Study: NCT00515411

Adverse event: Allerg react/hypersens (incl drug fever)
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 54 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 54 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Atrial tachycardia/Paroxysmal Atrial Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 54 at risk

Adverse event: Blood/Bone Marrow, other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 54 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Colitis, infectious
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 54 at risk

Adverse event: Death not assoc w CTCAE term- Death NOS
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 54 at risk

Adverse event: Death not assoc w CTCAE term-Disease prog NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 54 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 54 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 54 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 54 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 54 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 54 at risk

Adverse event: Fever (in the absence of neutropenia)
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 54 at risk

Adverse event: Fistula, GI- Small bowel NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Gastrointestinal, other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 54 at risk

Adverse event: Glucose, high (hyperglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 54 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 54 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 54 at risk

Adverse event: Hemorrhage, Stoma (GI)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Hemorrhage, Upper GI NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 54 at risk

Adverse event: Ileus, GI (func obstruction of bowel)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 54 at risk

Adverse event: Inf norm ANC/gr1/2 neut-Catheter-related
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 54 at risk

Adverse event: Inf unknown ANC-Abdomen NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 54 at risk

Adverse event: Infection w/ Gr 3/4 neut, Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 54 at risk

Adverse event: Infection, other
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 54 at risk

Adverse event: International normalised ratio
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 54 at risk

Adverse event: Leukocytes (total WBC)
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 54 at risk

Adverse event: Metabolic/Lab - Other (specify)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 54 at risk

Adverse event: Mucositis (Clin exam)- Oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Muscle weakness - Right-sided
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 54 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 54 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 54 at risk

Adverse event: Obstruction, GI- Small bowel NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 54 at risk

Adverse event: Obstruction, GI- Stomach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Pain - Abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 54 at risk

Adverse event: Pain - Back
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 54 at risk

Adverse event: Pain - Cardiac/heart
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 54 at risk

Adverse event: Pain - Chest wall
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 54 at risk

Adverse event: Pain - Neck
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 54 at risk

Adverse event: Pain - Stomach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 54 at risk

Adverse event: Sodium, low (hyponatremia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 54 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 54 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 54 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 54 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 54 at risk

Adverse event: Wound complication, non-infectious
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 54 at risk

Adverse event: Allerg react/hypersens (incl drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 54 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 54 at risk

Adverse event: Aspiration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Atrial tachycardia/Paroxysmal Atrial Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 54 at risk

Adverse event: Blood/Bone Marrow, other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 54 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Colitis, infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 54 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 54 at risk

Adverse event: Death not assoc w CTCAE term- Death NOS
Serious: no
Organ System: General disorders
Frequency: 2 affected / 54 at risk

Adverse event: Death not assoc w CTCAE term-Disease prog NOS
Serious: no
Organ System: General disorders
Frequency: 1 affected / 54 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 54 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 54 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 54 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 54 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 54 at risk

Adverse event: Fever (in the absence of neutropenia)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 54 at risk

Adverse event: Fistula, GI- Small bowel NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Gastrointestinal, other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 54 at risk

Adverse event: Glucose, high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 54 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 54 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 54 at risk

Adverse event: Hemorrhage, Stoma (GI)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Hemorrhage, Upper GI NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 54 at risk

Adverse event: Ileus, GI (func obstruction of bowel)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 54 at risk

Adverse event: Inf norm ANC/gr1/2 neut-Catheter-related
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 54 at risk

Adverse event: Inf unknown ANC-Abdomen NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 54 at risk

Adverse event: Infection w/ Gr 3/4 neut, Lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 54 at risk

Adverse event: Infection, other
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 54 at risk

Adverse event: International normalised ratio
Serious: no
Organ System: Investigations
Frequency: 1 affected / 54 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 54 at risk

Adverse event: Metabolic/Lab - Other (specify)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 54 at risk

Adverse event: Mucositis (Clin exam)- Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Muscle weakness - Right-sided
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 54 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 54 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 5 affected / 54 at risk

Adverse event: Obstruction, GI- Small bowel NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 54 at risk

Adverse event: Obstruction, GI- Stomach
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Pain - Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 54 at risk

Adverse event: Pain - Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 54 at risk

Adverse event: Pain - Cardiac/heart
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 54 at risk

Adverse event: Pain - Chest wall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 54 at risk

Adverse event: Pain - Neck
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 54 at risk

Adverse event: Pain - Stomach
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 54 at risk

Adverse event: Sodium, low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 54 at risk

Adverse event: Syncope (fainting)
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 54 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 54 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 54 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 54 at risk

Adverse event: Wound complication, non-infectious
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 54 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 31 at risk

Adverse event: Cardiac General, other
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 31 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 31 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 31 at risk

Adverse event: Death not assoc w CTCAE term-Disease prog NOS
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 31 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 31 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 31 at risk

Adverse event: Distension/bloating, abdominal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 31 at risk

Adverse event: Localized Edema - trunk/genital
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 31 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 31 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 31 at risk

Adverse event: Hemorrhage, Stomach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Hemorrhage/Bleeding, other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 31 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 31 at risk

Adverse event: Inf norm ANC/gr1/2 neut-Urinary(bladder)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Infection, other
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 31 at risk

Adverse event: Leak, GI- Leak NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Leukocytes (total WBC)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 31 at risk

Adverse event: Mucositis (Clin exam)- Oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Mucositis (func/sympt)- Oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Muscle weakness - Right-sided
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 31 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 31 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 31 at risk

Adverse event: Obstruction, GI- Colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Obstruction, GI- Small bowel NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Pain - Abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 31 at risk

Adverse event: Pain - Chest/thorax NOS
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 31 at risk

Adverse event: Pain - Extremity-limb
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Perforation, GI- Cecum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 31 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 31 at risk

Adverse event: Ulcer, Esophagus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 31 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 31 at risk

Adverse event: Cardiac General, other
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 31 at risk

Adverse event: Cholecystitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 31 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 1 affected / 31 at risk

Adverse event: Death not assoc w CTCAE term-Disease prog NOS
Serious: no
Organ System: General disorders
Frequency: 4 affected / 31 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 31 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 31 at risk

Adverse event: Distension/bloating, abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 31 at risk

Adverse event: Edema: trunk/genital
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 31 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 31 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 31 at risk

Adverse event: Hemorrhage, Stomach
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Hemorrhage/Bleeding, other
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 31 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 31 at risk

Adverse event: Inf norm ANC/gr1/2 neut-Urinary(bladder)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Infection, other
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 31 at risk

Adverse event: Leak, GI- Leak NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 31 at risk

Adverse event: Mucositis (Clin exam)- Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Mucositis (func/sympt)- Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Muscle weakness - Right-sided
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 31 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 31 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 31 at risk

Adverse event: Obstruction, GI- Colon
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Obstruction, GI- Small bowel NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Pain - Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 31 at risk

Adverse event: Pain - Chest/thorax NOS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 31 at risk

Adverse event: Pain - Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Perforation, GI- Cecum
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Syncope (fainting)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 31 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 31 at risk

Adverse event: Ulcer, Esophagus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 31 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: Calcium, low (hypocalcemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 26 at risk

Adverse event: Cardiac General, other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Death not assoc w CTCAE term- Death NOS
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 26 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 26 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Dysphagia (Difficulty swallowing)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 26 at risk

Adverse event: Fever (in the absence of neutropenia)
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 26 at risk

Adverse event: Glucose, high (hyperglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 26 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 26 at risk

Adverse event: Hemorrhage, Stomach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Hemorrhage, Upper GI NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Inf norm ANC/gr1/2 neut-Urinary(bladder)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Infection, other
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 26 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: Leukocytes (total WBC)
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 26 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: Pain - Abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pain - Chest/thorax NOS
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pain - Extremity-limb
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pain - Head/headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pain - Other (specify)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pain - Throat/pharynx/larynx
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Phosphate, low (hypophosphatemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Potassium, low (hypokalemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 26 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 26 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 26 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: Calcium, low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 26 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Death not assoc w CTCAE term- Death NOS
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 26 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 26 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Dysphagia (Difficulty swallowing)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 26 at risk

Adverse event: Fever (in the absence of neutropenia)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 26 at risk

Adverse event: Glucose, high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 26 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 26 at risk

Adverse event: Hemorrhage, Stomach
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Hemorrhage, Upper GI NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Inf norm ANC/gr1/2 neut-Urinary(bladder)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Infection, other
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 26 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 26 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: Pain - Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pain - Chest/thorax NOS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pain - Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pain - Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pain - Other (specify)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pain - Throat/pharynx/larynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Phosphate, low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Potassium, low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: Syncope (fainting)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 26 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 26 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 26 at risk