Study: NCT01729494

Adverse event: Cardiovascular event
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 107 at risk

Adverse event: Infection Requiring Hospitalization
Serious: yes
Organ System: Infections and infestations
Notes: all infections which required for participant to be hospitalized.
Frequency: 24 affected / 107 at risk

Adverse event: Renal dysfunction resulting in hospitalization
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 30 affected / 107 at risk

Adverse event: Malignancy
Serious: yes
Organ System: Immune system disorders
Frequency: 7 affected / 107 at risk

Adverse event: Nausea/vomiting or GI requiring hospitalization
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 107 at risk

Adverse event: Mental status changes or neurological AE's
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 107 at risk

Adverse event: Hematologic events
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 59 affected / 107 at risk

Adverse event: Leukopenia WBC < 2000/mm3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 107 at risk

Adverse event: Anemia (Hg < 7gm/dL)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 107 at risk

Adverse event: Thrombocytopenia (PLT < 50,000/mm3)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 107 at risk

Adverse event: Gastrointestinal events
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 107 at risk

Adverse event: Nephrotoxicity events
Serious: no
Organ System: Renal and urinary disorders
Frequency: 22 affected / 107 at risk

Adverse event: Neurologic events
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 107 at risk

Adverse event: Electrolyte/metabolic events
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 107 at risk

Adverse event: Wound healing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 107 at risk

Adverse event: Musculoskeletal/Bone events
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 107 at risk

Adverse event: Cardiovascular event
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 104 at risk

Adverse event: Infection Requiring Hospitalization
Serious: yes
Organ System: Infections and infestations
Notes: all infections which required for participant to be hospitalized.
Frequency: 24 affected / 104 at risk

Adverse event: Renal dysfunction resulting in hospitalization
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 32 affected / 104 at risk

Adverse event: Malignancy
Serious: yes
Organ System: Immune system disorders
Frequency: 6 affected / 104 at risk

Adverse event: PTLD
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 104 at risk

Adverse event: Nausea/vomiting or GI requiring hospitalization
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 104 at risk

Adverse event: Hematologic events
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 55 affected / 104 at risk

Adverse event: Leukopenia WBC < 2000/mm3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 104 at risk

Adverse event: Anemia (Hg < 7gm/dL)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 104 at risk

Adverse event: Thrombocytopenia (PLT < 50,000/mm3)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 104 at risk

Adverse event: Gastrointestinal events
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 104 at risk

Adverse event: Nephrotoxicity events
Serious: no
Organ System: Renal and urinary disorders
Frequency: 28 affected / 104 at risk

Adverse event: Neurologic events
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 104 at risk

Adverse event: Electrolyte/metabolic events
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 104 at risk

Adverse event: Wound healing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 104 at risk

Adverse event: Musculoskeletal/Bone events
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 104 at risk

Adverse event: Cardiovascular event
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 105 at risk

Adverse event: Infection Requiring Hospitalization
Serious: yes
Organ System: Infections and infestations
Notes: all infections which required for participant to be hospitalized.
Frequency: 23 affected / 105 at risk

Adverse event: Renal dysfunction resulting in hospitalization
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 28 affected / 105 at risk

Adverse event: Malignancy
Serious: yes
Organ System: Immune system disorders
Frequency: 7 affected / 105 at risk

Adverse event: Nausea/vomiting or GI requiring hospitalization
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 105 at risk

Adverse event: Mental status changes or neurological AE's
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 105 at risk

Adverse event: Hematologic events
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 60 affected / 105 at risk

Adverse event: Leukopenia WBC < 2000/mm3
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 105 at risk

Adverse event: Anemia (Hg < 7gm/dL)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 105 at risk

Adverse event: Thrombocytopenia (PLT < 50,000/mm3)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Gastrointestinal events
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 50 affected / 105 at risk

Adverse event: Nephrotoxicity events
Serious: no
Organ System: Renal and urinary disorders
Frequency: 37 affected / 105 at risk

Adverse event: Neurologic events
Serious: no
Organ System: Nervous system disorders
Frequency: 33 affected / 105 at risk

Adverse event: Electrolyte/metabolic events
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 32 affected / 105 at risk

Adverse event: Wound healing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 105 at risk

Adverse event: Musculoskeletal/Bone events
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 105 at risk