Study: NCT00004635

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 138 at risk

Adverse event: Abdominal pain or cramping
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 138 at risk

Adverse event: Blood alkaline phosphatase
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 138 at risk

Adverse event: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 138 at risk

Adverse event: Chest pain (non-cardiac and non-pleuritis)
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 138 at risk

Adverse event: Alopecia
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 138 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 138 at risk

Adverse event: Arrhythmia-other
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 138 at risk

Adverse event: Arthralgia (joint pain)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 138 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 138 at risk

Adverse event: Ataxia (incoordination)
Serious: yes
Organ System: Nervous system disorders
Frequency: 12 affected / 138 at risk

Adverse event: Blood bilirubin
Serious: yes
Organ System: Investigations
Frequency: 8 affected / 138 at risk

Adverse event: Brusing (in absence of grade 3 or 4 thrombocytopenia)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 138 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 138 at risk

Adverse event: CPK (creatine phosphokinase)
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 138 at risk

Adverse event: Circulatory or cardiac-Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 138 at risk

Adverse event: Cognitive disturbance/learning problems
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 138 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 8 affected / 138 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 85 affected / 138 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 138 at risk

Adverse event: Constitutional symptoms-Other
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 138 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 138 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 138 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 33 affected / 138 at risk

Adverse event: Derma/Skin-Other: Lower lip lesion
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 138 at risk

Adverse event: Diarrhea (without colostomy)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 138 at risk

Adverse event: Dizziness/lightheadedness
Serious: yes
Organ System: Nervous system disorders
Frequency: 58 affected / 138 at risk

Adverse event: Dry eye
Serious: yes
Organ System: Eye disorders
Frequency: 6 affected / 138 at risk

Adverse event: Dry skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 138 at risk

Adverse event: Dyspepsia/heartburn
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 138 at risk

Adverse event: Dysphagia, esophagitis, odynophagia (painful swallowing)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 138 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 36 affected / 138 at risk

Adverse event: Dysuria (painful urination)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 138 at risk

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Frequency: 39 affected / 138 at risk

Adverse event: Erectile impotence
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 138 at risk

Adverse event: Extrapyramidal/involuntary movement/restlessness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 138 at risk

Adverse event: Fatigue (lethargy, malaise, asthenia)
Serious: yes
Organ System: General disorders
Frequency: 66 affected / 138 at risk

Adverse event: Fever (in absence of neutropenia, where neutropenia is defined as AGC<1.0x109/L)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 138 at risk

Adverse event: Flatulence
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 138 at risk

Adverse event: Flushing
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 138 at risk

Adverse event: GI-Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 138 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 138 at risk

Adverse event: Gynaecomastia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 7 affected / 138 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 25 affected / 138 at risk

Adverse event: Hearing-Other
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 138 at risk

Adverse event: Hematologic-Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 138 at risk

Adverse event: Hematuria (in the absence of vaginal bleeding)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 138 at risk

Adverse event: Hemoglobin (Hgb)
Serious: yes
Organ System: Investigations
Frequency: 21 affected / 138 at risk

Adverse event: Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis, other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 138 at risk

Adverse event: Hiccoughs (hiccups, singultus)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 138 at risk

Adverse event: Hot flashes/flashes
Serious: yes
Organ System: Vascular disorders
Frequency: 11 affected / 138 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 138 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 30 affected / 138 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 138 at risk

Adverse event: Hypermagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 138 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 138 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 138 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 138 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 138 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 138 at risk

Adverse event: Hypomagnesmia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 138 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 138 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 138 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 138 at risk

Adverse event: Hypothyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 3 affected / 138 at risk

Adverse event: Incontinence
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 138 at risk

Adverse event: Infection without neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 138 at risk

Adverse event: Infection, Other
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 138 at risk

Adverse event: Inner ear/hearing
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 138 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 138 at risk

Adverse event: Joint, muscle, or bone (osseous)-Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 138 at risk

Adverse event: Leukocytes (total WBC)
Serious: yes
Organ System: Investigations
Frequency: 13 affected / 138 at risk

Adverse event: Libido
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 138 at risk

Adverse event: Lymphatics
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 138 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 138 at risk

Adverse event: Amnesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 138 at risk

Adverse event: Mood alteration-anxiety agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 11 affected / 138 at risk

Adverse event: Mood alteration-depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 11 affected / 138 at risk

Adverse event: Mouth dryness
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 44 affected / 138 at risk

Adverse event: Muscle cramps (thigh)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 138 at risk

Adverse event: Muscle weakness (not due to neuropathy)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 138 at risk

Adverse event: Myalgia (muscle ache)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 20 affected / 138 at risk

Adverse event: Nail disorder
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 138 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 138 at risk

Adverse event: Neurologic-Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 138 at risk

Adverse event: Neuropathy cranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 138 at risk

Adverse event: Neuropathy motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 138 at risk

Adverse event: Neuropathy-sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 55 affected / 138 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 9 affected / 138 at risk

Adverse event: Ocular-Other
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 138 at risk

Adverse event: Pain-Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 138 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 138 at risk

Adverse event: Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 138 at risk

Adverse event: Photosensitivity reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 138 at risk

Adverse event: Platelets
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 138 at risk

Adverse event: Protrombin Time/INR-International Normalized Ratio of protrombin time
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 138 at risk

Adverse event: Pruritus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 138 at risk

Adverse event: Pulmonary-Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 138 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 138 at risk

Adverse event: Rectal bleeding/hematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 138 at risk

Adverse event: Rectal or perirectal pain (proctalgia)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 138 at risk

Adverse event: SGOT (AST)
Serious: yes
Organ System: Investigations
Frequency: 10 affected / 138 at risk

Adverse event: SGPT (ALT)
Serious: yes
Organ System: Investigations
Frequency: 9 affected / 138 at risk

Adverse event: Salivary gland changes
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 138 at risk

Adverse event: Secondary Malignancy-Other
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 138 at risk

Adverse event: Sense of smell
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 138 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 28 affected / 138 at risk

Adverse event: Skin-Other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 138 at risk

Adverse event: Stomatitis/pharyngitis (oral/pharyngeal mucositis)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 138 at risk

Adverse event: Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 138 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 138 at risk

Adverse event: Taste disturbance (dysgeusia)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 138 at risk

Adverse event: Tearing (watery eyes)
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 138 at risk

Adverse event: Thrombosis/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 138 at risk

Adverse event: Tremor
Serious: yes
Organ System: Nervous system disorders
Frequency: 18 affected / 138 at risk

Adverse event: Urinary frequency/urgency
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 138 at risk

Adverse event: Urticaria (hives, welts, wheals)
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 138 at risk

Adverse event: Ventricular arrhythmia (PVCs/bigeminy/trigeminy/ventricular tachycardia)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 138 at risk

Adverse event: Vision-blurred vision
Serious: yes
Organ System: Eye disorders
Frequency: 8 affected / 138 at risk

Adverse event: Vision-double vision (diplopia)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 138 at risk

Adverse event: Vision-flashing lights/floaters
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 138 at risk

Adverse event: Vision-night blindness (nyctalopia)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 138 at risk

Adverse event: Voice changes/stridor/larynx (e.g., hoarsneness, loss of voice, laryngitis)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 138 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 138 at risk

Adverse event: Weight increased
Serious: yes
Organ System: Investigations
Frequency: 9 affected / 138 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 138 at risk

Adverse event: Wound-infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 138 at risk

Adverse event: Renal/GU-Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 138 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 138 at risk

Adverse event: Sweating (diaphoresis)
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 138 at risk

Adverse event: Cardiac-ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 138 at risk

Adverse event: Cardiac-left ventricular function
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 138 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 138 at risk

Adverse event: Dry mouth
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 138 at risk

Adverse event: Endocrine-Other
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 138 at risk

Adverse event: Blood lactate dehydrogenase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 138 at risk

Adverse event: Metabolic-Other
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 138 at risk

Adverse event: Neuropathic pain (e.g., jaw pain, neurologic pain, phantom limb pain, post-infectious neuralgia, or
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 138 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 138 at risk

Adverse event: Rigors/chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 138 at risk

Adverse event: Vision-photophobia
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 138 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 138 at risk

Adverse event: Seizure(s)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 138 at risk

Adverse event: Vasovagal episode
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 138 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 138 at risk

Adverse event: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 138 at risk

Adverse event: Abdominal pain or cramping
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 138 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 2 affected / 138 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 138 at risk

Adverse event: Cardiac left ventricular function
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 138 at risk

Adverse event: Cardiac-ischemia/infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 138 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 138 at risk

Adverse event: Circulatory or cardiac-Other
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 138 at risk

Adverse event: Endocrine-Other
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 138 at risk

Adverse event: Coag-Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 138 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 138 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 9 affected / 138 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 138 at risk

Adverse event: Dizziness/lightheadedness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 138 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 138 at risk

Adverse event: Dyspepsia/heartburn
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 138 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 138 at risk

Adverse event: Fatigue (lethargy, malaise, asthenia)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 138 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 138 at risk

Adverse event: Hearing-Other
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 138 at risk

Adverse event: Hematuria (in the absence of vaginal bleeding)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 138 at risk

Adverse event: Hemoglobin (Hgb)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 138 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 138 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 138 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 138 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 138 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 138 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 138 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 138 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 138 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 138 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 138 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 138 at risk

Adverse event: Hypomagnesmia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 138 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 138 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 138 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 138 at risk

Adverse event: Incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 138 at risk

Adverse event: Infection without neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 138 at risk

Adverse event: Infection, Other
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 138 at risk

Adverse event: Inner ear/hearing
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 138 at risk

Adverse event: Joint, muscle, or bone (osseous)-Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 138 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 138 at risk

Adverse event: Middle ear/hearing
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 138 at risk

Adverse event: Mood alteration-anxiety agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 138 at risk

Adverse event: Mouth dryness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 138 at risk

Adverse event: Myalgia (muscle ache)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 138 at risk

Adverse event: Myositis (inflammation/damage of muscle)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 138 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 138 at risk

Adverse event: Neuropathic pain (e.g., jaw pain, neurologic pain, phantom limb pain, post-infectious neuralgia, or
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 138 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 138 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 138 at risk

Adverse event: Ocular-Other
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 138 at risk

Adverse event: Pain-Other
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 138 at risk

Adverse event: Photosensitivity reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 138 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 138 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 138 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 138 at risk

Adverse event: Pulmonary-Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 138 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 138 at risk

Adverse event: Renal/GU-Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 138 at risk

Adverse event: SGPT (ALT)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 138 at risk

Adverse event: Secondary Malignancy-Other
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 138 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 138 at risk

Adverse event: Skin-Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 138 at risk

Adverse event: Stomatitis/pharyngitis (oral/pharyngeal mucositis)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 138 at risk

Adverse event: Trauma R. big toe
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 138 at risk

Adverse event: Ureteral obstruction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 138 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 138 at risk

Adverse event: Voice changes/stridor/larynx (e.g., hoarsneness, loss of voice, laryngitis)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 138 at risk

Adverse event: Wound
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 138 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 138 at risk

Adverse event: Abdominal pain or cramping
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 124 at risk

Adverse event: Blood alkaline phosphatase
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 124 at risk

Adverse event: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 124 at risk

Adverse event: Chest pain (non-cardiac and non-pleuritis)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 124 at risk

Adverse event: Alopecia
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 124 at risk

Adverse event: Arthralgia (joint pain)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 124 at risk

Adverse event: Ataxia (incoordination)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 124 at risk

Adverse event: Blood bilirubin
Serious: yes
Organ System: Investigations
Frequency: 16 affected / 124 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 124 at risk

Adverse event: CPK (creatine phosphokinase)
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 124 at risk

Adverse event: Circulatory or cardiac-Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 124 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 124 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 124 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 124 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 124 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 124 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 124 at risk

Adverse event: Diarrhea (without colostomy)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 124 at risk

Adverse event: Dizziness/lightheadedness
Serious: yes
Organ System: Nervous system disorders
Frequency: 18 affected / 124 at risk

Adverse event: Dry eye
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 124 at risk

Adverse event: Dry skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 124 at risk

Adverse event: Dyspepsia/heartburn
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 124 at risk

Adverse event: Dysphagia, esophagitis, odynophagia (painful swallowing)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 124 at risk

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 124 at risk

Adverse event: Fatigue (lethargy, malaise, asthenia)
Serious: yes
Organ System: General disorders
Frequency: 37 affected / 124 at risk

Adverse event: Flatulence
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 124 at risk

Adverse event: GI-Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 124 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 124 at risk

Adverse event: Gynaecomastia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 124 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 13 affected / 124 at risk

Adverse event: Hematologic-Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 124 at risk

Adverse event: Hematuria (in the absence of vaginal bleeding)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 124 at risk

Adverse event: Hemoglobin (Hgb)
Serious: yes
Organ System: Investigations
Frequency: 8 affected / 124 at risk

Adverse event: Hot flashes/flashes
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 124 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 124 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 124 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 124 at risk

Adverse event: Hypermagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 124 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 124 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 124 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 124 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 124 at risk

Adverse event: Hypomagnesmia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 124 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 124 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 124 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 124 at risk

Adverse event: Hypothyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 124 at risk

Adverse event: Incontinence
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 124 at risk

Adverse event: Infection without neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 124 at risk

Adverse event: Inner ear/hearing
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 124 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 11 affected / 124 at risk

Adverse event: Joint, muscle, or bone (osseous)-Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 124 at risk

Adverse event: Leukocytes (total WBC)
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 124 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 124 at risk

Adverse event: Amnesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 124 at risk

Adverse event: Mood alteration-anxiety agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 124 at risk

Adverse event: Mood alteration-depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 124 at risk

Adverse event: Mouth dryness
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 124 at risk

Adverse event: Muscle weakness (not due to neuropathy)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 124 at risk

Adverse event: Myalgia (muscle ache)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 124 at risk

Adverse event: Nail disorder
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 124 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 124 at risk

Adverse event: Neurologic-Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 124 at risk

Adverse event: Neuropathy motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 124 at risk

Adverse event: Neuropathy-sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 23 affected / 124 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 124 at risk

Adverse event: Ocular-Other
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 124 at risk

Adverse event: Pain-Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 124 at risk

Adverse event: Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 124 at risk

Adverse event: Photosensitivity reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 124 at risk

Adverse event: Platelets
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 124 at risk

Adverse event: Pruritus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 124 at risk

Adverse event: Pulmonary-Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 124 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 124 at risk

Adverse event: Rectal bleeding/hematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 124 at risk

Adverse event: Rectal or perirectal pain (proctalgia)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: SGOT (AST)
Serious: yes
Organ System: Investigations
Frequency: 16 affected / 124 at risk

Adverse event: SGPT (ALT)
Serious: yes
Organ System: Investigations
Frequency: 12 affected / 124 at risk

Adverse event: Salivary gland changes
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: Secondary Malignancy-Other
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 124 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 124 at risk

Adverse event: Skin-Other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 124 at risk

Adverse event: Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 124 at risk

Adverse event: Taste disturbance (dysgeusia)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 124 at risk

Adverse event: Thrombosis/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 124 at risk

Adverse event: Tremor
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 124 at risk

Adverse event: Urinary frequency/urgency
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 124 at risk

Adverse event: Urticaria (hives, welts, wheals)
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 124 at risk

Adverse event: Vision-blurred vision
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 124 at risk

Adverse event: Vision-double vision (diplopia)
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 124 at risk

Adverse event: Vision-flashing lights/floaters
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 124 at risk

Adverse event: Voice changes/stridor/larynx (e.g., hoarsneness, loss of voice, laryngitis)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 124 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 124 at risk

Adverse event: Weight increased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 124 at risk

Adverse event: Renal/GU-Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 124 at risk

Adverse event: Cardiac-ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 124 at risk

Adverse event: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 124 at risk

Adverse event: Abdominal pain or cramping
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 124 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 124 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 124 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 124 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 5 affected / 124 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 124 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 124 at risk

Adverse event: Fatigue (lethargy, malaise, asthenia)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 124 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 124 at risk

Adverse event: Hematuria (in the absence of vaginal bleeding)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 124 at risk

Adverse event: Hemoglobin (Hgb)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 124 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 124 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 124 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 124 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 124 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 124 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 124 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 124 at risk

Adverse event: Hypomagnesmia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 124 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 124 at risk

Adverse event: Incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 124 at risk

Adverse event: Infection without neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 124 at risk

Adverse event: Infection, Other
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 124 at risk

Adverse event: Joint, muscle, or bone (osseous)-Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 124 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 124 at risk

Adverse event: Mood alteration-anxiety agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 124 at risk

Adverse event: Myalgia (muscle ache)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 124 at risk

Adverse event: Ocular-Other
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 124 at risk

Adverse event: Pain-Other
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 124 at risk

Adverse event: Photosensitivity reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 124 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 124 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 124 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 124 at risk

Adverse event: Renal/GU-Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 124 at risk

Adverse event: Secondary Malignancy-Other
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 124 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 124 at risk

Adverse event: Skin-Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 124 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 124 at risk

Adverse event: Arthralgia (joint pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 124 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 124 at risk

Adverse event: CPK (creatine phosphokinase)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 124 at risk

Adverse event: Diarrhea (without colostomy)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 124 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 124 at risk

Adverse event: Hepatic-Other
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 124 at risk

Adverse event: Hot flashes/flashes
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 124 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 124 at risk

Adverse event: Infection with unknown ANC
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 124 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 124 at risk

Adverse event: Mood alteration-depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 124 at risk

Adverse event: Rectal bleeding/hematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 124 at risk

Adverse event: SGOT (AST)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 124 at risk

Adverse event: Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 124 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 124 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 124 at risk

Adverse event: GI-Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: Haemoglobinuria
Serious: no
Organ System: Investigations
Frequency: 1 affected / 124 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 124 at risk

Adverse event: Vasovagal episode
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 124 at risk

Adverse event: Vision-blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 124 at risk

Adverse event: Pyramidal tract dysfunction (e.g., increased tone, hyperreflexia, positive Babinski, decreased fine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 124 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 124 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 124 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 124 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 124 at risk

Adverse event: Arrhythmia-Other
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 124 at risk

Adverse event: Ataxia (incoordination)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 124 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Investigations
Frequency: 1 affected / 124 at risk

Adverse event: Chest pain (non-cardiac and non-pleuritic)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 124 at risk

Adverse event: Constitutional symptoms-Other
Serious: no
Organ System: General disorders
Frequency: 2 affected / 124 at risk

Adverse event: Fever (in absence of neutropenia where neutropenia is defined as AGC<1.0x109)L
Serious: no
Organ System: General disorders
Frequency: 1 affected / 124 at risk

Adverse event: Dysuria (painful urination)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 124 at risk

Adverse event: Extrapyramidal/involuntary movement/restlessness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 124 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Erectile impotence
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 159 at risk

Adverse event: Extrapyramidal/involuntary movement/restlessness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: Fatigue (lethargy, malaise, asthenia)
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 159 at risk

Adverse event: Gynaecomastia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 159 at risk

Adverse event: Hot flashes/flashes
Serious: yes
Organ System: Vascular disorders
Frequency: 11 affected / 159 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 159 at risk

Adverse event: Joint, muscle, or bone (osseous)-Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: Libido
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 159 at risk

Adverse event: Muscle weakness (not due to neuropathy)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: Urinary frequency/urgency
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 159 at risk

Adverse event: Cardiac-ischemia/infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Dizziness/lightheadedness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 159 at risk

Adverse event: Fatigue (lethargy, malaise, asthenia)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 159 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 159 at risk

Adverse event: Infection, Other
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 159 at risk

Adverse event: Joint, muscle, or bone (osseous)-Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 159 at risk

Adverse event: Mouth dryness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Pain-Other
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 159 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: Skin-Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 159 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 159 at risk

Adverse event: Sweating (diaphoresis)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Muscle weakness (not due to neuropathy)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: GI-Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Allergy-Other
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 159 at risk

Adverse event: Blood alkaline phosphatase
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 159 at risk

Adverse event: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 159 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Arthralgia (joint pain)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 159 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: Ataxia (incoordination)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 159 at risk

Adverse event: Blood bilirubin
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 159 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 159 at risk

Adverse event: CPK (creatine phosphokinase)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 159 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 159 at risk

Adverse event: Constitutional symptoms-Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 159 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 159 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 159 at risk

Adverse event: Diarrhea (without colostomy)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 159 at risk

Adverse event: Dizziness/lightheadedness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 159 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 159 at risk

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 159 at risk

Adverse event: Erectile impotence
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 11 affected / 159 at risk

Adverse event: Fatigue (lethargy, malaise, asthenia)
Serious: yes
Organ System: General disorders
Frequency: 21 affected / 159 at risk

Adverse event: Fever (in absence of neutropenia, where neutropenia is defined as AGC<1.0x109/L)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 159 at risk

Adverse event: Flushing
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 159 at risk

Adverse event: Gynaecomastia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 159 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 159 at risk

Adverse event: Hematologic-Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 159 at risk

Adverse event: Hematuria (in the absence of vaginal bleeding)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 159 at risk

Adverse event: Hemoglobin (Hgb)
Serious: yes
Organ System: Investigations
Frequency: 8 affected / 159 at risk

Adverse event: Hot flashes/flashes
Serious: yes
Organ System: Vascular disorders
Frequency: 102 affected / 159 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 159 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 159 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 159 at risk

Adverse event: Hypermagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 159 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 159 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 159 at risk

Adverse event: Hypomagnesmia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 159 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 159 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 159 at risk

Adverse event: Incontinence
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 159 at risk

Adverse event: Infection without neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 159 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 159 at risk

Adverse event: Leukocytes (total WBC)
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 159 at risk

Adverse event: Libido
Serious: yes
Organ System: Psychiatric disorders
Frequency: 13 affected / 159 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 159 at risk

Adverse event: Mood alteration-anxiety agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 159 at risk

Adverse event: Mood alteration-depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 159 at risk

Adverse event: Muscle weakness (not due to neuropathy)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: Myalgia (muscle ache)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 159 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Neurologic-Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 159 at risk

Adverse event: Neuropathy-sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 159 at risk

Adverse event: Pain-Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 159 at risk

Adverse event: Platelets
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 159 at risk

Adverse event: Pruritus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: Pulmonary-Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 159 at risk

Adverse event: Rectal bleeding/hematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: SGOT (AST)
Serious: yes
Organ System: Investigations
Frequency: 12 affected / 159 at risk

Adverse event: SGPT (ALT)
Serious: yes
Organ System: Investigations
Frequency: 16 affected / 159 at risk

Adverse event: Sense of smell
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 159 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Skin-Other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Tearing (watery eyes)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 159 at risk

Adverse event: Thrombosis/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 159 at risk

Adverse event: Urinary frequency/urgency
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 159 at risk

Adverse event: Vision-blurred vision
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 159 at risk

Adverse event: Weight increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 159 at risk

Adverse event: Pleuritic pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Sweating (diaphoresis)
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 159 at risk

Adverse event: Cardiac-ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 159 at risk

Adverse event: Impotency
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 159 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Hypercholesterolaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 159 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 3 affected / 159 at risk

Adverse event: Cardiac-ischemia/infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 1 affected / 159 at risk

Adverse event: Dizziness/lightheadedness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 159 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Fatigue (lethargy, malaise, asthenia)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 159 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 159 at risk

Adverse event: Hematuria (in the absence of vaginal bleeding)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 159 at risk

Adverse event: Hemoglobin (Hgb)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 159 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 159 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 159 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 159 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 159 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 159 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 159 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 159 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 159 at risk

Adverse event: Hypomagnesmia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 159 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 159 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 159 at risk

Adverse event: Incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 159 at risk

Adverse event: Infection without neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 159 at risk

Adverse event: Joint, muscle, or bone (osseous)-Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 159 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 159 at risk

Adverse event: Myalgia (muscle ache)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 159 at risk

Adverse event: Myositis (inflammation/damage of muscle)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 159 at risk

Adverse event: Ocular-Other
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 159 at risk

Adverse event: Pain-Other
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 159 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: SGPT (ALT)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 159 at risk

Adverse event: Secondary Malignancy-Other
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 159 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 159 at risk

Adverse event: Skin-Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: CPK (creatine phosphokinase)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 159 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 159 at risk

Adverse event: Diarrhea (without colostomy)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 159 at risk

Adverse event: Erectile impotence
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 159 at risk

Adverse event: Hematologic-Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 159 at risk

Adverse event: Hepatic-Other
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 159 at risk

Adverse event: Hot flashes/flashes
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 159 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 159 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 159 at risk

Adverse event: Infection with unknown ANC
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 159 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 159 at risk

Adverse event: Mood alteration-depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 159 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Proctitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Rectal bleeding/hematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 159 at risk

Adverse event: SGOT (AST)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 159 at risk

Adverse event: Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 159 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 159 at risk

Adverse event: Taste disturbance (dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 159 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 159 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 159 at risk

Adverse event: GI-Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk