Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 10:15 PM
Ignite Modification Date: 2025-12-25 @ 7:49 PM
NCT ID: NCT02362035
Description: All participants in this study received both study drugs and were analyzed together as a single treatment arm. There were 3 Stages to the study (representing different disease histologies) and not 3 arms in the study. Study data are presented by disease histology for all subjects in Stage 1 (N=30) and Stage 2 (N=131) as TOTAL subjects (N=161). Stage 3 of the study was not conducted.
Frequency Threshold: 0
Time Frame: For each subject, adverse event data were collected from first dose of study drug until 30 days after the last dose, until the end of the study (data cutoff date of 14 July 2020).
Study: NCT02362035
Study Brief: ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Acalabrutinib + Pembrolizumab All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted. 69 None 75 161 157 161 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Anaemia of malignant disease SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Hyperviscosity syndrome SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Lymphadenitis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Cardiogenic shock SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 23.0 View
Hypercalcaemia of malignancy SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Gastric haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Gastric ulcer haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Large intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Retroperitoneal mass SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Systemic inflammatory response syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Drug-induced liver injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Autoimmune disorder SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 23.0 View
Cytokine release syndrome SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 23.0 View
Abdominal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Epiglottitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Meningitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Necrotising fasciitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Neutropenic sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pneumocystis jirovecii pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pneumonia mycoplasmal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Staphylococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Foot fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Lactic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Tumour lysis syndrome SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Tumour flare SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Cervical cord compression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Hyponatraemic seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Tubulointerstitial nephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Respiratory disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Skin necrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Swelling face SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Increased tendency to bruise SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Iron deficiency anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Lymph node pain SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Methaemoglobinaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Microcytic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Polycythaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Cardiomegaly SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Myocardial calcification SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Ear congestion SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 23.0 View
Ear discomfort SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 23.0 View
Ear haemorrhage SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 23.0 View
Eustachian tube dysfunction SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 23.0 View
Excessive cerumen production SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 23.0 View
Hypoacusis SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 23.0 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 23.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 23.0 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.0 View
Inappropriate antidiuretic hormone secretion SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.0 View
Borderline glaucoma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Chalazion SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Conjunctival haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Eye pruritus SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Eyelid rash SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Anal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Anal incontinence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Change of bowel habit SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Frequent bowel movements SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Gastric haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Gingival bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Gingival discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Hyperaesthesia teeth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Impaired gastric emptying SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Intestinal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Lip swelling SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Mouth haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Mouth ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Oesophageal spasm SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Oesophageal stenosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Oral disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Palatal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Drug withdrawal syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Early satiety SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Exercise tolerance decreased SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Facial pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Feeling cold SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Infusion site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Nodule SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Polyp SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Systemic inflammatory response syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Thirst SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Ulcer SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Autoimmune hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Allergy to arthropod sting SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 23.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 23.0 View
Hypogammaglobulinaemia SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 23.0 View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 23.0 View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Candida infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Epiglottitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Escherichia bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Labyrinthitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Localised infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Lymphangitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Mucosal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Nasal herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Nocardiosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Onychomycosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Otitis externa SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pharyngitis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pneumonia streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pyuria SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Rash pustular SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Vulvovaginal mycotic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Animal bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Arthropod sting SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Eye contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Foreign body SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Incision site complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Joint injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Ligament sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Lip injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Muscle contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Periorbital haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Post procedural diarrhoea SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Procedural vomiting SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Skin abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Skin injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Vaccination complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Wrist fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Amylase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Blood immunoglobulin g decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Blood thyroid stimulating hormone increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Blood uric acid increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Heart rate irregular SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Immunoglobulins decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Influenza a virus test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Oxygen saturation decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Protein total decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Serum ferritin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Tri-iodothyronine free decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Cachexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Iron deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Lactic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Vitamin d deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Arthropathy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Bursitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Coccydynia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Groin pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Joint range of motion decreased SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Joint stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Muscle tightness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Osteopenia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Osteoporosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Pain in jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Synovial cyst SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Temporomandibular joint syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Tendonitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Tenosynovitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Trigger finger SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Winged scapula SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Acrochordon SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Squamous cell carcinoma of skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Tumour compression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Tumour pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Dizziness postural SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Facial paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Head discomfort SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Parkinsonism SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Sciatic nerve neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Sinus headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Taste disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Vocal cord paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Abnormal dreams SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Alcoholism SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Dyssomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Hypertonic bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Micturition urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Nephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Nocturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Polyuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Urinary tract obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Atrophic vulvovaginitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 23.0 View
Erectile dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 23.0 View
Genital lesion SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 23.0 View
Haematospermia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 23.0 View
Nipple pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 23.0 View
Oedema genital SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 23.0 View
Penile pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 23.0 View
Prostatitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 23.0 View
Vaginal haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 23.0 View
Vulvovaginal pruritus SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 23.0 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Bronchial hyperreactivity SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Bronchial secretion retention SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Laryngeal inflammation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Laryngeal oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Nasal dryness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Paranasal sinus discomfort SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Erythema multiforme SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Keloid scar SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Keratosis pilaris SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Night sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Onychoclasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Pain of skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Palmar-plantar erythrodysaesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Papule SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Psoriasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Purpura SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Rash erythematous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Rash macular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Rash papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Rash pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Skin discolouration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Skin necrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Skin plaque SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Skin sensitisation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Skin ulcer haemorrhage SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Urticaria papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Aortic stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Lymphocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Deafness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 23.0 View
Deafness neurosensory SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 23.0 View
Macular degeneration SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Periorbital swelling SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Vitreous degeneration SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Cheilitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Colitis microscopic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Duodenal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Epigastric discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Epiploic appendagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Food poisoning SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Paraesthesia oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Proctitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Axillary pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Catheter site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Eye infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Fungal skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Gingival abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Herpes simplex SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Histoplasmosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Histoplasmosis disseminated SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Respiratory tract infection viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Rhinovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Root canal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Soft tissue infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Fluid retention SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Glucose tolerance impaired SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypernatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hyperphosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Hypovolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Increased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Cancer pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Chronic myelomonocytic leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Colon adenoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Lipoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Malignant melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Malignant melanoma in situ SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Melanocytic naevus SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Prostate cancer recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.0 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Post-traumatic stress disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Stress SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Bladder spasm SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Paranasal sinus hypersecretion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pharyngeal disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pharyngeal haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pulmonary haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Respiratory tract congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Tachypnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Throat irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Tracheal oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Upper-airway cough syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Actinic keratosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Angioedema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Dandruff SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Decubitus ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Drug eruption SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Lymphoedema SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Pallor SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Thrombophlebitis superficial SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Vasculitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View