Study: NCT01442714

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Notes: Including: Neutropenia
Frequency: 25 affected / 33 at risk

Adverse event: Respiratory complications
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Including: dyspnea, pneumonia, aspiration pneumonitis
Frequency: 8 affected / 33 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 33 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: including: sepsis with acute dysfunction
Frequency: 2 affected / 33 at risk

Adverse event: Death on study
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 33 at risk

Adverse event: Cardiac complications
Serious: yes
Organ System: Cardiac disorders
Notes: Including: atrial flutters, asystole
Frequency: 2 affected / 33 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 33 at risk

Adverse event: Colon Volvulus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Neck pain and stiffness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Progressive disease
Serious: yes
Organ System: Infections and infestations
Notes: worsening AML
Frequency: 2 affected / 33 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: General disorders
Notes: right groin and facial (periorbital)
Frequency: 2 affected / 33 at risk

Adverse event: Generalized weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: lethargic
Frequency: 2 affected / 33 at risk

Adverse event: Graft vs host disease (GvHD)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Neck complications
Serious: yes
Organ System: Infections and infestations
Notes: Including: abscess, pain and stiffness
Frequency: 2 affected / 33 at risk

Adverse event: Rigors secondary to fever
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Body pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: back, abdomen
Frequency: 2 affected / 33 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Disseminated intravascular coagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: (DIC)
Frequency: 1 affected / 33 at risk

Adverse event: Vomitting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Skin infections
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: sweet syndrome
Frequency: 2 affected / 33 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 33 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Notes: In feet and fingers. Includes Peripheral Neuropathy.
Frequency: 2 affected / 33 at risk

Adverse event: Oedema
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: on lower extremities
Frequency: 2 affected / 33 at risk

Adverse event: apneic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 33 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Crackles at right base of lung
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Upper and lower extremities
Frequency: 2 affected / 33 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Difficulty urinating
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 33 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 33 at risk

Adverse event: Fungal pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 33 at risk

Adverse event: Left carotid
Serious: no
Organ System: Cardiac disorders
Notes: artery stenosis and endarterectomy
Frequency: 2 affected / 33 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 33 at risk

Adverse event: skin nodules
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 33 at risk

Adverse event: Tachycardiac
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 33 at risk

Adverse event: Ecchymoses on site injections
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Elevated LFT (AST>AST)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 33 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 33 at risk

Adverse event: erythema and conjunctival injection of right eye
Serious: no
Organ System: Infections and infestations
Notes: including hemorrhaging and swelling
Frequency: 2 affected / 33 at risk

Adverse event: erythematous lesions at injection site at abdomen
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: fracture of left fibula
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 33 at risk

Adverse event: hyperglycemic
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Hypotension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Hypertrophy of her gums
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 33 at risk

Adverse event: epigastic pain after eating
Serious: no
Organ System: Gastrointestinal disorders
Notes: intermittent
Frequency: 1 affected / 33 at risk

Adverse event: episodes of chest pressure
Serious: no
Organ System: Cardiac disorders
Notes: intermittent
Frequency: 1 affected / 33 at risk

Adverse event: Large bruise
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: on right tight
Frequency: 1 affected / 33 at risk

Adverse event: Left hip injury
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Left leg pain
Serious: no
Organ System: General disorders
Notes: including sciatica and cramping
Frequency: 3 affected / 33 at risk

Adverse event: left thyroid nodule
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Mild erythema at abdominal injection site
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Mouth soures/ thrush
Serious: no
Organ System: General disorders
Notes: including oral ulcer
Frequency: 4 affected / 33 at risk

Adverse event: Night sweats
Serious: no
Organ System: General disorders
Frequency: 2 affected / 33 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 33 at risk

Adverse event: Open sore of lower lip
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Redness and itching of eyes
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 33 at risk

Adverse event: Tremors
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 33 at risk

Adverse event: Significant Cytopenias
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Glossodynia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 33 at risk

Adverse event: Stress urinary incontinence
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Sudden loss of central vision
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 33 at risk

Adverse event: Swollen Knee
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Taste changes
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: tender facial skin
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Unspecified arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 33 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Allergies
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 33 at risk