Adverse Events Module

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Adverse Events Module

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

Adverse Events Module path is as follows:

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

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

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

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 4:26 PM
Ignite Modification Date: 2025-12-25 @ 2:19 PM
NCT ID: NCT03391466
Description: All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
Frequency Threshold: 5
Time Frame: All-cause mortality and Adverse events: Up to 74.9 months
Study: NCT03391466
Study Brief: Study of Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Standard of Care Therapy Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen: * R-ICE: rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours CI on Day 2 + mesna, carboplatin AUC 5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3; * R-ESHAP: rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day CI Days 1-4, cytarabine 2g/m\^2 on Day 5; * R-GDP: rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin AUC=5; or * R-DHAP: rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\^2. Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant. 101 None 78 168 166 168 View
Axicabtagene Ciloleucel Treatment Participants received cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0. 81 None 96 170 170 170 View
Retreatment Axicabtagene Ciloleucel Participants who achieved a partial response or complete response and subsequently experienced disease progression received a second course of conditioning chemotherapy (cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion) for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD 19 CAR transduced autologous T cells/kg. 3 None 2 10 10 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Facial paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Vascular access complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Guillain-Barre syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Hemiparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Blood fibrinogen decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Troponin I increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Acute myeloid leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Adenocarcinoma of colon SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Adenocarcinoma pancreas SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Anal squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
B-cell lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Lung adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Metastatic malignant melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Myelodysplastic syndrome SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Plasma cell myeloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Spindle cell sarcoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Cognitive disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Dyspraxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.1 View
Coagulopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.1 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.1 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.1 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Heart failure with reduced ejection fraction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Enterovesical fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Food poisoning SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Gastric ulcer perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Lower gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Oesophageal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Oral disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Incarcerated hernia SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.1 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.1 View
Anal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Arthritis infective SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Covid-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Cytomegalovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Fungal cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Furuncle SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Gastrointestinal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Hepatitis B reactivation SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Metapneumovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Parainfluenzae virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Pelvic abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Pneumococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Pneumocystis jirovecii pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Pneumonia legionella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Pneumonia staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Progressive multifocal leukoencephalopathy SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Pseudomonal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Rhinovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Salmonella bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Blood stem cell harvest failure SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Bladder transitional cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Ductal adenocarcinoma of pancreas SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Hepatocellular carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Large granular lymphocytosis SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Spinal cord compression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.1 View
Bradyphrenia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.1 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.1 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.1 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.1 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.1 View
Faecaluria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.1 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Lung opacity SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Tachypnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.1 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.1 View
Haematopoietic stem cell mobilisation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 27.1 View
Angiopathy SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.1 View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.1 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.1 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.1 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.1 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 27.1 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Hypertransaminasaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.1 View
Hypogammaglobulinaemia SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 27.1 View
Furuncle SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Serum ferritin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.1 View
Micturition urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.1 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.1 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.1 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.1 View
Night sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.1 View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.1 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Pseudomonas infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Hyperaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.1 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View