Study: NCT02530320

Adverse event: Ataxia - G2
Serious: yes
Organ System: Nervous system disorders
Notes: No relation; Intensity: Hospitalization; Action: None
Frequency: 1 affected / 34 at risk

Adverse event: Cognitive disturbance - G3
Serious: yes
Organ System: General disorders
Notes: No relation; Intensity: Hospitalization; Action: Delay of treatment
Frequency: 1 affected / 34 at risk

Adverse event: Seizure - G2
Serious: yes
Organ System: General disorders
Notes: Relation:No; Intensity: Hospitalization; Action: None
Frequency: 1 affected / 34 at risk

Adverse event: Dysphasia - G3
Serious: yes
Organ System: General disorders
Notes: Relation: No; Intensity: Hospitalization; Action: None
Frequency: 1 affected / 34 at risk

Adverse event: Surgical and medical procedures - Other, glioma exeresis - G1
Serious: yes
Organ System: Surgical and medical procedures
Notes: No Relation; Intensity: Relevant medical; Action:None
Frequency: 1 affected / 34 at risk

Adverse event: Cognitive impairment - G3
Serious: yes
Organ System: General disorders
Notes: Relation: No; Intensity: Hospitalization; Action: None
Frequency: 1 affected / 34 at risk

Adverse event: General disorders and administration site conditions - Other, clinical deterioration - G3
Serious: yes
Organ System: General disorders
Notes: Relation: No; Intensity: Hospitalization; Action: None
Frequency: 1 affected / 34 at risk

Adverse event: Hyperglycaemia - G4
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Relation: No; Intensity: Hospitalization; Action:None
Frequency: 1 affected / 34 at risk

Adverse event: Confusion - G3
Serious: yes
Organ System: General disorders
Notes: Relation:No; Intensity: Hospitalization; Interruption of treatment
Frequency: 1 affected / 34 at risk

Adverse event: Muscle weakness left-sided - G2
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Relation: No Intensity: Hospitalization. Action: None
Frequency: 1 affected / 34 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Immune system disorders
Frequency: 24 affected / 34 at risk

Adverse event: Fatigue
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 34 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 34 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 34 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 34 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 34 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 34 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 34 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 5 affected / 34 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 34 at risk

Adverse event: Cephalea
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 34 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 34 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 34 at risk

Adverse event: Hemiparesis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 34 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 34 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 34 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 34 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 34 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 34 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 34 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 34 at risk

Adverse event: Injury, poisoning and procedural complications - other, Lip wound
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 34 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 34 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 34 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 34 at risk