Study: NCT00194714

Adverse event: CNS Cerebrovascular Ischema
Serious: yes
Organ System: Nervous system disorders
Notes: This was a Grade 4 event that was unrelated to the study treatment
Frequency: 1 affected / 21 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: This was a Grade 2 event that was determined to be possibly related to the study treatment
Frequency: 1 affected / 21 at risk

Adverse event: Ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: This was recorded as a Grade 3 event that was possibly related to the study treatment. This occurred after the patient spent time in the sun.
Frequency: 1 affected / 21 at risk

Adverse event: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to study treatment
Frequency: 1 affected / 21 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Notes: 28 events were deemed related; 5 were deemed unrelated to the study treatment
Frequency: 10 affected / 21 at risk

Adverse event: Anaemia
Serious: no
Organ System: Investigations
Notes: 4 events were deemed related; 7 events were deemed unrelated to study treatment
Frequency: 9 affected / 21 at risk

Adverse event: Platelets low
Serious: no
Organ System: Investigations
Notes: 4 events were deemed related; 2 events were deemed unrelated to the study treatment
Frequency: 3 affected / 21 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Notes: 27 events were deemed related; 2 were deemed unrelated to study treatment
Frequency: 10 affected / 21 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Investigations
Notes: Due to steroids; Unrelated to study treatment
Frequency: 1 affected / 21 at risk

Adverse event: Eosinophilia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 21 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 7 affected / 21 at risk

Adverse event: Palpatations
Serious: no
Organ System: Cardiac disorders
Notes: 2 of the events were deemed related; 7 of the events were deemed unrelated to study treatment
Frequency: 6 affected / 21 at risk

Adverse event: Supraventricular and nodal arrhythmia
Serious: no
Organ System: Cardiac disorders
Notes: This event was deemed possibly related to study treatment
Frequency: 1 affected / 21 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Not related to study treatment
Frequency: 4 affected / 21 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Notes: Events deemed related to study treatment
Frequency: 3 affected / 21 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: Cardiac disorders
Notes: Not related to study treatment
Frequency: 1 affected / 21 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: 2 events were deemed related; 2 events were deemed unrelated to study treatment
Frequency: 4 affected / 21 at risk

Adverse event: Rigors/Chills
Serious: no
Organ System: General disorders
Notes: 16 events were deemed related; 4 events were deemed unrelated to study treatment
Frequency: 12 affected / 21 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: 38 events were deemed related; 4 events were deemed unrelated
Frequency: 20 affected / 21 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Weepiness
Serious: no
Organ System: General disorders
Notes: Not related to study treatment
Frequency: 1 affected / 21 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 21 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Notes: All events were related to administration of study treatment
Frequency: 20 affected / 21 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 21 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 21 at risk

Adverse event: Pruritis/Itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 20 events deemed related; 2 events deemed unrelated to study treatment
Frequency: 12 affected / 21 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 21 at risk

Adverse event: Rash/acneiiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 21 at risk

Adverse event: Urticaria (hives, welts, wheals)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Events are related to study treatment
Frequency: 4 affected / 21 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Not related to study treatment
Frequency: 2 affected / 21 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 3 events deemed related; 2 events deemed unrelated to study treatment
Frequency: 3 affected / 21 at risk

Adverse event: Ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Not related to study treatment
Frequency: 1 affected / 21 at risk

Adverse event: Skin breakdown/decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Related to study treatment
Frequency: 1 affected / 21 at risk

Adverse event: Hypopigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Related to study treatment
Frequency: 1 affected / 21 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Notes: 1 event was related; 1 event was not related to study treatment
Frequency: 2 affected / 21 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: 6 events are deemed related; 11 events are deemed unrelated to study treatment
Frequency: 11 affected / 21 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: 13 events deemed related; 9 events deemed unrelated to study treatment
Frequency: 12 affected / 21 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 21 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not related to study treatment
Frequency: 4 affected / 21 at risk

Adverse event: Mucositis/stomatisis (functional/symptomatic)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not related to study treatment
Frequency: 1 affected / 21 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not related to study treatment
Frequency: 1 affected / 21 at risk

Adverse event: Hemorrhage, GU
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Infection with normal ANC or GRA1 or 2 neutrophils
Serious: no
Organ System: Infections and infestations
Notes: Not related to study treatment
Frequency: 10 affected / 21 at risk

Adverse event: Infection without neutrophils
Serious: no
Organ System: Infections and infestations
Notes: Not related to study treatment
Frequency: 1 affected / 21 at risk

Adverse event: Edema:limb
Serious: no
Organ System: General disorders
Notes: 8 events were deemed related; 8 events were deemed unrelated to study treatment
Frequency: 8 affected / 21 at risk

Adverse event: Edema: Head and neck
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Swelling left breast
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Not related to study treatment
Frequency: 1 affected / 21 at risk

Adverse event: Lymphnode pain
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 21 at risk

Adverse event: aspartate aminotransferase (AST)/SGOT
Serious: no
Organ System: Investigations
Notes: 1 event deemed related; 5 events deemed unrelated to study treatment
Frequency: 2 affected / 21 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Not related to study treatment
Frequency: 2 affected / 21 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Not related to study treatment
Frequency: 2 affected / 21 at risk

Adverse event: Alanine aminotransferase increased (ALT)/SGPT
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Not related to study treatment
Frequency: 2 affected / 21 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Not related to study treatment
Frequency: 2 affected / 21 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Notes: 1 event was related; 7 events unrelated to study treatment
Frequency: 3 affected / 21 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Not related to study treatment
Frequency: 1 affected / 21 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to study treatment
Frequency: 1 affected / 21 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: 8 events deemed related; 3 events deemed unrelated to study treatment
Frequency: 8 affected / 21 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Notes: Not related to study treatment
Frequency: 1 affected / 21 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 21 at risk

Adverse event: Neuropathy: motor
Serious: no
Organ System: Nervous system disorders
Notes: Not related to study treatment
Frequency: 2 affected / 21 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Pain - Headache
Serious: no
Organ System: Nervous system disorders
Notes: 27/42 events were deemed related to the study treatment
Frequency: 14 affected / 21 at risk

Adverse event: Pain - Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 21 at risk

Adverse event: Pain - Leg cramps
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Pain - Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 21 at risk

Adverse event: Pain - Arlthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 21 at risk

Adverse event: Pain - Neck
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Pain - Chest Wall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Pain - Rib
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Pain - Bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 21 at risk

Adverse event: Pain - Injection site
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 21 at risk

Adverse event: Pain - Breast
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 21 at risk

Adverse event: Pain - Lung
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Pain - Lymphnode
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 21 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 33 events were deemed related; 10 events were deemed unrelated to study treatment
Frequency: 13 affected / 21 at risk

Adverse event: Pain - Pleuritic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: After liver biopsy
Frequency: 1 affected / 21 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to study treatment
Frequency: 3 affected / 21 at risk

Adverse event: Bronchospasm, wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Hemorrhage/Bleeding associated with surgery, intra-operative or postoperative
Serious: no
Organ System: Surgical and medical procedures
Notes: Not related to study treatment
Frequency: 1 affected / 21 at risk

Adverse event: Urine leukocytes
Serious: no
Organ System: Renal and urinary disorders
Notes: Not related to study treatment
Frequency: 1 affected / 21 at risk

Adverse event: Flu-like syndrome
Serious: no
Organ System: General disorders
Notes: Related to study treatment
Frequency: 7 affected / 21 at risk

Adverse event: Vision - blurred
Serious: no
Organ System: Eye disorders
Notes: Not related to study treatment
Frequency: 1 affected / 21 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: This event was Grade 2 and deemed related to the study treatment
Frequency: 1 affected / 21 at risk

Adverse event: Infection Other - PAC infection
Serious: no
Organ System: Infections and infestations
Notes: This was a Grade 2 events that was unrelated to the study treatment
Frequency: 1 affected / 21 at risk

Adverse event: Infection Other - Cold
Serious: no
Organ System: Infections and infestations
Notes: Unrelated to study treatment
Frequency: 1 affected / 21 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Unrelated to study treatment
Frequency: 1 affected / 21 at risk

Adverse event: Pain - Extremity Limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Notes: This event was deemed unrelated to study treatment
Frequency: 1 affected / 21 at risk