Study: NCT01118351

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 19 at risk

Adverse event: Hemorrhage, GI - Rectum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Hemorrhage, GU - Urinary NOS
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 19 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pain - Abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 19 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 19 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 19 at risk

Adverse event: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 19 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 19 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 19 at risk

Adverse event: AST, SGOT(serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 19 at risk

Adverse event: Bicarbonate, serum-low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 19 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 19 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 19 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 19 at risk

Adverse event: Temperature intolerance
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 19 at risk

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 19 at risk

Adverse event: Distension/bloating, abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 19 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 19 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 19 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 19 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 19 at risk

Adverse event: Edema: head and neck
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 5 affected / 19 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 14 affected / 19 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
Frequency: 1 affected / 19 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 19 at risk

Adverse event: Flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 5 affected / 19 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: GGT (gamma-Glutamyl transpeptidase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 19 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 19 at risk

Adverse event: Glucose, serum-low (hypoglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 19 at risk

Adverse event: Hair loss/alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 19 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 19 at risk

Adverse event: Hemorrhage, GI - Rectum
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 19 at risk

Adverse event: Hemorrhage, GI - Varices (rectal)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Hemorrhage, GU - Bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 19 at risk

Adverse event: Hemorrhage, GU - Urinary NOS
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 19 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory - Nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 19 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 19 at risk

Adverse event: Hypopigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) - Bladder (urinary)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Mucosa
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Infection with unknown ANC - Urinary tract NOS
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 19 at risk

Adverse event: INR (International Normalized Ratio of prothrombin time)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 19 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 19 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 19 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 19 at risk

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 19 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Mood alteration - Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 19 at risk

Adverse event: Mucositis/stomatitis (clinical exam) - Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 19 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic) - Esophagus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 19 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic) - Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 19 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 19 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 19 at risk

Adverse event: Light/dark adaptation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 19 at risk

Adverse event: Retinal tears
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pain - Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pain - Anus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pain - Extremity-limb
Serious: no
Organ System: General disorders
Frequency: 2 affected / 19 at risk

Adverse event: Pain - Head/headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pain - Joint
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pain - Middle ear
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pain - Oral cavity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Diffuse Arthralgia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 19 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 19 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 19 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 19 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: PTT (Partial Thromboplastin Time)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 19 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 19 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 19 at risk

Adverse event: Hemorrhage/Hematuria (Intermittent)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 19 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 19 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Skin breakdown/decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Sodium, serum-high (hypernatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 19 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 19 at risk

Adverse event: Stricture/stenosis (including anastomotic), GU - Urethra
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 19 at risk

Adverse event: Supraventricular and nodal arrhythmia - Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

Adverse event: Sweating (diaphoresis)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Syndromes - Other (Cold)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 19 at risk

Adverse event: Urinary retention (including neurogenic bladder)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 19 at risk

Adverse event: Urine color change
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 19 at risk

Adverse event: Urticaria (hives, welts, wheals)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 19 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 2 affected / 19 at risk

Adverse event: Skin-Yellowing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Tender Scalp
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Greying/course hair
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Warm, tight "sunburn-like" skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: GI (Other)-Dry Mucous Membranes, Nasal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Stomach "cramping" with flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pain, Abdominal (Gas Cramps)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pain, Chest (Gas Cramps)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Urinary, burning
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 19 at risk