Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 10:24 PM
Ignite Modification Date: 2025-12-25 @ 7:55 PM
NCT ID: NCT02671435
Description: All-cause mortality data was analyzed as per ITT population, and AE/SAE data was analyzed as per As-treated population.
Frequency Threshold: 0
Time Frame: Day 1 through 246.9 weeks (maximum observed duration)
Study: NCT02671435
Study Brief: A Study of Durvalumab (MEDI4736) and Monalizumab in 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
Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W Participants received intravenous (IV) infusions of durvalumab 1500 mg every 4 weeks (Q4W) in combination with monalizumab 22.5 mg every 2 weeks (Q2W) up to 3 years until unacceptable toxicity, documentation of confirmed disease progression (PD), or documentation of subject withdrawal for another reason. 1 None 1 3 3 3 View
Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W Participants received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 75 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason. 3 None 0 3 3 3 View
Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W Participants received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 225 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason. 0 None 1 3 3 3 View
Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W Participants received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason. 16 None 8 18 18 18 View
Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W Participants received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q4W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason. 14 None 4 18 16 18 View
Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) Participants with microsatellite-stable colorectal cancer (MSS-CRC) received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason. 29 None 11 40 39 40 View
Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) Participants with ovarian cancer received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason. 34 None 16 40 40 40 View
Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) Participants with endometrial MSS received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason. 28 None 17 40 39 40 View
Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) Participants with non-small cell lung cancer (NSCLC) received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason. 19 None 7 20 20 20 View
Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W Participants with first-line (1L) MSS-CRC received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W plus mFOLFOX (oxaliplatin 85 mg/m\^2 IV infusion, folinic acid 400 mg/m\^2 infusion, fluorouracil 400 mg/m\^2 IV bolus, followed by 2400 mg/m\^2 continuous IV infusion over 46 to 48 hours on Day 1) Q2W plus IV infusion of bevacizumab 5 mg/kg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason. 10 None 10 18 18 18 View
Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W Participants with 1L MSS-CRC received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W, plus mFOLFOX6 (oxaliplatin 85 mg/m\^2, folinic acid 400 mg/m\^2, fluorouracil 400 mg/m\^2 IV bolus, followed by 2400 mg/m\^2 continuous IV infusion over 46 to 48 hours on Day 1) Q2W plus IV infusion of cetuximab (loading dose of 400 mg/m\^2 on Day 1, followed by maintenance dose of 250 mg/m\^2 IV infusion every week starting on Day 8, then changed to 500 mg/m\^2 IV infusion Q2W) up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason. 8 None 11 18 18 18 View
Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W Participants with recurrent or metastatic third-line (3L) RAS mutant MSS-CRC received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W plus IV infusion of cetuximab 500 mg/m\^2 on Day 1 then 500 mg/m\^2 IV infusion Q2W starting on Day 15 up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason. 29 None 10 39 39 39 View
Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W Participants with recurrent or metastatic 3L RAS mutant MSS-CRC received IV infusion of monalizumab 750 mg Q2W plus IV infusion of cetuximab 500 mg/m\^2 on Day 1 then 500 mg/m\^2 IV infusion Q2W starting on Day 15 up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason. 29 None 5 41 41 41 View
Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W Participants with recurrent or metastatic 3L RAS/BRAF wild type MSS-CRC received IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W plus IV infusion of cetuximab 500 mg/m\^2 on Day 1 then 500 mg/m\^2 IV infusion Q2W starting on Day 15 up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason. 29 None 9 44 44 44 View
Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W Participants with recurrent or metastatic 3L RAS/BRAF wild type MSS-CRC received IV infusion of monalizumab 750 mg Q2W plus IV infusion of cetuximab 500 mg/m\^2 on Day 1 then 500 mg/m\^2 IV infusion Q2W starting on Day 15 up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason. 27 None 11 37 36 37 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Lower gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Small intestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Lower limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Pelvic fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Post procedural complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Diabetic ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Failure to thrive SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Cancer pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Myelofibrosis SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Encephalitis autoimmune SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Metabolic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Bipolar disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Nephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Subcapsular renal haematoma SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Urinary tract obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Intermenstrual bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Lymphoedema SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Pelvic venous thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Vena cava thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Colonic fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrointestinal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Large intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Large intestinal stenosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Large intestine perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Hypothermia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Systemic inflammatory response syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Bile duct stenosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Biliary obstruction SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Anaphylactic shock SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Biliary sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Encephalomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Infective exacerbation of chronic obstructive airways disease SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Kidney infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Metapneumovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Peritonitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Blood magnesium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Blood thyroid stimulating hormone increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood triglycerides increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood uric acid decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood uric acid increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Carbohydrate antigen 125 increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Cardiac murmur SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Eosinophil count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
General physical condition abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Ear pruritus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
International normalised ratio increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Tri-iodothyronine free decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Troponin i increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Urine leukocyte esterase positive SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Hypoacusis SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
White blood cells urine positive SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Adult failure to thrive SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 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
Electrolyte imbalance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Middle ear effusion SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Failure to thrive SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperamylasaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypercreatininaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperlipasaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypermagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Otorrhoea SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Hyperphosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypervolaemia 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
Hypochloraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypophagia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Iron deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Polydipsia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Type 2 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Vitamin b12 deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Vitamin d deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Gouty arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Groin pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Euthyroid sick syndrome SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Musculoskeletal discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Neck mass SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain in jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Sacral pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Spondylitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Temporomandibular joint syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Hallucinations, mixed SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Cancer pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Malignant ascites SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Initial insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Tumour associated fever 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
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Balance disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Burning sensation SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Central nervous system necrosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cerebrospinal fluid leakage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cognitive disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Disturbance in attention SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dysaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Thyroid mass SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Encephalomalacia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Facial paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hypersomnia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Lhermitte's sign SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Thyroiditis SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Middle insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Metabolic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Mood swings SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Speech disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Iron deficiency anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Amaurosis fugax SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Taste disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Device occlusion SYSTEMATIC_ASSESSMENT Product Issues MedDRA View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Depressed mood SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Blepharitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Lip dry SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Lower gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Odynophagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Paraesthesia oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Proctalgia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Proctitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Rectal discharge SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Rectal spasm SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Rectal tenesmus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Retroperitoneal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Umbilical hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Administration site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Adverse drug reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Catheter site dermatitis SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Catheter site erosion SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Catheter site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Complication associated with device SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Cyst SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Nervousness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Device related thrombosis SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders MedDRA View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Generalised oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Hernia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Nightmare SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Atrioventricular block first degree SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Hernia pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site induration SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Localised oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Medical device pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Secretion discharge SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Temperature intolerance SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Temperature regulation disorder SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Cardiomegaly SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Xerosis SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Hypertransaminasaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Jaundice SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Anaphylactic reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Conduction disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Infusion related hypersensitivity reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Abdominal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bacteriuria SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Biliary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Breast abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Candida infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Clostridium bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cystitis pseudomonal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Enterocolitis infectious SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Escherichia sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Escherichia urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Eye infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gingivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Hordeolum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Keratitis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Kidney infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lip infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Medical device site infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Mucosal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nail infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Oral fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Oral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Otitis externa SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Penile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Peritonitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pyuria SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Rash pustular 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
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Staphylococcal skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Streptococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tinea pedis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Urinary tract infection fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Vaginal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Nail injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Post-traumatic pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Procedural nausea SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Stoma site discomfort SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Stoma site pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Deafness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Sunburn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Wrist fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Activated partial thromboplastin time prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Amylase SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Amylase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Bacterial test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood albumin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Ear disorder SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood creatine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood fibrinogen increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Early satiety SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Facial pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Blepharospasm SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Bladder irritation SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Bladder pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Chromaturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Hypertonic bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Nocturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Conjunctival haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal infarct SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal tubular necrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Urinary fistula SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Urinary tract obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Urinary tract pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Urine flow decreased SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Breast pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Erectile dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Female genital tract fistula SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Intermenstrual bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Menstruation irregular SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Oedema genital SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Ovarian mass SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Postmenopausal haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Scrotal dermatitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Vaginal discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Vaginal haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Vulvovaginal discomfort SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Vulvovaginal dryness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Vulvovaginal inflammation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Eye discharge SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Dry throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Laryngeal haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Nasal dryness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nasal ulcer SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Oropharyngeal discomfort SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pleuritic pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Pulmonary haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pulmonary pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Respiratory tract congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Sinus pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Sleep apnoea syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Tachypnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Throat irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Eye pruritus SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Throat tightness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Upper-airway cough syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Blister SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatitis acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatomyositis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Drug eruption SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Eyelids pruritus SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Hirsutism SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Hypertrichosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Ingrowing nail SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Intertrigo SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Lichen planus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Madarosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Miliaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Nail discolouration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Nail disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Nail pigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Night sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Onychalgia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Onychoclasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pain of skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Palmar-plantar erythrodysaesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Ocular hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Photosensitivity reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pruritus allergic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Psoriasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash macular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash vesicular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Periorbital oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Seborrhoeic dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin discolouration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin erosion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin exfoliation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin fissures SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin mass SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Skin toxicity SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Trichorrhexis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Central venous catheterisation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Pterygium SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Jugular vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Lymphoedema SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Visual impairment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Vitreous floaters SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal rigidity SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Anal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Anal incontinence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Anorectal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Autoimmune pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Defaecation urgency SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Epigastric discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Eructation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Food poisoning SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Frequent bowel movements SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Glossodynia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Thrombocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Haemorrhoidal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Hyperaesthesia teeth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Hypoaesthesia oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Impaired gastric emptying SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View