Sitagliptin Umbilical Cord Blood Transplant Study

• Sponsor: Indiana University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT00862719
• Collaborator: (none)
• Enrollment: 29
• Location: 1
• Arms: 3
• Duration (Months): 71.1
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The main purpose of this trial is to study whether the drug sitagliptin can be given safely to patients undergoing umbilical cord blood transplantation to speed up engraftment (recovery of blood counts after transplant).

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Myeloid, Acute; Acute Lymphoblastic Leukemia; Myelodysplasia; Leukemia, Myelogenous, Chronic; Lymphoma, Non-Hodgkin	Drug: Sitagliptin	Phase 2

Detailed Description

Umbilical cord blood (UCB) is increasingly used as a source of stem cells for patients with blood cancers who need an allogeneic stem cell transplant (a transplant with stem cells from another person) but who have no suitably matched donors. The advantages of UCB are that (1) it is associated with less risk of transmitting an infection from a donor, (2) it can be more safely given even if not completely matched compared to bone marrow or blood stem cells, and (3) it is much more quickly available than unrelated donor bone marrow or blood stem cells. While more commonly used for transplantation in children, UCB is increasingly being used in adults. However, because they are larger than children, the relatively smaller stem cell dose in UCB is major limitation for transplantation in adults, and engraftment can be delayed. This study is investigating whether the drug sitagliptin can be used to increase and speed up engraftment in adults receiving UCB transplantation, overcoming the limitation of small stem cell doses associated with umbilical cord blood.

Sitagliptin is a drug given in tablet form that has been recently approved by the Food and Drug Administration (FDA) for the treatment of certain patients with diabetes mellitus (a disease that results in high blood sugar). Sitagliptin has been given to both normal healthy volunteers and diabetic patients and has been found to be safe and well-tolerated. The drug improves control of blood sugar in diabetics by inhibiting an enzyme called "CD26/DPP-IV." Recent studies at Indiana University (and other centers) have shown that this same enzyme plays an important role in the way transplanted stem cells find their way to the bone marrow and engraft. Transplant studies in mice have found that inhibiting CD26/DPP-IV significantly increases the engraftment of stem cells. Based on these studies, it is believed that drugs that inhibit CD26/DPP-IV, such as sitagliptin, may also increase engraftment in patients who receive clinical stem cell transplants.

Study Design

• Study Type: Interventional
• Actual Enrollment: 29 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Trial of Inhibition of CD26 Peptidase Using Sitagliptin to Enhance Engraftment After Umbilical Cord Blood Transplantation for Adults With Hematological Malignancies
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Nov 1, 2012
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sitagliptin once per day 600 mg sitagliptin once per day orally starting on Day -1 for a total of 4 doses	Drug: Sitagliptin; 600 mg sitagliptin taken orally per the schedule listed in each of the three separate arms.; Other Names: Januvia
Experimental: Sitagliptin twice per day 600 mg sitagliptin twice per day orally starting on Day -1 for a total of 8 doses	Drug: Sitagliptin; 600 mg sitagliptin taken orally per the schedule listed in each of the three separate arms.; Other Names: Januvia
Experimental: Sitagliptin three times per day 600 mg sitagliptin three times per day orally starting on Day -1 for a total of 12 doses	Drug: Sitagliptin; 600 mg sitagliptin taken orally per the schedule listed in each of the three separate arms.; Other Names: Januvia

Outcome Measures

Primary Outcome Measures

1. Cumulative Incidence of Patients With Engraftment by Day +30 Following Transplant [Transplant (Day 0) through Day +30]

   Evaluate the efficacy of CD26/DPP-IV inhibition in increasing the cumulative incidence of adult patients with hematological malignancies engrafting by day +30 following transplantation of UCB by 30 percent. The cumulative incidence of patients achieving this will be reported. The value of the estimate will be from bootstrapping 1000 samples with replacement of the data and the 95% confidence interval will be calculated using the percentile method.

Secondary Outcome Measures

1. Time to Neutrophil Engraftment [Transplant (Day 0) up to 1 year]

   Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophils is defined as the time from day 0 to the date of the first of three consecutive days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l. Patients who did not have neutrophil engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided. For the RCD group, all patients engrafted before day +30, except one patient who died at day 28 before engraftment. For the PD group, all patients engrafted before day +100, except one patient who died on day +103 before engraftment. For the 600 mg sitagliptin/12 hours group, two patients engrafted before day +100, and the other two patients died before day +100 before engraftment. The one patient on 600 mg sitagliptin/8 hours died on day +14 before engraftment.

2. Time to Platelet Engraftment [Transplant (Day 0) up to 1 year]

   Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive days after transplantation during which the platelet count is at least 20 x109/l without transfusion support. Only patients who achieved engraftment of platelets will be included in the analysis. The median and 95% confidence intervals will be provided.

3. Treatment Related Adverse Events Grade 3 or Higher for Non-hematological Toxicity [Transplant (Day 0) up to 3 years]

   Number of unique patients who had a treatment related (possible, probable or definite) non-hematological adverse event that was graded 3 or greater.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 59 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients must have one of the following disease types with disease-specific features as outlined in the protocol:

• Acute myeloid leukemia (AML)

• Acute lymphoblastic leukemia (ALL)

• Myelodysplasia

• Chronic myelogenous leukemia

• Patients with aggressive non-Hodgkin's lymphoma (NHL), including diffuse large cell lymphoma, mediastinal B-cell lymphoma, transformed lymphoma, mantle cell lymphoma, and peripheral T cell lymphoma

• Hodgkin's lymphoma

• Relapsed Multiple Myeloma

• At least 35 days following start of preceding leukemia induction cytotoxic chemotherapy

• Patient age 18-55 years

• Karnofsky Performance status ≥ 70%

• No availability of a consenting HLA-matched related donor who is either matched fully matched or mismatched at only one locus of HLA-A, -B, and DRB1.

• No availability of a readily available HLA-matched volunteer unrelated donor (8 of 8 allele match at HLA-A, -B, -C and -DRB1). Patients with unstable disease who are in danger of significant disease progression while waiting to procure volunteer donor cells will be eligible to be treated on this protocol, even if a matched donor is available.

• Patients must have a matched or partially matched UCB unit with greater than 1.8 x10-7 nucleated cells/kg of recipient weight at the time of cryopreservation.

• No current uncontrolled bacterial, viral or fungal infection (defined as currently taking medication and progression of clinical symptoms).

• No HIV disease. Patients with immune dysfunction are at a significantly higher risk of infection from intensive immunosuppressive therapies.

• Non pregnant and non-nursing. Treatment under this protocol would expose a fetus to significant risks.

• Required baseline laboratory values as defined in the protocol

Exclusion Criteria:

• Symptomatic uncontrolled coronary artery disease or congestive heart failure.

• Severe hypoxemia with room air PaO2 less than 70, supplemental oxygen dependence, or DLCO less than 50 percent predicted

• Patients with central nervous system (CNS) involvement refractory to intrathecal chemotherapy

• Prior allogeneic or autologous hematopoietic stem cell transplant in the last 6 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IU Simon Cancer Center	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

• Indiana University School of Medicine

Investigators

• Principal Investigator: Sherif Farag, MD, PhD, IU Simon Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Indiana University School of Medicine
• ClinicalTrials.gov Identifier: NCT00862719
• Other Study ID Numbers: 0812-15; IUCRO-0223
• First Posted: Mar 17, 2009
• Last Update Posted: Oct 7, 2016
• Last Verified: Aug 1, 2016

• Additional relevant MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Non-Hodgkin; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Sitagliptin Phosphate

Study Results

Participant Flow

Recruitment Details	Initially based on single arm 2 stage design using 600 mg sitagliptin/24 hrs in RBC replete and RBC depleted UCB units. In an unplanned interim analysis after 1st 20 enrolled pts, protocol was amended to exclude RBC replete UCB units due to worse outcomes and to test more frequent dosing of sitagliptin due to suboptimal inhibition of plasma DPP-IV.

Arm/Group Title	Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs	Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24	600 mg Sitagliptin/12 Hrs	600 mg Sitagliptin/8 Hrs
Arm/Group Description	600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients	600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients	600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses	600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
Period Title: Overall Study
STARTED	17	7	4	1
COMPLETED	7	1	0	0
NOT COMPLETED	10	6	4	1

Baseline Characteristics

Arm/Group Title	Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs	Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24	600 mg Sitagliptin/12 Hrs	600 mg Sitagliptin/8 Hrs	Total
Arm/Group Description	600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients	600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients	600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses	600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses	Total of all reporting groups
Overall Participants	17	7	4	1	29
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	17 100%	7 100%	4 100%	1 100%	29 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.6 (10.86)	34.8 (8.95)	46.9 (7.94)	54.9 (0)	40.6 (10.62)
Sex: Female, Male (Count of Participants)
Female	12 70.6%	4 57.1%	2 50%	1 100%	19 65.5%
Male	5 29.4%	3 42.9%	2 50%	0 0%	10 34.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	0 0%	0 0%
Not Hispanic or Latino	17 100%	7 100%	4 100%	1 100%	29 100%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	3 17.6%	2 28.6%	0 0%	0 0%	5 17.2%
White	14 82.4%	5 71.4%	4 100%	1 100%	24 82.8%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Cumulative Incidence of Patients With Engraftment by Day +30 Following Transplant
Description	Evaluate the efficacy of CD26/DPP-IV inhibition in increasing the cumulative incidence of adult patients with hematological malignancies engrafting by day +30 following transplantation of UCB by 30 percent. The cumulative incidence of patients achieving this will be reported. The value of the estimate will be from bootstrapping 1000 samples with replacement of the data and the 95% confidence interval will be calculated using the percentile method.
Time Frame	Transplant (Day 0) through Day +30

Outcome Measure Data

Analysis Population Description

Modified Intent to treat population (mITT) - all patients receiving at least one dose of study drug and receiving REB depleted UCB units only

Arm/Group Title	Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs
Arm/Group Description	600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
Measure Participants	17
Number (95% Confidence Interval) [percentage of participants]	88 517.6%

2. Secondary Outcome

Title	Time to Neutrophil Engraftment
Description	Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophils is defined as the time from day 0 to the date of the first of three consecutive days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l. Patients who did not have neutrophil engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided. For the RCD group, all patients engrafted before day +30, except one patient who died at day 28 before engraftment. For the PD group, all patients engrafted before day +100, except one patient who died on day +103 before engraftment. For the 600 mg sitagliptin/12 hours group, two patients engrafted before day +100, and the other two patients died before day +100 before engraftment. The one patient on 600 mg sitagliptin/8 hours died on day +14 before engraftment.
Time Frame	Transplant (Day 0) up to 1 year

Outcome Measure Data

Analysis Population Description

All patients enrolled and received treatment.

Arm/Group Title	Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs	Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24	600 mg Sitagliptin/12 Hrs	600 mg Sitagliptin/8 Hrs
Arm/Group Description	600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients	600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients	600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses	600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
Measure Participants	17	7	4	1
Median (95% Confidence Interval) [days]	21	35	51	14

3. Secondary Outcome

Title	Time to Platelet Engraftment
Description	Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive days after transplantation during which the platelet count is at least 20 x109/l without transfusion support. Only patients who achieved engraftment of platelets will be included in the analysis. The median and 95% confidence intervals will be provided.
Time Frame	Transplant (Day 0) up to 1 year

Outcome Measure Data

Analysis Population Description

All patients enrolled and received treatment who achieved platelet recovery/engraftment of platelets.

Arm/Group Title	Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs	Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24	600 mg Sitagliptin/12 Hrs	600 mg Sitagliptin/8 Hrs
Arm/Group Description	600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients	600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients	600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses	600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
Measure Participants	17	7	4	1
Median (95% Confidence Interval) [days]	77	91	NA	NA

4. Secondary Outcome

Title	Treatment Related Adverse Events Grade 3 or Higher for Non-hematological Toxicity
Description	Number of unique patients who had a treatment related (possible, probable or definite) non-hematological adverse event that was graded 3 or greater.
Time Frame	Transplant (Day 0) up to 3 years

Outcome Measure Data

Analysis Population Description

All patients enrolled and received treatment.

Arm/Group Title	Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs	Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24	600 mg Sitagliptin/12 Hrs	600 mg Sitagliptin/8 Hrs
Arm/Group Description	600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients	600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients	600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses	600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
Measure Participants	17	7	4	1
Number [participants]	0 0%	0 0%	0 0%	1 100%

Adverse Events

Time Frame	up to 3 years
Arm/Group Title	Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs		Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24		600 mg Sitagliptin/12 Hrs		600 mg Sitagliptin/8 Hrs
Arm/Group Description	600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients		600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients		600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses		600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
All Cause Mortality
	Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs		Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24		600 mg Sitagliptin/12 Hrs		600 mg Sitagliptin/8 Hrs
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs		Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24		600 mg Sitagliptin/12 Hrs		600 mg Sitagliptin/8 Hrs
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/17 (64.7%)		6/7 (85.7%)		2/4 (50%)		1/1 (100%)
Blood and lymphatic system disorders
BLOOD/BONE MARROW - OTHER	0/17 (0%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
LYMPHATICS - OTHER	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
Cardiac disorders
CARDIAC ARRHYTHMIA - OTHER	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
CARDIAC GENERAL - OTHER	0/17 (0%)		0/7 (0%)		0/4 (0%)		1/1 (100%)
RESTRICTIVE CARDIOMYOPATHY	0/17 (0%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
Gastrointestinal disorders
DIARRHEA	4/17 (23.5%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
NAUSEA	3/17 (17.6%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
PAIN - ABDOMEN NOS	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
VOMITING	3/17 (17.6%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
General disorders
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
HYPOTHERMIA	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
Hepatobiliary disorders
HEPATOBILIARY/PANCREAS - OTHER	0/17 (0%)		0/7 (0%)		1/4 (25%)		0/1 (0%)
LIVER DYSFUNCTION/FAILURE (CLINICAL)	0/17 (0%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
Immune system disorders
ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
Infections and infestations
FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE	2/17 (11.8%)		1/7 (14.3%)		0/4 (0%)		1/1 (100%)
INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E	4/17 (23.5%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
INFECTION - OTHER	4/17 (23.5%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - BLOOD	0/17 (0%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - BRONCHUS	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - SINUS	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
INFECTION WITH UNKNOWN ANC - LUNG (PNEUMONIA)	1/17 (5.9%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
INFECTION WITH UNKNOWN ANC - SINUS	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
Investigations
CERVICAL SPINE-RANGE OF MOTION	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
Musculoskeletal and connective tissue disorders
PAIN - EXTREMITY-LIMB	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
Nervous system disorders
CONFUSION	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
PAIN - HEAD/HEADACHE	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
Renal and urinary disorders
RENAL FAILURE	0/17 (0%)		0/7 (0%)		1/4 (25%)		0/1 (0%)
Respiratory, thoracic and mediastinal disorders
ADULT RESPIRATORY DISTRESS SYNDROME (ARDS)	0/17 (0%)		3/7 (42.9%)		0/4 (0%)		0/1 (0%)
DYSPNEA (SHORTNESS OF BREATH)	2/17 (11.8%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
EDEMA, LARYNX	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
HYPOXIA	5/17 (29.4%)		0/7 (0%)		0/4 (0%)		1/1 (100%)
PLEURAL EFFUSION (NON-MALIGNANT)	0/17 (0%)		0/7 (0%)		1/4 (25%)		0/1 (0%)
PULMONARY/UPPER RESPIRATORY - OTHER	2/17 (11.8%)		2/7 (28.6%)		0/4 (0%)		1/1 (100%)
Vascular disorders
HEMORRHAGE, GI - ABDOMEN NOS	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
HEMORRHAGE, GI - LOWER GI NOS	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
HEMORRHAGE, GU - URINARY NOS	0/17 (0%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - LUNG	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - RESPIRATORY TRACT NOS	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
HYPOTENSION	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		1/1 (100%)
VASCULAR - OTHER	0/17 (0%)		0/7 (0%)		0/4 (0%)		1/1 (100%)
Other (Not Including Serious) Adverse Events
	Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs		Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24		600 mg Sitagliptin/12 Hrs		600 mg Sitagliptin/8 Hrs
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/17 (100%)		7/7 (100%)		4/4 (100%)		1/1 (100%)
Blood and lymphatic system disorders
BLOOD/BONE MARROW - OTHER	1/17 (5.9%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
COAGULATION - OTHER	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
HEMOLYSIS (E.G., IMMUNE HEMOLYTIC ANEMIA, DRUG-RELATED HEMOLYSIS)	2/17 (11.8%)		2/7 (28.6%)		0/4 (0%)		0/1 (0%)
LYMPHATICS - OTHER	3/17 (17.6%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
Cardiac disorders
CARDIAC ARRHYTHMIA - OTHER	5/17 (29.4%)		4/7 (57.1%)		1/4 (25%)		1/1 (100%)
CARDIAC GENERAL - OTHER	3/17 (17.6%)		3/7 (42.9%)		0/4 (0%)		0/1 (0%)
PERICARDIAL EFFUSION (NON-MALIGNANT)	3/17 (17.6%)		2/7 (28.6%)		0/4 (0%)		0/1 (0%)
RESTRICTIVE CARDIOMYOPATHY	0/17 (0%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - ATRIAL TACHYCARDIA/PAROXYSMAL ATRIAL TACHYCARDIA	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - SINUS BRADYCARDIA	2/17 (11.8%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - SINUS TACHYCARDIA	7/17 (41.2%)		2/7 (28.6%)		0/4 (0%)		0/1 (0%)
VALVULAR HEART DISEASE	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
VENTRICULAR ARRHYTHMIA - VENTRICULAR TACHYCARDIA	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
Ear and labyrinth disorders
AUDITORY/EAR - OTHER	1/17 (5.9%)		0/7 (0%)		1/4 (25%)		0/1 (0%)
PAIN - MIDDLE EAR	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
Endocrine disorders
THYROID FUNCTION, LOW (HYPOTHYROIDISM)	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
Eye disorders
DRY EYE SYNDROME	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
OPHTHALMOPLEGIA/DIPLOPIA (DOUBLE VISION)	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
PAIN - EYE	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
RETINAL DETACHMENT	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
VISION-BLURRED VISION	3/17 (17.6%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
VISION-FLASHING LIGHTS/FLOATERS	1/17 (5.9%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
WATERY EYE (EPIPHORA, TEARING)	0/17 (0%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
Gastrointestinal disorders
ASCITES (NON-MALIGNANT)	4/17 (23.5%)		0/7 (0%)		1/4 (25%)		0/1 (0%)
COLITIS	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
COLITIS, INFECTIOUS (E.G., CLOSTRIDIUM DIFFICILE)	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
CONSTIPATION	4/17 (23.5%)		3/7 (42.9%)		1/4 (25%)		0/1 (0%)
DIARRHEA	17/17 (100%)		7/7 (100%)		4/4 (100%)		1/1 (100%)
DISTENSION/BLOATING, ABDOMINAL	4/17 (23.5%)		1/7 (14.3%)		2/4 (50%)		0/1 (0%)
DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)	2/17 (11.8%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
DYSPHAGIA (DIFFICULTY SWALLOWING)	1/17 (5.9%)		2/7 (28.6%)		0/4 (0%)		0/1 (0%)
FLATULENCE	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
GASTRITIS (INCLUDING BILE REFLUX GASTRITIS)	0/17 (0%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
GASTROINTESTINAL - OTHER	3/17 (17.6%)		0/7 (0%)		1/4 (25%)		0/1 (0%)
HEARTBURN/DYSPEPSIA	1/17 (5.9%)		0/7 (0%)		1/4 (25%)		0/1 (0%)
HEMORRHOIDS	1/17 (5.9%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
HICCOUGHS (HICCUPS, SINGULTUS)	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
INCONTINENCE, ANAL	0/17 (0%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
MUCOSITIS/STOMATITIS (CLINICAL EXAM) - ESOPHAGUS	1/17 (5.9%)		0/7 (0%)		1/4 (25%)		0/1 (0%)
MUCOSITIS/STOMATITIS (CLINICAL EXAM) - ORAL CAVITY	15/17 (88.2%)		7/7 (100%)		3/4 (75%)		1/1 (100%)
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) - ORAL CAVITY	1/17 (5.9%)		1/7 (14.3%)		1/4 (25%)		0/1 (0%)
NAUSEA	15/17 (88.2%)		5/7 (71.4%)		4/4 (100%)		1/1 (100%)
OBSTRUCTION, GI - STOMACH	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
OCULAR/VISUAL - OTHER	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
PAIN - ABDOMEN NOS	13/17 (76.5%)		3/7 (42.9%)		3/4 (75%)		0/1 (0%)
PAIN - ANUS	0/17 (0%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
PAIN - DENTAL/TEETH/PERIDONTAL	0/17 (0%)		0/7 (0%)		1/4 (25%)		0/1 (0%)
PAIN - RECTUM	2/17 (11.8%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
TASTE ALTERATION (DYSGEUSIA)	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
VOMITING	14/17 (82.4%)		6/7 (85.7%)		4/4 (100%)		0/1 (0%)
General disorders
EDEMA: HEAD AND NECK	3/17 (17.6%)		1/7 (14.3%)		1/4 (25%)		1/1 (100%)
EDEMA: LIMB	12/17 (70.6%)		4/7 (57.1%)		2/4 (50%)		1/1 (100%)
EDEMA: TRUNK/GENITAL	5/17 (29.4%)		0/7 (0%)		1/4 (25%)		0/1 (0%)
EDEMA: VISCERA	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
FATIGUE (ASTHENIA, LETHARGY, MALAISE)	2/17 (11.8%)		3/7 (42.9%)		0/4 (0%)		0/1 (0%)
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)	14/17 (82.4%)		4/7 (57.1%)		2/4 (50%)		0/1 (0%)
PAIN - BUTTOCK	0/17 (0%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
PAIN - CHEST WALL	2/17 (11.8%)		2/7 (28.6%)		0/4 (0%)		0/1 (0%)
PAIN - CHEST/THORAX NOS	2/17 (11.8%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
PAIN - OTHER	11/17 (64.7%)		3/7 (42.9%)		1/4 (25%)		1/1 (100%)
PAIN - PAIN NOS	3/17 (17.6%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
RIGORS/CHILLS	0/17 (0%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
SWEATING (DIAPHORESIS)	0/17 (0%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
Hepatobiliary disorders
CHOLECYSTITIS	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
HEPATOBILIARY/PANCREAS - OTHER	2/17 (11.8%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
LIVER DYSFUNCTION/FAILURE (CLINICAL)	1/17 (5.9%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
Immune system disorders
ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)	7/17 (41.2%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
ALLERGY/IMMUNOLOGY - OTHER	0/17 (0%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
SERUM SICKNESS	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
Infections and infestations
FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE	13/17 (76.5%)		5/7 (71.4%)		3/4 (75%)		1/1 (100%)
INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E	11/17 (64.7%)		4/7 (57.1%)		2/4 (50%)		0/1 (0%)
INFECTION - OTHER	11/17 (64.7%)		4/7 (57.1%)		3/4 (75%)		1/1 (100%)
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - ANAL/PERIANAL	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - BLADDER (URINARY)	2/17 (11.8%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - BLOOD	2/17 (11.8%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - COLON	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - LUNG (PNEUMONIA)	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - PARANASAL	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - SINUS	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - SMALL BOWEL NOS	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - URINARY TRACT NOS	3/17 (17.6%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
INFECTION WITH UNKNOWN ANC - BLADDER (URINARY)	1/17 (5.9%)		0/7 (0%)		1/4 (25%)		0/1 (0%)
INFECTION WITH UNKNOWN ANC - BLOOD	0/17 (0%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
INFECTION WITH UNKNOWN ANC - COLON	2/17 (11.8%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
INFECTION WITH UNKNOWN ANC - CONJUNCTIVA	0/17 (0%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
INFECTION WITH UNKNOWN ANC - EYE NOS	2/17 (11.8%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
INFECTION WITH UNKNOWN ANC - LUNG (PNEUMONIA)	2/17 (11.8%)		2/7 (28.6%)		0/4 (0%)		0/1 (0%)
INFECTION WITH UNKNOWN ANC - MIDDLE EAR (OTITIS MEDIA)	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
INFECTION WITH UNKNOWN ANC - SINUS	6/17 (35.3%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
INFECTION WITH UNKNOWN ANC - SKIN (CELLULITIS)	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
INFECTION WITH UNKNOWN ANC - SOFT TISSUE NOS	0/17 (0%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
INFECTION WITH UNKNOWN ANC - UPPER AIRWAY NOS	3/17 (17.6%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
INFECTION WITH UNKNOWN ANC - URINARY TRACT NOS	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
Injury, poisoning and procedural complications
WOUND COMPLICATION, NON-INFECTIOUS	2/17 (11.8%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
Investigations
ALKALINE PHOSPHATASE	15/17 (88.2%)		4/7 (57.1%)		2/4 (50%)		0/1 (0%)
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)	17/17 (100%)		4/7 (57.1%)		3/4 (75%)		1/1 (100%)
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)	17/17 (100%)		6/7 (85.7%)		4/4 (100%)		1/1 (100%)
BICARBONATE, SERUM-LOW	2/17 (11.8%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
CARDIAC TROPONIN I (CTNI)	0/17 (0%)		0/7 (0%)		0/4 (0%)		1/1 (100%)
CREATININE	12/17 (70.6%)		5/7 (71.4%)		3/4 (75%)		1/1 (100%)
HAPTOGLOBIN	0/17 (0%)		0/7 (0%)		1/4 (25%)		0/1 (0%)
HEMOGLOBIN	2/17 (11.8%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
ILEUS, GI (FUNCTIONAL OBSTRUCTION OF BOWEL, I.E., NEUROCONSTIPATION)	0/17 (0%)		0/7 (0%)		1/4 (25%)		0/1 (0%)
METABOLIC/LABORATORY - OTHER	5/17 (29.4%)		1/7 (14.3%)		2/4 (50%)		0/1 (0%)
NEUTROPHILS/GRANULOCYTES (ANC/AGC)	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
PLATELETS	1/17 (5.9%)		2/7 (28.6%)		0/4 (0%)		0/1 (0%)
PROLONGED QTC INTERVAL	0/17 (0%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
WEIGHT GAIN	2/17 (11.8%)		0/7 (0%)		2/4 (50%)		0/1 (0%)
WEIGHT LOSS	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
Metabolism and nutrition disorders
ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)	11/17 (64.7%)		4/7 (57.1%)		3/4 (75%)		1/1 (100%)
ANOREXIA	2/17 (11.8%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
BILIRUBIN (HYPERBILIRUBINEMIA)	15/17 (88.2%)		6/7 (85.7%)		2/4 (50%)		1/1 (100%)
CALCIUM, SERUM-LOW (HYPOCALCEMIA)	8/17 (47.1%)		3/7 (42.9%)		3/4 (75%)		0/1 (0%)
DEHYDRATION	3/17 (17.6%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)	10/17 (58.8%)		3/7 (42.9%)		3/4 (75%)		0/1 (0%)
GLUCOSE, SERUM-LOW (HYPOGLYCEMIA)	2/17 (11.8%)		0/7 (0%)		1/4 (25%)		0/1 (0%)
MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)	7/17 (41.2%)		3/7 (42.9%)		2/4 (50%)		0/1 (0%)
PHOSPHATE, SERUM-LOW (HYPOPHOSPHATEMIA)	7/17 (41.2%)		4/7 (57.1%)		3/4 (75%)		0/1 (0%)
POTASSIUM, SERUM-HIGH (HYPERKALEMIA)	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
POTASSIUM, SERUM-LOW (HYPOKALEMIA)	5/17 (29.4%)		5/7 (71.4%)		2/4 (50%)		0/1 (0%)
SODIUM, SERUM-HIGH (HYPERNATREMIA)	4/17 (23.5%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
SODIUM, SERUM-LOW (HYPONATREMIA)	6/17 (35.3%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
TRIGLYCERIDE, SERUM-HIGH (HYPERTRIGLYCERIDEMIA)	3/17 (17.6%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
Musculoskeletal and connective tissue disorders
FRACTURE	2/17 (11.8%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - EXTREMITY-LOWER	0/17 (0%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - EXTREMITY-UPPER	2/17 (11.8%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - WHOLE BODY/GENERALIZED	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
MUSCULOSKELETAL/SOFT TISSUE - OTHER	2/17 (11.8%)		1/7 (14.3%)		1/4 (25%)		0/1 (0%)
OSTEOPOROSIS	2/17 (11.8%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
PAIN - BACK	8/17 (47.1%)		1/7 (14.3%)		1/4 (25%)		0/1 (0%)
PAIN - BONE	6/17 (35.3%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
PAIN - EXTREMITY-LIMB	5/17 (29.4%)		1/7 (14.3%)		1/4 (25%)		0/1 (0%)
PAIN - JOINT	2/17 (11.8%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
PAIN - MUSCLE	2/17 (11.8%)		2/7 (28.6%)		0/4 (0%)		0/1 (0%)
PAIN - NECK	2/17 (11.8%)		1/7 (14.3%)		1/4 (25%)		0/1 (0%)
SOFT TISSUE NECROSIS - EXTREMITY-LOWER	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
Nervous system disorders
CONFUSION	7/17 (41.2%)		3/7 (42.9%)		1/4 (25%)		0/1 (0%)
DIZZINESS	5/17 (29.4%)		0/7 (0%)		0/4 (0%)		1/1 (100%)
ENCEPHALOPATHY	3/17 (17.6%)		2/7 (28.6%)		2/4 (50%)		0/1 (0%)
EXTRAPYRAMIDAL/INVOLUNTARY MOVEMENT/RESTLESSNESS	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
MEMORY IMPAIRMENT	0/17 (0%)		2/7 (28.6%)		0/4 (0%)		0/1 (0%)
MOOD ALTERATION - AGITATION	1/17 (5.9%)		0/7 (0%)		1/4 (25%)		0/1 (0%)
MOOD ALTERATION - ANXIETY	2/17 (11.8%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
MOOD ALTERATION - DEPRESSION	4/17 (23.5%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
NEUROLOGY - OTHER	2/17 (11.8%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
NEUROPATHY: MOTOR	0/17 (0%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
NEUROPATHY: SENSORY	7/17 (41.2%)		1/7 (14.3%)		2/4 (50%)		0/1 (0%)
PAIN - HEAD/HEADACHE	9/17 (52.9%)		4/7 (57.1%)		1/4 (25%)		1/1 (100%)
PAIN - NEURALGIA/PERIPHERAL NERVE	0/17 (0%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
SEIZURE	1/17 (5.9%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
SOMNOLENCE/DEPRESSED LEVEL OF CONSCIOUSNESS	0/17 (0%)		1/7 (14.3%)		2/4 (50%)		0/1 (0%)
SYNCOPE (FAINTING)	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
TREMOR	4/17 (23.5%)		4/7 (57.1%)		0/4 (0%)		0/1 (0%)
Psychiatric disorders
INSOMNIA	3/17 (17.6%)		3/7 (42.9%)		0/4 (0%)		0/1 (0%)
PSYCHOSIS (HALLUCINATIONS/DELUSIONS)	0/17 (0%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
Renal and urinary disorders
BLADDER SPASMS	6/17 (35.3%)		2/7 (28.6%)		1/4 (25%)		0/1 (0%)
CYSTITIS	2/17 (11.8%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
INCONTINENCE, URINARY	0/17 (0%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
PAIN - BLADDER	2/17 (11.8%)		1/7 (14.3%)		1/4 (25%)		0/1 (0%)
RENAL FAILURE	1/17 (5.9%)		0/7 (0%)		2/4 (50%)		1/1 (100%)
RENAL/GENITOURINARY - OTHER	1/17 (5.9%)		1/7 (14.3%)		0/4 (0%)		1/1 (100%)
URINARY FREQUENCY/URGENCY	2/17 (11.8%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
URINE COLOR CHANGE	0/17 (0%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
Reproductive system and breast disorders
IRREGULAR MENSES (CHANGE FROM BASELINE)	2/17 (11.8%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
PAIN - PELVIS	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
PAIN - URETHRA	2/17 (11.8%)		0/7 (0%)		1/4 (25%)		0/1 (0%)
PAIN - VAGINA	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
VAGINAL DISCHARGE (NON-INFECTIOUS)	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
VAGINAL DRYNESS	2/17 (11.8%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
Respiratory, thoracic and mediastinal disorders
PAIN - THROAT/PHARYNX/LARYNX	4/17 (23.5%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
ADULT RESPIRATORY DISTRESS SYNDROME (ARDS)	1/17 (5.9%)		1/7 (14.3%)		1/4 (25%)		0/1 (0%)
BRONCHOSPASM, WHEEZING	1/17 (5.9%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
COUGH	8/17 (47.1%)		4/7 (57.1%)		0/4 (0%)		1/1 (100%)
DYSPNEA (SHORTNESS OF BREATH)	8/17 (47.1%)		3/7 (42.9%)		3/4 (75%)		0/1 (0%)
EDEMA, LARYNX	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
HYPOXIA	11/17 (64.7%)		4/7 (57.1%)		1/4 (25%)		1/1 (100%)
NASAL CAVITY/PARANASAL SINUS REACTIONS	1/17 (5.9%)		0/7 (0%)		1/4 (25%)		0/1 (0%)
PLEURAL EFFUSION (NON-MALIGNANT)	7/17 (41.2%)		1/7 (14.3%)		1/4 (25%)		1/1 (100%)
PNEUMONITIS/PULMONARY INFILTRATES	2/17 (11.8%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
PULMONARY/UPPER RESPIRATORY - OTHER	4/17 (23.5%)		2/7 (28.6%)		1/4 (25%)		1/1 (100%)
VOICE CHANGES/DYSARTHRIA (E.G., HOARSENESS, LOSS OR ALTERATION IN VOICE, LARYNGITIS)	1/17 (5.9%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN - OTHER	5/17 (29.4%)		2/7 (28.6%)		2/4 (50%)		0/1 (0%)
DRY SKIN	2/17 (11.8%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
PAIN - SKIN	2/17 (11.8%)		0/7 (0%)		1/4 (25%)		0/1 (0%)
PRURITUS/ITCHING	6/17 (35.3%)		1/7 (14.3%)		1/4 (25%)		0/1 (0%)
RASH/DESQUAMATION	6/17 (35.3%)		3/7 (42.9%)		0/4 (0%)		0/1 (0%)
RASH: ACNE/ACNEIFORM	7/17 (41.2%)		0/7 (0%)		2/4 (50%)		0/1 (0%)
RASH: DERMATITIS ASSOCIATED WITH RADIATION - RADIATION	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
RASH: ERYTHEMA MULTIFORME (E.G., STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS)	2/17 (11.8%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
RASH: HAND-FOOT SKIN REACTION	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
SKIN BREAKDOWN/DECUBITUS ULCER	1/17 (5.9%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
ULCERATION	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
Vascular disorders
HEMORRHAGE, CNS	0/17 (0%)		0/7 (0%)		0/4 (0%)		1/1 (100%)
HEMORRHAGE, GI - ABDOMEN NOS	4/17 (23.5%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
HEMORRHAGE, GI - ANUS	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
HEMORRHAGE, GI - LOWER GI NOS	2/17 (11.8%)		1/7 (14.3%)		1/4 (25%)		0/1 (0%)
HEMORRHAGE, GI - UPPER GI NOS	1/17 (5.9%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
HEMORRHAGE, GU - BLADDER	4/17 (23.5%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
HEMORRHAGE, GU - URINARY NOS	5/17 (29.4%)		3/7 (42.9%)		2/4 (50%)		0/1 (0%)
HEMORRHAGE, GU - VAGINA	4/17 (23.5%)		2/7 (28.6%)		0/4 (0%)		0/1 (0%)
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - BRONCHOPULMONARY NOS	0/17 (0%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - NOSE	5/17 (29.4%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
HEMORRHAGE/BLEEDING - OTHER	0/17 (0%)		1/7 (14.3%)		0/4 (0%)		0/1 (0%)
HYPERTENSION	6/17 (35.3%)		2/7 (28.6%)		0/4 (0%)		0/1 (0%)
HYPOTENSION	9/17 (52.9%)		3/7 (42.9%)		3/4 (75%)		0/1 (0%)
PERIPHERAL ARTERIAL ISCHEMIA	0/17 (0%)		0/7 (0%)		0/4 (0%)		1/1 (100%)
PULMONARY HYPERTENSION	1/17 (5.9%)		0/7 (0%)		0/4 (0%)		0/1 (0%)
VASCULAR - OTHER	2/17 (11.8%)		0/7 (0%)		1/4 (25%)		0/1 (0%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.