Study: NCT01466686

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade NS
Frequency: 1 affected / 30 at risk

Adverse event: Death (Disease Progression)
Serious: yes
Organ System: General disorders
Notes: Grade 5
Frequency: 19 affected / 30 at risk

Adverse event: Death (NOS)
Serious: yes
Organ System: General disorders
Notes: Grade 5
Frequency: 4 affected / 30 at risk

Adverse event: Aphasia
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 4
Frequency: 1 affected / 30 at risk

Adverse event: Disease progression
Serious: yes
Organ System: General disorders
Notes: Grade 4
Frequency: 6 affected / 30 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Notes: Grade 4
Frequency: 1 affected / 30 at risk

Adverse event: Intraparenchymal Hemorrhage of Brain
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 4
Frequency: 1 affected / 30 at risk

Adverse event: Lymphocyte Count Decrease
Serious: yes
Organ System: Investigations
Notes: Grade 4
Frequency: 1 affected / 30 at risk

Adverse event: Personality/Behavioral CTC
Serious: yes
Organ System: Psychiatric disorders
Notes: Grade 4
Frequency: 1 affected / 30 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Notes: Grade 3
Frequency: 2 affected / 30 at risk

Adverse event: Ambulatory Dysfunction / Inability to Walk
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3
Frequency: 2 affected / 30 at risk

Adverse event: Aphasia
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3
Frequency: 1 affected / 30 at risk

Adverse event: Anal incontinence
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 30 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Psychiatric disorders
Notes: Grade 3
Frequency: 3 affected / 30 at risk

Adverse event: Disease progression
Serious: yes
Organ System: General disorders
Notes: Grade 3
Frequency: 4 affected / 30 at risk

Adverse event: DVT (NOS)
Serious: yes
Organ System: Vascular disorders
Notes: Grade 3
Frequency: 2 affected / 30 at risk

Adverse event: DVT (RLE)
Serious: yes
Organ System: Vascular disorders
Notes: Grade 3
Frequency: 1 affected / 30 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Notes: Grade 3
Frequency: 3 affected / 30 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3
Frequency: 1 affected / 30 at risk

Adverse event: Hyperglycemia / Elevated Glucose
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grade 3
Frequency: 2 affected / 30 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 1 affected / 30 at risk

Adverse event: Lymphocyte count decreased
Serious: yes
Organ System: Investigations
Notes: Grade 3
Frequency: 6 affected / 30 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Notes: Grade 3
Frequency: 1 affected / 30 at risk

Adverse event: Amnesia
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3
Frequency: 1 affected / 30 at risk

Adverse event: Motor Neuropathy
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3
Frequency: 2 affected / 30 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 30 at risk

Adverse event: Ocular-Visual
Serious: yes
Organ System: Eye disorders
Notes: Grade 3
Frequency: 1 affected / 30 at risk

Adverse event: Pain (knee)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 3
Frequency: 1 affected / 30 at risk

Adverse event: Pain (lower back)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 3
Frequency: 1 affected / 30 at risk

Adverse event: Pain (NOS)
Serious: yes
Organ System: General disorders
Notes: Grade 3
Frequency: 1 affected / 30 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Notes: Grade 3
Frequency: 1 affected / 30 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3
Frequency: 3 affected / 30 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3
Frequency: 2 affected / 30 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3
Frequency: 1 affected / 30 at risk

Adverse event: Speech Impairment
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3
Frequency: 2 affected / 30 at risk

Adverse event: Status epilepticus
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3
Frequency: 1 affected / 30 at risk

Adverse event: Tinnitus
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Grade 3
Frequency: 1 affected / 30 at risk

Adverse event: Urinary incontinence
Serious: yes
Organ System: Renal and urinary disorders
Notes: Grade 3
Frequency: 1 affected / 30 at risk

Adverse event: Weakness (lower extremity)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 3
Frequency: 3 affected / 30 at risk

Adverse event: Weakness (NOS)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 3
Frequency: 1 affected / 30 at risk