Study: NCT00433511

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 12 affected / 972 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 972 at risk

Adverse event: Leukocytes decreased
Serious: yes
Organ System: Investigations
Frequency: 32 affected / 972 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 972 at risk

Adverse event: Neutrophils decreased
Serious: yes
Organ System: Investigations
Frequency: 166 affected / 972 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 972 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 972 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 972 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 972 at risk

Adverse event: Vasovagal episode
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 972 at risk

Adverse event: Cardiac-ischemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 972 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 20 affected / 972 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 972 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 972 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 972 at risk

Adverse event: cardiac-other
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 972 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 66 affected / 972 at risk

Adverse event: Fever w/o neutropenia
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 972 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 972 at risk

Adverse event: Obesity
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 972 at risk

Adverse event: Rigors/chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 972 at risk

Adverse event: Weight increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 972 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 972 at risk

Adverse event: International normalised ratio increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 972 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 972 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 972 at risk

Adverse event: Nail disorder
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 972 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 972 at risk

Adverse event: Radiation dermatitis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 972 at risk

Adverse event: Hand-foot reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 972 at risk

Adverse event: Ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 972 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 972 at risk

Adverse event: Wound - non-infectious
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 972 at risk

Adverse event: Death - disease progression NOS
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 972 at risk

Adverse event: Death - sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 972 at risk

Adverse event: Hot flush
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 972 at risk

Adverse event: Pancreatic glucose intolerance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 972 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 972 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 972 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 972 at risk

Adverse event: Teeth
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 972 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 972 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 972 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 972 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 972 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 972 at risk

Adverse event: Muco/stomatitis (symptom) oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 972 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 972 at risk

Adverse event: Perforation, appendix
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 972 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 972 at risk

Adverse event: GI-other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 972 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 972 at risk

Adverse event: Rectum, hemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 972 at risk

Adverse event: Vagina, hemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 972 at risk

Adverse event: Surgical hemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 972 at risk

Adverse event: Hemorrhage-other
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 972 at risk

Adverse event: Colitis, infectious (e.g. C.diff)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 972 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 33 affected / 972 at risk

Adverse event: Infection w/ gr3-4 neut, colon
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 972 at risk

Adverse event: Infection w/ gr3-4 neut, external ear
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 972 at risk

Adverse event: Infection w/ gr3-4 neut, foreign body
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 972 at risk

Adverse event: Infection w/ gr3-4 neut, rectum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 972 at risk

Adverse event: Infection w/ gr3-4 neut, skin
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 972 at risk

Adverse event: Infection w/ gr3-4 neut, upper airway
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 972 at risk

Adverse event: Infection w/ gr3-4 neut, urinary tract
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 972 at risk

Adverse event: Infection Gr0-2 neut, bladder
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 972 at risk

Adverse event: Infection Gr0-2 neut, bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 972 at risk

Adverse event: Infection Gr0-2 neut, catheter
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 972 at risk

Adverse event: Infection Gr0-2 neut, colon
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 972 at risk

Adverse event: Infection Gr0-2 neut, dental-tooth
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 972 at risk

Adverse event: Infection Gr0-2 neut, foreign body
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 972 at risk

Adverse event: Infection Gr0-2 neut, kidney
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 972 at risk

Adverse event: Infection Gr0-2 neut, lung
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 972 at risk

Adverse event: Infection Gr0-2 neut, nerve-periph
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 972 at risk

Adverse event: Infection Gr0-2 neut, nose
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 972 at risk

Adverse event: Infection Gr0-2 neut, skin
Serious: yes
Organ System: Infections and infestations
Frequency: 19 affected / 972 at risk

Adverse event: Infection Gr0-2 neut, soft tissue
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 972 at risk

Adverse event: Infection Gr0-2 neut, ungual
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 972 at risk

Adverse event: Infection Gr0-2 neut, upper airway
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 972 at risk

Adverse event: Infection Gr0-2 neut, urinary tract
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 972 at risk

Adverse event: Infection Gr0-2 neut, wound
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 972 at risk

Adverse event: Infection w/ unk ANC ungual (nails)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 972 at risk

Adverse event: Opportunistic infection lymphopenia>=gr1
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 972 at risk

Adverse event: Infection w/ gr3-4 neut, blood
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 972 at risk

Adverse event: Infection Gr0-2 neut, blood
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 972 at risk

Adverse event: Infection-other
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 972 at risk

Adverse event: Edema limb
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 972 at risk

Adverse event: Lymphedema-related fibrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 972 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 972 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 972 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 972 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 972 at risk

Adverse event: Hypertriglyceridaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 972 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 972 at risk

Adverse event: Joint effusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 972 at risk

Adverse event: Nonneuropathic lower extr muscle weak
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 972 at risk

Adverse event: Nonneuropathic generalized weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 972 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 972 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 972 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 972 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 972 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 11 affected / 972 at risk

Adverse event: Memory impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 972 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 972 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 9 affected / 972 at risk

Adverse event: Neuropathy CN V jaw / face-sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 972 at risk

Adverse event: Neuropathy-motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 972 at risk

Adverse event: Neuropathy-sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 82 affected / 972 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 972 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 972 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 12 affected / 972 at risk

Adverse event: Vision-blurred
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 972 at risk

Adverse event: Abdomen, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 972 at risk

Adverse event: Anus, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 972 at risk

Adverse event: Back, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 972 at risk

Adverse event: Bone, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 972 at risk

Adverse event: Breast, pain
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 972 at risk

Adverse event: Cardiac/heart, pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 972 at risk

Adverse event: Chest/thoracic pain NOS
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 972 at risk

Adverse event: Extremity-limb, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 972 at risk

Adverse event: Head/headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 23 affected / 972 at risk

Adverse event: Joint, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 26 affected / 972 at risk

Adverse event: Muscle, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 972 at risk

Adverse event: Neuropathic, pain
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 972 at risk

Adverse event: Oral cavity, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 972 at risk

Adverse event: Pleura, pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 972 at risk

Adverse event: Rectum, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 972 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 972 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 32 affected / 972 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 972 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 972 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 972 at risk

Adverse event: Voice changes/dysarthria
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 972 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 972 at risk

Adverse event: Renal/GU-other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 972 at risk

Adverse event: Irregular menses
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 972 at risk

Adverse event: Cytokine release syndrome
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 972 at risk

Adverse event: Vascular access,Thrombosis/embolism
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 972 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 39 affected / 972 at risk

Adverse event: Vascular-Other (Specify)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 972 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 37 affected / 972 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 188 affected / 972 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 52 affected / 972 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 16 affected / 1922 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 32 affected / 1922 at risk

Adverse event: Leukocytes decreased
Serious: yes
Organ System: Investigations
Frequency: 92 affected / 1922 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 13 affected / 1922 at risk

Adverse event: Neutrophils decreased
Serious: yes
Organ System: Investigations
Frequency: 389 affected / 1922 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 11 affected / 1922 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1922 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Sinus arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1922 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1922 at risk

Adverse event: Vasovagal episode
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1922 at risk

Adverse event: Cardiac-ischemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1922 at risk

Adverse event: Cardiac troponin I (cTnI) increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1922 at risk

Adverse event: C-P arrest, non-fatal, cause unknown
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 147 affected / 1922 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 11 affected / 1922 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1922 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 38 affected / 1922 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1922 at risk

Adverse event: Cardiomyopathy, restrictive
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1922 at risk

Adverse event: Cor pulmonale
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Valvular heart disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1922 at risk

Adverse event: cardiac-other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 188 affected / 1922 at risk

Adverse event: Fever w/o neutropenia
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 1922 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 1922 at risk

Adverse event: Obesity
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1922 at risk

Adverse event: Rigors/chills
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1922 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 1922 at risk

Adverse event: International normalised ratio increased
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 1922 at risk

Adverse event: Coagulation-other
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1922 at risk

Adverse event: Dry skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Injection site reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Nail disorder
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 1922 at risk

Adverse event: Pruritus/itching
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1922 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 32 affected / 1922 at risk

Adverse event: Chemoradiation dermatitis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1922 at risk

Adverse event: Radiation dermatitis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1922 at risk

Adverse event: Hand-foot reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 1922 at risk

Adverse event: Skin breakdown/decubitus ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1922 at risk

Adverse event: Ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1922 at risk

Adverse event: Wound - non-infectious
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 17 affected / 1922 at risk

Adverse event: Skin-other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1922 at risk

Adverse event: Death - disease progression NOS
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1922 at risk

Adverse event: Hot flush
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 1922 at risk

Adverse event: Pancreatic glucose intolerance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 26 affected / 1922 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1922 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 1922 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 54 affected / 1922 at risk

Adverse event: Periodontal disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 66 affected / 1922 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1922 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1922 at risk

Adverse event: Fistula, Abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Fistula, Anus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1922 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1922 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 1922 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 1922 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1922 at risk

Adverse event: Muco/stomatitis by exam, oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1922 at risk

Adverse event: Muco/stomatitis by exam, pharynx
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1922 at risk

Adverse event: Muco/stomatitis (symptom) oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 55 affected / 1922 at risk

Adverse event: Muco/stomatitis (symptom) pharynx
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 54 affected / 1922 at risk

Adverse event: Obstruction, cecum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Obstruction, colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Obstruction, small bowel NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Perforation, colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Ulcer, anus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 49 affected / 1922 at risk

Adverse event: GI-other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 1922 at risk

Adverse event: Lower GI, hemorrhage NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1922 at risk

Adverse event: Rectum, hemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 1922 at risk

Adverse event: Stomach, hemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Upper GI, hemorrhage NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Bladder, hemorrhage
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Uterus, hemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Vagina, hemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 1922 at risk

Adverse event: Nose, hemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 1922 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Colitis, infectious (e.g. C.diff)
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 1922 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 77 affected / 1922 at risk

Adverse event: Infection w/ gr3-4 neut, anal/perianal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1922 at risk

Adverse event: Infection w/ gr3-4 neut, bladder
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1922 at risk

Adverse event: Infection w/ gr3-4 neut, bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1922 at risk

Adverse event: Infection w/ gr3-4 neut, catheter relate
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1922 at risk

Adverse event: Infection w/ gr3-4 neut, colon
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 1922 at risk

Adverse event: Infection w/ gr3-4 neut, dental-tooth
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1922 at risk

Adverse event: Infection w/ gr3-4 neut, foreign body
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1922 at risk

Adverse event: Infection w/ gr3-4 neut, joint
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1922 at risk

Adverse event: Infection w/ gr3-4 neut, kidney
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1922 at risk

Adverse event: Infection w/ gr3-4 neut, lung
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 1922 at risk

Adverse event: Infection w/ gr3-4 neut, lymphatic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1922 at risk

Adverse event: Infection w/ gr3-4 neut, mucosa
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1922 at risk

Adverse event: Infection w/ gr3-4 neut, paranasal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1922 at risk

Adverse event: Infection w/ gr3-4 neut, sinus
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1922 at risk

Adverse event: Infection w/ gr3-4 neut, skin
Serious: yes
Organ System: Infections and infestations
Frequency: 12 affected / 1922 at risk

Adverse event: Infection w/ gr3-4 neut, sm bowel NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1922 at risk

Adverse event: Infection w/ gr3-4 neut, soft tissue NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1922 at risk

Adverse event: Infection w/ gr3-4 neut, upper airway
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1922 at risk

Adverse event: Infection w/ gr3-4 neut, urinary tract
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 1922 at risk

Adverse event: Infection w/ gr3-4 neut, vagina
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1922 at risk

Adverse event: Infection w/ gr3-4 neut, vulva
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1922 at risk

Adverse event: Infection w/ gr3-4 neut, wound
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 1922 at risk

Adverse event: Infection Gr0-2 neut, abdomen
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1922 at risk

Adverse event: Infection Gr0-2 neut, anal/perianl
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 1922 at risk

Adverse event: Infection Gr0-2 neut, appendix
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1922 at risk

Adverse event: Infection Gr0-2 neut, bladder
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1922 at risk

Adverse event: Infection Gr0-2 neut, bone
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1922 at risk

Adverse event: Infection Gr0-2 neut, bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1922 at risk

Adverse event: Infection Gr0-2 neut, catheter
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 1922 at risk

Adverse event: Infection Gr0-2 neut, colon
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 1922 at risk

Adverse event: Infection Gr0-2 neut, external ear
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1922 at risk

Adverse event: Infection Gr0-2 neut, eye NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1922 at risk

Adverse event: Infection Gr0-2 neut, foreign body
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1922 at risk

Adverse event: Infection Gr0-2 neut, gallbladder
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1922 at risk

Adverse event: Infection Gr0-2 neut, lung
Serious: yes
Organ System: Infections and infestations
Frequency: 19 affected / 1922 at risk

Adverse event: Infection Gr0-2 neut, lymphatic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1922 at risk

Adverse event: Infection Gr0-2 neut, meninges
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1922 at risk

Adverse event: Infection Gr0-2 neut, middle ear
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1922 at risk

Adverse event: Infection Gr0-2 neut, muscle
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1922 at risk

Adverse event: Infection Gr0-2 neut, nerve-periph
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1922 at risk

Adverse event: Infection Gr0-2 neut, oral cavity
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1922 at risk

Adverse event: Infection Gr0-2 neut, pancreas
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1922 at risk

Adverse event: Infection Gr0-2 neut, pelvis NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1922 at risk

Adverse event: Infection Gr0-2 neut, rectum
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1922 at risk

Adverse event: Infection Gr0-2 neut, sinus
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1922 at risk

Adverse event: Infection Gr0-2 neut, skin
Serious: yes
Organ System: Infections and infestations
Frequency: 25 affected / 1922 at risk

Adverse event: Infection Gr0-2 neut, soft tissue
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 1922 at risk

Adverse event: Infection Gr0-2 neut, ungual
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1922 at risk

Adverse event: Infection Gr0-2 neut, upper airway
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1922 at risk

Adverse event: Infection Gr0-2 neut, urinary tract
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 1922 at risk

Adverse event: Infection Gr0-2 neut, wound
Serious: yes
Organ System: Infections and infestations
Frequency: 15 affected / 1922 at risk

Adverse event: Infection w/ unk ANC dental-tooth
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1922 at risk

Adverse event: Infection w/ unk ANC foreign body
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 1922 at risk

Adverse event: Infection w/ unk ANC sinus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1922 at risk

Adverse event: Infection w/ unk ANC skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1922 at risk

Adverse event: Infection w/ unk ANC ungual (nails)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1922 at risk

Adverse event: Infection w/ unk ANC urinary tract NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1922 at risk

Adverse event: Infection w/ unk ANC wound
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1922 at risk

Adverse event: Opportunistic infection lymphopenia>=gr1
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1922 at risk

Adverse event: Infection w/ gr3-4 neut, blood
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 1922 at risk

Adverse event: Infection Gr0-2 neut, blood
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 1922 at risk

Adverse event: Infection-other
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 1922 at risk

Adverse event: Edema head and neck
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1922 at risk

Adverse event: Edema limb
Serious: yes
Organ System: General disorders
Frequency: 12 affected / 1922 at risk

Adverse event: Edema trunk/genital
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Edema visceral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Lymphedema-related fibrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1922 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1922 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1922 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1922 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1922 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Lipase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1922 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 1922 at risk

Adverse event: Proteinuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 1922 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 1922 at risk

Adverse event: Hyperuricaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Extremity upper (function)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Local complication - device/prosthesis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1922 at risk

Adverse event: Nonneuropathic generalized weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1922 at risk

Adverse event: Myositis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Seroma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1922 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 1922 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 1922 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 1922 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 15 affected / 1922 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1922 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 1922 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 14 affected / 1922 at risk

Adverse event: Neuropathy-motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 1922 at risk

Adverse event: Neuropathy-sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 153 affected / 1922 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 1922 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1922 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1922 at risk

Adverse event: Speech impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 34 affected / 1922 at risk

Adverse event: Tremor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Neurologic-other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Dry eye
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Vision-blurred
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Tearing
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Abdomen, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 1922 at risk

Adverse event: Anus, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1922 at risk

Adverse event: Back, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 1922 at risk

Adverse event: Bladder, pain
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Bone, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 1922 at risk

Adverse event: Breast, pain
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Cardiac/heart, pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1922 at risk

Adverse event: Chest wall, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 1922 at risk

Adverse event: Chest/thoracic pain NOS
Serious: yes
Organ System: General disorders
Frequency: 25 affected / 1922 at risk

Adverse event: Dental/teeth/peridontal, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 1922 at risk

Adverse event: External ear, pain
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Extremity-limb, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 1922 at risk

Adverse event: Gallbladder, pain
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Head/headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 73 affected / 1922 at risk

Adverse event: Joint, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 37 affected / 1922 at risk

Adverse event: Muscle, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 38 affected / 1922 at risk

Adverse event: Neck, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1922 at risk

Adverse event: Neuropathic, pain
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1922 at risk

Adverse event: Oral cavity, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 1922 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1922 at risk

Adverse event: Rectum, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 1922 at risk

Adverse event: Skin, pain
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 1922 at risk

Adverse event: Pain-other
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 1922 at risk

Adverse event: (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1922 at risk

Adverse event: Bronchospasm, wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1922 at risk

Adverse event: (DLCO) decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1922 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 1922 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 60 affected / 1922 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 1922 at risk

Adverse event: Nasal cavity/paranasal sinus reaction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1922 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 27 affected / 1922 at risk

Adverse event: Voice changes/dysarthria
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 1922 at risk

Adverse event: Pulmonary/Upper Respiratory-other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 1922 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Obstruction-ureteral
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 1922 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Urinary frequency/urgency
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Renal/GU-other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 1922 at risk

Adverse event: Intra-op injury Breast
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1922 at risk

Adverse event: Intra-op injury Parathyroid
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1922 at risk

Adverse event: Irregular menses
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 10 affected / 1922 at risk

Adverse event: Sexual/Reproductive function-Other
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1922 at risk

Adverse event: Flu-like syndrome
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1922 at risk

Adverse event: Vascular access,Thrombosis/embolism
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 1922 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 71 affected / 1922 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 103 affected / 1922 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 356 affected / 1922 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 117 affected / 1922 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 16 affected / 1942 at risk

Adverse event: Hearing w/o audiogr not in monitor prg
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 26 affected / 1942 at risk

Adverse event: Leukocytes decreased
Serious: yes
Organ System: Investigations
Frequency: 98 affected / 1942 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 8 affected / 1942 at risk

Adverse event: Neutrophils decreased
Serious: yes
Organ System: Investigations
Frequency: 400 affected / 1942 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 19 affected / 1942 at risk

Adverse event: Sinus arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1942 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1942 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Arrhythmia supraventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1942 at risk

Adverse event: Vasovagal episode
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1942 at risk

Adverse event: PVCs
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Torsade de pointes
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Cardiac-ischemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 1942 at risk

Adverse event: Cardiac troponin I (cTnI) increased
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 1942 at risk

Adverse event: Cardiac troponin T (cTnT) increased
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 1942 at risk

Adverse event: C-P arrest, non-fatal, cause unknown
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 138 affected / 1942 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 1942 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 1942 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 43 affected / 1942 at risk

Adverse event: Pericardial effusion (non-malignant)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1942 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Cardiomyopathy, restrictive
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 1942 at risk

Adverse event: Valvular heart disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1942 at risk

Adverse event: cardiac-other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 195 affected / 1942 at risk

Adverse event: Fever w/o neutropenia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 1942 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 1942 at risk

Adverse event: Obesity
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Rigors/chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Weight increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1942 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 1942 at risk

Adverse event: Constitutional, other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1942 at risk

Adverse event: International normalised ratio increased
Serious: yes
Organ System: Investigations
Frequency: 9 affected / 1942 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 1942 at risk

Adverse event: Coagulation-other
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1942 at risk

Adverse event: Dry skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Induration/fibrosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Injection site reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Nail disorder
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 1942 at risk

Adverse event: Pruritus/itching
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1942 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 1942 at risk

Adverse event: Rash: acne/acneiform
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Erythema multiforme
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Hand-foot reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 1942 at risk

Adverse event: Skin breakdown/decubitus ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1942 at risk

Adverse event: Ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 1942 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Wound - non-infectious
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 1942 at risk

Adverse event: Skin-other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1942 at risk

Adverse event: Death - disease progression NOS
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1942 at risk

Adverse event: Hot flush
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 1942 at risk

Adverse event: Pancreatic glucose intolerance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 29 affected / 1942 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 1942 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 37 affected / 1942 at risk

Adverse event: Teeth
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 1942 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 1942 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1942 at risk

Adverse event: Fistula, Anus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Fistula, Rectum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1942 at risk

Adverse event: Fistula, Small bowel NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 1942 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 1942 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1942 at risk

Adverse event: Leak, incl. anastomotic, Leak NOS
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1942 at risk

Adverse event: Muco/stomatitis by exam, oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1942 at risk

Adverse event: Muco/stomatitis by exam, rectum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Muco/stomatitis (symptom) esophagus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1942 at risk

Adverse event: Muco/stomatitis (symptom) oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 57 affected / 1942 at risk

Adverse event: Muco/stomatitis (symptom) rectum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 57 affected / 1942 at risk

Adverse event: Obstruction, small bowel NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Perforation, colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1942 at risk

Adverse event: Stenosis (incl anastomotic) esophagus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Ulcer, duodenum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 44 affected / 1942 at risk

Adverse event: GI-other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 1942 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1942 at risk

Adverse event: CNS, hemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1942 at risk

Adverse event: Abdomen, hemorrhage NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Lower GI, hemorrhage NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1942 at risk

Adverse event: Rectum, hemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 1942 at risk

Adverse event: Upper GI, hemorrhage NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1942 at risk

Adverse event: Bladder, hemorrhage
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Urinary hemorrhage NOS
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Uterus, hemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Vagina, hemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 1942 at risk

Adverse event: Lung, hemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Nose, hemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 1942 at risk

Adverse event: Hemorrhage-other
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 1942 at risk

Adverse event: Liver dysfunction/failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Hepatic-other
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Colitis, infectious (e.g. C.diff)
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1942 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 91 affected / 1942 at risk

Adverse event: Infection w/ gr3-4 neut, bladder
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 1942 at risk

Adverse event: Infection w/ gr3-4 neut, bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1942 at risk

Adverse event: Infection w/ gr3-4 neut, catheter relate
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 1942 at risk

Adverse event: Infection w/ gr3-4 neut, colon
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1942 at risk

Adverse event: Infection w/ gr3-4 neut, dental-tooth
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1942 at risk

Adverse event: Infection w/ gr3-4 neut, foreign body
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1942 at risk

Adverse event: Infection w/ gr3-4 neut, kidney
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1942 at risk

Adverse event: Infection w/ gr3-4 neut, lip/perioral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1942 at risk

Adverse event: Infection w/ gr3-4 neut, lung
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 1942 at risk

Adverse event: Infection w/ gr3-4 neut, mediastinum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1942 at risk

Adverse event: Infection w/ gr3-4 neut, middle ear
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1942 at risk

Adverse event: Infection w/ gr3-4 neut, mucosa
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1942 at risk

Adverse event: Infection w/ gr3-4 neut, oral cavity
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1942 at risk

Adverse event: Infection w/ gr3-4 neut, paranasal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1942 at risk

Adverse event: Infection w/ gr3-4 neut, sinus
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1942 at risk

Adverse event: Infection w/ gr3-4 neut, skin
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 1942 at risk

Adverse event: Infection w/ gr3-4 neut, upper airway
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1942 at risk

Adverse event: Infection w/ gr3-4 neut, urinary tract
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 1942 at risk

Adverse event: Infection w/ gr3-4 neut, wound
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 1942 at risk

Adverse event: Infection Gr0-2 neut, anal/perianl
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1942 at risk

Adverse event: Infection Gr0-2 neut, appendix
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1942 at risk

Adverse event: Infection Gr0-2 neut, bladder
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 1942 at risk

Adverse event: Infection Gr0-2 neut, bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1942 at risk

Adverse event: Infection Gr0-2 neut, catheter
Serious: yes
Organ System: Infections and infestations
Frequency: 16 affected / 1942 at risk

Adverse event: Infection Gr0-2 neut, colon
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1942 at risk

Adverse event: Infection Gr0-2 neut, dental-tooth
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1942 at risk

Adverse event: Infection Gr0-2 neut, eye NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1942 at risk

Adverse event: Infection Gr0-2 neut, foreign body
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1942 at risk

Adverse event: Infection Gr0-2 neut, gallbladder
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1942 at risk

Adverse event: Infection Gr0-2 neut, heart
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1942 at risk

Adverse event: Infection Gr0-2 neut, kidney
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1942 at risk

Adverse event: Infection Gr0-2 neut, lip/perioral
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1942 at risk

Adverse event: Infection Gr0-2 neut, lung
Serious: yes
Organ System: Infections and infestations
Frequency: 27 affected / 1942 at risk

Adverse event: Infection Gr0-2 neut, nerve-periph
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1942 at risk

Adverse event: Infection Gr0-2 neut, pharynx
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1942 at risk

Adverse event: Infection Gr0-2 neut, rectum
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1942 at risk

Adverse event: Infection Gr0-2 neut, sinus
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 1942 at risk

Adverse event: Infection Gr0-2 neut, skin
Serious: yes
Organ System: Infections and infestations
Frequency: 22 affected / 1942 at risk

Adverse event: Infection Gr0-2 neut, sm bowel
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1942 at risk

Adverse event: Infection Gr0-2 neut, soft tissue
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1942 at risk

Adverse event: Infection Gr0-2 neut, stomach
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1942 at risk

Adverse event: Infection Gr0-2 neut, ungual
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 1942 at risk

Adverse event: Infection Gr0-2 neut, upper airway
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 1942 at risk

Adverse event: Infection Gr0-2 neut, urinary tract
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1942 at risk

Adverse event: Infection Gr0-2 neut, vagina
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1942 at risk

Adverse event: Infection Gr0-2 neut, vein
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1942 at risk

Adverse event: Infection Gr0-2 neut, vulva
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1942 at risk

Adverse event: Infection Gr0-2 neut, wound
Serious: yes
Organ System: Infections and infestations
Frequency: 12 affected / 1942 at risk

Adverse event: Infection w/ unk ANC anal/perianal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1942 at risk

Adverse event: Infection w/ unk ANC catheter related
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1942 at risk

Adverse event: Infection w/ unk ANC lung
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1942 at risk

Adverse event: Infection w/ unk ANC skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1942 at risk

Adverse event: Infection w/ unk ANC wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1942 at risk

Adverse event: Infection w/ gr3-4 neut, blood
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 1942 at risk

Adverse event: Infection Gr0-2 neut, blood
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 1942 at risk

Adverse event: Infection-other
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1942 at risk

Adverse event: Edema head and neck
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Edema limb
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 1942 at risk

Adverse event: Edema visceral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 1942 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 1942 at risk

Adverse event: Hypercholesterolaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1942 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1942 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 1942 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Lipase increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1942 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 1942 at risk

Adverse event: Proteinuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 1942 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 1942 at risk

Adverse event: Hypertriglyceridaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Extremity-lower (gait/walking)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1942 at risk

Adverse event: Nonneuropathic lower extr muscle weak
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1942 at risk

Adverse event: Nonneuropathic generalized weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1942 at risk

Adverse event: Osteoporosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Seroma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1942 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1942 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 1942 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 1942 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 18 affected / 1942 at risk

Adverse event: Laryngeal nerve dysfunction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Memory impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Mental status
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 1942 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 16 affected / 1942 at risk

Adverse event: Neuropathy CN II vision
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Neuropathy-motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 1942 at risk

Adverse event: Neuropathy-sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 172 affected / 1942 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 1942 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1942 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 22 affected / 1942 at risk

Adverse event: Neurologic-other
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 1942 at risk

Adverse event: Vision-blurred
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 1942 at risk

Adverse event: Abdomen, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 1942 at risk

Adverse event: Back, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 1942 at risk

Adverse event: Bladder, pain
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Bone, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 1942 at risk

Adverse event: Buttock, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Cardiac/heart, pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1942 at risk

Adverse event: Chest wall, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1942 at risk

Adverse event: Chest/thoracic pain NOS
Serious: yes
Organ System: General disorders
Frequency: 25 affected / 1942 at risk

Adverse event: Dental/teeth/peridontal, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1942 at risk

Adverse event: Extremity-limb, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 1942 at risk

Adverse event: Gallbladder, pain
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 1942 at risk

Adverse event: Head/headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 72 affected / 1942 at risk

Adverse event: Joint, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 43 affected / 1942 at risk

Adverse event: Middle ear, pain
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Muscle, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 30 affected / 1942 at risk

Adverse event: Neck, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1942 at risk

Adverse event: Oral cavity, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1942 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Perineum, pain
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Rectum, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1942 at risk

Adverse event: Stomach, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Throat/pharynx/larynx, pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1942 at risk

Adverse event: Pain-other
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 1942 at risk

Adverse event: (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Bronchospasm, wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1942 at risk

Adverse event: (DLCO) decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1942 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 1942 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 63 affected / 1942 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 1942 at risk

Adverse event: Nasal cavity/paranasal sinus reaction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1942 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 1942 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 1942 at risk

Adverse event: Pulmonary fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Voice changes/dysarthria
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 1942 at risk

Adverse event: Pulmonary/Upper Respiratory-other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 1942 at risk

Adverse event: Bladder spasms
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1942 at risk

Adverse event: Obstruction-ureteral
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 1942 at risk

Adverse event: Urinary frequency/urgency
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Renal/GU-other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 1942 at risk

Adverse event: Secondary malignancy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1942 at risk

Adverse event: Intra-op injury Pharynx
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1942 at risk

Adverse event: Irregular menses
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 8 affected / 1942 at risk

Adverse event: Vaginitis (not due to infection)
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Sexual/Reproductive function-Other
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Flu-like syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Syndromes-other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1942 at risk

Adverse event: Vascular access,Thrombosis/embolism
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 1942 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 65 affected / 1942 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 87 affected / 1942 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 334 affected / 1942 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 119 affected / 1942 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Hearing-other
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 1168 at risk

Adverse event: Myelodysplastic syndrome
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1168 at risk

Adverse event: Neutrophils decreased
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 1168 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Sinus arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Cardiac-ischemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1168 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 131 affected / 1168 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 34 affected / 1168 at risk

Adverse event: Cardiomyopathy, restrictive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1168 at risk

Adverse event: cardiac-other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 31 affected / 1168 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 1168 at risk

Adverse event: Obesity
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Weight increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1168 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 10 affected / 1168 at risk

Adverse event: International normalised ratio increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1168 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1168 at risk

Adverse event: Nail disorder
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 1168 at risk

Adverse event: Radiation dermatitis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 1168 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Wound - non-infectious
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 17 affected / 1168 at risk

Adverse event: Skin-other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 1168 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Death - disease progression NOS
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 1168 at risk

Adverse event: Hot flush
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 1168 at risk

Adverse event: Hyopthyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 1168 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 1168 at risk

Adverse event: Teeth
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 1168 at risk

Adverse event: Fistula, Rectum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Leak, incl. anastomotic, biliary tree
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1168 at risk

Adverse event: Muco/stomatitis (symptom) oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 1168 at risk

Adverse event: Perforation, colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Perforation, small bowel NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Stenosis (incl anastomotic) esophagus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1168 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 1168 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1168 at risk

Adverse event: CNS, hemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Lower GI, hemorrhage NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Rectum, hemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1168 at risk

Adverse event: Upper GI, hemorrhage NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Nose, hemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1168 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 1168 at risk

Adverse event: Liver dysfunction/failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Infection w/ gr3-4 neut, neck NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1168 at risk

Adverse event: Infection Gr0-2 neut, catheter
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1168 at risk

Adverse event: Infection Gr0-2 neut, foreign body
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1168 at risk

Adverse event: Infection Gr0-2 neut, lung
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1168 at risk

Adverse event: Infection Gr0-2 neut, rectum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1168 at risk

Adverse event: Infection Gr0-2 neut, sinus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1168 at risk

Adverse event: Infection Gr0-2 neut, skin
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 1168 at risk

Adverse event: Infection Gr0-2 neut, soft tissue
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1168 at risk

Adverse event: Infection Gr0-2 neut, ungual
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1168 at risk

Adverse event: Infection Gr0-2 neut, urinary tract
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1168 at risk

Adverse event: Infection Gr0-2 neut, vagina
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1168 at risk

Adverse event: Infection Gr0-2 neut, wound
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1168 at risk

Adverse event: Infection w/ unk ANC catheter related
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1168 at risk

Adverse event: Infection w/ unk ANC foreign body
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1168 at risk

Adverse event: Infection w/ unk ANC gallbladder
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1168 at risk

Adverse event: Infection w/ unk ANC meninges
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1168 at risk

Adverse event: Infection w/ unk ANC skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1168 at risk

Adverse event: Infection w/ unk ANC ungual (nails)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1168 at risk

Adverse event: Infection w/ unk ANC wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1168 at risk

Adverse event: Infection Gr0-2 neut, blood
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1168 at risk

Adverse event: Infection-other
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1168 at risk

Adverse event: Edema limb
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 1168 at risk

Adverse event: Edema trunk/genital
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1168 at risk

Adverse event: Lymphedema-related fibrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Lymphatics-other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1168 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1168 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1168 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1168 at risk

Adverse event: Proteinuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 20 affected / 1168 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1168 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1168 at risk

Adverse event: Fibrosis-deep connective tissue
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 1168 at risk

Adverse event: Local complication - device/prosthesis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1168 at risk

Adverse event: Nonneuropathic lower extr muscle weak
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Nonneuropathic upper extr muscle weak
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Myositis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Osteonecrosis (avascular necrosis)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1168 at risk

Adverse event: Seroma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1168 at risk

Adverse event: Soft tissue necrosis, neck
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Soft tissue necrosis, thoracic
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 1168 at risk

Adverse event: Musculoskeletal/soft tissue-other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 1168 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 1168 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 1168 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 1168 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 1168 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 8 affected / 1168 at risk

Adverse event: Neuropathy-motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1168 at risk

Adverse event: Neuropathy-sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 49 affected / 1168 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1168 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 1168 at risk

Adverse event: Neurologic-other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 1168 at risk

Adverse event: Diplopia
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Vision-blurred
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Abdomen, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 1168 at risk

Adverse event: Back, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 1168 at risk

Adverse event: Bone, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1168 at risk

Adverse event: Breast, pain
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Cardiac/heart, pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Chest wall, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1168 at risk

Adverse event: Chest/thoracic pain NOS
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 1168 at risk

Adverse event: External ear, pain
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Extremity-limb, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1168 at risk

Adverse event: Head/headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 26 affected / 1168 at risk

Adverse event: Joint, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 40 affected / 1168 at risk

Adverse event: Muscle, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 24 affected / 1168 at risk

Adverse event: Neck, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Neuropathic, pain
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1168 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Sinus, pain
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Stomach, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Vagina, pain
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Bronchospasm, wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 1168 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 1168 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1168 at risk

Adverse event: Nasal cavity/paranasal sinus reaction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1168 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1168 at risk

Adverse event: Voice changes/dysarthria
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1168 at risk

Adverse event: Pulmonary/Upper Respiratory-other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1168 at risk

Adverse event: Obstruction-ureteral
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1168 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Renal/GU-other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1168 at risk

Adverse event: Irregular menses
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 9 affected / 1168 at risk

Adverse event: Vascular access,Thrombosis/embolism
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1168 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 15 affected / 1168 at risk

Adverse event: Vessel injury Extremity-upper
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1168 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 64 affected / 1168 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 182 affected / 1168 at risk