Study: NCT00549848

Adverse event: Allergic reaction to Asparaginase
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 28 affected / 206 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 50 affected / 206 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 16 affected / 206 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
Serious: no
Organ System: General disorders
Frequency: 156 affected / 206 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 206 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 206 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic), Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 47 affected / 206 at risk

Adverse event: Typhlitis (cecal inflammation)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 206 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 206 at risk

Adverse event: Pancreatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 206 at risk

Adverse event: Colitis, infectious (e.g., Clostridium difficile)
Serious: no
Organ System: Infections and infestations
Frequency: 83 affected / 206 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Fever of unknown origin without clinically or microbiologically documented infection (ANC \<1.0 x 10e9/L, fever \>=38.5 degrees C)
Frequency: 163 affected / 206 at risk

Adverse event: Infection, Blood
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
Frequency: 38 affected / 206 at risk

Adverse event: Infection, Catheter-related
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
Frequency: 14 affected / 206 at risk

Adverse event: Infection, Lip/perioral
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
Frequency: 9 affected / 206 at risk

Adverse event: Infection, Lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
Frequency: 37 affected / 206 at risk

Adverse event: Infection, Middle ear (otitis media)
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
Frequency: 30 affected / 206 at risk

Adverse event: Infection, Oral cavity-gums (gingivitis)
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
Frequency: 32 affected / 206 at risk

Adverse event: Infection, Rectum
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
Frequency: 7 affected / 206 at risk

Adverse event: Infection, Sinus
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
Frequency: 21 affected / 206 at risk

Adverse event: Infection, Skin (cellulitis)
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
Frequency: 42 affected / 206 at risk

Adverse event: Infection, Upper airway NOS
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
Frequency: 92 affected / 206 at risk

Adverse event: Infection, Urinary tract NOS
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
Frequency: 11 affected / 206 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Blood
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 206 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Catheter-related
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 206 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Conjunctiva
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 206 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, External ear (otitis externa)
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 206 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Lip/perioral
Serious: no
Organ System: Infections and infestations
Frequency: 35 affected / 206 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 49 affected / 206 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Middle ear (otitis media)
Serious: no
Organ System: Infections and infestations
Frequency: 84 affected / 206 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Oral cavity-gums (gingivitis)
Serious: no
Organ System: Infections and infestations
Frequency: 50 affected / 206 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Sinus
Serious: no
Organ System: Infections and infestations
Frequency: 66 affected / 206 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Skin (cellulitis)
Serious: no
Organ System: Infections and infestations
Frequency: 91 affected / 206 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Ungual (nails)
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 206 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 133 affected / 206 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Urinary tract NOS
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 206 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Vagina
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 206 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Frequency: 32 affected / 206 at risk

Adverse event: AST, SGOT(serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Investigations
Frequency: 22 affected / 206 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Investigations
Frequency: 11 affected / 206 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 206 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 206 at risk

Adverse event: Triglyceride, serum-high (hypertriglyceridemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 206 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 19 affected / 206 at risk

Adverse event: Osteonecrosis (avascular necrosis)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 85 affected / 206 at risk

Adverse event: Neuropathy: motor
Serious: no
Organ System: Nervous system disorders
Frequency: 53 affected / 206 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 206 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 36 affected / 206 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 206 at risk

Adverse event: Tumour lysis syndrome
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 25 affected / 206 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 206 at risk

Adverse event: Pain, Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 43 affected / 206 at risk

Adverse event: Pain, Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 22 affected / 206 at risk

Adverse event: Pain, Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 206 at risk

Adverse event: Pain, Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 206 at risk

Adverse event: Pain, Neuralgia/peripheral nerve
Serious: no
Organ System: Nervous system disorders
Frequency: 155 affected / 206 at risk

Adverse event: Allergic reaction to Asparaginase
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 30 affected / 208 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 47 affected / 208 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 19 affected / 208 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
Serious: no
Organ System: General disorders
Frequency: 147 affected / 208 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 208 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 208 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic), Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 63 affected / 208 at risk

Adverse event: Typhlitis (cecal inflammation)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 208 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 208 at risk

Adverse event: Pancreatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 208 at risk

Adverse event: Colitis, infectious (e.g., Clostridium difficile)
Serious: no
Organ System: Infections and infestations
Frequency: 61 affected / 208 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Fever of unknown origin without clinically or microbiologically documented infection (ANC \<1.0 x 10e9/L, fever \>=38.5 degrees C)
Frequency: 160 affected / 208 at risk

Adverse event: Infection, Blood
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
Frequency: 48 affected / 208 at risk

Adverse event: Infection, Catheter-related
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
Frequency: 17 affected / 208 at risk

Adverse event: Infection, Lip/perioral
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
Frequency: 17 affected / 208 at risk

Adverse event: Infection, Lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
Frequency: 47 affected / 208 at risk

Adverse event: Infection, Middle ear (otitis media)
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
Frequency: 38 affected / 208 at risk

Adverse event: Infection, Oral cavity-gums (gingivitis)
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
Frequency: 35 affected / 208 at risk

Adverse event: Infection, Rectum
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
Frequency: 15 affected / 208 at risk

Adverse event: Infection, Sinus
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
Frequency: 23 affected / 208 at risk

Adverse event: Infection, Skin (cellulitis)
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
Frequency: 41 affected / 208 at risk

Adverse event: Infection, Upper airway NOS
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
Frequency: 110 affected / 208 at risk

Adverse event: Infection, Urinary tract NOS
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
Frequency: 14 affected / 208 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Blood
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 208 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Catheter-related
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 208 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Conjunctiva
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 208 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, External ear (otitis externa)
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 208 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Lip/perioral
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 208 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 46 affected / 208 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Middle ear (otitis media)
Serious: no
Organ System: Infections and infestations
Frequency: 80 affected / 208 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Oral cavity-gums (gingivitis)
Serious: no
Organ System: Infections and infestations
Frequency: 48 affected / 208 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Sinus
Serious: no
Organ System: Infections and infestations
Frequency: 51 affected / 208 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Skin (cellulitis)
Serious: no
Organ System: Infections and infestations
Frequency: 80 affected / 208 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Ungual (nails)
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 208 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 136 affected / 208 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Urinary tract NOS
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 208 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Vagina
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 208 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Frequency: 30 affected / 208 at risk

Adverse event: AST, SGOT(serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Investigations
Frequency: 25 affected / 208 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Investigations
Frequency: 14 affected / 208 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 23 affected / 208 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 208 at risk

Adverse event: Triglyceride, serum-high (hypertriglyceridemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 208 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 25 affected / 208 at risk

Adverse event: Osteonecrosis (avascular necrosis)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 79 affected / 208 at risk

Adverse event: Neuropathy: motor
Serious: no
Organ System: Nervous system disorders
Frequency: 54 affected / 208 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 208 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 38 affected / 208 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 208 at risk

Adverse event: Tumour lysis syndrome
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 36 affected / 208 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 208 at risk

Adverse event: Pain, Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 208 at risk

Adverse event: Pain, Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 208 at risk

Adverse event: Pain, Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 208 at risk

Adverse event: Pain, Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 208 at risk

Adverse event: Pain, Neuralgia/peripheral nerve
Serious: no
Organ System: Nervous system disorders
Frequency: 160 affected / 208 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 184 at risk

Adverse event: Infection, Blood
Serious: yes
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
Frequency: 1 affected / 184 at risk

Adverse event: Allergic reaction to Asparaginase
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 18 affected / 184 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 58 affected / 184 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 184 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
Serious: no
Organ System: General disorders
Frequency: 116 affected / 184 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 184 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 184 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic), Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 184 at risk

Adverse event: Typhlitis (cecal inflammation)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 184 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 184 at risk

Adverse event: Pancreatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 184 at risk

Adverse event: Colitis, infectious (e.g., Clostridium difficile)
Serious: no
Organ System: Infections and infestations
Frequency: 55 affected / 184 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Fever of unknown origin without clinically or microbiologically documented infection (ANC \<1.0 x 10e9/L, fever \>=38.5 degrees C)
Frequency: 124 affected / 184 at risk

Adverse event: Infection, Blood
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
Frequency: 45 affected / 184 at risk

Adverse event: Infection, Catheter-related
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
Frequency: 8 affected / 184 at risk

Adverse event: Infection, Lip/perioral
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
Frequency: 8 affected / 184 at risk

Adverse event: Infection, Lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
Frequency: 22 affected / 184 at risk

Adverse event: Infection, Middle ear (otitis media)
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
Frequency: 22 affected / 184 at risk

Adverse event: Infection, Oral cavity-gums (gingivitis)
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
Frequency: 27 affected / 184 at risk

Adverse event: Infection, Rectum
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
Frequency: 11 affected / 184 at risk

Adverse event: Infection, Sinus
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
Frequency: 6 affected / 184 at risk

Adverse event: Infection, Skin (cellulitis)
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
Frequency: 39 affected / 184 at risk

Adverse event: Infection, Upper airway NOS
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
Frequency: 85 affected / 184 at risk

Adverse event: Infection, Urinary tract NOS
Serious: no
Organ System: Infections and infestations
Notes: Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
Frequency: 7 affected / 184 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Blood
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 184 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Catheter-related
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 184 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Conjunctiva
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 184 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, External ear (otitis externa)
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 184 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Lip/perioral
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 184 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 184 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Middle ear (otitis media)
Serious: no
Organ System: Infections and infestations
Frequency: 56 affected / 184 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Oral cavity-gums (gingivitis)
Serious: no
Organ System: Infections and infestations
Frequency: 47 affected / 184 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Sinus
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 184 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Skin (cellulitis)
Serious: no
Organ System: Infections and infestations
Frequency: 70 affected / 184 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Ungual (nails)
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 184 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 105 affected / 184 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Urinary tract NOS
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 184 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils, Vagina
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 184 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Frequency: 29 affected / 184 at risk

Adverse event: AST, SGOT(serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Investigations
Frequency: 21 affected / 184 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Investigations
Frequency: 19 affected / 184 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 25 affected / 184 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 184 at risk

Adverse event: Triglyceride, serum-high (hypertriglyceridemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 184 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 21 affected / 184 at risk

Adverse event: Osteonecrosis (avascular necrosis)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 57 affected / 184 at risk

Adverse event: Neuropathy: motor
Serious: no
Organ System: Nervous system disorders
Frequency: 56 affected / 184 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 184 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 36 affected / 184 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 184 at risk

Adverse event: Tumour lysis syndrome
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 184 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 184 at risk

Adverse event: Pain, Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 184 at risk

Adverse event: Pain, Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 184 at risk

Adverse event: Pain, Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 184 at risk

Adverse event: Pain, Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 184 at risk

Adverse event: Pain, Neuralgia/peripheral nerve
Serious: no
Organ System: Nervous system disorders
Frequency: 128 affected / 184 at risk