Study: NCT01060007

Adverse event: Aspartate aminotransferase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 79 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 79 at risk

Adverse event: Blood alkaline phosphatase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 79 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 79 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 79 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 79 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 79 at risk

Adverse event: Edema (axilla)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 79 at risk

Adverse event: Erythema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 79 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 79 at risk

Adverse event: Flatulence
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 79 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 79 at risk

Adverse event: Hypercholesterolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 79 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 79 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 79 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 79 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 79 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 79 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 79 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 79 at risk

Adverse event: International normalised ratio
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 79 at risk

Adverse event: Infection with normal ANC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 79 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 79 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 79 at risk

Adverse event: Muscle spasm - bladder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 79 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 79 at risk

Adverse event: Pain, Dysuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 79 at risk

Adverse event: Platelets
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 79 at risk

Adverse event: Port-A-Cath Pain
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 79 at risk

Adverse event: Rigors/chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 79 at risk

Adverse event: Peripheral sensory neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 79 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 79 at risk

Adverse event: ALT, SGPT (acute)
Serious: no
Organ System: Investigations
Frequency: 34 affected / 79 at risk

Adverse event: ALT, SGPT (late)
Serious: no
Organ System: Investigations
Frequency: 24 affected / 79 at risk

Adverse event: AST, SGOT (acute)
Serious: no
Organ System: Investigations
Frequency: 35 affected / 79 at risk

Adverse event: AST, SGOT (late)
Serious: no
Organ System: Investigations
Frequency: 30 affected / 79 at risk

Adverse event: Abdominal pain (acute)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 79 at risk

Adverse event: Abdominal pain (late)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 79 at risk

Adverse event: Alkaline phosphatase (acute)
Serious: no
Organ System: Investigations
Frequency: 22 affected / 79 at risk

Adverse event: Alkaline phosphatase (late)
Serious: no
Organ System: Investigations
Frequency: 33 affected / 79 at risk

Adverse event: Allergic reaction/hypersensitivity (late)
Serious: no
Organ System: Immune system disorders
Frequency: 5 affected / 79 at risk

Adverse event: Anal incontinence (acute)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 79 at risk

Adverse event: Anal incontinence (late)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 79 at risk

Adverse event: Anorexia (acute)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 36 affected / 79 at risk

Adverse event: Anorexia (late)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 79 at risk

Adverse event: Back pain (acute)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 79 at risk

Adverse event: Back pain (late)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 79 at risk

Adverse event: Bladder pain (acute)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 11 affected / 79 at risk

Adverse event: Buttock pain (acute)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 79 at risk

Adverse event: Chest pain (acute)
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 79 at risk

Adverse event: Constipation (acute)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 79 at risk

Adverse event: Constipation (late)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 79 at risk

Adverse event: Cough (acute)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 79 at risk

Adverse event: Cough (late)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 79 at risk

Adverse event: Creatinine (acute)
Serious: no
Organ System: Investigations
Frequency: 13 affected / 79 at risk

Adverse event: Creatinine (late)
Serious: no
Organ System: Investigations
Frequency: 13 affected / 79 at risk

Adverse event: Dehydration (acute)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 79 at risk

Adverse event: Dehydration (late)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 79 at risk

Adverse event: Diarrhea (acute)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 56 affected / 79 at risk

Adverse event: Diarrhea (late)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 79 at risk

Adverse event: Dizziness (acute)
Serious: no
Organ System: Nervous system disorders
Frequency: 26 affected / 79 at risk

Adverse event: Dizziness (late)
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 79 at risk

Adverse event: Dry skin (acute)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 79 at risk

Adverse event: Dyspnea (acute)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 79 at risk

Adverse event: Dyspnea (late)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 79 at risk

Adverse event: Edema: limb (acute)
Serious: no
Organ System: General disorders
Frequency: 11 affected / 79 at risk

Adverse event: Edema: limb (late)
Serious: no
Organ System: General disorders
Frequency: 7 affected / 79 at risk

Adverse event: Erectile dysfunction (late)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 79 at risk

Adverse event: Fatigue (acute)
Serious: no
Organ System: General disorders
Frequency: 64 affected / 79 at risk

Adverse event: Fatigue (late)
Serious: no
Organ System: General disorders
Frequency: 47 affected / 79 at risk

Adverse event: Fever (acute)
Serious: no
Organ System: General disorders
Frequency: 6 affected / 79 at risk

Adverse event: Fever (late)
Serious: no
Organ System: General disorders
Frequency: 6 affected / 79 at risk

Adverse event: Fistula, GI (late)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 79 at risk

Adverse event: Flatulence (acute)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 79 at risk

Adverse event: GI Leak (late)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 79 at risk

Adverse event: Hair loss/alopecia (acute)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 79 at risk

Adverse event: Headache (acute)
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 79 at risk

Adverse event: Headache (late)
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 79 at risk

Adverse event: Heartburn/dyspepsia (acute)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 79 at risk

Adverse event: Heartburn/dyspepsia (late)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 79 at risk

Adverse event: Hemoglobin (acute)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 75 affected / 79 at risk

Adverse event: Hemoglobin (late)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 64 affected / 79 at risk

Adverse event: Hemorrhage, GI, Rectum (acute)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 79 at risk

Adverse event: Hemorrhage, GI: melena (acute)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 79 at risk

Adverse event: Hot flashes/flushes (acute)
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 79 at risk

Adverse event: Hyperbilirubinemia (acute)
Serious: no
Organ System: Investigations
Frequency: 9 affected / 79 at risk

Adverse event: Hyperbilirubinemia (late)
Serious: no
Organ System: Investigations
Frequency: 8 affected / 79 at risk

Adverse event: Hypercalcemia (late)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 79 at risk

Adverse event: Hyperglycemia (acute)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 34 affected / 79 at risk

Adverse event: Hyperglycemia (late)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 79 at risk

Adverse event: Hyperkalemia (acute)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 79 at risk

Adverse event: Hyperkalemia (late)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 79 at risk

Adverse event: Hypoalbuminemia (acute)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 47 affected / 79 at risk

Adverse event: Hypoalbuminemia (late)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 45 affected / 79 at risk

Adverse event: Hypocalcemia (acute)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 66 affected / 79 at risk

Adverse event: Hypocalcemia (late)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 36 affected / 79 at risk

Adverse event: Hypoglycemia (acute)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 79 at risk

Adverse event: Hypokalemia (acute)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 79 at risk

Adverse event: Hypokalemia (late)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 23 affected / 79 at risk

Adverse event: Hypomagnesemia (acute)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 79 at risk

Adverse event: Hypomagnesemia (late)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 79 at risk

Adverse event: Hyponatremia (acute)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 41 affected / 79 at risk

Adverse event: Hyponatremia (late)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 33 affected / 79 at risk

Adverse event: Hypophosphatemia (acute)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 79 at risk

Adverse event: INR (acute)
Serious: no
Organ System: Investigations
Frequency: 21 affected / 79 at risk

Adverse event: INR (late)
Serious: no
Organ System: Investigations
Frequency: 6 affected / 79 at risk

Adverse event: Ileus, GI (acute)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 79 at risk

Adverse event: Ileus, GI (late)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 79 at risk

Adverse event: Infection - UTI (acute)
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 79 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils (acute)
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 79 at risk

Adverse event: Infection with normal ANC or Grade 1/2 neutrophils: abdomen (acute)
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 79 at risk

Adverse event: Infection with normal ANC or Grade 1/2 neutrophils: skin (late)
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 79 at risk

Adverse event: Insomnia (acute)
Serious: no
Organ System: Psychiatric disorders
Frequency: 26 affected / 79 at risk

Adverse event: Insomnia (late)
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 79 at risk

Adverse event: Jaw pain (acute)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 79 at risk

Adverse event: Joint pain (acute)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 79 at risk

Adverse event: Leak, GI (acute)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 79 at risk

Adverse event: Leg pain (late)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 79 at risk

Adverse event: Leukopenia (acute)
Serious: no
Organ System: Investigations
Frequency: 59 affected / 79 at risk

Adverse event: Leukopenia (late)
Serious: no
Organ System: Investigations
Frequency: 53 affected / 79 at risk

Adverse event: Lymphopenia (acute)
Serious: no
Organ System: Investigations
Frequency: 71 affected / 79 at risk

Adverse event: Lymphopenia (late)
Serious: no
Organ System: Investigations
Frequency: 59 affected / 79 at risk

Adverse event: Mood alteration - anxiety (acute)
Serious: no
Organ System: Psychiatric disorders
Frequency: 27 affected / 79 at risk

Adverse event: Mood alteration - depression (acute)
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 79 at risk

Adverse event: Mood alteration-anxiety (late)
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 79 at risk

Adverse event: Mood alteration-depression (late)
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 79 at risk

Adverse event: Mucositis/stomatitis (clinical exam) (acute)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 79 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic) (acute)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 79 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic) (late)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 79 at risk

Adverse event: Muscle pain (acute)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 79 at risk

Adverse event: Muscle weakness (late)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 79 at risk

Adverse event: Nausea (acute)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 51 affected / 79 at risk

Adverse event: Nausea (late)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 45 affected / 79 at risk

Adverse event: Neuropathy-sensory (late)
Serious: no
Organ System: Nervous system disorders
Frequency: 51 affected / 79 at risk

Adverse event: Neuropathy: sensory (acute)
Serious: no
Organ System: Nervous system disorders
Frequency: 69 affected / 79 at risk

Adverse event: Neutrophils/granulocytes (acute)
Serious: no
Organ System: Investigations
Frequency: 37 affected / 79 at risk

Adverse event: Neutrophils/granulocytes (late)
Serious: no
Organ System: Investigations
Frequency: 30 affected / 79 at risk

Adverse event: Nose bleed (acute)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 79 at risk

Adverse event: PTT (acute)
Serious: no
Organ System: Investigations
Frequency: 16 affected / 79 at risk

Adverse event: Pain: Dysuria (acute)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 79 at risk

Adverse event: Perianal skin pain (acute)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 79 at risk

Adverse event: Platelets (acute)
Serious: no
Organ System: Investigations
Frequency: 45 affected / 79 at risk

Adverse event: Platelets (late)
Serious: no
Organ System: Investigations
Frequency: 46 affected / 79 at risk

Adverse event: Pruritus/itching (acute)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 79 at risk

Adverse event: Rash/desquamation (acute)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 79 at risk

Adverse event: Rash/desquamation (late)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 79 at risk

Adverse event: Rash: dermatitis associated with radiation (acute)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 79 at risk

Adverse event: Rash: hand-foot skin reaction (acute)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 79 at risk

Adverse event: Rectal pain (acute)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 79 at risk

Adverse event: Rigors/chills (acute)
Serious: no
Organ System: General disorders
Frequency: 11 affected / 79 at risk

Adverse event: Rigors/chills (late)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 79 at risk

Adverse event: Small bowel NOS obstruction (late)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 79 at risk

Adverse event: Sweating (acute)
Serious: no
Organ System: General disorders
Frequency: 10 affected / 79 at risk

Adverse event: Taste alteration (acute)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 79 at risk

Adverse event: Taste alteration (late)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 79 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 79 at risk

Adverse event: Thrombosis/thrombus/embolism (acute)
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 79 at risk

Adverse event: Urgency, GI (acute)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 79 at risk

Adverse event: Urinary frequency/urgency (acute)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 79 at risk

Adverse event: Urinary frequency/urgency (late)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 79 at risk

Adverse event: Urinary retention (acute)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 79 at risk

Adverse event: Urinary retention (late)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 79 at risk

Adverse event: Vomiting (acute)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 79 at risk

Adverse event: Vomiting (late)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 79 at risk

Adverse event: Weight loss (acute)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 79 at risk

Adverse event: Weight loss (late)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 79 at risk

Adverse event: Wound complication, non-infectious (acute)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 79 at risk

Adverse event: Wound complication, non-infectious (late)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 79 at risk