Study: NCT01580410

Adverse event: Low WBC
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 58 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 58 at risk

Adverse event: Low Hemoglobin
Serious: yes
Organ System: Investigations
Frequency: 35 affected / 58 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 58 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 58 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 58 at risk

Adverse event: Obstruction, GI: Small bowel
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 58 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 58 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 58 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 58 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 58 at risk

Adverse event: Low ANC
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 58 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 58 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 58 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 58 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 58 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 58 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 58 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Investigations
Frequency: 16 affected / 58 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 58 at risk

Adverse event: serum glutamic pyruvic transaminase
Serious: yes
Organ System: Investigations
Frequency: 12 affected / 58 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Investigations
Frequency: 13 affected / 58 at risk

Adverse event: serum glutamic oxaloacetic transaminase
Serious: yes
Organ System: Investigations
Frequency: 16 affected / 58 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Confusional state
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Mood alteration: Agitation
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 58 at risk

Adverse event: Anxiety
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Depression
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Pain: Abdomen
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 58 at risk

Adverse event: Acidosis
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 58 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 58 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 58 at risk

Adverse event: Blood creatine phosphokinase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 58 at risk

Adverse event: Pain: Chest/thorax
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 58 at risk

Adverse event: Disseminated intravascular coagulation
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 58 at risk

Adverse event: Prolonged QTc interval
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 58 at risk

Adverse event: functional obstruction of bowel
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 58 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 20 affected / 58 at risk

Adverse event: Malabsorption
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 58 at risk

Adverse event: Death not associated with CTCAE term: Multi-organ failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Pain: Muscle
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 58 at risk

Adverse event: infection associated with Lymphopenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 58 at risk

Adverse event: Pain: Skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 58 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 58 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: International Normalized Ratio of prothrombin time
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 58 at risk

Adverse event: Pain: Scrotum
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 58 at risk

Adverse event: Urinary with low grade neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 58 at risk

Adverse event: Mental status
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Hemorrhage, GI: Lower GI
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 58 at risk

Adverse event: Hemorrhage/bleeding associated with surgery, intra-operative or postoperative
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 58 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Abdomen
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 58 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Peritoneal cavity
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 58 at risk

Adverse event: Troponin I
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 58 at risk

Adverse event: Ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 58 at risk

Adverse event: Fistula, GI: Abdomen
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 58 at risk

Adverse event: Leak (including anastomotic), GI: Leak
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Leak (including anastomotic), GI: Small bowel
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Necrosis, GI: Small bowel
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Lung Infection with high grade neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 58 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Pelvis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 58 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 58 at risk

Adverse event: Infection with unknown ANC: Peritoneal cavity
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 58 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy): Left-sided
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 58 at risk

Adverse event: Prolonged intubation after pulmonary resection (>24 hrs after surgery)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 58 at risk

Adverse event: Infection with high grade neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 58 at risk

Adverse event: Blood Infection with high grade neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 58 at risk

Adverse event: Low WBC
Serious: no
Organ System: Investigations
Frequency: 11 affected / 58 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 33 affected / 58 at risk

Adverse event: Low Hemoglobin
Serious: no
Organ System: Investigations
Frequency: 22 affected / 58 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 58 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 58 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 58 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 20 affected / 58 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 31 affected / 58 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 2 affected / 58 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Investigations
Frequency: 2 affected / 58 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 58 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 58 at risk

Adverse event: Hypertension
Serious: no
Organ System: General disorders
Frequency: 2 affected / 58 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 58 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 58 at risk

Adverse event: Low ANC
Serious: no
Organ System: Investigations
Frequency: 2 affected / 58 at risk

Adverse event: Taste disorder
Serious: no
Organ System: General disorders
Frequency: 4 affected / 58 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 11 affected / 58 at risk

Adverse event: Dermatology/Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 58 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 58 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 30 affected / 58 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 26 affected / 58 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 42 affected / 58 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 58 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Investigations
Frequency: 8 affected / 58 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 35 affected / 58 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 26 affected / 58 at risk

Adverse event: Bicarbonate serum-low
Serious: no
Organ System: Investigations
Frequency: 2 affected / 58 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Investigations
Frequency: 33 affected / 58 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 58 at risk

Adverse event: serum glutamic pyruvic transaminase
Serious: no
Organ System: Investigations
Frequency: 31 affected / 58 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 58 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 58 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 58 at risk

Adverse event: serum glutamic oxaloacetic transaminase
Serious: no
Organ System: Investigations
Frequency: 31 affected / 58 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 58 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 58 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 58 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 58 at risk

Adverse event: Dysphagia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Fever without neutropenia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 58 at risk

Adverse event: Constitutional Symptoms - Other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Cardiac Arrhythmia - Other
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 58 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 58 at risk

Adverse event: Edema: limb
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 58 at risk

Adverse event: Edema: trunk/genital
Serious: no
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Edema: viscera
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 58 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 2 affected / 58 at risk

Adverse event: Confusional state
Serious: no
Organ System: General disorders
Frequency: 2 affected / 58 at risk

Adverse event: Mood alteration: Agitation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Anxiety
Serious: no
Organ System: General disorders
Frequency: 5 affected / 58 at risk

Adverse event: Depression
Serious: no
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 58 at risk

Adverse event: Distension bloating, abdominal
Serious: no
Organ System: General disorders
Frequency: 4 affected / 58 at risk

Adverse event: Pain: Abdomen
Serious: no
Organ System: General disorders
Frequency: 8 affected / 58 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 58 at risk

Adverse event: Pain: Joint
Serious: no
Organ System: General disorders
Frequency: 2 affected / 58 at risk

Adverse event: Ascites (non-malignant)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 58 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 58 at risk

Adverse event: Conduction abnormality/atrioventricular heart block
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 58 at risk

Adverse event: Pain: Back
Serious: no
Organ System: General disorders
Frequency: 2 affected / 58 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 58 at risk

Adverse event: Bladder pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Right ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 58 at risk

Adverse event: Wound complication, non-infectious
Serious: no
Organ System: General disorders
Frequency: 10 affected / 58 at risk

Adverse event: Skin breakdown/decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 58 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 58 at risk

Adverse event: Haematoma
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 58 at risk

Adverse event: Hiccoughs (hiccups, singultus)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 58 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 58 at risk

Adverse event: functional obstruction of bowel
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 58 at risk

Adverse event: Watery eye (epiphora, tearing)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 58 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 24 affected / 58 at risk

Adverse event: Pain: Muscle
Serious: no
Organ System: General disorders
Frequency: 4 affected / 58 at risk

Adverse event: Pain: Neuralgia/peripheral nerve
Serious: no
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Pain Oral cavity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 58 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 58 at risk

Adverse event: International Normalized Ratio of prothrombin time
Serious: no
Organ System: Investigations
Frequency: 1 affected / 58 at risk

Adverse event: Supraventricular and nodal arrhythmia: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 58 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 58 at risk

Adverse event: Pain: Stomach
Serious: no
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Supraventricular and nodal arrhythmia: Supraventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 58 at risk

Adverse event: Pain: Urethra
Serious: no
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Urinary with low grade neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 58 at risk

Adverse event: Hemorrhage GU: Urinary
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 58 at risk

Adverse event: Leak (including anastomotic), GI: Pancreas
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 58 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Leak (including anastomotic), GI: Leak
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Mucositis/stomatitis Oral cavity
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 58 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Wound
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 58 at risk

Adverse event: Infection with unknown ANC Lung (pneumonia)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Prolonged chest tube drainage or air leak after pulmonary resection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Intra-operative injury: NERVES: Peripheral sensory
Serious: no
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Low WBC
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 61 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 61 at risk

Adverse event: Low Hemoglobin
Serious: yes
Organ System: Investigations
Frequency: 36 affected / 61 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 61 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 61 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 61 at risk

Adverse event: Obstruction, GI: Small bowel
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 61 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 61 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 61 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 61 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 61 at risk

Adverse event: Low ANC
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 61 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 61 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 61 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 61 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 61 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 61 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Investigations
Frequency: 19 affected / 61 at risk

Adverse event: serum glutamic pyruvic transaminase
Serious: yes
Organ System: Investigations
Frequency: 9 affected / 61 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Investigations
Frequency: 14 affected / 61 at risk

Adverse event: serum glutamic oxaloacetic transaminase
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 61 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 61 at risk

Adverse event: Confusional state
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: Mood alteration: Agitation
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 61 at risk

Adverse event: Anxiety
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 61 at risk

Adverse event: Depression
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: Pain: Abdomen
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 61 at risk

Adverse event: Acidosis
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 61 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 61 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: functional obstruction of bowel
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 61 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 25 affected / 61 at risk

Adverse event: Malabsorption
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 61 at risk

Adverse event: Pain: Muscle
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 61 at risk

Adverse event: infection associated with Lymphopenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 61 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 61 at risk

Adverse event: Hemorrhage, GI: Lower GI
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 61 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Abdomen
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Peritoneal cavity
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 61 at risk

Adverse event: Troponin I
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 61 at risk

Adverse event: Leak (including anastomotic), GI: Leak
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Prolonged intubation after pulmonary resection (>24 hrs after surgery)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 61 at risk

Adverse event: Blood Infection with high grade neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Low WBC
Serious: no
Organ System: Investigations
Frequency: 22 affected / 61 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 27 affected / 61 at risk

Adverse event: Low Hemoglobin
Serious: no
Organ System: Investigations
Frequency: 22 affected / 61 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 61 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 61 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 61 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 19 affected / 61 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 27 affected / 61 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 2 affected / 61 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Investigations
Frequency: 1 affected / 61 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 61 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 61 at risk

Adverse event: Hypertension
Serious: no
Organ System: General disorders
Frequency: 3 affected / 61 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 61 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 61 at risk

Adverse event: Low ANC
Serious: no
Organ System: Investigations
Frequency: 3 affected / 61 at risk

Adverse event: Taste disorder
Serious: no
Organ System: General disorders
Frequency: 4 affected / 61 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 61 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 22 affected / 61 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 34 affected / 61 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 42 affected / 61 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 61 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Investigations
Frequency: 6 affected / 61 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 29 affected / 61 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 31 affected / 61 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Investigations
Frequency: 35 affected / 61 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 61 at risk

Adverse event: serum glutamic pyruvic transaminase
Serious: no
Organ System: Investigations
Frequency: 37 affected / 61 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Investigations
Frequency: 6 affected / 61 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 61 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 61 at risk

Adverse event: serum glutamic oxaloacetic transaminase
Serious: no
Organ System: Investigations
Frequency: 43 affected / 61 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 61 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 61 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 61 at risk

Adverse event: Fever without neutropenia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 61 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 61 at risk

Adverse event: Edema: limb
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 61 at risk

Adverse event: Edema: trunk/genital
Serious: no
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: Edema: viscera
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 61 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 2 affected / 61 at risk

Adverse event: Anxiety
Serious: no
Organ System: General disorders
Frequency: 4 affected / 61 at risk

Adverse event: Depression
Serious: no
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Distension bloating, abdominal
Serious: no
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: Pain: Abdomen
Serious: no
Organ System: General disorders
Frequency: 18 affected / 61 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Pain: Joint
Serious: no
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 61 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Bladder pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: Wound complication, non-infectious
Serious: no
Organ System: General disorders
Frequency: 8 affected / 61 at risk

Adverse event: Skin breakdown/decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 61 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Haematoma
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 61 at risk

Adverse event: Hiccoughs (hiccups, singultus)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: functional obstruction of bowel
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 61 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 21 affected / 61 at risk

Adverse event: Pain: Muscle
Serious: no
Organ System: General disorders
Frequency: 5 affected / 61 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 61 at risk

Adverse event: International Normalized Ratio of prothrombin time
Serious: no
Organ System: Investigations
Frequency: 1 affected / 61 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 61 at risk

Adverse event: Supraventricular and nodal arrhythmia: Supraventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 61 at risk

Adverse event: Urinary with low grade neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Hemorrhage GU: Urinary
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 61 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: Mucositis/stomatitis Oral cavity
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 61 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Wound
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk