Study: NCT00121134

Adverse event: Lower GI bleed
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 40 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 40 at risk

Adverse event: Abdomen, pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 40 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 40 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 40 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 40 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 40 at risk

Adverse event: back,pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 40 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 40 at risk

Adverse event: bone, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 40 at risk

Adverse event: breast,pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 40 at risk

Adverse event: Contusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 40 at risk

Adverse event: chest wall, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 40 at risk

Adverse event: Chest/thoracic pain NOS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 40 at risk

Adverse event: Constitutional, other
Serious: no
Organ System: General disorders
Frequency: 2 affected / 40 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 40 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 40 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 40 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 40 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 40 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 40 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 40 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 40 at risk

Adverse event: Edema limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 40 at risk

Adverse event: Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 40 at risk

Adverse event: Extrapyramidal movement
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Extremity-limb, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 40 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 21 affected / 40 at risk

Adverse event: fever w/o neutropenia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 40 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Gastrointestinal-other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 31 affected / 40 at risk

Adverse event: hematologic-other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 40 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 40 at risk

Adverse event: hemorrhage-other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 40 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Hot flush
Serious: no
Organ System: General disorders
Frequency: 16 affected / 40 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 40 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 12 affected / 40 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 40 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hypertension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 40 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 40 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 40 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 40 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 40 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 40 at risk

Adverse event: Infection Gr0-2 neut, bronchus
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 40 at risk

Adverse event: Infection Gr0-2 neut, sinus
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 40 at risk

Adverse event: Infection Gr0-2 neut, skin
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Infection Gr0-2 neut, upper airway
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 40 at risk

Adverse event: Infection Gr0-2 neut, urinary tract
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 40 at risk

Adverse event: Infection w/unk ANC upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Infection-other
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 40 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 40 at risk

Adverse event: irregular menses
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 40 at risk

Adverse event: joint, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 31 affected / 40 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 40 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Metabolic/laboratory-other
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 40 at risk

Adverse event: Muco/stomatitis(symptom) oral cavity
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 40 at risk

Adverse event: Muco/stomatitis by exam, oral cavity
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Muscle, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 40 at risk

Adverse event: Musculoskeletal/soft tissue-other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 40 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 40 at risk

Adverse event: Neck,pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 40 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 40 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 40 at risk

Adverse event: Nonneuropathic generalized weakness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 40 at risk

Adverse event: Nose, hemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 40 at risk

Adverse event: Oral cavity, hemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Oral gums, pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pain
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 40 at risk

Adverse event: Pain-other
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 40 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 40 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 40 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 21 affected / 40 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 40 at risk

Adverse event: Pulmonary/upper respiratory-other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 40 at risk

Adverse event: Radiation dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 40 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Rectum, hemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 40 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Skin-other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 40 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 40 at risk

Adverse event: Taste disorder
Serious: no
Organ System: General disorders
Frequency: 7 affected / 40 at risk

Adverse event: Tearing
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 40 at risk

Adverse event: Throat/Pharynx/larynx,pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 40 at risk

Adverse event: Vaginal discharge (non-infectious)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 40 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 40 at risk

Adverse event: Vision-blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 40 at risk

Adverse event: Voice changes/dysarthria
Serious: no
Organ System: General disorders
Frequency: 4 affected / 40 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 40 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Wound-non-infectious
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Cardiac-other
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 41 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 12 affected / 41 at risk

Adverse event: Abdomen, pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 41 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 41 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 41 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 41 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 41 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 41 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: back,pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 41 at risk

Adverse event: Blood bicarbonate
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 41 at risk

Adverse event: bone, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 41 at risk

Adverse event: breast,pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 41 at risk

Adverse event: Contusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 41 at risk

Adverse event: chest wall, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 41 at risk

Adverse event: Chest/thoracic pain NOS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 41 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 41 at risk

Adverse event: Constitutional, other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 41 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 41 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 41 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 41 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 41 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 41 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 41 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 41 at risk

Adverse event: Edema limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 41 at risk

Adverse event: Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Extremity-limb, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 41 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 29 affected / 41 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 41 at risk

Adverse event: fever w/o neutropenia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 41 at risk

Adverse event: Gastrointestinal-other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 41 at risk

Adverse event: Hand-foot reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 28 affected / 41 at risk

Adverse event: hematologic-other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 41 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 41 at risk

Adverse event: hemorrhage-other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 41 at risk

Adverse event: Hot flush
Serious: no
Organ System: General disorders
Frequency: 10 affected / 41 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 41 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 9 affected / 41 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 41 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 41 at risk

Adverse event: Hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Hypertension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 41 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 41 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 4 affected / 41 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 41 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 41 at risk

Adverse event: Infection Gr0-2 neut, sinus
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 41 at risk

Adverse event: Infection Gr0-2 neut, skin
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 41 at risk

Adverse event: Infection Gr0-2 neut, upper airway
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 41 at risk

Adverse event: Infection Gr0-2 neut, urinary tract
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Infection-other
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 41 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 41 at risk

Adverse event: joint, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 41 at risk

Adverse event: joint-function
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 41 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Metabolic/laboratory-other
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 41 at risk

Adverse event: Muco/stomatitis(symptom) oral cavity
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 41 at risk

Adverse event: Muco/stomatitis by exam, oral cavity
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 41 at risk

Adverse event: Muscle, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 41 at risk

Adverse event: Musculoskeletal/soft tissue-other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 41 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 41 at risk

Adverse event: Nasal cavity/paranasal sinus reaction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 41 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 41 at risk

Adverse event: Neck,pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 41 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 41 at risk

Adverse event: Nose, hemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 41 at risk

Adverse event: Oral cavity, hemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Pain-other
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 41 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 41 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 41 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 28 affected / 41 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 41 at risk

Adverse event: Pulmonary/upper respiratory-other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 41 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 41 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 41 at risk

Adverse event: Skin-other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 41 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 41 at risk

Adverse event: Taste disorder
Serious: no
Organ System: General disorders
Frequency: 4 affected / 41 at risk

Adverse event: Throat/Pharynx/larynx,pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Vagina, hemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 41 at risk

Adverse event: Vaginal discharge (non-infectious)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 41 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 41 at risk

Adverse event: Vision-blurred
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 41 at risk

Adverse event: Voice changes/dysarthria
Serious: no
Organ System: General disorders
Frequency: 5 affected / 41 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 41 at risk

Adverse event: Wound-non-infectious
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Cardiac-other
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 41 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 41 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 41 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 41 at risk

Adverse event: Abdomen, pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 41 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 41 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 41 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 41 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 41 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 41 at risk

Adverse event: back,pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 41 at risk

Adverse event: Blood bicarbonate
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 41 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 41 at risk

Adverse event: bone, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 41 at risk

Adverse event: breast,pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 41 at risk

Adverse event: Contusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 41 at risk

Adverse event: Chelitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 41 at risk

Adverse event: chest wall, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Chest/thoracic pain NOS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 41 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 41 at risk

Adverse event: Constitutional, other
Serious: no
Organ System: General disorders
Frequency: 3 affected / 41 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 41 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 41 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 41 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 41 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 41 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 41 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 41 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 41 at risk

Adverse event: Edema limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 41 at risk

Adverse event: Extremity-limb, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 41 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 29 affected / 41 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 41 at risk

Adverse event: fever w/o neutropenia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 41 at risk

Adverse event: Gastrointestinal-other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 41 at risk

Adverse event: Hand-foot reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 37 affected / 41 at risk

Adverse event: Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 41 at risk

Adverse event: hematologic-other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 41 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 41 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 41 at risk

Adverse event: Hot flush
Serious: no
Organ System: General disorders
Frequency: 11 affected / 41 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 7 affected / 41 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 41 at risk

Adverse event: Hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 41 at risk

Adverse event: Hypertension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 41 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 41 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 41 at risk

Adverse event: Infection Gr0-2 neut, bronchus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Infection Gr0-2 neut, sinus
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 41 at risk

Adverse event: Infection Gr0-2 neut, upper airway
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 41 at risk

Adverse event: Infection Gr0-2 neut, urinary tract
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 41 at risk

Adverse event: Infection-other
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 41 at risk

Adverse event: irregular menses
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 41 at risk

Adverse event: joint, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 23 affected / 41 at risk

Adverse event: joint-function
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 41 at risk

Adverse event: Metabolic/laboratory-other
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 41 at risk

Adverse event: Muco/stomatitis(symptom) oral cavity
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 41 at risk

Adverse event: Muco/stomatitis by exam, oral cavity
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 41 at risk

Adverse event: Muscle, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 41 at risk

Adverse event: Musculoskeletal/soft tissue-other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 41 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Nasal cavity/paranasal sinus reaction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 41 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 41 at risk

Adverse event: Neck,pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 41 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 41 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 41 at risk

Adverse event: Nose, hemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 41 at risk

Adverse event: Oral cavity, hemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Pain-other
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 41 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 41 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 25 affected / 41 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 41 at risk

Adverse event: Pulmonary/upper respiratory-other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 41 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 41 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 41 at risk

Adverse event: Rectum, hemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 41 at risk

Adverse event: Skin-other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 41 at risk

Adverse event: Taste disorder
Serious: no
Organ System: General disorders
Frequency: 7 affected / 41 at risk

Adverse event: Throat/Pharynx/larynx,pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Vaginal discharge (non-infectious)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 41 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 41 at risk

Adverse event: Vision-blurred
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 41 at risk

Adverse event: Voice changes/dysarthria
Serious: no
Organ System: General disorders
Frequency: 3 affected / 41 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 41 at risk

Adverse event: Cardiac-other
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 41 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 40 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 40 at risk

Adverse event: Abdomen, pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 40 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 40 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 40 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 40 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 40 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 40 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 40 at risk

Adverse event: back,pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 40 at risk

Adverse event: Blood bicarbonate
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 40 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 40 at risk

Adverse event: bone, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: breast,pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Contusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 40 at risk

Adverse event: buttock, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: chest wall, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Chest/thoracic pain NOS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 40 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 40 at risk

Adverse event: Constitutional, other
Serious: no
Organ System: General disorders
Frequency: 4 affected / 40 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 40 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 40 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 40 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 40 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 40 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 40 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 40 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 40 at risk

Adverse event: Edema limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 40 at risk

Adverse event: Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 40 at risk

Adverse event: Extremity-limb, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 40 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 29 affected / 40 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 40 at risk

Adverse event: fever w/o neutropenia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 40 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Gastrointestinal-other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 40 at risk

Adverse event: Hand-foot reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 38 affected / 40 at risk

Adverse event: Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 26 affected / 40 at risk

Adverse event: hematologic-other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 40 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 40 at risk

Adverse event: hemorrhage-other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 40 at risk

Adverse event: Hot flush
Serious: no
Organ System: General disorders
Frequency: 18 affected / 40 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 10 affected / 40 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 40 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 40 at risk

Adverse event: Hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Hypertension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 40 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 40 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 40 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 40 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 40 at risk

Adverse event: Infection Gr0-2 neut, sinus
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 40 at risk

Adverse event: Infection Gr0-2 neut, skin
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 40 at risk

Adverse event: Infection Gr0-2 neut, upper airway
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Infection Gr0-2 neut, urinary tract
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Infection w/unk ANC upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 40 at risk

Adverse event: Infection-other
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 40 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 40 at risk

Adverse event: irregular menses
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 40 at risk

Adverse event: joint, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 24 affected / 40 at risk

Adverse event: joint-function
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 40 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 40 at risk

Adverse event: Metabolic/laboratory-other
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 40 at risk

Adverse event: Muco/stomatitis(symptom) oral cavity
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 40 at risk

Adverse event: Muco/stomatitis by exam, oral cavity
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 40 at risk

Adverse event: Muscle, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 40 at risk

Adverse event: Musculoskeletal/soft tissue-other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 40 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Nasal cavity/paranasal sinus reaction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 40 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 40 at risk

Adverse event: Neck,pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 40 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 40 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 40 at risk

Adverse event: Nonneuropathic generalized weakness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Nose, hemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 40 at risk

Adverse event: Oral cavity, hemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 40 at risk

Adverse event: Oral gums, pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 40 at risk

Adverse event: Pain-other
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 40 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 40 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 21 affected / 40 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 40 at risk

Adverse event: Pulmonary/upper respiratory-other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 40 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 40 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 40 at risk

Adverse event: Skin-other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 40 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Taste disorder
Serious: no
Organ System: General disorders
Frequency: 8 affected / 40 at risk

Adverse event: Tearing
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 40 at risk

Adverse event: Throat/Pharynx/larynx,pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 40 at risk

Adverse event: Vagina, hemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 40 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 40 at risk

Adverse event: Vision-blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 40 at risk

Adverse event: Voice changes/dysarthria
Serious: no
Organ System: General disorders
Frequency: 2 affected / 40 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 40 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 3 affected / 40 at risk

Adverse event: Wound-non-infectious
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Cardiac-other
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 40 at risk