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 @ 9:17 PM
Ignite Modification Date: 2025-12-25 @ 7:05 PM
NCT ID: NCT02545504
Description: All-Cause Mortality:The Intent-to-Treat Analysis Set included all randomized participants.Serious Adverse Events and Other Adverse Events: The Safety Analysis Set included all participants who received at least one dose of andecaliximab/placebo.
Frequency Threshold: 5
Time Frame: All-Cause Mortality: First dose date up to 42 months; Adverse Events: First dose date up to the last dose date (maximum: 161.7 weeks) plus 30 to 55 days
Study: NCT02545504
Study Brief: Andecaliximab With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Andecaliximab + mFOLFOX6 Participants received andecaliximab 800 mg IV plus mFOLFOX6 (LV+5-FU+OXA) IV as per standard of care on Days 1 and 15 of each 28-day treatment cycle during Cycles 1-6, followed by andecaliximab 800 mg IV plus LV+5-FU on Days 1 and 15 during subsequent cycles until disease progression, unacceptable toxicity, consent withdrawal, or the participant's refusal of treatment for up to 161.7 weeks. 174 None 103 216 209 216 View
Placebo + mFOLFOX6 Participants received placebo IV plus mFOLFOX6 (LV+5-FU+OXA) as per standard of care on Days 1 and 15 of each 28-day treatment cycle during Cycles 1-6, followed by placebo IV plus LV+5-FU on Days 1 and 15 during subsequent cycles until disease progression, unacceptable toxicity, consent withdrawal, or the participant's refusal of treatment for up to 112.3 weeks. 168 None 108 210 203 210 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22.0 View
Disseminated intravascular coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22.0 View
Febrile bone marrow aplasia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Atrioventricular block second degree SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Cardiovascular disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Duodenal ulcer perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Gastric haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Gastric perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Gastric stenosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Gastrointestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Gastrointestinal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Gastrointestinal toxicity SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Impaired gastric emptying SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Incarcerated inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Intestinal pseudo-obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Large intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Obstruction gastric SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Oesophageal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Oesophageal stenosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Acute on chronic liver failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22.0 View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22.0 View
Cholangitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22.0 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22.0 View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22.0 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22.0 View
Jaundice cholestatic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22.0 View
Anaphylactic reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 22.0 View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 22.0 View
Anal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Diarrhoea infectious SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Neutropenic sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Oesophageal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Pneumonia necrotising SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Postoperative wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Pyelonephritis acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Vascular device infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Accidental overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Anastomotic ulcer SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Fibula fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Meniscus injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Subcutaneous haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Vascular access complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Body temperature increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Electrocardiogram QT prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
General physical condition abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Occult blood positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Cachexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.0 View
Failure to thrive SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.0 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Osteolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Cancer pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22.0 View
Metastases to meninges SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22.0 View
Oesophageal carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22.0 View
Tumour haemorrhage SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22.0 View
Tumour necrosis SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22.0 View
Carotid arteriosclerosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Hydrocephalus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Neurological decompensation SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Vocal cord paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Device dislocation SYSTEMATIC_ASSESSMENT Product Issues MedDRA 22.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22.0 View
Nephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22.0 View
Urine flow decreased SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22.0 View
Prostatitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 22.0 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.0 View
Swelling face SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.0 View
Arteriosclerosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22.0 View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22.0 View
Peripheral venous disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22.0 View
Poor venous access SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22.0 View
Venous thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Temperature intolerance SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.0 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Dysaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Neurotoxicity SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Taste disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22.0 View