Study: NCT00703820

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 33 affected / 133 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 45 affected / 133 at risk

Adverse event: AST, SGOT (serum glutamic oxaloacetic transaminase)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 133 at risk

Adverse event: Acidosis (metabolic or respiratory)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 133 at risk

Adverse event: Allbumin, serum-low (hypoalbuminemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 133 at risk

Adverse event: Alkalosis (metabolic or respiratory)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 133 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 133 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 133 at risk

Adverse event: Sodium, serum-high (hypernatremia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 133 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 133 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 133 at risk

Adverse event: Lipase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 133 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 133 at risk

Adverse event: GGT (gamma-Glutamyl transpeptidase)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 133 at risk

Adverse event: Magnesium, serum-high (hypermagnesemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 133 at risk

Adverse event: Potassium, serum-ghigh (hyperkalemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 133 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 133 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 133 at risk

Adverse event: Amylase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 133 at risk

Adverse event: Tumour lysis syndrome
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 133 at risk

Adverse event: Uric acid, serum-high (hyperuricemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 133 at risk

Adverse event: Blood fibrinogen
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 133 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 133 at risk

Adverse event: Metabolic/Laboratory
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 133 at risk

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 133 at risk

Adverse event: Calcium, serum-high (hypercalcemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 133 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 133 at risk

Adverse event: Mucositis/stomatitis (clinical exam), oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 133 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 133 at risk

Adverse event: Typhlitis (cecal inflammation)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 133 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 133 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 133 at risk

Adverse event: Hemorrhage, GI, Oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: Pain, Abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 133 at risk

Adverse event: Gastrointestinal - Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 133 at risk

Adverse event: Distension/bloating, abdominal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: Enteritis (inflammation of the small bowel)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 133 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 133 at risk

Adverse event: Hemorrhage, GI, Lower GI NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic), oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 133 at risk

Adverse event: Pain, rectum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 133 at risk

Adverse event: Perforation, GI, appendix
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: Dysphagia (difficulty swallowing)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 133 at risk

Adverse event: Pain, dental/teeth/peridontal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: Gastritis (including bile reflux gastritis)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 133 at risk

Adverse event: Pain, stomach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: Mucotitis/stomatitis (functional/symptomatic), esophagus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: Pain, lip
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 133 at risk

Adverse event: Pain, head/headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 133 at risk

Adverse event: Neuropathy: sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 133 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 133 at risk

Adverse event: Hemorrhage, CNS
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 133 at risk

Adverse event: Neuropathy: motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 133 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 133 at risk

Adverse event: Ataxia (incoordination)
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 133 at risk

Adverse event: Speech impairment (e.g., dysphasia or aphasia)
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 133 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 133 at risk

Adverse event: CNS necrosis/cystic progression
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 133 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 133 at risk

Adverse event: Neurology - other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 133 at risk

Adverse event: Neuropathy: cranial, CN IX Motor-pharynx; sensory-ear, pharynx, tongue
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 133 at risk

Adverse event: Infection (documented clinically or microbiologically documented, ANC<1.0x10e9/L, fever>38.5C),blood
Serious: yes
Organ System: Infections and infestations
Frequency: 20 affected / 133 at risk

Adverse event: Infection (documented clinically or microbioogically) with Grade 3 or 4 neutrophils (ANC<1.0x10e9/L)
Serious: yes
Organ System: Infections and infestations
Frequency: 71 affected / 133 at risk

Adverse event: Infection - other
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 133 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 133 at risk

Adverse event: Colitis, infectious (e.g., Clostridium difficile)
Serious: yes
Organ System: Infections and infestations
Frequency: 21 affected / 133 at risk

Adverse event: Infection with unknown ANC, blood
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 133 at risk

Adverse event: Infection with unknown ANC, urinary tract NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 133 at risk

Adverse event: Infection with unknown ANC, catheter-related
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 133 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: yes
Organ System: Immune system disorders
Frequency: 11 affected / 133 at risk

Adverse event: Febrile neutropenia (fever of unknown origin: not clinically or microbiologically documented)
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: ANC \<1.0x10e9/L, fever \>=38.5C
Frequency: 90 affected / 133 at risk

Adverse event: DIC (disseminated intravascular coagulation)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 133 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 133 at risk

Adverse event: Ocular surface disease
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 133 at risk

Adverse event: Keratitis (corneal inflammation/corneal ulceration)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 133 at risk

Adverse event: Vision-photophobia
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 133 at risk

Adverse event: Death not associated with CTCAE term, multi-organ failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 133 at risk

Adverse event: Constitutional symptoms - other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 133 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 133 at risk

Adverse event: Injection site reaction/extravasation changes
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 133 at risk

Adverse event: Pain - other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 133 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0x10e9/L)
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 133 at risk

Adverse event: Death not associated with CTCAE term, sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 133 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 133 at risk

Adverse event: Pulmonary/upper respiratory - other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 133 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 133 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: Adult Respiratory Distress Syndrome (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 133 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory, nose
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 133 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory, bronchopulmonary NOS
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 133 at risk

Adverse event: Valvular heart disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Prolonged QTc interval
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 133 at risk

Adverse event: Supraventricular and nodal arrhythmia, sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Right ventricular dysfunction (cor pulmonale)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Pericardial effusion (non-malignant)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 133 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Supraventricular and nodal arrhythmia, sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 133 at risk

Adverse event: Rash: acne/acneiform
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 133 at risk

Adverse event: Pruritus/itching
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 133 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 133 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 133 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 133 at risk

Adverse event: Capillary leak syndrome
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 133 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 133 at risk

Adverse event: Pain, back
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 133 at risk

Adverse event: Pain, extremity-limb
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 133 at risk

Adverse event: PTT (Partial Thromboplastin Time)
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 133 at risk

Adverse event: INR (International Normalized Ratio of prothrombin time)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 133 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 133 at risk

Adverse event: Urinary frequency/urgency
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 133 at risk

Adverse event: Mood alteration, euphoria
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 133 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 133 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 133 at risk

Adverse event: Tinnitus
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 133 at risk

Adverse event: Pain, vagina
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 133 at risk

Adverse event: Hemorrhage, GU, iuterus
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 133 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 9 affected / 133 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 48 affected / 129 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 48 affected / 129 at risk

Adverse event: AST, SGOT (serum glutamic oxaloacetic transaminase)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 129 at risk

Adverse event: Acidosis (metabolic or respiratory)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 129 at risk

Adverse event: Allbumin, serum-low (hypoalbuminemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 129 at risk

Adverse event: Alkalosis (metabolic or respiratory)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 129 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 129 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 129 at risk

Adverse event: Sodium, serum-high (hypernatremia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 129 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 129 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 129 at risk

Adverse event: Lipase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 129 at risk

Adverse event: Blood alkaline phosphatase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 129 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 129 at risk

Adverse event: GGT (gamma-Glutamyl transpeptidase)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 129 at risk

Adverse event: Magnesium, serum-high (hypermagnesemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 129 at risk

Adverse event: Potassium, serum-ghigh (hyperkalemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 129 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 129 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 129 at risk

Adverse event: Amylase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 129 at risk

Adverse event: Tumour lysis syndrome
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 129 at risk

Adverse event: Uric acid, serum-high (hyperuricemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 129 at risk

Adverse event: Bicarbonate, serum-low
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 129 at risk

Adverse event: Glucose, serum-low (hypoglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 129 at risk

Adverse event: Blood fibrinogen
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 129 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 129 at risk

Adverse event: Metabolic/Laboratory
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 129 at risk

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 129 at risk

Adverse event: Calcium, serum-high (hypercalcemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 129 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 129 at risk

Adverse event: Pain, throat/pharynx/larynx
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 129 at risk

Adverse event: Mucositis/stomatitis (clinical exam), oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 129 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 129 at risk

Adverse event: Typhlitis (cecal inflammation)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 129 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 129 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 129 at risk

Adverse event: Hemorrhage, GI, Oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 129 at risk

Adverse event: Pain, Abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 129 at risk

Adverse event: Pain, Anus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 129 at risk

Adverse event: Gastrointestinal - Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 129 at risk

Adverse event: Heartburn/dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 129 at risk

Adverse event: Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 129 at risk

Adverse event: Proctitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 129 at risk

Adverse event: Obstruction, GI, Sotmach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 129 at risk

Adverse event: Pain, rectum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 129 at risk

Adverse event: Dysphagia (difficulty swallowing)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 129 at risk

Adverse event: Pain, oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 129 at risk

Adverse event: Mucositis/stomatitis (clinical exam), small bowel
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 129 at risk

Adverse event: Incontinence, anal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 129 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 129 at risk

Adverse event: Pain, head/headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 129 at risk

Adverse event: Neuropathy: sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 129 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 129 at risk

Adverse event: Hemorrhage, CNS
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 129 at risk

Adverse event: Neuropathy: cranial, CN VI lateral deviation of eye
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 129 at risk

Adverse event: Neuropathy: motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 129 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 129 at risk

Adverse event: Neurology - other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 129 at risk

Adverse event: Vasovagal episode
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 129 at risk

Adverse event: Infection (documented clinically or microbiologically documented, ANC<1.0x10e9/L, fever>38.5C),blood
Serious: yes
Organ System: Infections and infestations
Frequency: 21 affected / 129 at risk

Adverse event: Infection (documented clinically or microbioogically) with Grade 3 or 4 neutrophils (ANC<1.0x10e9/L)
Serious: yes
Organ System: Infections and infestations
Frequency: 77 affected / 129 at risk

Adverse event: Infection - other
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 129 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils
Serious: yes
Organ System: Infections and infestations
Frequency: 15 affected / 129 at risk

Adverse event: Colitis, infectious (e.g., Clostridium difficile)
Serious: yes
Organ System: Infections and infestations
Frequency: 18 affected / 129 at risk

Adverse event: Infection with unknown ANC, blood
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 129 at risk

Adverse event: Infection with unknown ANC, lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 129 at risk

Adverse event: Infection with unknown ANC, catheter-related
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 129 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: yes
Organ System: Immune system disorders
Frequency: 8 affected / 129 at risk

Adverse event: Allergy/immunology - other
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 129 at risk

Adverse event: Allergic reaction to Asparaginase
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 129 at risk

Adverse event: Febrile neutropenia (fever of unknown origin: not clinically or microbiologically documented)
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: ANC \<1.0x10e9/L, fever \>=38.5C
Frequency: 95 affected / 129 at risk

Adverse event: DIC (disseminated intravascular coagulation)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 129 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 129 at risk

Adverse event: Ocular surface disease
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 129 at risk

Adverse event: Optic disc edema
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 129 at risk

Adverse event: Constitutional symptoms - other
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 129 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 129 at risk

Adverse event: Pain - other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 129 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0x10e9/L)
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 129 at risk

Adverse event: Edema: head and neck
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 129 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 129 at risk

Adverse event: Pulmonary/upper respiratory - other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 129 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 129 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 129 at risk

Adverse event: Adult Respiratory Distress Syndrome (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 129 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory, nose
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 129 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 129 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 129 at risk

Adverse event: Hiccoughs (hiccups, singultus)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 129 at risk

Adverse event: Cardiac general - other
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 129 at risk

Adverse event: Prolonged QTc interval
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 129 at risk

Adverse event: Supraventricular and nodal arrhythmia, sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 129 at risk

Adverse event: Pericardial effusion (non-malignant)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 129 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 129 at risk

Adverse event: Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 129 at risk

Adverse event: Dermatology/skin - other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 129 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 129 at risk

Adverse event: Pruritus/itching
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 129 at risk

Adverse event: Hemorrhage/bleeding - other
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 129 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 129 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 129 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 129 at risk

Adverse event: Capillary leak syndrome
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 129 at risk

Adverse event: Pain, back
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 129 at risk

Adverse event: Pain, extremity-limb
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 129 at risk

Adverse event: Pain, buttock
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 129 at risk

Adverse event: Pain, muscle
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 129 at risk

Adverse event: Pain, joint
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 129 at risk

Adverse event: Growth and development - other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 129 at risk

Adverse event: PTT (Partial Thromboplastin Time)
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 129 at risk

Adverse event: INR (International Normalized Ratio of prothrombin time)
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 129 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 129 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 129 at risk

Adverse event: Glomerular filtration rate
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 129 at risk

Adverse event: Incontinence, urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 129 at risk

Adverse event: Urinary retention (including neurogenic bladder)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 129 at risk

Adverse event: Mood alteration, anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 129 at risk

Adverse event: Mood alteration, depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 129 at risk

Adverse event: Personality/behavioral
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 129 at risk

Adverse event: Mood alteration, agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 129 at risk

Adverse event: Thrombosis/embolism (vascular access-related
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 129 at risk

Adverse event: Liver dysfunction/failure (clinical)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 129 at risk

Adverse event: Hepatobiliary/pancreas - other
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 129 at risk

Adverse event: Otitis, middle ear (non-infectious)
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 129 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 9 affected / 129 at risk