Study: NCT00946712

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 632 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 632 at risk

Adverse event: Cardiac General-Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 632 at risk

Adverse event: Cardiac-ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 632 at risk

Adverse event: Cardiopulmonary arrest, cause unknown (non-fatal)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 632 at risk

Adverse event: SVT and nodal arrhythmia - Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 632 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 632 at risk

Adverse event: Gastrointestinal-Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 632 at risk

Adverse event: Hemorrhage, GI - Duodenum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 632 at risk

Adverse event: Hemorrhage, GI - Esophagus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 632 at risk

Adverse event: Perforation, GI - Duodenum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 632 at risk

Adverse event: Perforation, GI - Stomach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 632 at risk

Adverse event: Ulcer, GI - Duodenum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 632 at risk

Adverse event: Death not associated with CTCAE term - Death NOS
Serious: yes
Organ System: General disorders
Frequency: 12 affected / 632 at risk

Adverse event: Syndromes-Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 632 at risk

Adverse event: Inf (clin/microbio) w/Gr 3-4 neuts - Lung
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 632 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils - Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 632 at risk

Adverse event: Infection with unknown ANC - Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 632 at risk

Adverse event: Intra-operative Injury-Other
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 632 at risk

Adverse event: Vessel injury-artery - Aorta
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 632 at risk

Adverse event: Carbon monoxide diffusion capacity (DL(co))
Serious: yes
Organ System: Investigations
Frequency: 8 affected / 632 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 632 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 632 at risk

Adverse event: Acidosis (metabolic or respiratory)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 632 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 632 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 632 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 632 at risk

Adverse event: Uric acid, serum-high (hyperuricemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 632 at risk

Adverse event: Muscle weakness, not d/t neuropathy - body/general
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 632 at risk

Adverse event: Death - Disease progression NOS
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 9 affected / 632 at risk

Adverse event: Tumour flare
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 632 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 632 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 632 at risk

Adverse event: Carbon monoxide diffusion capacity (DL(co))
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 632 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 632 at risk

Adverse event: Hemorrhage, pulmo/upper resp- Bronchopulmonary NOS
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 632 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory - Pleura
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 632 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 632 at risk

Adverse event: Obstruction/stenosis of airway - Bronchus
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 632 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 632 at risk

Adverse event: Pulmonary/Upper Respiratory-Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 632 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 632 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 632 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 434 affected / 632 at risk

Adverse event: Vision-blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 38 affected / 632 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 261 affected / 632 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 195 affected / 632 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 70 affected / 632 at risk

Adverse event: Mucositis/stomatitis (clinical exam) - Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 74 affected / 632 at risk

Adverse event: Mucositis/stomatitis (functional/symp) - Oral cav
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 632 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 304 affected / 632 at risk

Adverse event: Pain - Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 60 affected / 632 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 150 affected / 632 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 80 affected / 632 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 494 affected / 632 at risk

Adverse event: Fever in absence of neutropenia, ANC lt1.0x10e9/L
Serious: no
Organ System: General disorders
Frequency: 56 affected / 632 at risk

Adverse event: Pain - Chest/thorax NOS
Serious: no
Organ System: General disorders
Frequency: 72 affected / 632 at risk

Adverse event: Pain-Other
Serious: no
Organ System: General disorders
Frequency: 63 affected / 632 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 49 affected / 632 at risk

Adverse event: Allergic reaction/hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 37 affected / 632 at risk

Adverse event: Infection-Other
Serious: no
Organ System: Infections and infestations
Frequency: 35 affected / 632 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Frequency: 82 affected / 632 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Investigations
Frequency: 81 affected / 632 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 138 affected / 632 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Investigations
Frequency: 30 affected / 632 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 52 affected / 632 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 258 affected / 632 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 139 affected / 632 at risk

Adverse event: Metabolic/Laboratory-Other
Serious: no
Organ System: Investigations
Frequency: 39 affected / 632 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 252 affected / 632 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 270 affected / 632 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 163 affected / 632 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 211 affected / 632 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 245 affected / 632 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 117 affected / 632 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 104 affected / 632 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 290 affected / 632 at risk

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 201 affected / 632 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 34 affected / 632 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 135 affected / 632 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 194 affected / 632 at risk

Adverse event: Muscle weakness, not d/t neuropathy - Extrem-lower
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 56 affected / 632 at risk

Adverse event: Muscle weakness, not d/t neuropathy - body/general
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 110 affected / 632 at risk

Adverse event: Pain - Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 109 affected / 632 at risk

Adverse event: Pain - Bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 50 affected / 632 at risk

Adverse event: Pain - Chest wall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 43 affected / 632 at risk

Adverse event: Pain - Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 131 affected / 632 at risk

Adverse event: Pain - Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 192 affected / 632 at risk

Adverse event: Pain - Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 160 affected / 632 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 129 affected / 632 at risk

Adverse event: Neuropathy: motor
Serious: no
Organ System: Nervous system disorders
Frequency: 62 affected / 632 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 386 affected / 632 at risk

Adverse event: Pain - Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 80 affected / 632 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Nervous system disorders
Frequency: 131 affected / 632 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 31 affected / 632 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 95 affected / 632 at risk

Adverse event: Mood alteration - anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 61 affected / 632 at risk

Adverse event: Mood alteration - depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 58 affected / 632 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 36 affected / 632 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 48 affected / 632 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 239 affected / 632 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 285 affected / 632 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory - Nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 86 affected / 632 at risk

Adverse event: Pulmonary/Upper Respiratory-Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 632 at risk

Adverse event: Voice changes/dysarthria
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 40 affected / 632 at risk

Adverse event: Dermatology/Skin-Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 632 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 64 affected / 632 at risk

Adverse event: Hair loss/Alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 315 affected / 632 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 37 affected / 632 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 49 affected / 632 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 42 affected / 632 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 40 affected / 632 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 632 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 124 affected / 632 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 55 affected / 632 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 54 affected / 632 at risk

Adverse event: DIC (disseminated intravascular coagulation)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 627 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 627 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 627 at risk

Adverse event: Thrombotic microangiopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 627 at risk

Adverse event: Cardiac General-Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 627 at risk

Adverse event: Cardiac-ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 627 at risk

Adverse event: Cardiopulmonary arrest, cause unknown (non-fatal)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 627 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 627 at risk

Adverse event: Adrenal insufficiency
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 627 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 627 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 627 at risk

Adverse event: Gastrointestinal-Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 627 at risk

Adverse event: Hemorrhage, GI - Upper GI NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 627 at risk

Adverse event: Perforation, GI - Colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 627 at risk

Adverse event: Death - Multi-organ failure
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 627 at risk

Adverse event: Death not associated with CTCAE term - Death NOS
Serious: yes
Organ System: General disorders
Frequency: 12 affected / 627 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 627 at risk

Adverse event: Syndromes-Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 627 at risk

Adverse event: Liver dysfunction/failure (clinical)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 627 at risk

Adverse event: Allergic reaction/hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 8 affected / 627 at risk

Adverse event: Cytokine release syndrome/acute infusion reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 627 at risk

Adverse event: Inf (clin/microbio) w/Gr 3-4 neuts - Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 627 at risk

Adverse event: Inf (clin/microbio) w/Gr 3-4 neuts - Esophagus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 627 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils - Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 627 at risk

Adverse event: Inf w/normal ANC or Gr 1-2 neutrophils - Lung
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 627 at risk

Adverse event: Infection with unknown ANC - Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 627 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 627 at risk

Adverse event: AST, SGOT
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 627 at risk

Adverse event: Carbon monoxide diffusion capacity (DL(co))
Serious: yes
Organ System: Investigations
Frequency: 8 affected / 627 at risk

Adverse event: Leukocytes (total WBC)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 627 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 627 at risk

Adverse event: Neuroendocrine: ADH secretion abnormality
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 627 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 627 at risk

Adverse event: Platelets
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 627 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 627 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 627 at risk

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 627 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 627 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 627 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 627 at risk

Adverse event: Death - Disease progression NOS
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 17 affected / 627 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 627 at risk

Adverse event: Neurology-Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 627 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 627 at risk

Adverse event: Carbon monoxide diffusion capacity (DL(co))
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 627 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 627 at risk

Adverse event: Hemorrhage, pulmo/upper resp- Bronchopulmonary NOS
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 627 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory - Lung
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 627 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 627 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 627 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 627 at risk

Adverse event: Pulmonary/Upper Respiratory-Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 627 at risk

Adverse event: Voice changes/dysarthria
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 627 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 627 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 627 at risk

Adverse event: Visceral arterial ischemia (non-myocardial)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 627 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 384 affected / 627 at risk

Adverse event: Vision-blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 33 affected / 627 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 302 affected / 627 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 243 affected / 627 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 109 affected / 627 at risk

Adverse event: Mucositis/stomatitis (clinical exam) - Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 162 affected / 627 at risk

Adverse event: Mucositis/stomatitis (functional/symp) - Oral cav
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 74 affected / 627 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 318 affected / 627 at risk

Adverse event: Pain - Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 86 affected / 627 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 168 affected / 627 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 84 affected / 627 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 474 affected / 627 at risk

Adverse event: Fever in absence of neutropenia, ANC lt1.0x10e9/L
Serious: no
Organ System: General disorders
Frequency: 47 affected / 627 at risk

Adverse event: Pain - Chest/thorax NOS
Serious: no
Organ System: General disorders
Frequency: 72 affected / 627 at risk

Adverse event: Pain-Other
Serious: no
Organ System: General disorders
Frequency: 80 affected / 627 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 56 affected / 627 at risk

Adverse event: Allergic reaction/hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 90 affected / 627 at risk

Adverse event: Infection-Other
Serious: no
Organ System: Infections and infestations
Frequency: 53 affected / 627 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Frequency: 148 affected / 627 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Investigations
Frequency: 141 affected / 627 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 169 affected / 627 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Investigations
Frequency: 32 affected / 627 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 45 affected / 627 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 289 affected / 627 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 166 affected / 627 at risk

Adverse event: Metabolic/Laboratory-Other
Serious: no
Organ System: Investigations
Frequency: 49 affected / 627 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 305 affected / 627 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 233 affected / 627 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 181 affected / 627 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 244 affected / 627 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 241 affected / 627 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 179 affected / 627 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 118 affected / 627 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 266 affected / 627 at risk

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 349 affected / 627 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 34 affected / 627 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 200 affected / 627 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 205 affected / 627 at risk

Adverse event: Muscle weakness, not d/t neuropathy - Extrem-lower
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 59 affected / 627 at risk

Adverse event: Muscle weakness, not d/t neuropathy - body/general
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 122 affected / 627 at risk

Adverse event: Pain - Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 126 affected / 627 at risk

Adverse event: Pain - Bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 60 affected / 627 at risk

Adverse event: Pain - Chest wall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 38 affected / 627 at risk

Adverse event: Pain - Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 150 affected / 627 at risk

Adverse event: Pain - Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 194 affected / 627 at risk

Adverse event: Pain - Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 149 affected / 627 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 167 affected / 627 at risk

Adverse event: Neuropathy: motor
Serious: no
Organ System: Nervous system disorders
Frequency: 67 affected / 627 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 368 affected / 627 at risk

Adverse event: Pain - Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 84 affected / 627 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Nervous system disorders
Frequency: 147 affected / 627 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 40 affected / 627 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 131 affected / 627 at risk

Adverse event: Mood alteration - anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 70 affected / 627 at risk

Adverse event: Mood alteration - depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 60 affected / 627 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 50 affected / 627 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 66 affected / 627 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 248 affected / 627 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 290 affected / 627 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory - Nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 115 affected / 627 at risk

Adverse event: Pulmonary/Upper Respiratory-Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 38 affected / 627 at risk

Adverse event: Voice changes/dysarthria
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 37 affected / 627 at risk

Adverse event: Dermatology/Skin-Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 82 affected / 627 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 220 affected / 627 at risk

Adverse event: Hair loss/Alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 293 affected / 627 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 67 affected / 627 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 122 affected / 627 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 155 affected / 627 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 425 affected / 627 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 54 affected / 627 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 96 affected / 627 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 79 affected / 627 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 68 affected / 627 at risk