Study: NCT00974233

Adverse event: Grade 4 neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: SAEs included any grade 2-3 unexpected event with at least probable attribution, grade 4-5 toxicity regardless of attribution. Number of events includes worst grade toxicity per patient.
Frequency: 14 affected / 34 at risk

Adverse event: Grade 3 neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Includes all events of grade 3 neutropenia, regardless of whether or not resulted in hospitalization of other definition of SAE.
Frequency: 6 affected / 34 at risk

Adverse event: Grade 4 thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Includes all events of grade 4 thrombocytopenia, as required by definition of SAE per protocol.
Frequency: 2 affected / 34 at risk

Adverse event: Grade 3 thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Includes all events of grade 3 thrombocytopenia, regardless of whether or not resulted in hospitalization of other definition of SAE.
Frequency: 5 affected / 34 at risk

Adverse event: Grade 4 leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Includes all events of grade 4 leukopenia, as defined by SAE reporting per protocol.
Frequency: 5 affected / 34 at risk

Adverse event: Grade 3 leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Includes all events of grade 3 leukopenia, regardless of whether or not resulted in hospitalization of other definition of SAE.
Frequency: 5 affected / 34 at risk

Adverse event: Grade 3 febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 34 at risk

Adverse event: Grade 5 infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Grade 4 infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Grade 3 tumor lysis syndrome
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 34 at risk

Adverse event: Second primary malignancy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Includes events that occurred during treatment and during long-term follow-up phase of treatment.
Frequency: 1 affected / 34 at risk

Adverse event: Grade 5 heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 34 at risk

Adverse event: Grade 3 Infections
Serious: no
Organ System: Infections and infestations
Notes: Worst grade toxicity per patient. Includes toxicities that are expected and not meeting other criteria for serious per protocol.
Frequency: 10 affected / 34 at risk

Adverse event: Grade 3 fatigue
Serious: no
Organ System: General disorders
Notes: Worst grade toxicity per patient. Includes toxicities that are expected and not meeting other criteria for serious per protocol.
Frequency: 2 affected / 34 at risk

Adverse event: Grade 3 emesis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Worst grade toxicity per patient. Includes toxicities that are expected and not meeting other criteria for serious per protocol.
Frequency: 2 affected / 34 at risk

Adverse event: Grade 3 diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Worst grade toxicity per patient. Includes toxicities that are expected and not meeting other criteria for serious per protocol.
Frequency: 3 affected / 34 at risk

Adverse event: Grade 3 hypophosphatemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Worst grade toxicity per patient. Includes toxicities that are expected and not meeting other criteria for serious per protocol.
Frequency: 2 affected / 34 at risk

Adverse event: Grade 3 elevated AST/ALT
Serious: no
Organ System: Hepatobiliary disorders
Notes: Worst grade toxicity per patient. Includes toxicities that are expected and not meeting other criteria for serious per protocol.
Frequency: 4 affected / 34 at risk

Adverse event: Grade 1-2 AST/ALT
Serious: no
Organ System: Hepatobiliary disorders
Notes: Worst grade toxicity per patient. Includes toxicities that are expected and not meeting other criteria for serious per protocol.
Frequency: 4 affected / 34 at risk

Adverse event: Grade 1-2 rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Worst grade toxicity per patient. Includes toxicities that are expected and not meeting other criteria for serious per protocol.
Frequency: 5 affected / 34 at risk

Adverse event: Grade 1-2 emesis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Worst grade toxicity per patient. Includes toxicities that are expected and not meeting other criteria for serious per protocol.
Frequency: 2 affected / 34 at risk

Adverse event: Grade 2 stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Worst grade toxicity per patient. Includes toxicities that are expected and not meeting other criteria for serious per protocol.
Frequency: 2 affected / 34 at risk

Adverse event: Grade 4 neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: SAEs included any grade 2-3 unexpected event with at least probable attribution, grade 4-5 toxicity regardless of attribution. Number of events includes worst grade toxicity per patient.
Frequency: 2 affected / 19 at risk

Adverse event: Grade 3 neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Includes all events of grade 3 neutropenia, regardless of whether or not resulted in hospitalization of other definition of SAE.
Frequency: 7 affected / 19 at risk

Adverse event: Grade 3 thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Includes all events of grade 3 thrombocytopenia, regardless of whether or not resulted in hospitalization of other definition of SAE.
Frequency: 1 affected / 19 at risk

Adverse event: Grade 4 leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Includes all events of grade 4 leukopenia, as defined by SAE reporting per protocol.
Frequency: 1 affected / 19 at risk

Adverse event: Grade 3 leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Includes all events of grade 3 leukopenia, regardless of whether or not resulted in hospitalization of other definition of SAE.
Frequency: 6 affected / 19 at risk

Adverse event: Grade 3 febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Grade 4 infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Grade 3 thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Second primary malignancy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Includes events that occurred during treatment and during long-term follow-up phase of treatment.
Frequency: 1 affected / 19 at risk

Adverse event: Grade 3 prolonged QTc interval
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

Adverse event: Grade 3 Infections
Serious: no
Organ System: Infections and infestations
Notes: Worst grade toxicity per patient. Includes toxicities that are expected and not meeting other criteria for serious per protocol.
Frequency: 4 affected / 19 at risk

Adverse event: Grade 1-2 fatigue
Serious: no
Organ System: General disorders
Notes: Worst grade toxicity per patient. Includes toxicities that are expected and not meeting other criteria for serious per protocol.
Frequency: 6 affected / 19 at risk

Adverse event: Grade 1-2 nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Worst grade toxicity per patient. Includes toxicities that are expected and not meeting other criteria for serious per protocol.
Frequency: 4 affected / 19 at risk

Adverse event: Grade 1-2 night sweats
Serious: no
Organ System: General disorders
Notes: Worst grade toxicity per patient. Includes toxicities that are expected and not meeting other criteria for serious per protocol.
Frequency: 3 affected / 19 at risk

Adverse event: Grade 1-2 rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Worst grade toxicity per patient. Includes toxicities that are expected and not meeting other criteria for serious per protocol.
Frequency: 5 affected / 19 at risk

Adverse event: Grade 1-2 cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Worst grade toxicity per patient. Includes toxicities that are expected and not meeting other criteria for serious per protocol.
Frequency: 4 affected / 19 at risk

Adverse event: Grade 1-2 headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 19 at risk

Adverse event: Grade 1-2 musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Worst grade toxicity per patient. Includes toxicities that are expected and not meeting other criteria for serious per protocol.
Frequency: 6 affected / 19 at risk

Adverse event: Grade 3 pain NOS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Worst grade toxicity per patient. Includes toxicities that are expected and not meeting other criteria for serious per protocol.
Frequency: 2 affected / 19 at risk

Adverse event: Grade 1-2 hyperglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Worst grade toxicity per patient. Includes toxicities that are expected and not meeting other criteria for serious per protocol.
Frequency: 4 affected / 19 at risk

Adverse event: Grade 1-2 emesis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Worst grade toxicity per patient. Includes toxicities that are expected and not meeting other criteria for serious per protocol.
Frequency: 1 affected / 19 at risk