RIB FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
SKELETAL INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
BREAST PAIN SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
VULVOVAGINAL DRYNESS SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
BREAST HAEMORRHAGE SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
BREAST TENDERNESS SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
CERVICAL POLYP SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
DYSPAREUNIA SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
GENITAL DISCHARGE SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
GENITAL RASH SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
METRORRHAGIA SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
ALANINE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
BLOOD PRESSURE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
BLOOD ALKALINE PHOSPHATASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
GAMMA-GLUTAMYLTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
HEPATIC ENZYME INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
URINE ODOUR ABNORMAL SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
HAEMATURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
NEPHROLITHIASIS SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
LYMPHADENOPATHY SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
HEPATIC PAIN SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
CHOLELITHIASIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
HEPATIC FUNCTION ABNORMAL SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
LIVER TENDERNESS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
CONTRAST MEDIA ALLERGY SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
SEASONAL ALLERGY SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
HYPERSENSITIVITY SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
CANCER PAIN SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
INFECTED NEOPLASM SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
METASTASES TO CENTRAL NERVOUS SYSTEM SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
TUMOUR PAIN SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
ATRIAL FIBRILLATION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
LEFT VENTRICULAR DYSFUNCTION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
PALPITATIONS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View