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: 2025-12-25 @ 3:23 AM
Ignite Modification Date: 2025-12-26 @ 2:02 AM
NCT ID: NCT00315705
Description: In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of adverse event tables.
Frequency Threshold: 0
Time Frame: Treatment emergent adverse experiences collected in Phase 1 from day 1 up to 9.5 months. Phase 2 also lasted up to 9.5 months and started after Phase 1.
Study: NCT00315705
Study Brief: A Study of Clofarabine in Combination With Etoposide and Cyclophosphamide in Children With Acute Leukemias.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Phase 1 - Cohort 4 Participants were treated with clofarabine 30 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2. None None 9 10 10 10 View
Phase 1 - Cohort 5 Participants were treated with clofarabine 40 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2. None None 6 6 6 6 View
Phase 1 - Total All participants from Cohorts 1-5 in Phase 1 None None 24 25 25 25 View
Phase 2: Clofarabine, Etoposide, Cyclophosphamide Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m\^2, etoposide 100 mg/m\^2 and cyclophosphamide 440 mg/m\^2 delivered intravenously. None None 21 25 25 25 View
Phase 1 - Cohort 1 Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 340 mg/m\^2. None None 3 3 3 3 View
Phase 1 - Cohort 2 Participants were treated with clofarabine 20 mg/m\^2, etoposide 75 mg/m\^2, and cyclophosphamide 440 mg/m\^2. None None 3 3 3 3 View
Phase 1 - Cohort 3 Participants were treated with clofarabine 20 mg/m\^2, etoposide 100 mg/m\^2, and cyclophosphamide 440 mg/m\^2. None None 3 3 3 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Intracardiac mass SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Trichiasis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Caecitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Gingival bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Rectal fissure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Generalised oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.0 View
Venoocclusive liver disease SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.0 View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 13.0 View
Acinetobacter bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Alpha haemolytic streptococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Bacterial sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
BK virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Bronchopulmonary aspergillosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Central nervous system infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Cerebral fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Clostridial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Cytomegalovirus viraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Ear infection fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Enterobacter bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Enterobacter infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Enterococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Enterococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Escherichia bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Escherichia infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Human herpesvirus 6 infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Klebsiella bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Klebsiella infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Lobar pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Meningitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Meningitis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Otitis media bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Pelvic abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Perirectal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Pneumonia fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Pulmonary mycosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Sinusitis fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Staphylococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Staphylococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Streptococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Streptococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Urinary tract infection enterococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Viraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Wound infection staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Fungal test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Polyomavirus test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hypernatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Tumour lysis syndrome SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Malignant neoplasm progression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Post herpetic neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Cystitis haemorrhagic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Genital rash SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.0 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Capillary leak syndrome SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View
Venoocclusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Bone marrow failure SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Disseminated intravascular coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Bone marrow failure SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Coagulopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Disseminated intravascular coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Splenomegaly SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Left ventricular dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Left ventricular hypertrophy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Tricuspid valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Ventricular extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Deafness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 13.0 View
Deafness neurosensory SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 13.0 View
Deafness unilateral SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 13.0 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 13.0 View
Mixed deafness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 13.0 View
Cushingoid SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 13.0 View
Conjunctival hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Ectropion SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Exophthalmos SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Eye haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Eye swelling SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Eyelid oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Retinal exudates SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Retinopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Scleral haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Anal fissure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Cheilitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Eructation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Faecal incontinence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Gingival bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Gingival pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Lip blister SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Lip dry SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Mouth haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Mouth ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Oesophageal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Oral disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Oral pruritus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Painful defaecation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Pancreatic atrophy SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Perianal erythema SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Proctalgia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Proctitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Rectal fissure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Tongue discolouration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Application site rash SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Catheter site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Catheter site haematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Catheter site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Catheter site rash SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Catheter site related reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Device occlusion SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Face oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Feeling abnormal SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Generalised oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Hypothermia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Pneumatosis SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Puncture site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.0 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.0 View
Cholestasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.0 View
Gallbladder disorder SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.0 View
Hepatic steatosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.0 View
Hepatomegaly SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.0 View
Hepatosplenomegaly SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.0 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.0 View
Jaundice SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.0 View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 13.0 View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
BK virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Brain abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Bronchopulmonary aspergillosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Catheter site cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Enterobacter bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Enterococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Enterococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Escherichia urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Gastrointestinal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Herpes zoster multi-dermatomal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Keratitis herpetic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Onychomycosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Otitis media chronic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Sinusitis fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Staphylococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Streptococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Allergic transfusion reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Excoriation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Incision site haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Joint injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Joint sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Post lumbar puncture syndrome SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Post procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Postoperative wound complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Transfusion reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Antimicrobial susceptibility test sensitive SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Bacterial test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Blood albumin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Blood amylase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Blood bicarbonate decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Blood phosphorus increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Blood urea increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Brain natriuretic peptide increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Cardiac murmur SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Coagulation test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Culture stool positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Fibrin d dimer increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Fungal test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Occult blood positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Polyomavirus test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Protein total decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Prothrombin time prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Serum ferritin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Specific gravity urine abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Specific gravity urine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Urine ketone body SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Urine output decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Fluid imbalance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Fluid overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Fluid retention SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hypermagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hypernatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hyperphosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Polydipsia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Muscle fatigue SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Muscle twitching SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Osteopenia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Cancer pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
Malignant neoplasm progression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
Penile wart SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Cerebral thrombosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Dysaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Hydrocephalus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Panic attack SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Psychotic disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Social avoidant behaviour SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Haemoglobinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Kidney enlargement SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Micturition urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Oliguria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Urinary bladder haemorrhage SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Balanitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.0 View
Breast pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.0 View
Epididymal cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.0 View
Genital pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.0 View
Metrorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.0 View
Pelvic haematoma SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.0 View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.0 View
Vulvovaginal pruritus SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.0 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Alveolitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Lung infiltration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Painful respiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Pleuritic pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Tachypnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Upper respiratory tract congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Acanthosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Blister SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Decubitus ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Drug eruption SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Exfoliative rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Palmar-plantar erythrodysaesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Periorbital oedema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Pruritus generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Rash macular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Rash papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Red man syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Skin discolouration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Skin hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Intestinal dilatation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Infusion site extravasation SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Injection site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Irritability SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Clostridial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Conjunctivitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Conjunctivitis infective SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Urinary tract infection staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Wound infection staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Genital rash SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Sinus disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Sleep apnoea syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Skin disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Skin exfoliation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View