Study: NCT01611298

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Infection - Other: Gastrointestinal Abdomen
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 7 at risk

Adverse event: AST, SGOT(serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Investigations
Frequency: 6 affected / 7 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 7 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 7 at risk

Adverse event: Bicarbonate, serum-low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 7 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 7 at risk

Adverse event: Bruising (in absence of Grade 3 or 4 thrombocytopenia)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Calcium, serum-high (hypercalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 7 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 7 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 7 at risk

Adverse event: Mucosal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 7 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Fatigue (lethargy, malaise, asthenia)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Febrile neutropenia(fever of unknown origin wo clinically or microbiologically documented infection)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: ANC \< 1.0x10e9/L,fever \>=38.5 degrees C
Frequency: 2 affected / 7 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: 3 affected / 7 at risk

Adverse event: GGT (gamma-Glutamyl transpeptidase)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 7 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 7 at risk

Adverse event: Glucose, serum-low (hypoglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hemorrhage, GU - Urinary NOS
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 7 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 7 at risk

Adverse event: Infection(documented clinically or microbiologically) with Grade 3 or 4 neutrophils-Bladder(urinary)
Serious: no
Organ System: Infections and infestations
Notes: ANC \<1.0 x 10e9/L
Frequency: 1 affected / 7 at risk

Adverse event: Infection - Other: Mucosa
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Lipase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 7 at risk

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 7 at risk

Adverse event: Mucositis/stomatitis (clinical exam) - Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 7 at risk

Adverse event: PTT (Partial Thromboplastin Time)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 7 at risk

Adverse event: Pain - Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 7 at risk

Adverse event: Pain - Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Pain - Bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 7 at risk

Adverse event: Pain - Bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 7 at risk

Adverse event: Pain - Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 7 at risk

Adverse event: Pain - Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Pain - Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Pain - Other: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Pain - Other: Oral Cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Pain - Pain NOS
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Pain - Vagina
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 7 at risk

Adverse event: Personality/behavioral
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 7 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 7 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 7 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 7 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 7 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: Rhinorrhea
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 7 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 7 at risk

Adverse event: Sexual/Reproductive Function - Other: Menstrual cramps
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 7 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 7 at risk

Adverse event: Supraventricular and nodal arrhythmia - Sinus arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Triglyceride, serum-high (hypertriglyceridemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 7 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 7 at risk