Study: NCT01235793

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Notes: Temozolomide 431 mg/m\^2
Frequency: 1 affected / 11 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Temozolomide 351 mg/m\^2
Frequency: 1 affected / 11 at risk

Adverse event: Gait disturbances
Serious: yes
Organ System: Nervous system disorders
Notes: Temozolomide 431 mg/m\^2
Frequency: 1 affected / 11 at risk

Adverse event: Renal and Urinary disorders -Other, specify: High squamous epithelial cells
Serious: yes
Organ System: Renal and urinary disorders
Notes: Temozolomide 250 mg/m\^2
Frequency: 1 affected / 11 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Temozolomide 379 mg/m\^2, 611 mg/m\^2, and 762 mg/m\^2
Frequency: 3 affected / 11 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Temozolomide 351 mg/m\^2
Frequency: 1 affected / 11 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Notes: Temozolomide 351 mg/m\^2
Frequency: 1 affected / 11 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: Temozolomide 734 mg/m\^2
Frequency: 1 affected / 11 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Temozolomide 379 mg/m\^2, 521 mg/m\^2, 611 mg/m\^2, 734 mg/m\^2, and 762 mg/m\^2
Frequency: 5 affected / 11 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Temozolomide 351 mg/m\^2
Frequency: 1 affected / 11 at risk

Adverse event: Blood and lymphatic disorders -Other, specify: Pancytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Temozolomide 440 mg/m\^2
Frequency: 1 affected / 11 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Notes: Temozolomide 351 mg/m\^2
Frequency: 2 affected / 11 at risk

Adverse event: Facial paresis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Temozolomide 379 mg/m\^2
Frequency: 1 affected / 11 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Temozolomide 250 mg/m\^2 and 431 mg/m\^2
Frequency: 2 affected / 11 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Temozolomide 250 mg/m\^2 -1 participant, 287 mg/m\^2 -1 participant, 351 mg/m\^2 -1 participant (2 events), 379 mg/m\^2 -1 participant (2 events), 431 mg/m\^2 -1 participant, 521 mg/m\^2 -1 participant, 611 mg/m\^2 -1 participant, 693 mg/m\^2 -1 participant
Frequency: 9 affected / 11 at risk

Adverse event: Hypertryglyceridemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Temozolomide 734 mg/m\^2
Frequency: 1 affected / 11 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Temozolomide 440 mg/m\^2
Frequency: 1 affected / 11 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Temozolomide 250 mg/m\^2 and 287 mg/m\^2
Frequency: 2 affected / 11 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: Temozolomide 762 mg/m\^2
Frequency: 1 affected / 11 at risk

Adverse event: Infections and infestations -Other, specify: Ecoli bacteria
Serious: no
Organ System: Infections and infestations
Notes: Temozolomide 250 mg/m\^2
Frequency: 1 affected / 11 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Temozolomide 521 mg/m\^2
Frequency: 1 affected / 11 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: Temozolomide 762 mg/m\^2
Frequency: 1 affected / 11 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: Temozolomide 250 mg/m\^2 -1 participant, 287 mg/m\^2 -1 participant (2 events), and 431 mg/m\^2 -1 participant (2 events)
Frequency: 3 affected / 11 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Temozolomide 762 mg/m\^2
Frequency: 1 affected / 11 at risk

Adverse event: Musculoskeletal and connective tissue disorders -Other, specify: Neck weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Temozolomide 379 mg/m\^2
Frequency: 1 affected / 11 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: Temozolomide 250 mg/m\^2 -1 participant, 351 mg/m\^2 -1 participant (2 events), and 693 mg/m\^2 -1 participant
Frequency: 3 affected / 11 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: Temozolomide 250 mg/m\^2 -1 participant, 287 mg/m\^2 -1 participant, 351 mg/m\^2 -1 participant, 379 mg/m\^2 -1 participant, 431 mg/m\^2 -1 participant, 521 mg/m\^2 -1 participant, 611 mg/m\^2 -1 participant, 693 mg/m\^2, 734 mg/m\^2 -1 participant (2 events)
Frequency: 9 affected / 11 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Temozolomide 693 mg/m\^2
Frequency: 1 affected / 11 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Temozolomide 379 mg/m\^2
Frequency: 1 affected / 11 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Notes: Temozolomide 431 mg/m\^2
Frequency: 1 affected / 11 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: Temozolomide 287 mg/m\^2 -1 participant, 351 mg/m\^2 -1 participant (3 events), and 611 mg/m\^2 -1 participant
Frequency: 3 affected / 11 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: Temozolomide 250 mg/m\^2 -1 participant, 287 mg/m\^2 -1 participant, 351 mg/m\^2 -1 participant (4 events), 431 mg/m\^2 -1 participant, and 762 mg/m\^2 -1 participant (2 events)
Frequency: 5 affected / 11 at risk