Study: NCT00137111

Adverse event: Acidosis (metabolic or respiratory)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 498 at risk

Adverse event: Adult respiratory distress syndrome (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 498 at risk

Adverse event: Allergic Reaction to Asparaginase
Serious: yes
Organ System: Immune system disorders
Frequency: 6 affected / 498 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 498 at risk

Adverse event: Amylase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 498 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 498 at risk

Adverse event: Blood bilirubin
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 498 at risk

Adverse event: CNS hemorrhage/bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 498 at risk

Adverse event: Catheter-related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 498 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 498 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 498 at risk

Adverse event: DIC (disseminated intravascular coagulation)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 498 at risk

Adverse event: Dermatology/Skin-Other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 498 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 498 at risk

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 498 at risk

Adverse event: Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 498 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 498 at risk

Adverse event: Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 498 at risk

Adverse event: Hepatic-Other
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 498 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 498 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 498 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 498 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 498 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 498 at risk

Adverse event: Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia (ANC <1.0 x 10e
Serious: yes
Organ System: Infections and infestations
Frequency: 32 affected / 498 at risk

Adverse event: Infection without neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 498 at risk

Adverse event: Leukoencephalopathy associated with radiological findings
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 498 at risk

Adverse event: Lipase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 498 at risk

Adverse event: Liver dysfunction/failure (clinical),
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 498 at risk

Adverse event: Neuropathy-sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 498 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 498 at risk

Adverse event: Personality/behavioral
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 498 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 498 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 498 at risk

Adverse event: Pulmonary-Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 498 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 498 at risk

Adverse event: Seizure(s)
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 498 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 498 at risk

Adverse event: Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 498 at risk

Adverse event: Thrombosis/embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 498 at risk

Adverse event: Typhlitis (inflammation of cecum)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 498 at risk

Adverse event: Vision-blurred vision
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 498 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 498 at risk

Adverse event: Abdominal pain or cramping
Serious: no
Organ System: General disorders
Frequency: 47 affected / 498 at risk

Adverse event: Allergic Reaction to Asparaginase
Serious: no
Organ System: Immune system disorders
Frequency: 41 affected / 498 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 498 at risk

Adverse event: Catheter-related infection
Serious: no
Organ System: Infections and infestations
Frequency: 86 affected / 498 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 498 at risk

Adverse event: Diarrhea patients without colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 53 affected / 498 at risk

Adverse event: Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe
Serious: no
Organ System: Infections and infestations
Frequency: 436 affected / 498 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)
Serious: no
Organ System: General disorders
Frequency: 208 affected / 498 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 26 affected / 498 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 43 affected / 498 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 42 affected / 498 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 32 affected / 498 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 52 affected / 498 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 51 affected / 498 at risk

Adverse event: Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 379 affected / 498 at risk

Adverse event: Infection without neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 290 affected / 498 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 46 affected / 498 at risk

Adverse event: Osteonecrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 35 affected / 498 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 25 affected / 498 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 29 affected / 498 at risk

Adverse event: SGPT (ALT)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 76 affected / 498 at risk

Adverse event: Stomatitis/pharyngitis (oral/pharyngeal mucositis),
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 65 affected / 498 at risk

Adverse event: Thrombosis/embolism
Serious: no
Organ System: Cardiac disorders
Frequency: 31 affected / 498 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 498 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 59 affected / 498 at risk

Adverse event: Wound-infectious
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 43 affected / 498 at risk