Study: NCT00977470

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 38 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 38 at risk

Adverse event: Constitutional disorders - other
Serious: yes
Organ System: General disorders
Notes: Failure to Thrive
Frequency: 1 affected / 38 at risk

Adverse event: Skin - pain
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Respiratory - other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pneumomediastinum
Frequency: 1 affected / 38 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 38 at risk

Adverse event: Hearing-other
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 38 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Investigations
Frequency: 4 affected / 38 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 38 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 38 at risk

Adverse event: Hematologic-other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 38 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 38 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 38 at risk

Adverse event: Cardiac-other
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 38 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 25 affected / 38 at risk

Adverse event: Fever w/o neutropenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 38 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 4 affected / 38 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 38 at risk

Adverse event: Constitutional, other
Serious: no
Organ System: General disorders
Frequency: 5 affected / 38 at risk

Adverse event: International normalised ratio
Serious: no
Organ System: Investigations
Frequency: 1 affected / 38 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 38 at risk

Adverse event: Chelitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 38 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 38 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 38 at risk

Adverse event: Hypopigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 38 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 38 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 38 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 38 at risk

Adverse event: Skin breakdown/decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 38 at risk

Adverse event: Skin-other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 38 at risk

Adverse event: ADH secretion abnormality (eg SIADH)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 38 at risk

Adverse event: Hypoparathyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hyopthyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 38 at risk

Adverse event: Endocrine-other
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 38 at risk

Adverse event: Growth and Development, Other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 38 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 38 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 38 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 38 at risk

Adverse event: Distention/bloating, abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 38 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 38 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 38 at risk

Adverse event: Ileus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Muco/stomatitis by exam, anus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Muco/stomatitis by exam, oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Muco/stomatitis (symptom) oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 38 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 38 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 38 at risk

Adverse event: GI-other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Anus, hemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Vagina, hemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 38 at risk

Adverse event: Lung, hemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Nose, hemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 38 at risk

Adverse event: Hemorrhage-other
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Infection w/ gr3-4 neut, ungual (nails)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Infection Gr0-2 neut, bladder
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Infection Gr0-2 neut, bronchus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Infection Gr0-2 neut, lung
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Infection Gr0-2 neut, skin
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 38 at risk

Adverse event: Infection Gr0-2 neut, ungual
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 38 at risk

Adverse event: Infection Gr0-2 neut, upper airway
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 38 at risk

Adverse event: Infection Gr0-2 neut, urinary tract
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 38 at risk

Adverse event: Infection w/ unk ANC joint
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 38 at risk

Adverse event: Infection w/ unk ANC oral cavity/gums
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Infection w/ unk ANC skin (cellulitis)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Infection w/ unk ANC ungual (nails)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Infection w/ unk ANC upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Infection w/ unk ANC urinary tract NOS
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 38 at risk

Adverse event: Infection-other
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 38 at risk

Adverse event: Edema limb
Serious: no
Organ System: General disorders
Frequency: 6 affected / 38 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 38 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 38 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 38 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 38 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 38 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 38 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 38 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 38 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 38 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 38 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 38 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 38 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 38 at risk

Adverse event: Metabolic/Laboratory-other
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 38 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 38 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 38 at risk

Adverse event: Joint-function
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Nonneuropathic lower extr muscle weak
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Nonneuropathic generalized weakness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Musculoskeletal/soft tissue-other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 38 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 38 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 38 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 38 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 38 at risk

Adverse event: Neuropathy-motor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 38 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Neurologic-other
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 38 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 38 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 38 at risk

Adverse event: Eyelid dysfunction
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 38 at risk

Adverse event: Diplopia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 38 at risk

Adverse event: Vision-blurred
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 38 at risk

Adverse event: Ocular-other
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 38 at risk

Adverse event: Abdomen, pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 38 at risk

Adverse event: Back, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 38 at risk

Adverse event: Bone, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 38 at risk

Adverse event: Breast, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Buttock, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Chest wall, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 38 at risk

Adverse event: Chest/thoracic pain NOS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 38 at risk

Adverse event: Esophagus, pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: External ear, pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 38 at risk

Adverse event: Extremity-limb, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 38 at risk

Adverse event: Head/headache
Serious: no
Organ System: General disorders
Frequency: 11 affected / 38 at risk

Adverse event: Joint, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 38 at risk

Adverse event: Lymph node, pain
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Muscle, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Neck, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Oral cavity, pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Oral gums, pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 38 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Pelvic, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 38 at risk

Adverse event: Pleura, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Skin, pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 38 at risk

Adverse event: Stomach, pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Throat/pharynx/larynx, pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Pain-other
Serious: no
Organ System: General disorders
Frequency: 8 affected / 38 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 38 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 38 at risk

Adverse event: Nasal cavity/paranasal sinus reaction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Voice changes/dysarthria
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Pulmonary/Upper Respiratory-other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 38 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 38 at risk

Adverse event: Secondary malignancy
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 38 at risk

Adverse event: Breast volume/hypoplasia
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 38 at risk

Adverse event: Irregular menses
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 38 at risk

Adverse event: Sexual/Reproductive function-Other
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 38 at risk

Adverse event: Flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 3 affected / 38 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 38 at risk

Adverse event: Vascular-Other (Specify)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 38 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Infection, nos
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Allergy-other
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hearing-other
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 38 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Investigations
Frequency: 1 affected / 38 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hematologic-other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 38 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 38 at risk

Adverse event: Arrhythmia-other
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 38 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 38 at risk

Adverse event: Cardiac-other
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 38 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 27 affected / 38 at risk

Adverse event: Fever w/o neutropenia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 38 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 38 at risk

Adverse event: Constitutional, other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 38 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 38 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 38 at risk

Adverse event: Hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 38 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 38 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 38 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 38 at risk

Adverse event: Hand-foot reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Skin-other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 38 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 38 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 38 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 38 at risk

Adverse event: Diarrhea w/o prior colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 38 at risk

Adverse event: Distention/bloating, abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 38 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 38 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 38 at risk

Adverse event: Muco/stomatitis by exam, oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Muco/stomatitis (symptom) oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Muco/stomatitis (symptom) pharynx
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 38 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 38 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 38 at risk

Adverse event: GI-other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 38 at risk

Adverse event: Nose, hemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hemorrhage-other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Infection Gr0-2 neut, ungual
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 38 at risk

Adverse event: Infection Gr0-2 neut, upper airway
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 38 at risk

Adverse event: Infection Gr0-2 neut, urinary tract
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 38 at risk

Adverse event: Infection Gr0-2 neut, vagina
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Infection Gr0-2 neut, wound
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Infection w/ unk ANC eye NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Infection w/ unk ANC lung
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Infection w/ unk ANC ungual (nails)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Infection-other
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 38 at risk

Adverse event: Edema limb
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 38 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 38 at risk

Adverse event: ALT, SGPT
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 38 at risk

Adverse event: AST, SGOT
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 38 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 38 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 38 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 38 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 38 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 38 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 38 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 38 at risk

Adverse event: Metabolic/Laboratory-other
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 38 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 38 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 38 at risk

Adverse event: Musculoskeletal/soft tissue-other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 38 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 38 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 38 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 38 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 38 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Neurologic-other
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 38 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 38 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 38 at risk

Adverse event: Glaucoma
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 38 at risk

Adverse event: Retinopathy
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 38 at risk

Adverse event: Vision-blurred
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 38 at risk

Adverse event: Vision-flashing lights/floaters
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 38 at risk

Adverse event: Ocular-other
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 38 at risk

Adverse event: Abdomen, pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Back, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 38 at risk

Adverse event: Bone, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Chest wall, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Chest/thoracic pain NOS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 38 at risk

Adverse event: Extremity-limb, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Face, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Head/headache
Serious: no
Organ System: General disorders
Frequency: 7 affected / 38 at risk

Adverse event: Joint, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 38 at risk

Adverse event: Lip, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Muscle, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 38 at risk

Adverse event: Neck, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Oral cavity, pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 38 at risk

Adverse event: Pelvic, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Skin, pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Vagina, pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 38 at risk

Adverse event: Pain-other
Serious: no
Organ System: General disorders
Frequency: 8 affected / 38 at risk

Adverse event: Bronchospasm, wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 38 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 38 at risk

Adverse event: Hiccoughs
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Nasal cavity/paranasal sinus reaction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Voice changes/dysarthria
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 38 at risk

Adverse event: Pulmonary/Upper Respiratory-other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Renal/GU-other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 38 at risk