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 @ 12:23 PM
Ignite Modification Date: 2025-12-25 @ 12:03 PM
NCT ID: NCT01467661
Description: None
Frequency Threshold: 0
Time Frame: From start of study treatment (SPD422308) up to 12 days after the last dose of investigational product
Study: NCT01467661
Study Brief: Long-term Safety of SPD422 in Japanese Adults With Essential Thrombocythaemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SPD422: Safety Analysis Set Included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915). None None 21 53 53 53 View
SPD422: Post-marketing Trial Safety Analysis Set Included all subjects in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661). None None 1 33 13 33 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Leukocytosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
SPLENOMEGALY NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
ANGINA PECTORIS NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
CARDIAC FAILURE NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
CARDIAC FAILURE CONGESTIVE NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
PRINZMETAL ANGINA NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
CYTOGENETIC ABNORMALITY NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 15.1 View
VISUAL IMPAIRMENT NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
COLONIC POLYP NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
GASTRIC ULCER NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
GASTROINTESTINAL HAEMORRHAGE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
LOWER GASTROINTESTINAL HAEMORRHAGE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
MELAENA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
OEDEMA NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
PYREXIA NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
PNEUMONIA NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
PYELONEPHRITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
LACERATION NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
ANGIOIMMUNOBLASTIC T-CELL LYMPHOMA NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
PROSTATE CANCER NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
ALTERED STATE OF CONSCIOUSNESS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
CEREBRAL HAEMORRHAGE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
HEADACHE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
TRANSIENT ISCHAEMIC ATTACK NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
HAEMATURIA NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
INTERSTITIAL LUNG DISEASE NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
PNEUMOTHORAX NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
BASILAR ARTERY THROMBOSIS NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
CEREBRAL INFARCTION NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
LACUNAR INFARCTION NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
RHEUMATOID ARTHRITIS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
SPINAL OSTEOARTHRITIS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
TENDON CALCIFICATION NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
TENDONITIS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
ACOUSTIC NEUROMA NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
ANGIOIMMUNOBLASTIC T-CELL LYMPHOMA NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
LUNG NEOPLASM NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
MYELOFIBROSIS NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
NEOPLASM NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
PROSTATE CANCER NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
SEBORRHOEIC KERATOSIS NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
UTERINE LEIOMYOMA NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
NEURALGIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
TRANSIENT ISCHAEMIC ATTACK NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
ALTERED STATE OF CONSCIOUSNESS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
AMNESIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
CEREBRAL HAEMORRHAGE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
DIZZINESS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
DIZZINESS POSTURAL NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
DYSAESTHESIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
DYSGEUSIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
HEADACHE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
HYPERAESTHESIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
HYPOAESTHESIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
NEUROPATHY PERIPHERAL NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
PALATAL PALSY NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
PARAESTHESIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
SOMNOLENCE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
SUBARACHNOID HAEMORRHAGE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
SYNCOPE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
TREMOR NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
ANXIETY NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
INSOMNIA NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
RESTLESSNESS NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
CYSTITIS NONINFECTIVE NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
DYSURIA NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
HAEMATURIA NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
HAEMORRHAGE URINARY TRACT NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
HYDRONEPHROSIS NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
HYDROURETER NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
HYPERTONIC BLADDER NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
NEPHROLITHIASIS NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
NOCTURIA NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
POLLAKIURIA NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
PROTEINURIA NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
RENAL IMPAIRMENT NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
RENAL TUBULAR DISORDER NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
URINARY INCONTINENCE NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
BENIGN PROSTATIC HYPERPLASIA NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.1 View
CERVICAL DYSPLASIA NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.1 View
CYSTOCELE NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.1 View
ERECTILE DYSFUNCTION NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.1 View
GENITAL HAEMORRHAGE NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.1 View
VAGINAL HAEMORRHAGE NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.1 View
ASTHMA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
COUGH NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
DYSPNOEA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
EPISTAXIS NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
HAEMOPTYSIS NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
NIGHT SWEATS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
INTERSTITIAL LUNG DISEASE NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
OROPHARYNGEAL PAIN NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
PLEURAL EFFUSION NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
PNEUMONIA ASPIRATION NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
PNEUMOTHORAX NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
PULMONARY SARCOIDOSIS NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
SPUTUM INCREASED NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
UPPER RESPIRATORY TRACT INFLAMMATION NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
ASTEATOSIS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
CHRONIC PIGMENTED PURPURA NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
DERMAL CYST NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
DERMATITIS CONTACT NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
DRY SKIN NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
ECZEMA NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
ECZEMA ASTEATOTIC NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
ECZEMA NUMMULAR NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
ERYTHEMA NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
HAEMORRHAGE SUBCUTANEOUS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
SEBORRHOEIC DERMATITIS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
RASH NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
HEAT RASH NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
INGROWING NAIL NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
LYMPHOPENIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
NEUTROPENIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
RED BLOOD CELL ABNORMALITY NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
SPLENOMEGALY NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
THROMBOCYTOPENIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
ANGINA PECTORIS NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
AORTIC VALVE INCOMPETENCE NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
ARRHYTHMIA NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
ATRIAL FIBRILLATION NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
BUNDLE BRANCH BLOCK RIGHT NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
CARDIAC FAILURE NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
CARDIAC FAILURE CONGESTIVE NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
CARDIOMEGALY NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
CORONARY ARTERY STENOSIS NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
CYANOSIS NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
LONG QT SYNDROME NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
MITRAL VALVE INCOMPETENCE NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
PALPITATIONS NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
PERICARDIAL EFFUSION NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
PRINZMETAL ANGINA NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
SINUS TACHYCARDIA NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
SUPRAVENTRICULAR EXTRASYSTOLES NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
SUPRAVENTRICULAR TACHYCARDIA NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
TACHYCARDIA NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
VENTRICULAR EXTRASYSTOLES NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
CYTOGENETIC ABNORMALITY NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 15.1 View
EUSTACHIAN TUBE DYSFUNCTION NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 15.1 View
TINNITUS NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 15.1 View
VERTIGO NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 15.1 View
HYPOTHYROIDISM NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 15.1 View
AGE-RELATED MACULAR DEGENERATION NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
CATARACT NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
CONJUNCTIVAL HAEMORRHAGE NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
CONJUNCTIVITIS NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
DRY EYE NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
EYE SWELLING NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
OCULAR HYPERAEMIA NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
PTERYGIUM NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
RETINAL HAEMORRHAGE NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
VISUAL ACUITY REDUCED NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
VISUAL IMPAIRMENT NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
ABDOMINAL DISCOMFORT NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
ABDOMINAL DISTENSION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
ABDOMINAL PAIN NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
ABDOMINAL PAIN UPPER NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
ABDOMINAL TENDERNESS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
APHTHOUS STOMATITIS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
CHEILITIS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
COLITIS ISCHAEMIC NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
COLONIC POLYP NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
CONSTIPATION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
DENTAL CARIES NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
DIARRHOEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
DIVERTICULUM INTESTINAL NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
DRY MOUTH NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
DYSPEPSIA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
ENTEROCOLITIS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
EPIGASTRIC DISCOMFORT NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
FAECAL INCONTINENCE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
GASTRIC POLYPS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
GASTRIC ULCER NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
GASTRITIS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
GASTROINTESTINAL HAEMORRHAGE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
GASTROOESOPHAGEAL REFLUX DISEASE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
GINGIVAL BLEEDING NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
GINGIVAL HYPERTROPHY NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
HAEMATOCHEZIA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
HAEMORRHOIDS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
LOWER GASTROINTESTINAL HAEMORRHAGE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
MELAENA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
NAUSEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
OESOPHAGITIS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
PERIODONTAL DISEASE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
POLYP COLORECTAL NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
STOMATITIS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
VOMITING NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
ASTHENIA NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
CHEST DISCOMFORT NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
CHEST PAIN NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
CHILLS NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
FACE OEDEMA NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
FATIGUE NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
GAIT DISTURBANCE NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
MALAISE NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
OEDEMA NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
OEDEMA PERIPHERAL NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
PYREXIA NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
TENDERNESS NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
CHOLESTASIS NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.1 View
GALLBLADDER POLYP NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.1 View
HEPATIC FUNCTION ABNORMAL NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.1 View
HEPATIC STEATOSIS NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.1 View
BRONCHITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
CELLULITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
CHRONIC SINUSITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
CYSTITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
DERMATOPHYTOSIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
DIARRHOEA INFECTIOUS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
EAR INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
ENTERITIS INFECTIOUS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
FOLLICULITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
GASTROENTERITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
GASTROENTERITIS VIRAL NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
GASTROINTESTINAL INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
HAEMOPHILUS INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
HERPES ZOSTER NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
INFECTED SKIN ULCER NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
INFLUENZA NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
LIP INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
NASOPHARYNGITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
OESOPHAGEAL CANDIDIASIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
ONYCHOMYCOSIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
ORAL HERPES NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
OTITIS EXTERNA NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
OTITIS MEDIA NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
PARONYCHIA NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
PERICORONITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
PERIODONTITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
PHARYNGITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
PHARYNGITIS MYCOPLASMAL NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
PNEUMONIA NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
PYELONEPHRITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
RHINITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
TINEA PEDIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
UPPER RESPIRATORY TRACT INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
URETHRITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
URINARY TRACT INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
VAGINAL INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
ABDOMEN CRUSHING NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
CONTUSION NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
DEAFNESS TRAUMATIC NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
EPICONDYLITIS NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
EXCORIATION NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
FALL NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
PERIARTHRITIS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
PERIOSTITIS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
PIGMENTATION DISORDER NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
PRURITUS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
PURPURA NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
RASH ERYTHEMATOUS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
ROSACEA NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
URTICARIA NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
SKIN LESION EXCISION NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 15.1 View
ARTERIOSCLEROSIS NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
BASILAR ARTERY THROMBOSIS NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
CEREBRAL INFARCTION NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
ERYTHROMELALGIA NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
HAEMATOMA NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
HYPERTENSION NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
LACUNAR INFARCTION NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
ORTHOSTATIC HYPOTENSION NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
PERIPHERAL CIRCULATORY FAILURE NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
PERIPHERAL COLDNESS NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
RAYNAUD'S PHENOMENON NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
ANAEMIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
EOSINOPHILIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
IRON DEFICIENCY ANAEMIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
LEUKOCYTOSIS NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
LEUKOPENIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
LYMPHADENITIS NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
LYMPHADENOPATHY NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
FOOT FRACTURE NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
FRACTURE NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
FROSTBITE NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
HEAD INJURY NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
LACERATION NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
LIGAMENT SPRAIN NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
POST PROCEDURAL HAEMORRHAGE NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
RIB FRACTURE NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
PAIN IN EXTREMITY NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
SUBCUTANEOUS HAEMATOMA NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
THERMAL BURN NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
TOOTH FRACTURE NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
TRAUMATIC HAEMATOMA NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
WRIST FRACTURE NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
ALANINE AMINOTRANSFERASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
ASPARTATE AMINOTRANSFERASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
BLOOD ALKALINE PHOSPHATASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
BLOOD CREATININE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
BLOOD GLUCOSE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
BLOOD POTASSIUM DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
BLOOD PRESSURE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
BLOOD URIC ACID INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
BLOOD URINE PRESENT NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
C-REACTIVE PROTEIN INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
CRYSTAL URINE PRESENT NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
DIFFERENTIAL WHITE BLOOD CELL COUNT ABNORMAL NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
ELECTROCARDIOGRAM QT PROLONGED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
GAMMA-GLUTAMYLTRANSFERASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
GLUCOSE URINE PRESENT NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
HAEMOGLOBIN DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
HAPTOGLOBIN DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
HEPATIC ENZYME INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
METAMYELOCYTE COUNT INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
MYELOCYTE COUNT INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
PROSTATIC SPECIFIC ANTIGEN INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
PROTEIN URINE PRESENT NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
RED BLOOD CELL NUCLEATED MORPHOLOGY PRESENT NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
WEIGHT DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
WHITE BLOOD CELL COUNT DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
WHITE BLOOD CELL COUNT INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
DECREASED APPETITE NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
DEHYDRATION NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
FLUID RETENTION NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
GLUCOSE TOLERANCE IMPAIRED NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
HYPERGLYCAEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
HYPERKALAEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
HYPERLIPIDAEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
HYPERURICAEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
HYPOALBUMINAEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
HYPOGLYCAEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
METABOLIC DISORDER NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
ARTHRALGIA NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
BACK PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
FLANK PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
INTERVERTEBRAL DISC PROTRUSION NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
MUSCLE SPASMS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
MUSCLE TIGHTNESS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
MUSCULOSKELETAL PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
MUSCULOSKELETAL STIFFNESS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
MYALGIA NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
OSTEOARTHRITIS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
OSTEOPOROSIS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View