Trial Outcomes & Findings for Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia (NCT NCT01256398)

Last Updated: 2023-04-04

Results Overview

Estimated using the Kaplan-Meier estimator. Proportions will be estimated using point as well as interval estimators. All interval estimators will be constructed using the finite sample size sampling distribution at the unadjusted two-sided level of 0.05.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

66 participants

Primary outcome timeframe

At 3 years after CR

Results posted on

2023-04-04

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Chemotherapy, Transplant) All enrolled patients.\> \> Alemtuzumab: Given IV\> Allogeneic Hematopoietic Stem Cell Transplantation: Undergo peripheral blood allogeneic HCT\> Autologous Hematopoietic Stem Cell Transplantation: Undergo peripheral blood autologous HCT\> Cyclophosphamide: Given IV\> Cytarabine: Given IV\> Dasatinib: Given PO\> Daunorubicin Hydrochloride: Given IV\> Dexamethasone: Given PO or IV\> Etoposide Phosphate: Given IV\> Filgrastim: Given SC\> Fludarabine Phosphate: Given IV\> In Vitro-Treated Peripheral Blood Stem Cell Transplantation: Undergo peripheral blood autologous or allogeneic HCT\> Laboratory Biomarker Analysis: Correlative studies\> Leucovorin Calcium: Given IV or PO\> Melphalan: Given IV\> Mercaptopurine: Given PO\> Methotrexate: Given IT, IV, or PO\> Pegfilgrastim: Given SC\> Pharmacological Study: Correlative studies\> Tacrolimus: Given IV or PO\> Vincristine Sulfate: Given IV
Overall Study STARTED	66
Overall Study COMPLETED	65
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Chemotherapy, Transplant) All enrolled patients.\> \> Alemtuzumab: Given IV\> Allogeneic Hematopoietic Stem Cell Transplantation: Undergo peripheral blood allogeneic HCT\> Autologous Hematopoietic Stem Cell Transplantation: Undergo peripheral blood autologous HCT\> Cyclophosphamide: Given IV\> Cytarabine: Given IV\> Dasatinib: Given PO\> Daunorubicin Hydrochloride: Given IV\> Dexamethasone: Given PO or IV\> Etoposide Phosphate: Given IV\> Filgrastim: Given SC\> Fludarabine Phosphate: Given IV\> In Vitro-Treated Peripheral Blood Stem Cell Transplantation: Undergo peripheral blood autologous or allogeneic HCT\> Laboratory Biomarker Analysis: Correlative studies\> Leucovorin Calcium: Given IV or PO\> Melphalan: Given IV\> Mercaptopurine: Given PO\> Methotrexate: Given IT, IV, or PO\> Pegfilgrastim: Given SC\> Pharmacological Study: Correlative studies\> Tacrolimus: Given IV or PO\> Vincristine Sulfate: Given IV
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Chemotherapy, Transplant) n=65 Participants All enrolled patients.\> \> Alemtuzumab: Given IV\> Allogeneic Hematopoietic Stem Cell Transplantation: Undergo peripheral blood allogeneic HCT\> Autologous Hematopoietic Stem Cell Transplantation: Undergo peripheral blood autologous HCT\> Cyclophosphamide: Given IV\> Cytarabine: Given IV\> Dasatinib: Given PO\> Daunorubicin Hydrochloride: Given IV\> Dexamethasone: Given PO or IV\> Etoposide Phosphate: Given IV\> Filgrastim: Given SC\> Fludarabine Phosphate: Given IV\> In Vitro-Treated Peripheral Blood Stem Cell Transplantation: Undergo peripheral blood autologous or allogeneic HCT\> Laboratory Biomarker Analysis: Correlative studies\> Leucovorin Calcium: Given IV or PO\> Melphalan: Given IV\> Mercaptopurine: Given PO\> Methotrexate: Given IT, IV, or PO\> Pegfilgrastim: Given SC\> Pharmacological Study: Correlative studies\> Tacrolimus: Given IV or PO\> Vincristine Sulfate: Given IV
Age, Continuous	60.1 Years n=39 Participants
Sex: Female, Male Female	33 Participants n=39 Participants
Sex: Female, Male Male	32 Participants n=39 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=39 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	50 Participants n=39 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=39 Participants

PRIMARY outcome

Timeframe: At 3 years after CR

Population: All patients that reached CR and chose to continue with the study.

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy, Transplant) n=38 Participants All enrolled patients that reached CR during induction and continued to course 5.\> \> Alemtuzumab: Given IV\> Allogeneic Hematopoietic Stem Cell Transplantation: Undergo peripheral blood allogeneic HCT\> Autologous Hematopoietic Stem Cell Transplantation: Undergo peripheral blood autologous HCT\> Cyclophosphamide: Given IV\> Cytarabine: Given IV\> Dasatinib: Given PO\> Daunorubicin Hydrochloride: Given IV\> Dexamethasone: Given PO or IV\> Etoposide Phosphate: Given IV\> Filgrastim: Given SC\> Fludarabine Phosphate: Given IV\> In Vitro-Treated Peripheral Blood Stem Cell Transplantation: Undergo peripheral blood autologous or allogeneic HCT\> Laboratory Biomarker Analysis: Correlative studies\> Leucovorin Calcium: Given IV or PO\> Melphalan: Given IV\> Mercaptopurine: Given PO\> Methotrexate: Given IT, IV, or PO\> Pegfilgrastim: Given SC\> Pharmacological Study: Correlative studies\> Tacrolimus: Given IV or PO\> Vincristine Sulfate: Given IV
Disease Free Survival Defined From the Date of First Induction Complete Response (CR) to Relapse or Death Due to Any Cause	52.6 percentage of patients Interval 36.8 to 68.5

SECONDARY outcome

Timeframe: 10 years

Proportions will be estimated based on the combined and individual cohorts.

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy, Transplant) n=64 Participants All enrolled patients that reached CR during induction and continued to course 5.\> \> Alemtuzumab: Given IV\> Allogeneic Hematopoietic Stem Cell Transplantation: Undergo peripheral blood allogeneic HCT\> Autologous Hematopoietic Stem Cell Transplantation: Undergo peripheral blood autologous HCT\> Cyclophosphamide: Given IV\> Cytarabine: Given IV\> Dasatinib: Given PO\> Daunorubicin Hydrochloride: Given IV\> Dexamethasone: Given PO or IV\> Etoposide Phosphate: Given IV\> Filgrastim: Given SC\> Fludarabine Phosphate: Given IV\> In Vitro-Treated Peripheral Blood Stem Cell Transplantation: Undergo peripheral blood autologous or allogeneic HCT\> Laboratory Biomarker Analysis: Correlative studies\> Leucovorin Calcium: Given IV or PO\> Melphalan: Given IV\> Mercaptopurine: Given PO\> Methotrexate: Given IT, IV, or PO\> Pegfilgrastim: Given SC\> Pharmacological Study: Correlative studies\> Tacrolimus: Given IV or PO\> Vincristine Sulfate: Given IV
Probability of Being BCR-ABL Negative in the Bone Marrow and Peripheral Blood at the Completion of the CNS Prophylaxis Course (Restricted to Those Patients Achieving a CR)	0.667 proportion of participants

SECONDARY outcome

Timeframe: 10 years

Proportions will be estimated based on the combined and individual cohorts.

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy, Transplant) n=64 Participants All enrolled patients that reached CR during induction and continued to course 5.\> \> Alemtuzumab: Given IV\> Allogeneic Hematopoietic Stem Cell Transplantation: Undergo peripheral blood allogeneic HCT\> Autologous Hematopoietic Stem Cell Transplantation: Undergo peripheral blood autologous HCT\> Cyclophosphamide: Given IV\> Cytarabine: Given IV\> Dasatinib: Given PO\> Daunorubicin Hydrochloride: Given IV\> Dexamethasone: Given PO or IV\> Etoposide Phosphate: Given IV\> Filgrastim: Given SC\> Fludarabine Phosphate: Given IV\> In Vitro-Treated Peripheral Blood Stem Cell Transplantation: Undergo peripheral blood autologous or allogeneic HCT\> Laboratory Biomarker Analysis: Correlative studies\> Leucovorin Calcium: Given IV or PO\> Melphalan: Given IV\> Mercaptopurine: Given PO\> Methotrexate: Given IT, IV, or PO\> Pegfilgrastim: Given SC\> Pharmacological Study: Correlative studies\> Tacrolimus: Given IV or PO\> Vincristine Sulfate: Given IV
Feasibility of Maintenance Therapy in This Patient Population (Restricted to Those Patients Achieving a CR). Feasibility Will be Defined as the Number of Deaths Ocuring.	5 Participants

SECONDARY outcome

Timeframe: 10 years

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy, Transplant) n=65 Participants All enrolled patients that reached CR during induction and continued to course 5.\> \> Alemtuzumab: Given IV\> Allogeneic Hematopoietic Stem Cell Transplantation: Undergo peripheral blood allogeneic HCT\> Autologous Hematopoietic Stem Cell Transplantation: Undergo peripheral blood autologous HCT\> Cyclophosphamide: Given IV\> Cytarabine: Given IV\> Dasatinib: Given PO\> Daunorubicin Hydrochloride: Given IV\> Dexamethasone: Given PO or IV\> Etoposide Phosphate: Given IV\> Filgrastim: Given SC\> Fludarabine Phosphate: Given IV\> In Vitro-Treated Peripheral Blood Stem Cell Transplantation: Undergo peripheral blood autologous or allogeneic HCT\> Laboratory Biomarker Analysis: Correlative studies\> Leucovorin Calcium: Given IV or PO\> Melphalan: Given IV\> Mercaptopurine: Given PO\> Methotrexate: Given IT, IV, or PO\> Pegfilgrastim: Given SC\> Pharmacological Study: Correlative studies\> Tacrolimus: Given IV or PO\> Vincristine Sulfate: Given IV
Overall Survival (OS)	55.9 Months Interval 31.8 to Not enough events for upper limit calculation

SECONDARY outcome

Timeframe: 10 years

Population: All CR patients

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy, Transplant) n=64 Participants All enrolled patients that reached CR during induction and continued to course 5.\> \> Alemtuzumab: Given IV\> Allogeneic Hematopoietic Stem Cell Transplantation: Undergo peripheral blood allogeneic HCT\> Autologous Hematopoietic Stem Cell Transplantation: Undergo peripheral blood autologous HCT\> Cyclophosphamide: Given IV\> Cytarabine: Given IV\> Dasatinib: Given PO\> Daunorubicin Hydrochloride: Given IV\> Dexamethasone: Given PO or IV\> Etoposide Phosphate: Given IV\> Filgrastim: Given SC\> Fludarabine Phosphate: Given IV\> In Vitro-Treated Peripheral Blood Stem Cell Transplantation: Undergo peripheral blood autologous or allogeneic HCT\> Laboratory Biomarker Analysis: Correlative studies\> Leucovorin Calcium: Given IV or PO\> Melphalan: Given IV\> Mercaptopurine: Given PO\> Methotrexate: Given IT, IV, or PO\> Pegfilgrastim: Given SC\> Pharmacological Study: Correlative studies\> Tacrolimus: Given IV or PO\> Vincristine Sulfate: Given IV
Disease Free Survival (DFS)	29.7 Months Interval 21.5 to 43.0

SECONDARY outcome

Timeframe: 10 years

Proportion of patients reaching a CR. A CR requires the following: an absolute neutrophil count (segs and bands) \>1000/μL, no circulating blasts, platelets \>100,000/μL; adequate bone marrow cellularity with trilineage hematopoiesis, and \<5% marrow leukemia blast cells. All previous extramedullary manifestations of disease must be absent (e.g., lymphadenopathy, splenomegaly, skin or gum infiltration, testicular masses, or CNS involvement).

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy, Transplant) n=65 Participants All enrolled patients that reached CR during induction and continued to course 5.\> \> Alemtuzumab: Given IV\> Allogeneic Hematopoietic Stem Cell Transplantation: Undergo peripheral blood allogeneic HCT\> Autologous Hematopoietic Stem Cell Transplantation: Undergo peripheral blood autologous HCT\> Cyclophosphamide: Given IV\> Cytarabine: Given IV\> Dasatinib: Given PO\> Daunorubicin Hydrochloride: Given IV\> Dexamethasone: Given PO or IV\> Etoposide Phosphate: Given IV\> Filgrastim: Given SC\> Fludarabine Phosphate: Given IV\> In Vitro-Treated Peripheral Blood Stem Cell Transplantation: Undergo peripheral blood autologous or allogeneic HCT\> Laboratory Biomarker Analysis: Correlative studies\> Leucovorin Calcium: Given IV or PO\> Melphalan: Given IV\> Mercaptopurine: Given PO\> Methotrexate: Given IT, IV, or PO\> Pegfilgrastim: Given SC\> Pharmacological Study: Correlative studies\> Tacrolimus: Given IV or PO\> Vincristine Sulfate: Given IV
Response	.9846 proportion of participants

Adverse Events

Treatment (Chemotherapy, Transplant)

Serious events: 5 serious events

Other events: 65 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Chemotherapy, Transplant) n=65 participants at risk Vincristine Sulfate: Given IV
General disorders Multi-organ failure	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Infections and infestations Lung infection	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Infections and infestations Sepsis	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Treatment related secondary malignancy	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.

Other adverse events

Other adverse events
Measure	Treatment (Chemotherapy, Transplant) n=65 participants at risk Vincristine Sulfate: Given IV
Infections and infestations Infective myositis	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Infections and infestations Infections and infestations - Other, specify	27.7% 18/65 • Number of events 31 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Blood and lymphatic system disorders Anemia	90.8% 59/65 • Number of events 535 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	6.2% 4/65 • Number of events 5 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Blood and lymphatic system disorders Disseminated intravascular coagulation	15.4% 10/65 • Number of events 18 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Blood and lymphatic system disorders Febrile neutropenia	41.5% 27/65 • Number of events 41 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Blood and lymphatic system disorders Hemolysis	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Blood and lymphatic system disorders Leukocytosis	9.2% 6/65 • Number of events 6 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Blood and lymphatic system disorders Lymph node pain	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Cardiac disorders Atrial fibrillation	6.2% 4/65 • Number of events 4 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Cardiac disorders Cardiac disorders - Other, specify	9.2% 6/65 • Number of events 9 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Cardiac disorders Chest pain - cardiac	7.7% 5/65 • Number of events 5 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Cardiac disorders Heart failure	3.1% 2/65 • Number of events 2 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Cardiac disorders Left ventricular systolic dysfunction	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Cardiac disorders Mitral valve disease	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Cardiac disorders Myocardial infarction	6.2% 4/65 • Number of events 4 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Cardiac disorders Palpitations	9.2% 6/65 • Number of events 12 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Cardiac disorders Pericardial effusion	4.6% 3/65 • Number of events 6 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Cardiac disorders Pericarditis	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Cardiac disorders Pulmonary valve disease	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Cardiac disorders Sinus bradycardia	4.6% 3/65 • Number of events 3 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Cardiac disorders Sinus tachycardia	21.5% 14/65 • Number of events 35 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Cardiac disorders Supraventricular tachycardia	4.6% 3/65 • Number of events 8 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Cardiac disorders Tricuspid valve disease	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Cardiac disorders Ventricular arrhythmia	3.1% 2/65 • Number of events 3 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Cardiac disorders Ventricular tachycardia	3.1% 2/65 • Number of events 2 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Ear and labyrinth disorders Ear and labyrinth disorders - Other, specify	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Ear and labyrinth disorders Ear pain	3.1% 2/65 • Number of events 2 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Ear and labyrinth disorders External ear pain	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Ear and labyrinth disorders Tinnitus	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Ear and labyrinth disorders Vertigo	3.1% 2/65 • Number of events 2 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Ear and labyrinth disorders Vestibular disorder	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Endocrine disorders Cushingoid	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Endocrine disorders Endocrine disorders - Other, specify	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Endocrine disorders Hyperthyroidism	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Endocrine disorders Hypothyroidism	6.2% 4/65 • Number of events 5 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Eye disorders Blurred vision	16.9% 11/65 • Number of events 16 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Eye disorders Conjunctivitis	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Eye disorders Dry eye	10.8% 7/65 • Number of events 10 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Eye disorders Extraocular muscle paresis	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Eye disorders Eye disorders - Other, specify	4.6% 3/65 • Number of events 3 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Eye disorders Eye pain	3.1% 2/65 • Number of events 2 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Eye disorders Eyelid function disorder	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Eye disorders Floaters	3.1% 2/65 • Number of events 2 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Eye disorders Photophobia	3.1% 2/65 • Number of events 5 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Eye disorders Watering eyes	3.1% 2/65 • Number of events 3 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Gastrointestinal disorders Abdominal distension	9.2% 6/65 • Number of events 9 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Gastrointestinal disorders Abdominal pain	40.0% 26/65 • Number of events 54 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Gastrointestinal disorders Anal fistula	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Gastrointestinal disorders Anal hemorrhage	4.6% 3/65 • Number of events 3 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Gastrointestinal disorders Anal pain	3.1% 2/65 • Number of events 4 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Gastrointestinal disorders Ascites	3.1% 2/65 • Number of events 2 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Gastrointestinal disorders Bloating	7.7% 5/65 • Number of events 9 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Gastrointestinal disorders Colitis	9.2% 6/65 • Number of events 9 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Gastrointestinal disorders Colonic hemorrhage	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Gastrointestinal disorders Colonic perforation	3.1% 2/65 • Number of events 2 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Gastrointestinal disorders Constipation	56.9% 37/65 • Number of events 71 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Gastrointestinal disorders Diarrhea	72.3% 47/65 • Number of events 182 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Gastrointestinal disorders Dry mouth	12.3% 8/65 • Number of events 16 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Gastrointestinal disorders Dyspepsia	20.0% 13/65 • Number of events 16 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Gastrointestinal disorders Dysphagia	12.3% 8/65 • Number of events 11 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Gastrointestinal disorders Esophageal pain	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Gastrointestinal disorders Esophagitis	6.2% 4/65 • Number of events 6 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Gastrointestinal disorders Flatulence	4.6% 3/65 • Number of events 5 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Gastrointestinal disorders Gastric hemorrhage	3.1% 2/65 • Number of events 2 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Gastrointestinal disorders Gastric ulcer	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Gastrointestinal disorders Gastritis	4.6% 3/65 • Number of events 3 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Gastrointestinal disorders Gastroesophageal reflux disease	20.0% 13/65 • Number of events 22 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	18.5% 12/65 • Number of events 19 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Gastrointestinal disorders Hemorrhoidal hemorrhage	4.6% 3/65 • Number of events 3 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Gastrointestinal disorders Hemorrhoids	4.6% 3/65 • Number of events 3 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Gastrointestinal disorders Ileus	1.5% 1/65 • Number of events 2 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	3.1% 2/65 • Number of events 8 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Gastrointestinal disorders Mucositis oral	46.2% 30/65 • Number of events 39 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Gastrointestinal disorders Nausea	72.3% 47/65 • Number of events 199 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Gastrointestinal disorders Oral pain	3.1% 2/65 • Number of events 2 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Gastrointestinal disorders Rectal hemorrhage	1.5% 1/65 • Number of events 3 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Gastrointestinal disorders Rectal pain	4.6% 3/65 • Number of events 3 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Gastrointestinal disorders Small intestinal mucositis	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Gastrointestinal disorders Stomach pain	7.7% 5/65 • Number of events 6 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Gastrointestinal disorders Toothache	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Gastrointestinal disorders Vomiting	61.5% 40/65 • Number of events 106 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
General disorders Chills	30.8% 20/65 • Number of events 31 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
General disorders Edema face	3.1% 2/65 • Number of events 2 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
General disorders Edema limbs	47.7% 31/65 • Number of events 98 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
General disorders Facial pain	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
General disorders Fatigue	90.8% 59/65 • Number of events 318 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
General disorders Fever	43.1% 28/65 • Number of events 62 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
General disorders Gait disturbance	4.6% 3/65 • Number of events 6 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
General disorders General disorders and administration site conditions - Other, specify	10.8% 7/65 • Number of events 10 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
General disorders Infusion related reaction	6.2% 4/65 • Number of events 4 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
General disorders Injection site reaction	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
General disorders Localized edema	6.2% 4/65 • Number of events 5 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
General disorders Malaise	9.2% 6/65 • Number of events 17 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
General disorders Multi-organ failure	3.1% 2/65 • Number of events 2 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
General disorders Neck edema	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
General disorders Non-cardiac chest pain	16.9% 11/65 • Number of events 14 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
General disorders Pain	24.6% 16/65 • Number of events 42 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Immune system disorders Allergic reaction	3.1% 2/65 • Number of events 2 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Infections and infestations Appendicitis	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Infections and infestations Bladder infection	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Infections and infestations Bronchial infection	4.6% 3/65 • Number of events 3 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Infections and infestations Catheter related infection	10.8% 7/65 • Number of events 10 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Infections and infestations Enterocolitis infectious	9.2% 6/65 • Number of events 14 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Infections and infestations Hepatic infection	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Infections and infestations Joint infection	1.5% 1/65 • Number of events 5 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Infections and infestations Lip infection	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Infections and infestations Lung infection	21.5% 14/65 • Number of events 33 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Infections and infestations Mucosal infection	9.2% 6/65 • Number of events 9 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Infections and infestations Otitis media	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Infections and infestations Papulopustular rash	1.5% 1/65 • Number of events 2 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Infections and infestations Phlebitis infective	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Infections and infestations Prostate infection	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Infections and infestations Rash pustular	4.6% 3/65 • Number of events 3 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Infections and infestations Salivary gland infection	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Infections and infestations Sepsis	7.7% 5/65 • Number of events 7 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Infections and infestations Sinusitis	16.9% 11/65 • Number of events 15 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Infections and infestations Skin infection	10.8% 7/65 • Number of events 18 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Infections and infestations Soft tissue infection	3.1% 2/65 • Number of events 2 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Infections and infestations Tooth infection	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Infections and infestations Upper respiratory infection	27.7% 18/65 • Number of events 28 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Infections and infestations Urinary tract infection	21.5% 14/65 • Number of events 30 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Infections and infestations Vaginal infection	3.1% 2/65 • Number of events 2 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Infections and infestations Wound infection	1.5% 1/65 • Number of events 2 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Injury, poisoning and procedural complications Ankle fracture	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Injury, poisoning and procedural complications Bruising	20.0% 13/65 • Number of events 24 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Injury, poisoning and procedural complications Fall	12.3% 8/65 • Number of events 11 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Injury, poisoning and procedural complications Fracture	3.1% 2/65 • Number of events 2 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Injury, poisoning and procedural complications Postoperative hemorrhage	4.6% 3/65 • Number of events 3 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Injury, poisoning and procedural complications Wound dehiscence	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Investigations Activated partial thromboplastin time prolonged	18.5% 12/65 • Number of events 16 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Investigations Alanine aminotransferase increased	73.8% 48/65 • Number of events 204 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Investigations Alkaline phosphatase increased	56.9% 37/65 • Number of events 149 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Investigations Aspartate aminotransferase increased	69.2% 45/65 • Number of events 216 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Investigations Blood bilirubin increased	35.4% 23/65 • Number of events 37 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Investigations Cardiac troponin I increased	7.7% 5/65 • Number of events 6 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Investigations Cholesterol high	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Investigations Creatinine increased	43.1% 28/65 • Number of events 116 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Investigations Electrocardiogram QT corrected interval prolonged	12.3% 8/65 • Number of events 17 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Investigations Fibrinogen decreased	15.4% 10/65 • Number of events 10 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Investigations Haptoglobin decreased	3.1% 2/65 • Number of events 2 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Investigations INR increased	24.6% 16/65 • Number of events 22 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Investigations Investigations - Other, specify	12.3% 8/65 • Number of events 32 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Investigations Lymphocyte count decreased	63.1% 41/65 • Number of events 212 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Investigations Lymphocyte count increased	6.2% 4/65 • Number of events 4 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Investigations Neutrophil count decreased	93.8% 61/65 • Number of events 342 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Investigations Platelet count decreased	96.9% 63/65 • Number of events 413 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Investigations Serum amylase increased	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Investigations Weight gain	7.7% 5/65 • Number of events 5 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Investigations Weight loss	16.9% 11/65 • Number of events 121 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Investigations White blood cell decreased	83.1% 54/65 • Number of events 284 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Metabolism and nutrition disorders Acidosis	6.2% 4/65 • Number of events 4 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Metabolism and nutrition disorders Alkalosis	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Metabolism and nutrition disorders Anorexia	50.8% 33/65 • Number of events 98 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Metabolism and nutrition disorders Dehydration	15.4% 10/65 • Number of events 13 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Metabolism and nutrition disorders Hypercalcemia	9.2% 6/65 • Number of events 11 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Metabolism and nutrition disorders Hyperglycemia	78.5% 51/65 • Number of events 284 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Metabolism and nutrition disorders Hyperkalemia	26.2% 17/65 • Number of events 37 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Metabolism and nutrition disorders Hypermagnesemia	32.3% 21/65 • Number of events 32 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Metabolism and nutrition disorders Hypernatremia	23.1% 15/65 • Number of events 25 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Metabolism and nutrition disorders Hypertriglyceridemia	10.8% 7/65 • Number of events 16 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Metabolism and nutrition disorders Hyperuricemia	16.9% 11/65 • Number of events 53 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Metabolism and nutrition disorders Hypoalbuminemia	67.7% 44/65 • Number of events 189 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Metabolism and nutrition disorders Hypocalcemia	69.2% 45/65 • Number of events 129 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Metabolism and nutrition disorders Hypoglycemia	16.9% 11/65 • Number of events 27 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Metabolism and nutrition disorders Hypokalemia	70.8% 46/65 • Number of events 151 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Metabolism and nutrition disorders Hypomagnesemia	43.1% 28/65 • Number of events 80 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Metabolism and nutrition disorders Hyponatremia	58.5% 38/65 • Number of events 122 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Metabolism and nutrition disorders Hypophosphatemia	44.6% 29/65 • Number of events 61 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	4.6% 3/65 • Number of events 29 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Metabolism and nutrition disorders Tumor lysis syndrome	9.2% 6/65 • Number of events 6 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Musculoskeletal and connective tissue disorders Arthralgia	32.3% 21/65 • Number of events 34 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Musculoskeletal and connective tissue disorders Arthritis	1.5% 1/65 • Number of events 2 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Musculoskeletal and connective tissue disorders Back pain	43.1% 28/65 • Number of events 51 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Musculoskeletal and connective tissue disorders Bone pain	10.8% 7/65 • Number of events 8 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Musculoskeletal and connective tissue disorders Buttock pain	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Musculoskeletal and connective tissue disorders Chest wall pain	3.1% 2/65 • Number of events 3 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Musculoskeletal and connective tissue disorders Flank pain	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	21.5% 14/65 • Number of events 35 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Musculoskeletal and connective tissue disorders Joint effusion	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	6.2% 4/65 • Number of events 6 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	6.2% 4/65 • Number of events 5 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Musculoskeletal and connective tissue disorders Myalgia	16.9% 11/65 • Number of events 15 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Musculoskeletal and connective tissue disorders Neck pain	13.8% 9/65 • Number of events 17 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Musculoskeletal and connective tissue disorders Pain in extremity	24.6% 16/65 • Number of events 38 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	3.1% 2/65 • Number of events 2 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Nervous system disorders Ataxia	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Nervous system disorders Depressed level of consciousness	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Nervous system disorders Dizziness	33.8% 22/65 • Number of events 43 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Nervous system disorders Dysgeusia	12.3% 8/65 • Number of events 14 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Nervous system disorders Dysphasia	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Nervous system disorders Facial muscle weakness	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Nervous system disorders Headache	49.2% 32/65 • Number of events 86 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Nervous system disorders Hypersomnia	1.5% 1/65 • Number of events 2 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Nervous system disorders Intracranial hemorrhage	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Nervous system disorders Lethargy	7.7% 5/65 • Number of events 6 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Nervous system disorders Memory impairment	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Nervous system disorders Movements involuntary	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Nervous system disorders Nervous system disorders - Other, specify	6.2% 4/65 • Number of events 7 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Nervous system disorders Neuralgia	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Nervous system disorders Paresthesia	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Nervous system disorders Peripheral motor neuropathy	10.8% 7/65 • Number of events 9 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Nervous system disorders Peripheral sensory neuropathy	38.5% 25/65 • Number of events 118 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Nervous system disorders Phantom pain	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Nervous system disorders Presyncope	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Nervous system disorders Reversible posterior leukoencephalopathy syndrome	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Nervous system disorders Sinus pain	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Nervous system disorders Somnolence	4.6% 3/65 • Number of events 5 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Nervous system disorders Syncope	4.6% 3/65 • Number of events 3 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Nervous system disorders Tremor	10.8% 7/65 • Number of events 7 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Psychiatric disorders Agitation	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Psychiatric disorders Anxiety	30.8% 20/65 • Number of events 56 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Psychiatric disorders Confusion	9.2% 6/65 • Number of events 9 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Psychiatric disorders Delirium	1.5% 1/65 • Number of events 2 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Psychiatric disorders Delusions	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Psychiatric disorders Depression	16.9% 11/65 • Number of events 34 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Psychiatric disorders Hallucinations	6.2% 4/65 • Number of events 6 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Psychiatric disorders Insomnia	43.1% 28/65 • Number of events 51 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Psychiatric disorders Libido decreased	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Psychiatric disorders Libido increased	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Psychiatric disorders Psychiatric disorders - Other, specify	3.1% 2/65 • Number of events 2 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Psychiatric disorders Restlessness	3.1% 2/65 • Number of events 2 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Renal and urinary disorders Acute kidney injury	20.0% 13/65 • Number of events 39 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Renal and urinary disorders Bladder spasm	1.5% 1/65 • Number of events 3 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Renal and urinary disorders Chronic kidney disease	12.3% 8/65 • Number of events 36 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Renal and urinary disorders Cystitis noninfective	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Renal and urinary disorders Hematuria	9.2% 6/65 • Number of events 10 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Renal and urinary disorders Proteinuria	20.0% 13/65 • Number of events 19 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Renal and urinary disorders Renal and urinary disorders - Other, specify	12.3% 8/65 • Number of events 10 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Renal and urinary disorders Urinary frequency	13.8% 9/65 • Number of events 11 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Renal and urinary disorders Urinary incontinence	4.6% 3/65 • Number of events 6 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Renal and urinary disorders Urinary retention	4.6% 3/65 • Number of events 4 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Renal and urinary disorders Urinary tract pain	4.6% 3/65 • Number of events 7 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Renal and urinary disorders Urinary urgency	4.6% 3/65 • Number of events 3 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Reproductive system and breast disorders Testicular pain	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Reproductive system and breast disorders Uterine pain	3.1% 2/65 • Number of events 2 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Reproductive system and breast disorders Vaginal hemorrhage	4.6% 3/65 • Number of events 6 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	10.8% 7/65 • Number of events 13 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Atelectasis	10.8% 7/65 • Number of events 7 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	3.1% 2/65 • Number of events 2 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Cough	50.8% 33/65 • Number of events 72 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Dyspnea	53.8% 35/65 • Number of events 118 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Epistaxis	10.8% 7/65 • Number of events 7 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Hiccups	6.2% 4/65 • Number of events 4 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Hoarseness	3.1% 2/65 • Number of events 2 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Hypoxia	10.8% 7/65 • Number of events 7 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Laryngeal hemorrhage	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Nasal congestion	18.5% 12/65 • Number of events 20 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Pharyngeal mucositis	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Pleural effusion	40.0% 26/65 • Number of events 60 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Pneumonitis	3.1% 2/65 • Number of events 2 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Postnasal drip	6.2% 4/65 • Number of events 7 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Productive cough	12.3% 8/65 • Number of events 12 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	9.2% 6/65 • Number of events 6 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.1% 2/65 • Number of events 2 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	9.2% 6/65 • Number of events 10 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Sleep apnea	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Sore throat	27.7% 18/65 • Number of events 23 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Respiratory, thoracic and mediastinal disorders Wheezing	10.8% 7/65 • Number of events 7 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Skin and subcutaneous tissue disorders Alopecia	10.8% 7/65 • Number of events 12 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Skin and subcutaneous tissue disorders Bullous dermatitis	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Skin and subcutaneous tissue disorders Dry skin	21.5% 14/65 • Number of events 36 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Skin and subcutaneous tissue disorders Erythema multiforme	4.6% 3/65 • Number of events 3 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Skin and subcutaneous tissue disorders Nail loss	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Skin and subcutaneous tissue disorders Pain of skin	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Skin and subcutaneous tissue disorders Periorbital edema	3.1% 2/65 • Number of events 6 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Skin and subcutaneous tissue disorders Pruritus	29.2% 19/65 • Number of events 30 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Skin and subcutaneous tissue disorders Purpura	9.2% 6/65 • Number of events 12 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Skin and subcutaneous tissue disorders Rash acneiform	7.7% 5/65 • Number of events 12 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Skin and subcutaneous tissue disorders Rash maculo-papular	52.3% 34/65 • Number of events 79 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Skin and subcutaneous tissue disorders Scalp pain	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	24.6% 16/65 • Number of events 56 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Skin and subcutaneous tissue disorders Skin induration	3.1% 2/65 • Number of events 6 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Skin and subcutaneous tissue disorders Skin ulceration	4.6% 3/65 • Number of events 3 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Skin and subcutaneous tissue disorders Urticaria	10.8% 7/65 • Number of events 11 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Surgical and medical procedures Surgical and medical procedures - Other, specify	1.5% 1/65 • Number of events 1 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Vascular disorders Flushing	7.7% 5/65 • Number of events 6 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Vascular disorders Hematoma	9.2% 6/65 • Number of events 8 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Vascular disorders Hot flashes	10.8% 7/65 • Number of events 15 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Vascular disorders Hypertension	32.3% 21/65 • Number of events 68 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Vascular disorders Hypotension	24.6% 16/65 • Number of events 27 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Vascular disorders Superficial thrombophlebitis	3.1% 2/65 • Number of events 2 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.
Vascular disorders Thromboembolic event	10.8% 7/65 • Number of events 13 • 10 years This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to determine the severity of the reaction for adverse event reporting.

Additional Information

Matthew Wieduwilt, MD, PhD

University of California San Diego Moores Cancer Center

Phone: 858-822-6848

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60