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 @ 4:43 AM
Ignite Modification Date: 2025-12-26 @ 3:44 AM
NCT ID: NCT01390818
Description: None
Frequency Threshold: 0
Time Frame: Baseline up to 30 Days after last dose; assessed up to 4 years
Study: NCT01390818
Study Brief: Trial of MEK Inhibitor and PI3K/mTOR Inhibitor in Subjects With Locally Advanced or Metastatic Solid Tumors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MSC1936369B (Pimasertib) 15mg and SAR245409 30mg Once Daily MSC1936369B (Pimasertib) capsule administered at a single dose of 15 milligram (mg) on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) (DE cohort). None None 1 3 3 3 View
MSC1936369B (Pimasertib) 30mg and SAR245409 30mg Once Daily MSC1936369B (Pimasertib) capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) (DE cohort). None None 0 3 3 3 View
MSC1936369B (Pimasertib) 15mg and SAR245409 50mg Once Daily MSC1936369B (Pimasertib) capsule administered at a single dose of 15 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 of each cycle (21 days) (DE cohort). None None 2 3 3 3 View
MSC1936369B (Pimasertib) 30mg and SAR245409 50mg Once Daily MSC1936369B (Pimasertib) capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 of each cycle (21 days) (DE cohort). None None 1 4 4 4 View
MSC1936369B (Pimasertib) 60mg and SAR245409 50mg Once Daily MSC1936369B (Pimasertib) capsule administered at a single dose of 60 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 of each cycle (21 days) (DE cohort). None None 1 4 4 4 View
MSC1936369B (Pimasertib) 30mg and SAR245409 70mg Once Daily MSC1936369B (Pimasertib) capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 70 mg on day 1 of each cycle (21 days) (DE cohort). None None 1 3 3 3 View
MSC1936369B (Pimasertib) 60mg and SAR245409 70mg Once Daily MSC1936369B (Pimasertib) capsule administered at a single dose of 60 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 70 mg on day 1 of each cycle (21 days) (DE cohort). None None 14 19 19 19 View
MSC1936369B (Pimasertib) 90mg and SAR245409 70mg Once Daily MSC1936369B (Pimasertib) capsule administered at a single dose of 90 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 70 mg on day 1 of each cycle (21 days) (DE cohort). None None 10 14 14 14 View
MSC1936369B (Pimasertib) 60mg and SAR245409 90mg Once Daily MSC1936369B (Pimasertib) capsule administered at a single dose of 60 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 90 mg on day 1 of each cycle (21 days) (DE cohort). None None 1 3 3 3 View
MSC1936369B (Pimasertib) 60mg and SAR245409 30mg Twice Daily MSC1936369B (Pimasertib) capsule administered twice at a dose of 60 mg on day 1 and 15 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 30 mg on day 1 and 15 of each cycle (21 days) (DE cohort). None None 2 3 3 3 View
MSC1936369B (Pimasertib) 45mg and SAR245409 50mg Twice Daily MSC1936369B (Pimasertib) capsule administered twice at a dose of 45 mg on day 1 and 15 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 and 15 of each cycle (21 days) (DE cohort). None None 3 4 4 4 View
TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily Participants with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the participant (DSE Cohort). None None 16 26 26 26 View
NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily Participants with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the participant (DSE Cohort). None None 13 24 24 24 View
CRC: Pimasertib 60mg and SAR245409 70mg Once Daily Participants with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the participant (DSE Cohort). None None 10 18 18 18 View
MEL: Pimasertib 60mg and SAR245409 70mg Once Daily Participants with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the participant (DSE Cohort). None None 8 15 15 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ASPARTATE AMINOTRANSFERASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
ELECTROCARDIOGRAM QT PROLONGED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
DECREASED APPETITE NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.0) View
HEADACHE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
HEMIPARESIS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
SPINAL CORD COMPRESSION NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
SYNCOPE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
PSYCHOTIC DISORDER NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (18.0) View
PULMONARY EMBOLISM NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
RESPIRATORY FAILURE NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
ACUTE RESPIRATORY FAILURE NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
CHRONIC OBSTRUCTIVE PULMONARY DISEASE NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
HAEMOPTYSIS NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
PNEUMONITIS NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
EMBOLISM NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (18.0) View
ANAPHYLACTIC REACTION NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA (18.0) View
DIARRHOEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
DISEASE PROGRESSION NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
BILE DUCT OBSTRUCTION NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (18.0) View
HYPERBILIRUBINAEMIA NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (18.0) View
PELVIC ABSCESS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
SUBDURAL HAEMATOMA NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (18.0) View
DEHYDRATION NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.0) View
FAILURE TO THRIVE NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.0) View
HYPOKALAEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.0) View
GROIN PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.0) View
PAIN IN EXTREMITY NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.0) View
TUMOUR HAEMORRHAGE NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (18.0) View
PRESYNCOPE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
ACUTE KIDNEY INJURY NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (18.0) View
DYSPNOEA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
HYPOXIA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
DERMATITIS EXFOLIATIVE NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
HYPOTENSION NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (18.0) View
LUNG INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
TEMPORAL ARTERITIS NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (18.0) View
ATRIAL FLUTTER NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (18.0) View
ATRIAL FIBRILLATION NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (18.0) View
RIGHT VENTRICULAR DYSFUNCTION NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (18.0) View
LARGE INTESTINAL OBSTRUCTION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
PANCREATITIS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
STOMATITIS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
PNEUMONIA NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
ESCHERICHIA INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
ACCIDENTAL OVERDOSE NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (18.0) View
HUMERUS FRACTURE NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (18.0) View
FEBRILE NEUTROPENIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (18.0) View
ABDOMINAL PAIN UPPER NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
ASCITES NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
DYSPHAGIA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
SMALL INTESTINAL OBSTRUCTION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
PYREXIA NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
GAIT DISTURBANCE NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
HEPATIC FAILURE NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (18.0) View
CELLULITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
FUNGAL SKIN INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
INFLUENZA NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
FALL NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (18.0) View
BLOOD CREATININE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
HYPONATRAEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.0) View
HYPOGLYCAEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.0) View
BACK PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.0) View
MUSCULAR WEAKNESS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.0) View
METASTASES TO CENTRAL NERVOUS SYSTEM NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (18.0) View
LETHARGY NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
CONFUSIONAL STATE NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (18.0) View
HALLUCINATION NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (18.0) View
MENTAL STATUS CHANGES NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (18.0) View
VULVOVAGINAL PAIN NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (18.0) View
PLEURAL EFFUSION NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
DERMATITIS ACNEIFORM NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
RASH NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
DEEP VEIN THROMBOSIS NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (18.0) View
HYPERTENSION NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (18.0) View
FATIGUE NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
BILE DUCT STENOSIS NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (18.0) View
RASH MACULO-PAPULAR NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
SUPERIOR VENA CAVA SYNDROME NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (18.0) View
ANAEMIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (18.0) View
THROMBOCYTOPENIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (18.0) View
BRADYCARDIA NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (18.0) View
CARDIO-RESPIRATORY ARREST NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (18.0) View
ABDOMINAL PAIN NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
INTESTINAL ISCHAEMIA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
UPPER GASTROINTESTINAL HAEMORRHAGE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
FATIGUE NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
GENERALISED OEDEMA NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
SEPSIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
ABDOMINAL INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
ESCHERICHIA SEPSIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
GASTROENTERITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
OVERDOSE NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (18.0) View
LEUKOPENIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (18.0) View
NAUSEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
VOMITING NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
ABDOMINAL PAIN LOWER NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
MYOCARDIAL INFARCTION NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (18.0) View
SINUS BRADYCARDIA NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (18.0) View
HEARING IMPAIRED NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (18.0) View
VERTIGO NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (18.0) View
HYPOTHYROIDISM NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA (18.0) View
SUBRETINAL FLUID NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
VISUAL ACUITY REDUCED NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
VISUAL IMPAIRMENT NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
RETINAL DETACHMENT NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
PERIORBITAL OEDEMA NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
VISION BLURRED NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
DETACHMENT OF RETINAL PIGMENT EPITHELIUM NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
MACULAR DETACHMENT NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
VITREOUS FLOATERS NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
PHOTOPSIA NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
MACULAR FIBROSIS NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
MACULAR HOLE NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
EYELIDS PRURITUS NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
METAMORPHOPSIA NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
RETINAL DEGENERATION NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
DIARRHOEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
NAUSEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
VOMITING NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
RETCHING NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
SENSITIVITY OF TEETH NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
TOOTHACHE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
ENLARGED UVULA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
HYPOAESTHESIA ORAL NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
ABDOMINAL DISTENSION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
ABDOMINAL DISCOMFORT NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
OEDEMA PERIPHERAL NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
HERNIA PAIN NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
INFLUENZA LIKE ILLNESS NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
LOCAL SWELLING NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
MALAISE NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
MUCOSAL INFLAMMATION NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
NON-CARDIAC CHEST PAIN NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
INFLAMMATION NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
MUCOSAL DRYNESS NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
NODULE NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
TEMPERATURE INTOLERANCE NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
HYPERBILIRUBINAEMIA NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (18.0) View
HEPATIC CIRRHOSIS NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (18.0) View
SINUSITIS BACTERIAL NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
WEIGHT DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
SPINAL CORD COMPRESSION NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (18.0) View
SYNCOPE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
TRANSVERSE SINUS THROMBOSIS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
DELIRIUM NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (18.0) View
MAJOR DEPRESSION NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA (18.0) View
MENTAL STATUS CHANGES NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA (18.0) View
PLEURAL EFFUSION NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
SPUTUM INCREASED NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
TACHYPNOEA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
PRURITUS GENERALISED NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
ALOPECIA NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
ERYTHEMA NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
ANAEMIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (18.0) View
THROMBOCYTOPENIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (18.0) View
LEUKOCYTOSIS NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (18.0) View
LEUKOPENIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (18.0) View
IRON DEFICIENCY ANAEMIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (18.0) View
ANAEMIA MACROCYTIC NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (18.0) View
NEUTROPENIA NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (18.0) View
LEUKOCYTOSIS NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (18.0) View
SINUS TACHYCARDIA NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (18.0) View
PALPITATIONS NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (18.0) View
ATRIAL FLUTTER NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (18.0) View
PERICARDIAL EFFUSION NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (18.0) View
TACHYCARDIA NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (18.0) View
RETINAL HAEMORRHAGE NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
BLEPHARITIS NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
CATARACT NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
CHORIORETINOPATHY NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
DIPLOPIA NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
DRY EYE NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
EYE OEDEMA NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
EYE PAIN NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
GLAUCOMA NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
RETINAL EXUDATES NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
XANTHOPSIA NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
Halo Vision NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
EYE COLOUR CHANGE NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
EYE DISCHARGE NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
EYE PRURITUS NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
EYELID FUNCTION DISORDER NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (18.0) View
STOMATITIS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
DRY MOUTH NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
GASTROOESOPHAGEAL REFLUX DISEASE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
DYSPEPSIA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
CONSTIPATION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
ABDOMINAL PAIN NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
ABDOMINAL PAIN UPPER NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
FLATULENCE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
GASTRITIS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
ABDOMINAL PAIN LOWER NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
ASCITES NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
DIVERTICULUM NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
DYSPHAGIA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
EPIGASTRIC DISCOMFORT NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
ERUCTATION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
HAEMORRHOIDS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
HIATUS HERNIA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
LIP ULCERATION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
MELAENA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
MOUTH ULCERATION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
OESOPHAGITIS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
ORAL DYSAESTHESIA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
ORAL PAIN NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
RECTAL HAEMORRHAGE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
REFLUX GASTRITIS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
ANAL FISSURE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
GASTROINTESTINAL DISORDER NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
GASTROINTESTINAL INFLAMMATION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
GLOSSITIS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
LOWER GASTROINTESTINAL HAEMORRHAGE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
NEUROGENIC BOWEL NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
ORAL DISCOMFORT NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
ORAL MUCOSAL ERYTHEMA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
FATIGUE NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
PYREXIA NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
ASTHENIA NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
CHILLS NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
FACE OEDEMA NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
CHEST DISCOMFORT NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
CHEST PAIN NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
GAIT DISTURBANCE NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
PAIN NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
PERIPHERAL SWELLING NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
THROMBOSIS IN DEVICE NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
FACIAL PAIN NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
GENERALISED OEDEMA NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
PERFORMANCE STATUS DECREASED NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
EARLY SATIETY NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
JAUNDICE NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (18.0) View
HEPATITIS NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (18.0) View
PORTAL HYPERTENSION NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (18.0) View
DRUG HYPERSENSITIVITY NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA (18.0) View
URINARY TRACT INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
UPPER RESPIRATORY TRACT INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
CELLULITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
BACTERIAL INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
BODY TINEA NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
BRONCHITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
ENTEROCOCCAL BACTERAEMIA NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
FUNGAL SKIN INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
LUNG INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
OESOPHAGEAL INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
ORAL FUNGAL INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
PNEUMONIA NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
RASH PUSTULAR NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
SKIN INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
STAPHYLOCOCCAL INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
TINEA CRURIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
VULVOVAGINAL MYCOTIC INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
WOUND INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
ORAL CANDIDIASIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
DEVICE RELATED INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
ORAL HERPES NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
PARONYCHIA NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
RASH PUSTULAR NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
BACTERIAL VAGINOSIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
CATHETER SITE INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
FURUNCLE NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
HERPES VIRUS INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
LARYNGITIS VIRAL NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
LOCALISED INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
NAIL INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
NASOPHARYNGITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
ORAL INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
PHARYNGITIS STREPTOCOCCAL NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
PNEUMONIA FUNGAL NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
VAGINAL INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
VIRAL UPPER RESPIRATORY TRACT INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
VULVOVAGINAL MYCOTIC INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
FALL NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (18.0) View
ARTHROPOD BITE NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (18.0) View
CERVICAL VERTEBRAL FRACTURE NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (18.0) View
INCISION SITE ERYTHEMA NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (18.0) View
POST PROCEDURAL HAEMORRHAGE NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (18.0) View
PROCEDURAL PAIN NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (18.0) View
TOOTH FRACTURE NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (18.0) View
ASPARTATE AMINOTRANSFERASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
BLOOD CREATININE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
ALANINE AMINOTRANSFERASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
EJECTION FRACTION DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
BLOOD ALKALINE PHOSPHATASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
LYMPHOCYTE COUNT DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
BLOOD CHOLESTEROL INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
BLOOD CREATINE PHOSPHOKINASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
BLOOD POTASSIUM DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
BLOOD UREA INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
BLOOD URINE PRESENT NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
HAEMOGLOBIN DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
INTERNATIONAL NORMALISED RATIO INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
INTRAOCULAR PRESSURE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
PLATELET COUNT DECREASED NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (18.0) View
URINE OUTPUT DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
WEIGHT INCREASED NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (18.0) View
BLOOD BILIRUBIN INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
HEART RATE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
VITAMIN D DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
BLOOD PRESSURE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
BLOOD TESTOSTERONE DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
BREATH SOUNDS ABNORMAL NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
ELECTROCARDIOGRAM QT PROLONGED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
LIPASE INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
PROTHROMBIN TIME PROLONGED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
TRANSAMINASES INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
TROPONIN INCREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
WHITE BLOOD CELL COUNT DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
DECREASED APPETITE NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.0) View
DEHYDRATION NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.0) View
HYPOKALAEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.0) View
HYPERGLYCAEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.0) View
HYPONATRAEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.0) View
HYPOMAGNESAEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.0) View
HYPOPHOSPHATAEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.0) View
HYPOALBUMINAEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.0) View
HYPOCALCAEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.0) View
FLUID RETENTION NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.0) View
HYPERKALAEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.0) View
FAILURE TO THRIVE NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.0) View
FLUID OVERLOAD NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.0) View
HYPERTRIGLYCERIDAEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.0) View
HYPOGLYCAEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.0) View
HYPERAMYLASAEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.0) View
HYPOVOLAEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.0) View
MALNUTRITION NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.0) View
ARTHRALGIA NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.0) View
BACK PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.0) View
MYALGIA NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.0) View
PAIN IN EXTREMITY NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.0) View
MUSCLE SPASMS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.0) View
ARTHROPATHY NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.0) View
FLANK PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.0) View
JOINT EFFUSION NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.0) View
MUSCULAR WEAKNESS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.0) View
MUSCULOSKELETAL CHEST PAIN NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (18.0) View
MUSCULOSKELETAL PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.0) View
NECK PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.0) View
BONE PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.0) View
GROIN PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.0) View
MUSCLE TWITCHING NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.0) View
MUSCULOSKELETAL STIFFNESS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.0) View
ACROCHORDON NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (18.0) View
LIPOMA NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (18.0) View
TUMOUR HAEMORRHAGE NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (18.0) View
TUMOUR PAIN NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (18.0) View
INFECTED NEOPLASM NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (18.0) View
ONCOLOGIC COMPLICATION NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (18.0) View
DIZZINESS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
HEADACHE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
DYSGEUSIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
SOMNOLENCE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
COGNITIVE DISORDER NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
NEUROPATHY PERIPHERAL NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
PRESYNCOPE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
TREMOR NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
ATAXIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
BRAIN OEDEMA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
DEPRESSED LEVEL OF CONSCIOUSNESS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
DIZZINESS EXERTIONAL NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
HEMIANOPIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
HYPOAESTHESIA NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (18.0) View
LETHARGY NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
MEMORY IMPAIRMENT NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (18.0) View
PARAESTHESIA NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (18.0) View
PERIPHERAL SENSORY NEUROPATHY NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
PERONEAL NERVE PALSY NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (18.0) View
VISUAL FIELD DEFECT NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (18.0) View
BALANCE DISORDER NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
PARAPLEGIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
BURNING SENSATION NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
DYSARTHRIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
HYPOKINESIA NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (18.0) View
NEURALGIA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
SCIATICA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
SINUS HEADACHE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
ANXIETY NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (18.0) View
INSOMNIA NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (18.0) View
CONFUSIONAL STATE NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (18.0) View
AGITATION NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA (18.0) View
DEPRESSED MOOD NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (18.0) View
DEPRESSION NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (18.0) View
DEPRESSIVE SYMPTOM NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (18.0) View
HAEMATURIA NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (18.0) View
ACUTE KIDNEY INJURY NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (18.0) View
DYSURIA NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (18.0) View
NOCTURIA NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (18.0) View
PROTEINURIA NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (18.0) View
URINARY RETENTION NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (18.0) View
CHROMATURIA NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (18.0) View
MICTURITION URGENCY NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (18.0) View
NEUROGENIC BLADDER NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (18.0) View
POLYURIA NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (18.0) View
RENAL FAILURE NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (18.0) View
URINARY INCONTINENCE NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (18.0) View
URINARY TRACT PAIN NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (18.0) View
VAGINAL HAEMORRHAGE NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (18.0) View
BREAST PAIN NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (18.0) View
PELVIC PAIN NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (18.0) View
VAGINAL DISCHARGE NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (18.0) View
BREAST MASS NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (18.0) View
DYSPNOEA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
COUGH NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
DYSPNOEA EXERTIONAL NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
PRODUCTIVE COUGH NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
EPISTAXIS NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
NASAL CONGESTION NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
OROPHARYNGEAL PAIN NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
PLEURITIC PAIN NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
PNEUMONITIS NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
PULMONARY EMBOLISM NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
BRONCHOSPASM NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
DYSPHONIA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
HICCUPS NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
HYPOXIA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
LUNG INFILTRATION NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
WHEEZING NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
RHINORRHOEA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
HAEMOPTYSIS NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
HAEMOTHORAX NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
LARYNGEAL PAIN NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
PNEUMOTHORAX NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
PULMONARY CONGESTION NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
PULMONARY HAEMORRHAGE NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
SINUS CONGESTION NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
DERMATITIS ACNEIFORM NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
RASH MACULO-PAPULAR NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
PRURITUS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
RASH NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
DRY SKIN NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
SKIN DISORDER NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
ACNE NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
ACTINIC KERATOSIS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
DERMATITIS EXFOLIATIVE NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
ECCHYMOSIS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
GENERALISED ERYTHEMA NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
HAIR COLOUR CHANGES NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
HAIR GROWTH ABNORMAL NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
HYPERHIDROSIS NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
PAIN OF SKIN NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
PETECHIAE NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
RASH ERYTHEMATOUS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
RASH PAPULAR NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
RASH PRURITIC NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
SKIN LESION NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
SKIN ULCER NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
SKIN BURNING SENSATION NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
DECUBITUS ULCER NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
RASH GENERALISED NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
RASH MACULAR NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
SKIN FISSURES NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
NAIL DISCOLOURATION NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
PHOTOSENSITIVITY REACTION NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
SKIN DISCOLOURATION NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
SKIN EXFOLIATION NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
URTICARIA NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
HYPERTENSION NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
DEEP VEIN THROMBOSIS NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (18.0) View
FLUSHING NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (18.0) View
HOT FLUSH NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (18.0) View
HYPOTENSION NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (18.0) View
ORTHOSTATIC HYPOTENSION NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (18.0) View
SUPERIOR VENA CAVA SYNDROME NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (18.0) View
CAPILLARY LEAK SYNDROME NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (18.0) View
LYMPHOEDEMA NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (18.0) View
PHLEBITIS SUPERFICIAL NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (18.0) View