Study: NCT01827943

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Blood/Bone Marrow (SOC from CTCAE v3.0)
Frequency: 3 affected / 53 at risk

Adverse event: Platelets
Serious: yes
Organ System: Investigations
Notes: Blood/Bone Marrow (SOC from CTCAE v3.0)
Frequency: 3 affected / 53 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: yes
Organ System: General disorders
Notes: CONSTITUTIONAL SYMPTOMS (SOC from CTCAE v3.0)
Frequency: 1 affected / 53 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
Serious: yes
Organ System: General disorders
Notes: CONSTITUTIONAL SYMPTOMS (SOC from CTCAE v3.0)
Frequency: 6 affected / 53 at risk

Adverse event: Constitutional Symptoms - Other (Specify, __)
Serious: yes
Organ System: General disorders
Notes: CONSTITUTIONAL SYMPTOMS (SOC from CTCAE v3.0)
Frequency: 13 affected / 53 at risk

Adverse event: Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
Serious: yes
Organ System: Gastrointestinal disorders
Notes: GASTROINTESTINAL (SOC from CTCAE v3.0)
Frequency: 1 affected / 53 at risk

Adverse event: Mucositis/stomatitis (clinical exam)
Serious: yes
Organ System: Gastrointestinal disorders
Notes: GASTROINTESTINAL (SOC from CTCAE v3.0)
Frequency: 2 affected / 53 at risk

Adverse event: Obstruction, GI
Serious: yes
Organ System: Gastrointestinal disorders
Notes: GASTROINTESTINAL (SOC from CTCAE v3.0)
Frequency: 4 affected / 53 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: GASTROINTESTINAL (SOC from CTCAE v3.0)
Frequency: 1 affected / 53 at risk

Adverse event: Hemorrhage, CNS
Serious: yes
Organ System: Nervous system disorders
Notes: HEMORRHAGE/BLEEDING (SOC from CTCAE v3.0)
Frequency: 2 affected / 53 at risk

Adverse event: Liver dysfunction/failure (clinical)
Serious: yes
Organ System: Hepatobiliary disorders
Notes: HEPATOBILIARY / PANCREAS (SOC from CTCAE v3.0)
Frequency: 1 affected / 53 at risk

Adverse event: Infection - Other (Specify, __)
Serious: yes
Organ System: Infections and infestations
Notes: INFECTION (SOC from CTCAE v3.0)
Frequency: 9 affected / 53 at risk

Adverse event: Infection with unknown ANC
Serious: yes
Organ System: Infections and infestations
Notes: INFECTION (SOC from CTCAE v3.0)
Frequency: 1 affected / 53 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: METABOLIC LABORATORY (SOC from CTCAE v3.0)
Frequency: 1 affected / 53 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MUSCULOSKELETAL/SOFT TISSUE (SOC from CTCAE v3.0)
Frequency: 1 affected / 53 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other (Specify, __)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: MUSCULOSKELETAL/SOFT TISSUE (SOC from CTCAE v3.0)
Frequency: 1 affected / 53 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Notes: NEUROLOGY (SOC from CTCAE v3.0)
Frequency: 1 affected / 53 at risk

Adverse event: Mood alteration
Serious: yes
Organ System: Psychiatric disorders
Notes: NEUROLOGY (SOC from CTCAE v3.0)
Frequency: 1 affected / 53 at risk

Adverse event: Pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: PAIN (SOC from CTCAE v3.0)
Frequency: 1 affected / 53 at risk

Adverse event: Pain - Other (Specify, __)
Serious: yes
Organ System: General disorders
Notes: PAIN (SOC from CTCAE v3.0)
Frequency: 5 affected / 53 at risk

Adverse event: Adult Respiratory Distress Syndrome (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: PULMONARY / UPPER RESPIRATORY (SOC from CTCAE v3.0)
Frequency: 1 affected / 53 at risk

Adverse event: Pulmonary/Upper Respiratory - Other (Specify, __)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: PULMONARY / UPPER RESPIRATORY (SOC from CTCAE v3.0)
Frequency: 3 affected / 53 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: RENAL/GENITOURINARY (SOC from CTCAE v3.0)
Frequency: 2 affected / 53 at risk

Adverse event: Renal/Genitourinary - Other (Specify, __)
Serious: yes
Organ System: Renal and urinary disorders
Notes: RENAL/GENITOURINARY (SOC from CTCAE v3.0)
Frequency: 2 affected / 53 at risk

Adverse event: Urinary retention (including neurogenic bladder)
Serious: yes
Organ System: Renal and urinary disorders
Notes: RENAL/GENITOURINARY (SOC from CTCAE v3.0)
Frequency: 1 affected / 53 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Blood/Bone Marrow (SOC from CTCAE v3.0)
Frequency: 26 affected / 53 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Notes: Blood/Bone Marrow (SOC from CTCAE v3.0)
Frequency: 3 affected / 53 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Notes: Blood/Bone Marrow (SOC from CTCAE v3.0)
Frequency: 16 affected / 53 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: CARDIAC GENERAL (SOC from CTCAE V3.0)
Frequency: 4 affected / 53 at risk

Adverse event: Constitutional Symptoms - Other (Specify, __)
Serious: no
Organ System: General disorders
Notes: CONSTITUTIONAL SYMPTOMS (SOC from CTCAE v3.0)
Frequency: 20 affected / 53 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Notes: CONSTITUTIONAL SYMPTOMS (SOC from CTCAE v3.0)
Frequency: 39 affected / 53 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
Serious: no
Organ System: General disorders
Notes: CONSTITUTIONAL SYMPTOMS (SOC from CTCAE v3.0)
Frequency: 21 affected / 53 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: CONSTITUTIONAL SYMPTOMS (SOC from CTCAE v3.0)
Frequency: 5 affected / 53 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: CONSTITUTIONAL SYMPTOMS (SOC from CTCAE v3.0)
Frequency: 11 affected / 53 at risk

Adverse event: Dermatology/Skin - Other (Specify, __)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: DERMATOLOGY/SKIN (SOC from CTCAE V3.0)
Frequency: 13 affected / 53 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: DERMATOLOGY/SKIN (SOC from CTCAE V3.0)
Frequency: 14 affected / 53 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: DERMATOLOGY/SKIN (SOC from CTCAE V3.0)
Frequency: 8 affected / 53 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: DERMATOLOGY/SKIN (SOC from CTCAE V3.0)
Frequency: 8 affected / 53 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Gastrointestinal (SOC from CTCAE V3.0)
Frequency: 23 affected / 53 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal (SOC from CTCAE V3.0)
Frequency: 13 affected / 53 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Gastrointestinal (SOC from CTCAE V3.0)
Frequency: 3 affected / 53 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal (SOC from CTCAE V3.0)
Frequency: 15 affected / 53 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal (SOC from CTCAE V3.0)
Frequency: 3 affected / 53 at risk

Adverse event: Gastritis (including bile reflux gastritis)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal (SOC from CTCAE V3.0)
Frequency: 3 affected / 53 at risk

Adverse event: Gastrointestinal - Other (Specify, __)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal (SOC from CTCAE V3.0)
Frequency: 3 affected / 53 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal (SOC from CTCAE V3.0)
Frequency: 3 affected / 53 at risk

Adverse event: Mucositis/stomatitis (clinical exam)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal (SOC from CTCAE V3.0)
Frequency: 19 affected / 53 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal (SOC from CTCAE V3.0)
Frequency: 3 affected / 53 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal (SOC from CTCAE V3.0)
Frequency: 23 affected / 53 at risk

Adverse event: Obstruction, GI
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal (SOC from CTCAE V3.0)
Frequency: 6 affected / 53 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Nervous system disorders
Notes: Gastrointestinal (SOC from CTCAE V3.0)
Frequency: 10 affected / 53 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal (SOC from CTCAE V3.0)
Frequency: 15 affected / 53 at risk

Adverse event: Hemorrhage, GU
Serious: no
Organ System: Renal and urinary disorders
Notes: HEMORRHAGE/BLEEDING (SC from CTCAE V3.0)
Frequency: 3 affected / 53 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: HEMORRHAGE/BLEEDING (SC from CTCAE V3.0)
Frequency: 6 affected / 53 at risk

Adverse event: Infection - Other (Specify, __)
Serious: no
Organ System: Infections and infestations
Notes: INFECTION (SOC from CTCAE V3.0)
Frequency: 31 affected / 53 at risk

Adverse event: Edema:limb
Serious: no
Organ System: General disorders
Notes: LYMPHATICS (SOC from CTCAE V3.0)
Frequency: 14 affected / 53 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: METABOLIC/LABORATORY (SOC from CTCAE V3.0)
Frequency: 3 affected / 53 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: METABOLIC/LABORATORY (SOC from CTCAE V3.0)
Frequency: 4 affected / 53 at risk

Adverse event: Cholesterol, serum-high (hypercholesteremia)
Serious: no
Organ System: Investigations
Notes: METABOLIC/LABORATORY (SOC from CTCAE V3.0)
Frequency: 7 affected / 53 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: METABOLIC/LABORATORY (SOC from CTCAE V3.0)
Frequency: 6 affected / 53 at risk

Adverse event: Metabolic/Laboratory - Other (Specify, __)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: METABOLIC/LABORATORY (SOC from CTCAE V3.0)
Frequency: 3 affected / 53 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: METABOLIC/LABORATORY (SOC from CTCAE V3.0)
Frequency: 3 affected / 53 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: METABOLIC/LABORATORY (SOC from CTCAE V3.0)
Frequency: 4 affected / 53 at risk

Adverse event: Triglyceride, serum-high (hypertriglyceridemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: METABOLIC/LABORATORY (SOC from CTCAE V3.0)
Frequency: 13 affected / 53 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other (Specify, __)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MUSCULOSKELETAL/SOFT TISSUE (SOC from CTCAE V3.0)
Frequency: 6 affected / 53 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: NEUROLOGY (SOC from CTCAE V3.0)
Frequency: 3 affected / 53 at risk

Adverse event: Mood alteration
Serious: no
Organ System: Psychiatric disorders
Notes: NEUROLOGY (SOC from CTCAE V3.0)
Frequency: 13 affected / 53 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Notes: NEUROLOGY (SOC from CTCAE V3.0)
Frequency: 6 affected / 53 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: PAIN (SOC from CTCAEV3.0)
Frequency: 29 affected / 53 at risk

Adverse event: Pain - Other (Specify, __)
Serious: no
Organ System: General disorders
Notes: PAIN (SOC from CTCAEV3.0)
Frequency: 5 affected / 53 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: PULMONARY/UPPER RESPIRATORY (SOC from CTCAE V3.0)
Frequency: 6 affected / 53 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: PULMONARY/UPPER RESPIRATORY (SOC from CTCAE V3.0)
Frequency: 6 affected / 53 at risk

Adverse event: Pulmonary/Upper Respiratory - Other (Specify, __)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: PULMONARY/UPPER RESPIRATORY (SOC from CTCAE V3.0)
Frequency: 4 affected / 53 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Notes: RENAL/GENITOURINARY (SOC from CTCAE V3.0)
Frequency: 9 affected / 53 at risk

Adverse event: Renal/Genitourinary - Other (Specify, __)
Serious: no
Organ System: Renal and urinary disorders
Notes: RENAL/GENITOURINARY (SOC from CTCAE V3.0)
Frequency: 4 affected / 53 at risk