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 @ 1:16 AM
Ignite Modification Date: 2025-12-25 @ 11:25 PM
NCT ID: NCT01399593
Description: None
Frequency Threshold: 5
Time Frame: Adverse events were collected throughout the 3-year study period.
Study: NCT01399593
Study Brief: Safety & Efficacy of Eculizumab to Prevent AMR in Living Donor Kidney Transplant Recipients Requiring Desensitization
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Eculizumab Patients were to receive eculizumab 1200 mg prior to allograft transplantation (Day 0, starting approximately one hour prior to kidney allograft reperfusion), eculizumab 900 mg (Days 1, 7, 14, 21, and 28), and eculizumab 1200 mg (Weeks 5, 7 and 9). All doses of eculizumab were administered intravenously. 1 None 43 51 51 51 View
Standard of Care Patients received standard of care (SOC) prophylactic therapy for acute AMR according to the SOC choice at each participating investigative site, which could have included any combination of plasmapheresis (PP) and intravenous immunoglobulin (IVIg). Patients randomized to SOC who were diagnosed with AMR could have received eculizumab for the treatment of AMR after initially receiving PP and/or IVIg. 1 None 48 51 51 51 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Coagulopathy NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Haemolytic uraemic syndrome NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Microangiopathic haemolytic anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Abdominal sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Arteriovenous fistula site infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
BK virus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Bacterial sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Bronchopulmonary aspergillosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Cytomegalovirus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Cytomegalovirus viraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Device related sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Endocarditis bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Escherichia sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Escherichia urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Gastroenteritis cryptosporidial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Gastroenteritis norovirus NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Gastroenteritis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Giardiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Haemophilus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Klebsiella sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Lower respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Meningitis cryptococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Metapneumovirus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pneumonia cryptococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pneumonia fungal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pneumonia viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Postoperative wound infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pseudomonal sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pyelonephritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Renal abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Urinary tract infection bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Urinary tract infection enterococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Urinary tract infection pseudomonal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Normochromic normocytic anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Pancytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Acute myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Cardiac arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Cardiac failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Cardiac failure congestive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Cardiac perforation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Myocardial ischaemia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Sinus node dysfunction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Eye pain NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Abdominal hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Abdominal wall haematoma NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Colitis ulcerative NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Diverticulum NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Haemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Large intestine perforation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Mallory-Weiss Syndrome NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Pancreatitis acute NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Pancreatitis relapsing NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Small intestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Subileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Upper gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Hypothermia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Impaired healing NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Influenza like illness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Systemic inflammatory response syndrome NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Cholecystitis chronic NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.1 View
Drug hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 18.1 View
Kidney transplant rejection NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 18.1 View
Escherichia bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Escherichia pyelonephritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Otitis media NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Urinary tract infection staphylococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Urosepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Wound infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Arteriovenous fistula thrombosis NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Ateriovenous fistula site haemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Complications of transplanted kidney NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Delayed graft function NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Graft thrombosis NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Incisional hernia NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Post procedural haematoma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Post procedural haematuria NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Post procedural haemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Procedural pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Tendon rupture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Toxicity to various agents NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Upper limb fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Vascular graft complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Wound dehiscence NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Anti-glomerular basement membrane antibody NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Antibody test positive NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Drug level increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Diabetes mellitus inadequate control NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Fluid overload NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Gout NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hyperkalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Metabolic acidosis NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Myopathy NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Dermatofibrosarcoma protuberans NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
Post transplant lymphoproliferative disorder NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
Tonsil cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
Cerebellar haemorrhage NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Spinal claudication NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Focal segmental glomerulosclerosis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Glomerulonephritis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Hydronephrosis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Nephrectasia NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Nephrotic syndrome NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Proteinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Renal cyst NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Renal haemorrhage NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Renal impairment NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Renal injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Ureteric dilatation NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Urethral stenosis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Urinary incontinence NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Vesicoureteric reflux NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Haemorrhagic ovarian cyst NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 18.1 View
Ovarian cyst ruptured NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 18.1 View
Prostatomegaly NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 18.1 View
Lung disorder NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Pulmonary oedema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Convalescent NON_SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 18.1 View
Nephrostomy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.1 View
Circulatory collapse NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Hypovolaemic shock NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Lymphocele NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Superior vena cava occlusion NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Venous thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Hypofibrinogenaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Vision blurred NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Abdominal pain lower NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Localised intraabdominal fluid collection NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Mouth ulceration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Influenza like illness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Drug hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 18.1 View
Kidney transplant rejection NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 18.1 View
BK virus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Cytomegalovirus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Cytomegalovirus viraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Escherichia urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Lower respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Oral candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Urinary tract infection bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Urinary tract infection enterococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Arteriovenous fistula site complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Incision site pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Perinephric collection NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Procedural haemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Procedural pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Toxicity to various agents NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Wound secretion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Antibody test positive NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Liver function test abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Acidosis NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Diabetes mellitus NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Diabetes mellitus inadequate control NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Fluid overload NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hypercalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hyperkalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hyperlipidaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hyperphosphataemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hypocalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hypomagnesaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hypophosphataemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Metabolic acidosis NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Vitamin D deficiency NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Muscular weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Osteopenia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Osteoporosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Anuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Bladder spasm NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Dysuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Nocturia NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Oliguria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Polyuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Proteinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Renal impairment NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Renal tubular necrosis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Urinary retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Atelectasis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Dyspnoea exertional NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Pulmonary oedema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Haematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Lymphocele NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View