Study: NCT00074490

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

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

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

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1 at risk

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

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 34 at risk

Adverse event: AST, SGOT(serum glutamic oxaloacetic transaminase)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 34 at risk

Adverse event: Adult Respiratory Distress Syndrome (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 34 at risk

Adverse event: Alkalosis (metabolic or respiratory)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 34 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 34 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 34 at risk

Adverse event: Carbon monoxide diffusion capacity (DL(co))
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 34 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 34 at risk

Adverse event: Colitis, infectious (e.g., Clostridium difficile)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 34 at risk

Adverse event: Death not associated with CTCAE term::Death NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Death not associated with CTCAE term::Disease progression NOS
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 34 at risk

Adverse event: Death not associated with CTCAE term::Multi-organ failure
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 34 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 34 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Febrile neutropenia
Serious: yes
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: 2 affected / 34 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Gastrointestinal - Other (abdominal pain, nausea and diarrhea c/w GVHD)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 34 at risk

Adverse event: Hemorrhage, GI::Lower GI NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 34 at risk

Adverse event: Hemorrhage, GI::Upper GI NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory::Lung
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 34 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 34 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Infection (documented clinically or microbiologically)
Serious: yes
Organ System: Infections and infestations
Notes: with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Abdomen NOS
Frequency: 2 affected / 34 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Blood
Frequency: 8 affected / 34 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Lung (pneumonia)
Frequency: 1 affected / 34 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Skin (cellulites)
Frequency: 1 affected / 34 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Stomach
Frequency: 1 affected / 34 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Upper aerodigestive NOS
Frequency: 1 affected / 34 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Urinary tract NOS
Frequency: 1 affected / 34 at risk

Adverse event: Infection - Other (pseudomonas bacteremia/sepsis.)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 13 affected / 34 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Colon
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 34 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Infection with unknown ANC::Abdomen NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Mucositis/stomatitis (clinical exam)::Oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 34 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 34 at risk

Adverse event: PTT (Partial Thromboplastin Time)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 34 at risk

Adverse event: Pain::Abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 34 at risk

Adverse event: Pain::Back
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 34 at risk

Adverse event: Perforation, GI::Small bowel NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Pericardial effusion (non-malignant)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 34 at risk

Adverse event: Platelets
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 34 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Pruritus/itching
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 34 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 34 at risk

Adverse event: Rash: acne/acneiform
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 34 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 34 at risk

Adverse event: Restrictive cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 34 at risk

Adverse event: Secondary Malignancy - possibly related to cancer treatment (squamous cell carcinoma)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 34 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 34 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 34 at risk

Adverse event: Typhlitis (cecal inflammation)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Frequency: 17 affected / 34 at risk

Adverse event: AST, SGOT(serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Investigations
Frequency: 12 affected / 34 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 34 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 4 affected / 34 at risk

Adverse event: Alkalosis (metabolic or respiratory)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 34 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 34 at risk

Adverse event: CPK (creatine phosphokinase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 34 at risk

Adverse event: Calcium, serum-high (hypercalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 34 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 34 at risk

Adverse event: Cholecystitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 34 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 34 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 1 affected / 34 at risk

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 34 at risk

Adverse event: Dermatology/Skin - Other (Specify, __)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 34 at risk

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

Adverse event: Distension/bloating, abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 34 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 34 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 34 at risk

Adverse event: FEV(1)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 34 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 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: 5 affected / 34 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: 2 affected / 34 at risk

Adverse event: Blood fibrinogen
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 34 at risk

Adverse event: GGT (gamma-Glutamyl transpeptidase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 34 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 34 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 34 at risk

Adverse event: Induration/fibrosis (skin and subcutaneous tissue)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 34 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Blood
Frequency: 2 affected / 34 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
Serious: no
Organ System: Infections and infestations
Notes: (ANC \<1.0 x 10e9/L)::Colon
Frequency: 1 affected / 34 at risk

Adverse event: Infection (documented clinically or microbiologically)
Serious: no
Organ System: Infections and infestations
Notes: with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Esophagus
Frequency: 1 affected / 34 at risk

Adverse event: Infection (documented clinically or microbiologically)
Serious: no
Organ System: Infections and infestations
Notes: with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Gallbladder (cholecystitis)
Frequency: 1 affected / 34 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Lung (pneumonia)
Frequency: 2 affected / 34 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Skin (cellulites)
Frequency: 1 affected / 34 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Soft tissue NOS
Frequency: 1 affected / 34 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Upper airway NOS
Frequency: 1 affected / 34 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Urinary tract NOS
Frequency: 2 affected / 34 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Blood
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 34 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Brain (encephalitis, infectious)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Colon
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Eye NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 34 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: 1 affected / 34 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Peritoneal cavity
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Pharynx
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 34 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Rectum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Sinus
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 34 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 34 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Stomach
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 34 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: 12 affected / 34 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: 9 affected / 34 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Wound
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 34 at risk

Adverse event: Infection with unknown ANC::Bladder (urinary)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Infection with unknown ANC::Upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 34 at risk

Adverse event: Infection with unknown ANC::Urinary tract NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Infection with unknown ANC::Vagina
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Lipase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 34 at risk

Adverse event: Magnesium, serum-high (hypermagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 34 at risk

Adverse event: Mucositis/stomatitis (clinical exam)::Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

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

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 7 affected / 34 at risk

Adverse event: PTT (Partial Thromboplastin Time)
Serious: no
Organ System: Investigations
Frequency: 5 affected / 34 at risk

Adverse event: Pain - Other (jaw/scalp)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Pain::Abdomen NOS
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Pain::Oral-gums
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 34 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 7 affected / 34 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 34 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 34 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 34 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 34 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 34 at risk

Adverse event: Sexual/Reproductive Function - Other (Specify, __)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 34 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 34 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 34 at risk

Adverse event: Uric acid, serum-high (hyperuricemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 34 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 34 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 40 at risk

Adverse event: AST, SGOT(serum glutamic oxaloacetic transaminase)
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 40 at risk

Adverse event: Capillary leak syndrome
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 40 at risk

Adverse event: Blood alkaline phosphatase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 40 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Arthritis (non-septic)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 40 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 40 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 40 at risk

Adverse event: Cardiac Arrhythmia - Other (atrial fibrillation)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: Cardiac troponin I (cTnI)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Colitis, infectious (e.g., Clostridium difficile)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Conduction abnormality/atrioventricular heart block::AV Block-Second degree Mobitz Type II
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 40 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 40 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 40 at risk

Adverse event: Death not associated with CTCAE term::Death NOS
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 40 at risk

Adverse event: Death not associated with CTCAE term::Disease progression NOS
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 40 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 40 at risk

Adverse event: Dermatology/Skin - Other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: (skin thickening of chest, abdomen, back of legs and shoulders for the past 3-4 mon)
Frequency: 1 affected / 40 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 40 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Dry eye
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 40 at risk

Adverse event: Dysphagia (difficulty swallowing)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 40 at risk

Adverse event: Edema: head and neck
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 40 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 40 at risk

Adverse event: Febrile neutropenia
Serious: yes
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: 10 affected / 40 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
Serious: yes
Organ System: General disorders
Frequency: 14 affected / 40 at risk

Adverse event: Gastrointestinal - Other (Abdominal pain (GVHD of the gut)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 40 at risk

Adverse event: Glucose, serum-low (hypoglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 40 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 40 at risk

Adverse event: Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hemorrhage, GI::Rectum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hemorrhage, GI::Upper GI NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Hemorrhage, GU::Urinary NOS
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory::Lung
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hemorrhage/Bleeding - Other (Conjunctival, low platelet ct)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 40 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 40 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 40 at risk

Adverse event: Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 40 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Blood
Frequency: 5 affected / 40 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
Serious: yes
Organ System: Infections and infestations
Notes: (ANC \<1.0 x 10e9/L)::Catheter-related
Frequency: 7 affected / 40 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Colon
Frequency: 3 affected / 40 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Lung (pneumonia)
Frequency: 1 affected / 40 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Meninges (meningitis)
Frequency: 1 affected / 40 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Nose
Frequency: 2 affected / 40 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Rectum
Frequency: 3 affected / 40 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Sinus
Frequency: 1 affected / 40 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Skin (cellulites)
Frequency: 1 affected / 40 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Ungual (nails)
Frequency: 1 affected / 40 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Urinary tract NOS
Frequency: 1 affected / 40 at risk

Adverse event: Infection - Other (HHV6 reactivation; admitted for anemia & leukocytosis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 40 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Catheter-related
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 40 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Colon
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 40 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::External ear (otitis externa)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 12 affected / 40 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Pharynx
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Pleura (empyema)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Rectum
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 40 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Sinus
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 40 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 40 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Stomach
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 40 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 40 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Infection with unknown ANC::Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Infection with unknown ANC::Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 40 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 40 at risk

Adverse event: Leukocytes (total WBC)
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 40 at risk

Adverse event: Leukoencephalopathy (radiographic findings)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Metabolic/Laboratory - Other (steroid induced hyperglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 40 at risk

Adverse event: Mucositis/stomatitis (clinical exam)::Oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 40 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic)::Oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 40 at risk

Adverse event: Neuropathy: cranial::CN III Pupil, upper eyelid, extra ocular movements
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 40 at risk

Adverse event: Neuropathy: cranial::CN VI Lateral deviation of eye
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Neuropathy: motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Neuropathy: sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 15 affected / 40 at risk

Adverse event: Obstruction/stenosis of airway::Bronchus
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Ocular/Visual - Other (GVHD)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 40 at risk

Adverse event: Ocular/Visual - Other (ocular GVHD, restasis started; EXTENSIVE CGVHD)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 40 at risk

Adverse event: Osteonecrosis (avascular necrosis)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: PTT (Partial Thromboplastin Time)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: Pain::Abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Pain::Bone
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pain::Neck
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pancreatic endocrine: glucose intolerance
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 40 at risk

Adverse event: Platelets
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 40 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 40 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 40 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 40 at risk

Adverse event: Prolonged QTc interval
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 40 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 40 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 40 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Stricture/stenosis (including anastomotic), GU::Urethra
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 40 at risk

Adverse event: Supraventricular and nodal arrhythmia::Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: Supraventricular and nodal arrhythmia::Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: Supraventricular and nodal arrhythmia::Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: Supraventricular and nodal arrhythmia::Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 40 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 40 at risk

Adverse event: Thyroid function, high (hyperthyroidism, thyrotoxicosis)
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 40 at risk

Adverse event: Thyroid function, low (hypothyroidism)
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 40 at risk

Adverse event: Ulcer, GI::Stomach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Vasculitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 40 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 40 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Frequency: 34 affected / 40 at risk

Adverse event: AST, SGOT(serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Investigations
Frequency: 24 affected / 40 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 40 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 2 affected / 40 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Arthritis (non-septic)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 40 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 40 at risk

Adverse event: Calcium, serum-high (hypercalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 40 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 40 at risk

Adverse event: Carbon monoxide diffusion capacity (DL(co))
Serious: no
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: Colitis, infectious (e.g., Clostridium difficile)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 40 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 3 affected / 40 at risk

Adverse event: Dermatology/Skin - Other (Specify, __)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 40 at risk

Adverse event: Distension/bloating, abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 40 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Dysphagia (difficulty swallowing)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 40 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Edema: limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 40 at risk

Adverse event: Eyelid dysfunction
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 40 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 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: 1 affected / 40 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: 9 affected / 40 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 40 at risk

Adverse event: GGT (gamma-Glutamyl transpeptidase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 40 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 40 at risk

Adverse event: Gynaecomastia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 40 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 34 affected / 40 at risk

Adverse event: Hemorrhage, GU::Bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hemorrhage, GU::Urinary NOS
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 40 at risk

Adverse event: Hyperpigmentation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 40 at risk

Adverse event: Hypopigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 40 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Blood
Frequency: 1 affected / 40 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Catheter-related
Frequency: 3 affected / 40 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
Serious: no
Organ System: Infections and infestations
Notes: (ANC \<1.0 x 10e9/L)::Colon
Frequency: 3 affected / 40 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Joint
Frequency: 1 affected / 40 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Lung (pneumonia)
Frequency: 1 affected / 40 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Mucosa
Frequency: 1 affected / 40 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Oral cavity-gums (gingivitis)
Frequency: 1 affected / 40 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Pharynx
Frequency: 1 affected / 40 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Upper airway NOS
Frequency: 1 affected / 40 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Urinary tract NOS
Frequency: 1 affected / 40 at risk

Adverse event: Infection - Other (Specify, __)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Infection - Other (CMV reactivation)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Infection - Other (Possible bronchiolitis obliterans)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Infection - Other (Right arm pain and swelling-catheter celulitis)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Infection - Other (Sinusitis)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Bladder (urinary)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Blood
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 40 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Catheter-related
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Colon
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 40 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Conjunctiva
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 40 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Dental-tooth
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 40 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 40 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Mucosa
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Paranasal
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 40 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Pharynx
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 40 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Rectum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Sinus
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 40 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 40 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Stomach
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 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: 9 affected / 40 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: 11 affected / 40 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Vagina
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Wound
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 40 at risk

Adverse event: Infection with unknown ANC::Lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 40 at risk

Adverse event: Keratitis (corneal inflammation/corneal ulceration)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 40 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 6 affected / 40 at risk

Adverse event: Leukoencephalopathy (radiographic findings)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Lymphedema-related fibrosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 40 at risk

Adverse event: Magnesium, serum-high (hypermagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 40 at risk

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 40 at risk

Adverse event: Mood alteration::Agitation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Mucositis/stomatitis (clinical exam)::Large bowel
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Mucositis/stomatitis (clinical exam)::Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 40 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic)::Large bowel
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic)::Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 40 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 40 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 40 affected / 40 at risk

Adverse event: Ocular surface disease
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 40 at risk

Adverse event: Ocular/Visual - Other (GVHD Gd 1)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 40 at risk

Adverse event: Ocular/Visual - Other (Occular GVHD)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 40 at risk

Adverse event: PTT (Partial Thromboplastin Time)
Serious: no
Organ System: Investigations
Frequency: 10 affected / 40 at risk

Adverse event: Pain::Abdomen NOS
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pain::Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pain::Chest/thorax NOS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pain::Dental/teeth/peridontal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pain::Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pain::Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Pain::Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Pain::Neck
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Phlebitis (including superficial thrombosis)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 40 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 40 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 28 affected / 40 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 40 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 40 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 40 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 30 affected / 40 at risk

Adverse event: Renal/Genitourinary - Other (Specify, __)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 40 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Sexual/Reproductive Function - Other (Specify, __)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 40 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 40 at risk

Adverse event: Syncope (fainting)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 40 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 40 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 40 at risk

Adverse event: Thyroid function, low (hypothyroidism)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 40 at risk

Adverse event: Triglyceride, serum-high (hypertriglyceridemia)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 40 at risk

Adverse event: Uric acid, serum-high (hyperuricemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 40 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 40 at risk

Adverse event: Vaginal discharge (non-infectious)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 40 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 40 at risk

Adverse event: Vulvovaginal inflammation
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 40 at risk

Adverse event: Vaginitis (not due to infection)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 40 at risk

Adverse event: Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: yes
Organ System: Investigations
Frequency: 16 affected / 44 at risk

Adverse event: AST, SGOT(serum glutamic oxaloacetic transaminase)
Serious: yes
Organ System: Investigations
Frequency: 12 affected / 44 at risk

Adverse event: Acidosis (metabolic or respiratory)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 44 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 44 at risk

Adverse event: Blood alkaline phosphatase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 44 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 44 at risk

Adverse event: Arthritis (non-septic)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 44 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 44 at risk

Adverse event: Cardiac General - Other (congestive heart failure)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Cardiac troponin I (cTnI)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 44 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 44 at risk

Adverse event: Colitis, infectious (e.g., Clostridium difficile)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 44 at risk

Adverse event: Conduction abnormality/atrioventricular heart block::AV Block-First degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 44 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 44 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 44 at risk

Adverse event: Death not associated with CTCAE term::Death NOS
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 44 at risk

Adverse event: Death not associated with CTCAE term::Disease progression NOS
Serious: yes
Organ System: General disorders
Frequency: 12 affected / 44 at risk

Adverse event: Death not associated with CTCAE term::Sudden death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 44 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 44 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Dysphagia (difficulty swallowing)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 44 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 44 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Febrile neutropenia
Serious: yes
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: 25 affected / 44 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 44 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 44 at risk

Adverse event: Gastritis (including bile reflux gastritis)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 44 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 44 at risk

Adverse event: Hemorrhage, GI::Rectum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory::Bronchopulmonary NOS
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory::Nose
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 44 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 44 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 44 at risk

Adverse event: Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Infection (documented clinically
Serious: yes
Organ System: Infections and infestations
Notes: or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Bladder (urinary)
Frequency: 1 affected / 44 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Blood
Frequency: 13 affected / 44 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Bronchus
Frequency: 1 affected / 44 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Colon
Frequency: 3 affected / 44 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Lung (pneumonia)
Frequency: 12 affected / 44 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Mucosa
Frequency: 1 affected / 44 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Rectum
Frequency: 1 affected / 44 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Sinus
Frequency: 2 affected / 44 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Stomach
Frequency: 1 affected / 44 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Upper airway NOS
Frequency: 3 affected / 44 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Urinary tract NOS
Frequency: 2 affected / 44 at risk

Adverse event: Infection - Other (R. wrist septic arthritis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Infection - Other (worsening right great toe pain with drainage and now neutropenic)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Appendix
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 18 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Bone (osteomyelitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Brain (encephalitis, infectious)
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Catheter-related
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Colon
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 24 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Peritoneal cavity
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Sinus
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Stomach
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 44 at risk

Adverse event: Infection with unknown ANC::Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Infection with unknown ANC::Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 44 at risk

Adverse event: Infection with unknown ANC::Sinus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Infection with unknown ANC::Upper aerodigestive NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Infection with unknown ANC::Urinary tract NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Mental status
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 44 at risk

Adverse event: Mucositis/stomatitis (clinical exam)::Oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 44 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy)::Whole body/generalized
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 44 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 44 at risk

Adverse event: Neuropathy: motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 44 at risk

Adverse event: Neuropathy: sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 44 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 13 affected / 44 at risk

Adverse event: Obstruction, GI::Gallbladder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Obstruction/stenosis of airway::Trachea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Ophthalmoplegia/diplopia (double vision)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 44 at risk

Adverse event: Pain::Abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 44 at risk

Adverse event: Pain::Chest wall
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 44 at risk

Adverse event: Pain::Head/headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Pain::Oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Pain::Throat/pharynx/larynx
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Pancreatic endocrine: glucose intolerance
Serious: yes
Organ System: Endocrine disorders
Frequency: 5 affected / 44 at risk

Adverse event: Perforation, GI::Small bowel NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 44 at risk

Adverse event: Platelets
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 44 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 44 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 44 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 44 at risk

Adverse event: Prolonged QTc interval
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 44 at risk

Adverse event: Psychosis (hallucinations/delusions)
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 44 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 44 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 44 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 44 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Supraventricular and nodal arrhythmia::Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 44 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 44 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 44 at risk

Adverse event: Thrombotic microangiopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: (e.g., thrombotic thrombocytopenic purpura \[TTP\] or hemolytic uremic syndrome \[HUS\])
Frequency: 1 affected / 44 at risk

Adverse event: Thyroid function, low (hypothyroidism)
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 44 at risk

Adverse event: Triglyceride, serum-high (hypertriglyceridemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 44 at risk

Adverse event: Tumour lysis syndrome
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 44 at risk

Adverse event: Uric acid, serum-high (hyperuricemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hepatitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 44 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Frequency: 29 affected / 44 at risk

Adverse event: AST, SGOT(serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Investigations
Frequency: 20 affected / 44 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 44 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 3 affected / 44 at risk

Adverse event: Amylase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 44 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 44 at risk

Adverse event: Ascites (non-malignant)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 44 at risk

Adverse event: Calcium, serum-high (hypercalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 44 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 44 at risk

Adverse event: Carbon monoxide diffusion capacity (DL(co))
Serious: no
Organ System: Investigations
Frequency: 1 affected / 44 at risk

Adverse event: Cardiac troponin I (cTnI)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 44 at risk

Adverse event: Colitis, infectious (e.g., Clostridium difficile)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 44 at risk

Adverse event: Dermatology/Skin - Other (Specify, __)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 44 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 44 at risk

Adverse event: Dysphagia (difficulty swallowing)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 44 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Edema: limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 44 at risk

Adverse event: FEV(1)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 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: 3 affected / 44 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: 10 affected / 44 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 44 at risk

Adverse event: GGT (gamma-Glutamyl transpeptidase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 44 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 27 affected / 44 at risk

Adverse event: Hyperpigmentation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 44 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Induration/fibrosis (skin and subcutaneous tissue)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Infection (documented clinically or microbiologically)
Serious: no
Organ System: Infections and infestations
Notes: with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Anal/perianal
Frequency: 1 affected / 44 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Bladder (urinary)
Frequency: 1 affected / 44 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Blood
Frequency: 2 affected / 44 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
Serious: no
Organ System: Infections and infestations
Notes: (ANC \<1.0 x 10e9/L)::Colon
Frequency: 3 affected / 44 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Lung (pneumonia)
Frequency: 2 affected / 44 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Pharynx
Frequency: 1 affected / 44 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Upper airway NOS
Frequency: 1 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Blood
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Bronchus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Catheter-related
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Colon
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Conjunctiva
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 44 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: 1 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Mucosa
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Nerve-peripheral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Nose
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Paranasal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Pelvis NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Salivary gland
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Sinus
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 44 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: 17 affected / 44 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: 5 affected / 44 at risk

Adverse event: Infection with unknown ANC::Lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Infection with unknown ANC::Mucosa
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Infection with unknown ANC::Sinus
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 44 at risk

Adverse event: Infection with unknown ANC::Upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 44 at risk

Adverse event: Magnesium, serum-high (hypermagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 44 at risk

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 44 at risk

Adverse event: Mental status
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Mood alteration::Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Mucositis/stomatitis (clinical exam)::Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 44 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic)::Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Myositis (inflammation/damage of muscle)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 37 affected / 44 at risk

Adverse event: PTT (Partial Thromboplastin Time)
Serious: no
Organ System: Investigations
Frequency: 9 affected / 44 at risk

Adverse event: Pain::Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Pain::Esophagus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 44 at risk

Adverse event: Pain::Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Pancreatic endocrine: glucose intolerance
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 44 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 44 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 18 affected / 44 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 44 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 44 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 44 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 44 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 44 at risk

Adverse event: Sodium, serum-high (hypernatremia)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 44 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 44 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 44 at risk

Adverse event: Thyroid function, low (hypothyroidism)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 44 at risk

Adverse event: Triglyceride, serum-high (hypertriglyceridemia)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 44 at risk

Adverse event: Vulvovaginal inflammation
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 44 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 44 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 45 at risk

Adverse event: AST, SGOT(serum glutamic oxaloacetic transaminase)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 45 at risk

Adverse event: Amylase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 45 at risk

Adverse event: Blood/Bone Marrow - Other (engraftment syndrome)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Colitis, infectious (e.g., Clostridium difficile)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 45 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 45 at risk

Adverse event: Death not associated with CTCAE term::Death NOS
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 45 at risk

Adverse event: Death not associated with CTCAE term::Disease progression NOS
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 45 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 45 at risk

Adverse event: Dysphagia (difficulty swallowing)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Edema, larynx
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Febrile neutropenia
Serious: yes
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: 5 affected / 45 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 45 at risk

Adverse event: Hemorrhage, GI::Lower GI NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hemorrhage, GI::Upper GI NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 45 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory::Bronchopulmonary NOS
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory::Lung
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory::Nose
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hemorrhage/Bleeding - Other (Massive Intracranial hemorrhage of left frontal lobe mass)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hemorrhage/Bleeding - Other (diffuse alveolar hemorrhage)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 45 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Blood
Frequency: 1 affected / 45 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Lung (pneumonia)
Frequency: 2 affected / 45 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Skin (cellulites)
Frequency: 1 affected / 45 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Urinary tract NOS
Frequency: 1 affected / 45 at risk

Adverse event: Infection - Other (C.Diff: PCR +)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Infection - Other (Influenza A +)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 13 affected / 45 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Brain + Spinal cord (encephalomyelitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Colon
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 45 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 45 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Lymphatic
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 45 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Oral cavity-gums (gingivitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Sinus
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 45 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 45 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Stomach
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 45 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Infection with unknown ANC::Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 45 at risk

Adverse event: Infection with unknown ANC::Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Infection with unknown ANC::Meninges (meningitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Infection with unknown ANC::Sinus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Infection with unknown ANC::Upper airway NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 45 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 45 at risk

Adverse event: Lipase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 45 at risk

Adverse event: Metabolic/Laboratory - Other (ph>7.5 with life threating consequences ALKALOSIS)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 45 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy)::Whole body/generalized
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 45 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 45 at risk

Adverse event: Obstruction, GI::Small bowel NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Pain::Abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 45 at risk

Adverse event: Pain::Head/headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Pain::Oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Pericardial effusion (non-malignant)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 45 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 45 at risk

Adverse event: Platelets
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 45 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Psychosis (hallucinations/delusions)
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 45 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 45 at risk

Adverse event: Rash: acne/acneiform
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 45 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 45 at risk

Adverse event: Secondary Malignancy -
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: possibly related to cancer treatment (basal cell carcinoma (left supraclavicular). Start/end date is approx.)
Frequency: 1 affected / 45 at risk

Adverse event: Secondary Malignancy - possibly related to cancer treatment
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: (squamous cell carcinoma of skin x2 (forehead and left arm). Resolve date approx.)
Frequency: 1 affected / 45 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 45 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 45 at risk

Adverse event: Uric acid, serum-high (hyperuricemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 45 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Frequency: 36 affected / 45 at risk

Adverse event: AST, SGOT(serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Investigations
Frequency: 24 affected / 45 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 45 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 45 at risk

Adverse event: Alkalosis (metabolic or respiratory)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 45 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 45 at risk

Adverse event: Calcium, serum-high (hypercalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 45 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 45 at risk

Adverse event: Carbon monoxide diffusion capacity (DL(co))
Serious: no
Organ System: Investigations
Frequency: 1 affected / 45 at risk

Adverse event: Colitis, infectious (e.g., Clostridium difficile)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 45 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 1 affected / 45 at risk

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 45 at risk

Adverse event: Cytokine release syndrome/acute infusion reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 45 at risk

Adverse event: Dermatology/Skin - Other (Specify, __)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 45 at risk

Adverse event: Dermatology/Skin - Other (Specify, __)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 45 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 45 at risk

Adverse event: Distension/bloating, abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 45 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 45 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 45 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 45 at risk

Adverse event: Dysphagia (difficulty swallowing)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 45 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Edema: limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 45 at risk

Adverse event: FEV(1)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 45 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: 4 affected / 45 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: 1 affected / 45 at risk

Adverse event: GGT (gamma-Glutamyl transpeptidase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 45 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 45 at risk

Adverse event: Hemorrhage, GI::Colon
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hemorrhage, GI::Lower GI NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory::Nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Induration/fibrosis (skin and subcutaneous tissue)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 45 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Abdomen NOS
Frequency: 1 affected / 45 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Blood
Frequency: 2 affected / 45 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
Serious: no
Organ System: Infections and infestations
Notes: (ANC \<1.0 x 10e9/L)::Colon
Frequency: 1 affected / 45 at risk

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

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

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)::Urinary tract NOS
Frequency: 2 affected / 45 at risk

Adverse event: Infection - Other (Stool cultures 5/31: Yersinia, Novovirus as well as H. nana.
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Blood
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 45 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Colon
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 45 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Eye NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 45 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Mucosa
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 45 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Nose
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 45 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: 1 affected / 45 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Penis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Pharynx
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Rectum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Sinus
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 45 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 45 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: 26 affected / 45 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: 10 affected / 45 at risk

Adverse event: Infection with unknown ANC::Lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Infection with unknown ANC::Skin (cellulitis)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Infection with unknown ANC::Upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Infection with unknown ANC::Urinary tract NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 45 at risk

Adverse event: Magnesium, serum-high (hypermagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 45 at risk

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 45 at risk

Adverse event: Mucositis/stomatitis (clinical exam)::Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 45 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic)::Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy)::Extremity-upper
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 45 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 45 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 26 affected / 45 at risk

Adverse event: Ocular/Visual - Other (Specify, __)
Serious: no
Organ System: Eye disorders
Notes: Worsening Rt eye swelling on 6/1: MRI orbits 6/1 showed enlargement of eyelid nodule
Frequency: 1 affected / 45 at risk

Adverse event: Ocular/Visual - Other (red and itchy eyes)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 45 at risk

Adverse event: PTT (Partial Thromboplastin Time)
Serious: no
Organ System: Investigations
Frequency: 9 affected / 45 at risk

Adverse event: Pain::Abdomen NOS
Serious: no
Organ System: General disorders
Frequency: 2 affected / 45 at risk

Adverse event: Pain::Bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 45 at risk

Adverse event: Pain::Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Pancreatic endocrine: glucose intolerance
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 45 at risk

Adverse event: Phlebitis (including superficial thrombosis)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 45 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 45 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 23 affected / 45 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 45 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 45 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 45 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 45 at risk

Adverse event: Prolonged QTc interval
Serious: no
Organ System: Investigations
Frequency: 1 affected / 45 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 45 at risk

Adverse event: Pulmonary/Upper Respiratory - Other (Specify, __)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 45 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 45 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 45 at risk

Adverse event: Tumour lysis syndrome
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 45 at risk

Adverse event: Uric acid, serum-high (hyperuricemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 45 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 45 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 45 at risk