Trial Outcomes & Findings for Safety & Efficacy of Atorvastatin for Prophylaxis of Acute Graft Versus Host Disease in Patients With Hematological Malignancies HLA- Donor Hematopoietic Stem Cell Transplantation (NCT NCT01491958)

NCT ID: NCT01491958

Last Updated: 2018-01-23

Results Overview

The incidence of grades II to IV aGVHD at day +100 of atorvastatin administration. The grading of aGVHD and cGVHD were done using the Consensus Conference criteria.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

Up through day 100 following transplant

Results posted on

2018-01-23

Participant Flow

Patients who are candidates for HSCT using HLA matched related donors were eligible to be enrolled in the study.

Participant milestones

Participant milestones
Measure	Patients Patients will receive atorvastatin 40 mg starting at least 7 days before initiation of transplant conditioning regimen, to permit a 1 week observation period to rule out any atorvastatin-induced side effects before initiation of transplant conditioning. Patients will continue on atorvastatin with standard GVHD prophylaxis with tacrolimus and methotrexate until end of GVHD prophylaxis according to institutional standard guidelines, or until development of endpoint, which ever should occur first. Standard post transplant care will be administered.	Donors Related donors will receive atorvastatin 40 mg/day orally at least 14 days before anticipated first day of stem cell leukapheresis (LP) until successful completion of leukapheresis according to institutional guidelines. Peripheral blood stem cells will not be manipulated or T-depleted prior to administration.
Overall Study STARTED	40	40
Overall Study COMPLETED	40	40
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety & Efficacy of Atorvastatin for Prophylaxis of Acute Graft Versus Host Disease in Patients With Hematological Malignancies HLA- Donor Hematopoietic Stem Cell Transplantation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients n=40 Participants Patients will receive atorvastatin 40 mg starting at least 7 days before initiation of transplant conditioning regimen, to permit a 1 week observation period to rule out any atorvastatin-induced side effects before initiation of transplant conditioning. Patients will continue on atorvastatin with standard GVHD prophylaxis with tacrolimus and methotrexate until end of GVHD prophylaxis according to institutional standard guidelines, or until development of endpoint, which ever should occur first. Standard post transplant care will be administered.	Donor n=40 Participants Related donors will receive atorvastatin 40 mg/day orally at least 14 days before anticipated first day of stem cell leukapheresis (LP) until successful completion of leukapheresis according to institutional guidelines. Peripheral blood stem cells will not be manipulated or T-depleted prior to administration.	Total n=80 Participants Total of all reporting groups
Age, Continuous	51 years n=93 Participants	50 years n=4 Participants	51 years n=27 Participants
Sex: Female, Male Female	20 Participants n=93 Participants	20 Participants n=4 Participants	40 Participants n=27 Participants
Sex: Female, Male Male	20 Participants n=93 Participants	20 Participants n=4 Participants	40 Participants n=27 Participants
Region of Enrollment United States	40 patients n=93 Participants	40 patients n=4 Participants	80 patients n=27 Participants

PRIMARY outcome

Timeframe: Up through day 100 following transplant

The incidence of grades II to IV aGVHD at day +100 of atorvastatin administration. The grading of aGVHD and cGVHD were done using the Consensus Conference criteria.

Outcome measures

Outcome measures
Measure	Patients n=40 Participants Patients will receive atorvastatin 40 mg starting at least 7 days before initiation of transplant conditioning regimen, to permit a 1 week observation period to rule out any atorvastatin-induced side effects before initiation of transplant conditioning. Patients will continue on atorvastatin with standard GVHD prophylaxis with tacrolimus and methotrexate until end of GVHD prophylaxis according to institutional standard guidelines, or until development of endpoint, which ever should occur first. Standard post transplant care will be administered.
Percentage of Participants With Grades II to IV aGVHD at Day +100 of Atorvastatin Administration	30 percentage of patients Interval 17.0 to 45.0

SECONDARY outcome

Timeframe: Patients: Baseline, weekly for 9 weeks and then on days 84, 91-100, 180 and 365. Donors: at apheresis and then 30 days later.

Population: Only patients with evaluable data reported

Adverse events and toxicities were monitored in patients using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria.

Outcome measures

Outcome measures
Measure	Patients n=36 Participants Patients will receive atorvastatin 40 mg starting at least 7 days before initiation of transplant conditioning regimen, to permit a 1 week observation period to rule out any atorvastatin-induced side effects before initiation of transplant conditioning. Patients will continue on atorvastatin with standard GVHD prophylaxis with tacrolimus and methotrexate until end of GVHD prophylaxis according to institutional standard guidelines, or until development of endpoint, which ever should occur first. Standard post transplant care will be administered.
Safety of Atorvastatin in Transplant Recipients in Terms of Adverse Events and Toxicities. Grade 2 elevated liver enzymes	2 patients
Safety of Atorvastatin in Transplant Recipients in Terms of Adverse Events and Toxicities. Grade 4 elevated liver enzymes	1 patients

SECONDARY outcome

Timeframe: weekly for 12 weeks, 100 days, 6 months, and 12 months

Neutrophil engraftment will be defined as first of three consecutive days with ANC ≥ 0.5 x 109/L post-conditioning regimen induced nadir. Similarly platelet engraftment is defined as first day of platelet count ≥ 20,000 x 109/L, without transfusion for 7 consecutive days.

Outcome measures

Outcome measures
Measure	Patients n=40 Participants Patients will receive atorvastatin 40 mg starting at least 7 days before initiation of transplant conditioning regimen, to permit a 1 week observation period to rule out any atorvastatin-induced side effects before initiation of transplant conditioning. Patients will continue on atorvastatin with standard GVHD prophylaxis with tacrolimus and methotrexate until end of GVHD prophylaxis according to institutional standard guidelines, or until development of endpoint, which ever should occur first. Standard post transplant care will be administered.
Time to Neutrophil and Platelet Engraftment Neutrophil engraftment	18 days Interval 13.0 to 26.0
Time to Neutrophil and Platelet Engraftment Platelet engraftment	14 days Interval 9.0 to 29.0

SECONDARY outcome

Timeframe: up 1 year post transplant

cGVHD occurring anytime after day 100 post transplant will be termed chronic GVHD, and evaluated in patients who were followed for at least 100 days without early progression or death. Grading of cGVHD was done using the National Institutes of Health Consensus Development Project Criteria

Outcome measures

Outcome measures
Measure	Patients n=34 Participants Patients will receive atorvastatin 40 mg starting at least 7 days before initiation of transplant conditioning regimen, to permit a 1 week observation period to rule out any atorvastatin-induced side effects before initiation of transplant conditioning. Patients will continue on atorvastatin with standard GVHD prophylaxis with tacrolimus and methotrexate until end of GVHD prophylaxis according to institutional standard guidelines, or until development of endpoint, which ever should occur first. Standard post transplant care will be administered.
Percentage of Patients With Chronic Graft Versus Host Disease (cGVHD)	43 percentage of patients Interval 32.0 to 69.0

SECONDARY outcome

Timeframe: up to 12 months post transplant

Cumulative incidence of NRM will be calculated as the time from transplant until death not related to disease, where the competing risk for NRM was death due to disease. Patients who had not died were censored at last follow up.

Outcome measures

Outcome measures
Measure	Patients n=40 Participants Patients will receive atorvastatin 40 mg starting at least 7 days before initiation of transplant conditioning regimen, to permit a 1 week observation period to rule out any atorvastatin-induced side effects before initiation of transplant conditioning. Patients will continue on atorvastatin with standard GVHD prophylaxis with tacrolimus and methotrexate until end of GVHD prophylaxis according to institutional standard guidelines, or until development of endpoint, which ever should occur first. Standard post transplant care will be administered.
Non Relapse Mortality (NRM) at One Year	5.5 percentage of patients Interval 0.9 to 16.5

Adverse Events

Patients

Serious events: 5 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Patients n=36 participants at risk Patients will receive atorvastatin 40 mg starting at least 7 days before initiation of transplant conditioning regimen, to permit a 1 week observation period to rule out any atorvastatin-induced side effects before initiation of transplant conditioning. Patients will continue on atorvastatin with standard GVHD prophylaxis with tacrolimus and methotrexate until end of GVHD prophylaxis according to institutional standard guidelines, or until development of endpoint, which ever should occur first. Standard post transplant care will be administered.
Blood and lymphatic system disorders Febrile Neutropenia	2.8% 1/36 • Number of events 1 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Gastrointestinal disorders Abdominal Pain	2.8% 1/36 • Number of events 1 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Gastrointestinal disorders Constipation	2.8% 1/36 • Number of events 1 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Gastrointestinal disorders Diarrhea	2.8% 1/36 • Number of events 1 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Gastrointestinal disorders Nausea	2.8% 1/36 • Number of events 1 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Gastrointestinal disorders Vomiting	2.8% 1/36 • Number of events 1 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
General disorders Chills	2.8% 1/36 • Number of events 1 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Infections and infestations Urinary tract infection	2.8% 1/36 • Number of events 1 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Infections and infestations Wound infection	2.8% 1/36 • Number of events 1 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Investigations Alanine Aminotransferase increased	2.8% 1/36 • Number of events 1 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Investigations Aspartate Aminotransferase increased	2.8% 1/36 • Number of events 1 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Investigations Creatinine increased	5.6% 2/36 • Number of events 2 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Investigations Neutrophil count decreased	2.8% 1/36 • Number of events 1 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Investigations Weight loss	2.8% 1/36 • Number of events 1 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Metabolism and nutrition disorders Anorexia	2.8% 1/36 • Number of events 1 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Nervous system disorders Dysgeusia	2.8% 1/36 • Number of events 1 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Nervous system disorders Lethargy	2.8% 1/36 • Number of events 1 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Nervous system disorders Seizure	2.8% 1/36 • Number of events 1 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Psychiatric disorders Confusion	5.6% 2/36 • Number of events 2 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Vascular disorders Hypotension	2.8% 1/36 • Number of events 1 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)

Other adverse events

Other adverse events
Measure	Patients n=36 participants at risk Patients will receive atorvastatin 40 mg starting at least 7 days before initiation of transplant conditioning regimen, to permit a 1 week observation period to rule out any atorvastatin-induced side effects before initiation of transplant conditioning. Patients will continue on atorvastatin with standard GVHD prophylaxis with tacrolimus and methotrexate until end of GVHD prophylaxis according to institutional standard guidelines, or until development of endpoint, which ever should occur first. Standard post transplant care will be administered.
Blood and lymphatic system disorders Anemia	38.9% 14/36 • Number of events 16 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Blood and lymphatic system disorders Febrile Neutropenia	11.1% 4/36 • Number of events 4 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Cardiac disorders Palpitations	5.6% 2/36 • Number of events 2 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Cardiac disorders Sinus Tachycardia	5.6% 2/36 • Number of events 2 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Endocrine disorders Endocrine Disorders	5.6% 2/36 • Number of events 3 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Eye disorders Blurred Vision	5.6% 2/36 • Number of events 2 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Eye disorders Dry eye	11.1% 4/36 • Number of events 4 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Eye disorders Eye Disorders	5.6% 2/36 • Number of events 3 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Gastrointestinal disorders Abdominal Pain	16.7% 6/36 • Number of events 7 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Gastrointestinal disorders Constipation	16.7% 6/36 • Number of events 6 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Gastrointestinal disorders Diarrhea	52.8% 19/36 • Number of events 26 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Gastrointestinal disorders Dry mouth	25.0% 9/36 • Number of events 11 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Gastrointestinal disorders Dyspepsia	5.6% 2/36 • Number of events 2 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Gastrointestinal disorders Mucositis oral	55.6% 20/36 • Number of events 21 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Gastrointestinal disorders Nausea	66.7% 24/36 • Number of events 33 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Gastrointestinal disorders Oral pain	11.1% 4/36 • Number of events 5 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Gastrointestinal disorders Vomiting	27.8% 10/36 • Number of events 16 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
General disorders Edema limbs	19.4% 7/36 • Number of events 8 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
General disorders Fatigue	77.8% 28/36 • Number of events 34 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
General disorders Fever	27.8% 10/36 • Number of events 14 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
General disorders General Disorder	13.9% 5/36 • Number of events 6 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
General disorders Localized Edema	5.6% 2/36 • Number of events 3 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
General disorders Pain	30.6% 11/36 • Number of events 14 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Infections and infestations Infections	41.7% 15/36 • Number of events 18 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Infections and infestations Rhinitis Infective	5.6% 2/36 • Number of events 2 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Infections and infestations Upper Respiratory Infection	8.3% 3/36 • Number of events 3 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Infections and infestations Urinary Tract Infection	22.2% 8/36 • Number of events 9 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Injury, poisoning and procedural complications Brusing	5.6% 2/36 • Number of events 2 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Investigations Alanine Aminotransferase Increased	72.2% 26/36 • Number of events 47 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Investigations Alkaline Phosphatase Increased	33.3% 12/36 • Number of events 15 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Investigations Aspartate Aminotransferase Increased	72.2% 26/36 • Number of events 49 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Investigations Blood Bilirubin Increased	16.7% 6/36 • Number of events 6 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Investigations Cholesterol High	11.1% 4/36 • Number of events 4 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Investigations Creatinine Increased	69.4% 25/36 • Number of events 40 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Investigations INR Increased	5.6% 2/36 • Number of events 2 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Investigations Investigations-other	5.6% 2/36 • Number of events 2 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Investigations Lymphocyte Count Decreased	5.6% 2/36 • Number of events 2 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Investigations Neutrophil Count Decreased	25.0% 9/36 • Number of events 11 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Investigations Platelet Count Decreased	33.3% 12/36 • Number of events 18 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Investigations Weight loss	11.1% 4/36 • Number of events 4 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Investigations White Blood Cell Decreased	27.8% 10/36 • Number of events 20 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Metabolism and nutrition disorders Anorexia	36.1% 13/36 • Number of events 18 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Metabolism and nutrition disorders Hypercalcemia	13.9% 5/36 • Number of events 6 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Metabolism and nutrition disorders Hyperglycemia	63.9% 23/36 • Number of events 35 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Metabolism and nutrition disorders Hyperkalemia	8.3% 3/36 • Number of events 3 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Metabolism and nutrition disorders Hypermagnesemia	5.6% 2/36 • Number of events 3 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Metabolism and nutrition disorders Hypernatremia	5.6% 2/36 • Number of events 2 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Metabolism and nutrition disorders Hypertriglyceridemia	8.3% 3/36 • Number of events 3 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Metabolism and nutrition disorders Hypoalbuminemia	50.0% 18/36 • Number of events 28 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Metabolism and nutrition disorders Hypocalcemia	50.0% 18/36 • Number of events 32 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Metabolism and nutrition disorders Hypokalemia	30.6% 11/36 • Number of events 12 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Metabolism and nutrition disorders Hypomagnesemia	66.7% 24/36 • Number of events 50 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Metabolism and nutrition disorders Hyponatremia	50.0% 18/36 • Number of events 33 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Metabolism and nutrition disorders Hypophosphatemia	8.3% 3/36 • Number of events 4 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Metabolism and nutrition disorders Metabolism and nutrition disorders	8.3% 3/36 • Number of events 3 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Musculoskeletal and connective tissue disorders Arthralgia	11.1% 4/36 • Number of events 4 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Musculoskeletal and connective tissue disorders Back pain	11.1% 4/36 • Number of events 6 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Musculoskeletal and connective tissue disorders Generalized Muscle Weakness	5.6% 2/36 • Number of events 3 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Musculoskeletal and connective tissue disorders Muscleskeletal and Connective Tissues Disorder	5.6% 2/36 • Number of events 2 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Musculoskeletal and connective tissue disorders Myalgia	8.3% 3/36 • Number of events 3 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Musculoskeletal and connective tissue disorders Pain in Extremity	8.3% 3/36 • Number of events 3 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Nervous system disorders Dizziness	8.3% 3/36 • Number of events 3 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Nervous system disorders Dysgeusia	13.9% 5/36 • Number of events 6 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Nervous system disorders Headache	25.0% 9/36 • Number of events 14 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Nervous system disorders Peripheral Sensory Neuropathy	13.9% 5/36 • Number of events 7 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Psychiatric disorders Anxiety	8.3% 3/36 • Number of events 3 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Psychiatric disorders Confusion	8.3% 3/36 • Number of events 3 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Psychiatric disorders Insomnia	8.3% 3/36 • Number of events 3 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Renal and urinary disorders Acute Kidney Injury	13.9% 5/36 • Number of events 5 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Renal and urinary disorders Chronic Kidney Disease	5.6% 2/36 • Number of events 3 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Renal and urinary disorders Hematuria	5.6% 2/36 • Number of events 2 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Renal and urinary disorders Renal and Urinary disorders	13.9% 5/36 • Number of events 9 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Renal and urinary disorders Urinary Frequency	5.6% 2/36 • Number of events 2 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Respiratory, thoracic and mediastinal disorders Cough	13.9% 5/36 • Number of events 6 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Respiratory, thoracic and mediastinal disorders Dyspnea	27.8% 10/36 • Number of events 11 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Respiratory, thoracic and mediastinal disorders Epistaxis	5.6% 2/36 • Number of events 3 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Respiratory, thoracic and mediastinal disorders Nasal congestion	8.3% 3/36 • Number of events 3 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Respiratory, thoracic and mediastinal disorders Sore throat	11.1% 4/36 • Number of events 5 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Skin and subcutaneous tissue disorders Erythema Multiforme	8.3% 3/36 • Number of events 5 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Skin and subcutaneous tissue disorders Pruritus	13.9% 5/36 • Number of events 8 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Skin and subcutaneous tissue disorders Rash Acneiform	8.3% 3/36 • Number of events 4 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Skin and subcutaneous tissue disorders Rash Maculo-papular	36.1% 13/36 • Number of events 15 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorder	8.3% 3/36 • Number of events 3 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Skin and subcutaneous tissue disorders Skin hyperpigmentation	5.6% 2/36 • Number of events 2 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Vascular disorders Hypertension	19.4% 7/36 • Number of events 7 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Vascular disorders Hypotension	16.7% 6/36 • Number of events 6 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Vascular disorders Thromboembolic event	11.1% 4/36 • Number of events 4 Adverse events were assessed for 36 patients only using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0)

Additional Information

Yvonne Efebera, M.D

The Ohio State University Comprehensive Cancer Center

Phone: 614-293-3196

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place