Adverse Events Module

Adverse Events Module

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

Adverse Events Module path is as follows:

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

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

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

Adverse Events Module


Ignite Creation Date: 2025-12-24 @ 5:09 PM
Ignite Modification Date: 2025-12-25 @ 2:46 PM
NCT ID: NCT01525550
Description: The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Frequency Threshold: 0
Time Frame: Baseline up to 1939 days
Study: NCT01525550
Study Brief: A Study Of The Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sunitinib: Treatment Naive Cohort Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants. None None 17 61 59 61 View
Sunitinib: Later-Line Cohort Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy). None None 12 45 45 45 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Anal fistula NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Duodenal stenosis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Melaena NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Small intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Upper gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Disease progression NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Bile duct stone NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Hepatitis acute NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Non-alcoholic steatohepatitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 21.0 View
Abdominal abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Urosepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Hypercalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Cerebral haemorrhage NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Hepatic encephalopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Liver injury NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Peritonitis bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Subarachnoid haemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Arteriosclerosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Diabetes mellitus NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Glucose tolerance impaired NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypercalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hyperchloraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypercholesterolaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypercreatininaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hyperkalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypermagnesaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypernatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypertriglyceridaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hyperuricaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypocalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypochloraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypomagnesaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypophosphataemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypoproteinaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Iron deficiency NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Magnesium deficiency NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Malnutrition NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Vitamin B12 deficiency NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Vitamin D deficiency NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Flank pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Joint effusion NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Joint swelling NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Limb discomfort NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Muscular weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Glutathione s-transferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Musculoskeletal chest pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Myalgia intercostal NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Osteonecrosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Procalcitonin increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Spinal osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Spinal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Paraneoplastic syndrome NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.0 View
Amnesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Cognitive disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Dysaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Hyperaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Hypogeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Memory impairment NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Neuropathy peripheral NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Neurotoxicity NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Polyneuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Depressed mood NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Hallucination NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Chronic kidney disease NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Dysuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Glycosuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Nephrolithiasis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Proteinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Renal colic NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Renal disorder NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Genital erythema NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Menstruation irregular NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Penile erythema NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Perineal pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Vaginal haemorrhage NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Vaginal inflammation NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Choking NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Dysphonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Dyspnoea exertional NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Haemoptysis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Nasal disorder NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Protein total decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Nasal septum ulceration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Productive cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Rhinitis allergic NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Upper respiratory tract congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Actinic keratosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Blister NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Cold sweat NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Haemorrhage subcutaneous NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Hair colour changes NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Hyperhidrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Hyperkeratosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Macule NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Madarosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Nail discolouration NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Nail disorder NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Night sweats NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Onycholysis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Palmar-plantar erythrodysaesthesia syndrome NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Pigmentation disorder NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Skin discolouration NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Skin disorder NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Skin exfoliation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Skin fissures NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Skin hyperpigmentation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Skin hypopigmentation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Skin lesion NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Skin toxicity NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Swelling face NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Vitiligo NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Yellow skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Hospitalisation NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 21.0 View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Flushing NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Haemorrhage NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Hot flush NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Bone marrow failure NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Faeces pale NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Gastrointestinal disorder NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Cholecystitis chronic NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Blood potassium increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood albumin decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Electrocardiogram ST segment abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Glucose urine present NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Cystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Enterocolitis infectious NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Fungal oesophagitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Furuncle NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Gastroenteritis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Gingival abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Gingivitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Herpes zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Lung infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Oral candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Oral herpes NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Parainfluenzae virus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Paronychia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pulpitis dental NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Subcutaneous abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Tinea versicolour NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Tooth abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Vulvovaginal mycotic infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Limb injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Skin abrasion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Skin wound NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Sunburn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Tooth fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Wound NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood chloride decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood chromogranin A increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood folate decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood glucose increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood iron decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood lactate dehydrogenase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood phosphorus decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood potassium decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood pressure increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood thyroid stimulating hormone abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood thyroid stimulating hormone increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood triglycerides increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood urine present NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
C-reactive protein increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Ejection fraction decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Electrocardiogram T wave abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Electrocardiogram abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Gamma-glutamyltransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Glomerular filtration rate decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Haemoglobin decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Neutrophil count NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Occult blood positive NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Protein urine NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Protein urine present NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Red blood cell count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Red blood cells urine positive NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Thyroxine free decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Transaminases increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Tri-iodothyronine decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Tri-iodothyronine free decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Urinary sediment present NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Urobilinogen urine increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Vitamin B12 decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
White blood cell count NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
White blood cell count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
White blood cells urine positive NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Retinal vascular disorder NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Vision blurred NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Abdominal pain lower NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Abdominal tenderness NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Anal inflammation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Aphthous ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Ascites NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Duodenal stenosis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Epigastric discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Eructation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Frequent bowel movements NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Gingival bleeding NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Gingival pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Gingival swelling NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Glossodynia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Haemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Hyperchlorhydria NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Lip dry NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Melaena NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Mouth ulceration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Oral dysaesthesia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Oral mucosal blistering NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Oral pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Pancreatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Periodontal disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Proctalgia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Proctitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Rectal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Regurgitation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Salivary hypersecretion NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Face oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Facial pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Feeling cold NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Gait disturbance NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
General physical health deterioration NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Hyperpyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Influenza like illness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Mucosal inflammation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Mucous membrane disorder NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Cholangitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Cholelithiasis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Hepatic function abnormal NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Hepatomegaly NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Hyperbilirubinaemia NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Hypertransaminasaemia NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Jaundice NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Liver injury NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Contrast media allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 21.0 View
Hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 21.0 View
Abdominal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Thyroid hormones decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Total bile acids increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Facial paralysis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Nephropathy toxic NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Renal impairment NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Pneumonitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Tooth extraction NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 21.0 View
Chillblains NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Lymphocyte count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Hypoalbuminaemia NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Bilirubin conjugated increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Lymphopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Cardiac failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Cardiovascular symptom NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Nodal arrhythmia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Ventricular extrasystoles NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 21.0 View
Goitre NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 21.0 View
Hypothyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 21.0 View
Thyroid disorder NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 21.0 View
Cataract NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Dry eye NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Eye haemorrhage NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Eyelid bleeding NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Eyelid disorder NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Eyelid oedema NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Keratitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Lacrimation increased NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Ocular icterus NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Periorbital oedema NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View