Study: NCT00068692

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 123 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 123 at risk

Adverse event: Leukocytes decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 123 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 8 affected / 123 at risk

Adverse event: Neutrophils decreased
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 123 at risk

Adverse event: Hematologic-other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 123 at risk

Adverse event: Cardiac-ischemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 123 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 123 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 123 at risk

Adverse event: Fever w/o neutropenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 123 at risk

Adverse event: International normalised ratio increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 123 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 123 at risk

Adverse event: Radiation dermatitis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 123 at risk

Adverse event: Hand-foot reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 123 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 123 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 123 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 123 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 123 at risk

Adverse event: Leak, incl. anastomotic, rectum
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 123 at risk

Adverse event: Muco/stomatitis by exam, oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 123 at risk

Adverse event: Muco/stomatitis (symptom) oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 123 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 123 at risk

Adverse event: Obstruction, colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 123 at risk

Adverse event: Obstruction, small bowel NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 123 at risk

Adverse event: Proctitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 123 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 123 at risk

Adverse event: Surgical hemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 123 at risk

Adverse event: Infection w/ gr3-4 neut, abdomen NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 123 at risk

Adverse event: Infection Gr0-2 neut, abdomen
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 123 at risk

Adverse event: Infection Gr0-2 neut, penis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 123 at risk

Adverse event: Infection Gr0-2 neut, wound
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 123 at risk

Adverse event: Infection w/ unk ANC rectum
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 123 at risk

Adverse event: Infection Gr0-2 neut, blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 123 at risk

Adverse event: Infection w/ unk ANC blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 123 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 123 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 123 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 123 at risk

Adverse event: Hyperuricaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 123 at risk

Adverse event: Metabolic/Laboratory-other
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 123 at risk

Adverse event: Nonneuropathic generalized weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 123 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 123 at risk

Adverse event: Abdomen, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 123 at risk

Adverse event: Back, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 123 at risk

Adverse event: Neuropathic, pain
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 123 at risk

Adverse event: Oral cavity, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 123 at risk

Adverse event: Rectum, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 123 at risk

Adverse event: Pain-other
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 123 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 123 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 123 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 123 at risk

Adverse event: Leukocytes decreased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 123 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 13 affected / 123 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 123 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 123 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 123 at risk

Adverse event: Muco/stomatitis by exam, oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 123 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 123 at risk

Adverse event: Leukocytes decreased
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 27 at risk

Adverse event: Neutrophils decreased
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 27 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 27 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 27 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 27 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 27 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 27 at risk

Adverse event: Muco/stomatitis (symptom) pharynx
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 27 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: Metabolic/Laboratory-other
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 27 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 27 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 27 at risk

Adverse event: Leukocytes decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 27 at risk

Adverse event: Neutrophils decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 27 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 27 at risk

Adverse event: Hand-foot reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 27 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 27 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 27 at risk

Adverse event: Muco/stomatitis by exam, oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 27 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Abdomen, pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Leukocytes decreased
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 22 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 22 at risk

Adverse event: Neutrophils decreased
Serious: yes
Organ System: Investigations
Frequency: 9 affected / 22 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 22 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: Proctitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Abdomen, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Urethra, pain
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 22 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 22 at risk

Adverse event: Leukocytes decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 22 at risk

Adverse event: Neutrophils decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 22 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 22 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 22 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 22 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Muco/stomatitis (symptom) oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 22 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 22 at risk

Adverse event: Abdomen, pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Leukocytes decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 28 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 28 at risk

Adverse event: Neutrophils decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 28 at risk

Adverse event: Cardiac-ischemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 28 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 28 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 28 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 28 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 28 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 28 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Muco/stomatitis (symptom) pharynx
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Infection w/ gr3-4 neut, urinary tract
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 28 at risk

Adverse event: Nonneuropathic generalized weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Neuropathy-motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Abdomen, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Extremity-limb, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 28 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Leukocytes decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 28 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 28 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Muco/stomatitis (symptom) oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Abdomen, pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

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

Adverse event: Leukocytes decreased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 31 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 31 at risk

Adverse event: Neutrophils decreased
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 31 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 31 at risk

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

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 31 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Hand-foot reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 31 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 31 at risk

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

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 31 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 31 at risk

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

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

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 31 at risk

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

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

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 31 at risk

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

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

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

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

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

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

Adverse event: Neck, pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

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

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31 at risk

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

Adverse event: Neutrophils decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 31 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 31 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 31 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 31 at risk

Adverse event: Muco/stomatitis by exam, oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Muco/stomatitis (symptom) oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

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

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

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

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 33 at risk

Adverse event: Leukocytes decreased
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 33 at risk

Adverse event: Neutrophils decreased
Serious: yes
Organ System: Investigations
Frequency: 9 affected / 33 at risk

Adverse event: Hand-foot reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 33 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 33 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 33 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Muco/stomatitis by exam, pharynx
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: GI-other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 33 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 33 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 33 at risk

Adverse event: Neuropathy-sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 33 at risk

Adverse event: Abdomen, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Head/headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 33 at risk

Adverse event: Leukocytes decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 33 at risk

Adverse event: Neutrophils decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 33 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 33 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 33 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 33 at risk

Adverse event: Muco/stomatitis by exam, oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Muco/stomatitis (symptom) oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 33 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 33 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 33 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 33 at risk

Adverse event: Abdomen, pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Leukocytes decreased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 32 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 32 at risk

Adverse event: Neutrophils decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 32 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 32 at risk

Adverse event: International normalised ratio increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 32 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Hand-foot reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 32 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 32 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 32 at risk

Adverse event: Muco/stomatitis by exam, oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Muco/stomatitis (symptom) oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Muco/stomatitis (symptom) rectum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: GI-other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Infection Gr0-2 neut, catheter
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Infection Gr0-2 neut, lung
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 32 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 32 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 32 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Abdomen, pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Head/headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Throat/pharynx/larynx, pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Hiccoughs
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 32 at risk

Adverse event: Leukocytes decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 32 at risk

Adverse event: Neutrophils decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 32 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 32 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 32 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: Hand-foot reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 32 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 32 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 32 at risk

Adverse event: Muco/stomatitis by exam, oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: Muco/stomatitis (symptom) oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 32 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 32 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Abdomen, pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 32 at risk