Study: NCT00313586

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 55 affected / 99 at risk

Adverse event: Leukocytes
Serious: yes
Organ System: Investigations
Frequency: 69 affected / 99 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 99 at risk

Adverse event: Neutrophil count
Serious: yes
Organ System: Investigations
Frequency: 78 affected / 99 at risk

Adverse event: Platelets
Serious: yes
Organ System: Investigations
Frequency: 75 affected / 99 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 99 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 99 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 99 at risk

Adverse event: Disseminated intravascular coagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 99 at risk

Adverse event: Injection site reaction
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 99 at risk

Adverse event: Death - multiorgan failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 99 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 99 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 99 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 99 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 99 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 99 at risk

Adverse event: Muco/stomatitis by exam, oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 99 at risk

Adverse event: Muco/stomatitis (symptom) oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 99 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 99 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 99 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 99 at risk

Adverse event: Colitis, infectious (e.g. C.diff)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 99 at risk

Adverse event: Infection w/ gr3-4 neut, abdomen NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Infection w/ gr3-4 neut, bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Infection w/ gr3-4 neut, catheter relate
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 99 at risk

Adverse event: Infection w/ gr3-4 neut, foreign body
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Infection w/ gr3-4 neut, lung
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 99 at risk

Adverse event: Infection w/ gr3-4 neut, pharynx
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Infection w/ gr3-4 neut, sinus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Infection w/ gr3-4 neut, skin
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Infection w/ gr3-4 neut, upper airway
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Infection Gr0-2 neut, catheter
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Infection Gr0-2 neut, colon
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Infection Gr0-2 neut, lung
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Infection Gr0-2 neut, skin
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Infection Gr0-2 neut, urinary tract
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Infection Gr0-2 neut, wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Infection w/ unk ANC abdomen NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Infection w/ unk ANC urinary tract NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Infection w/ gr3-4 neut, blood
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 99 at risk

Adverse event: Infection Gr0-2 neut, blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 99 at risk

Adverse event: Blood alkaline phosphatase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 99 at risk

Adverse event: AST, SGOT
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 99 at risk

Adverse event: Blood bilirubin
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 99 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 99 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 99 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 99 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 99 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 99 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 99 at risk

Adverse event: Hyperuricaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 99 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 99 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 99 at risk

Adverse event: Extremity-limb, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 99 at risk

Adverse event: Head/headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 99 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 99 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 99 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 99 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 80 affected / 99 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Investigations
Frequency: 67 affected / 99 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 11 affected / 99 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Investigations
Frequency: 56 affected / 99 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 63 affected / 99 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 99 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 71 affected / 99 at risk

Adverse event: Fever w/o neutropenia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 99 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 99 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 4 affected / 99 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 99 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 99 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 99 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 99 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 41 affected / 99 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 99 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 99 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 99 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 99 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 99 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 99 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 99 at risk

Adverse event: Muco/stomatitis by exam, oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 99 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 49 affected / 99 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 99 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 99 at risk

Adverse event: Nose, hemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 99 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 99 at risk

Adverse event: Edema limb
Serious: no
Organ System: General disorders
Frequency: 7 affected / 99 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 99 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 11 affected / 99 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Investigations
Frequency: 15 affected / 99 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Investigations
Frequency: 14 affected / 99 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Investigations
Frequency: 11 affected / 99 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 99 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 18 affected / 99 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 30 affected / 99 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 99 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 99 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 99 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 99 at risk

Adverse event: Nonneuropathic generalized weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 99 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 99 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 99 at risk

Adverse event: Abdomen, pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 99 at risk

Adverse event: Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 99 at risk

Adverse event: Joint, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 99 at risk

Adverse event: Muscle, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 99 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 99 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 99 at risk

Adverse event: Autoimmune reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 98 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 54 affected / 98 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 98 at risk

Adverse event: Leukocytes
Serious: yes
Organ System: Investigations
Frequency: 65 affected / 98 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 98 at risk

Adverse event: Neutrophil count
Serious: yes
Organ System: Investigations
Frequency: 72 affected / 98 at risk

Adverse event: Platelets
Serious: yes
Organ System: Investigations
Frequency: 76 affected / 98 at risk

Adverse event: Heart block 3rd degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 98 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 98 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 98 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 98 at risk

Adverse event: Pericardial effusion (non-malignant)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 98 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 21 affected / 98 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 98 at risk

Adverse event: Constitutional, other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 98 at risk

Adverse event: Coagulation-other
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 98 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 98 at risk

Adverse event: Rash: acne/acneiform
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 98 at risk

Adverse event: Death - multiorgan failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 98 at risk

Adverse event: Death - sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 98 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 98 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 98 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 98 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 98 at risk

Adverse event: Obstruction, small bowel NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: CNS, hemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 98 at risk

Adverse event: Abdomen, hemorrhage NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: Lower GI, hemorrhage NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: Oral cavity, hemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: Nose, hemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: Colitis, infectious (e.g. C.diff)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 98 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 25 affected / 98 at risk

Adverse event: Infection w/ gr3-4 neut, anal/perianal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 98 at risk

Adverse event: Infection w/ gr3-4 neut, catheter relate
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 98 at risk

Adverse event: Infection w/ gr3-4 neut, colon
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 98 at risk

Adverse event: Infection w/ gr3-4 neut, lung
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 98 at risk

Adverse event: Infection w/ gr3-4 neut, muscle
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 98 at risk

Adverse event: Infection w/ gr3-4 neut, sinus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 98 at risk

Adverse event: Infection w/ gr3-4 neut, skin
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 98 at risk

Adverse event: Infection w/ gr3-4 neut, soft tissue NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 98 at risk

Adverse event: Infection w/ gr3-4 neut, upper airway
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 98 at risk

Adverse event: Infection w/ gr3-4 neut, urinary tract
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 98 at risk

Adverse event: Infection Gr0-2 neut, lung
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 98 at risk

Adverse event: Infection Gr0-2 neut, muscle
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 98 at risk

Adverse event: Infection w/ unk ANC urinary tract NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 98 at risk

Adverse event: Opportunistic infection lymphopenia>=gr1
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 98 at risk

Adverse event: Infection w/ gr3-4 neut, blood
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 98 at risk

Adverse event: Infection Gr0-2 neut, blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 98 at risk

Adverse event: Infection-other
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 98 at risk

Adverse event: Edema limb
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 98 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 98 at risk

Adverse event: ALT, SGPT
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 98 at risk

Adverse event: AST, SGOT
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 98 at risk

Adverse event: Blood bilirubin
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 98 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 98 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 98 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 98 at risk

Adverse event: Lipase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 98 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 98 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 98 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 98 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 98 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 98 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 98 at risk

Adverse event: Nonneuropathic generalized weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 98 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 98 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 98 at risk

Adverse event: Neuropathy CN II vision
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 98 at risk

Adverse event: Neuropathy-sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 98 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 98 at risk

Adverse event: Abdomen, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: Cardiac/heart, pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 98 at risk

Adverse event: Chest wall, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 98 at risk

Adverse event: Chest/thoracic pain NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 98 at risk

Adverse event: Extremity-limb, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 98 at risk

Adverse event: Head/headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 98 at risk

Adverse event: Joint, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 98 at risk

Adverse event: Muscle, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 98 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 98 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: Pulmonary/Upper Respiratory-other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 98 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 98 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 98 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 74 affected / 98 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Investigations
Frequency: 57 affected / 98 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 8 affected / 98 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Investigations
Frequency: 49 affected / 98 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 57 affected / 98 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 98 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 71 affected / 98 at risk

Adverse event: Fever w/o neutropenia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 98 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 98 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 5 affected / 98 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 98 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 15 affected / 98 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 98 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 98 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 42 affected / 98 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 98 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 98 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 49 affected / 98 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 39 affected / 98 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 98 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 98 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 98 at risk

Adverse event: Muco/stomatitis by exam, oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 98 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 55 affected / 98 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 98 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 98 at risk

Adverse event: Nose, hemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 98 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 98 at risk

Adverse event: Edema limb
Serious: no
Organ System: General disorders
Frequency: 23 affected / 98 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 41 affected / 98 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 17 affected / 98 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Investigations
Frequency: 12 affected / 98 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Investigations
Frequency: 11 affected / 98 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Investigations
Frequency: 11 affected / 98 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 42 affected / 98 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 26 affected / 98 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 40 affected / 98 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 98 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 98 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 98 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 36 affected / 98 at risk

Adverse event: Nonneuropathic generalized weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 98 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 98 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 98 at risk

Adverse event: Abdomen, pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 98 at risk

Adverse event: Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 98 at risk

Adverse event: Joint, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 98 at risk

Adverse event: Muscle, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 98 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 98 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 98 at risk