Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent Graft-Versus_Host Disease (GVHD) After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer

• Sponsor: Indiana University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT00975975
• Collaborator: (none)
• Enrollment: 17
• Location: 1
• Arm: 1
• Duration (Months): 50
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the effects (good and bad) of the medication basiliximab in combination with cyclosporine (investigational therapy) for the prevention of a complication of bone marrow transplantation known as graft-versus-host disease (GVHD). GVHD is a complication in which the cells of the transplanted bone marrow react against organs and tissues.

Condition or Disease	Intervention/Treatment	Phase
Acute Myelogenous Leukemia; Acute Lymphocytic Leukemia; Chronic Myelogenous Leukemia; Chronic Lymphocytic Leukemia; Myelodysplasia; Non-Hodgkin's Lymphoma; Hodgkin's Disease; Multiple Myeloma; Myelofibrosis; Anemia, Aplastic; Hemoglobinuria, Paroxysmal	Drug: Basiliximab	Phase 2

Detailed Description

This study is for patients with a blood condition or myelodysplasia (bone marrow disease) which has either not responded to treatment or is not treatable by conventional/routine medical treatments. Bone marrow transplantation is a medical treatment that involves giving high doses of chemotherapy followed by the transplantation of the blood-forming and immune cells from a relative or from a "matched" unrelated person through the National Marrow Donor Program, in an attempt to cure disease in the recipient (the person receiving the donated cells). Nonmyeloablative (bone-marrow preservation) bone marrow transplantation is a relatively new technique in which lower than usual doses of chemotherapy are given before transplantation, in hopes of reducing adverse side effects of the chemotherapy in transplant patients. Nonmyeloablative bone marrow transplantation has several advantages which doctors have determined are beneficial for this condition.

This research is being done because the complication of graft-versus-host disease can be bad for a person and there is no completely safe and effective way to prevent this complication. We know that cyclosporine helps but would like to know if the addition of basiliximab, given with cyclosporine, will decrease the incidence and/or severity of graft-versus-host disease after a transplant known as nonmyeloablative or "mini" transplant.

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent GVHD After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Basiliximab Basiliximab will be given by IV on Day +7 post transplant for recipients of matched unrelated cells. Basiliximab will be given by IV on Day +9 post transplant for recipients of matched related cells.	Drug: Basiliximab; Basiliximab given 1 time on Day +7 or Day +9.; Other Names: Simulect

Outcome Measures

Primary Outcome Measures

1. Grade 3-4 Acute GVHD Rate [Transplant (Day 0) up to 1 year]

   The percent of patients where a patient experienced a Grade 3 or 4 acute GVHD

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.

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. Patients who did not have platelet engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Acute myelogenous leukemia:

• Second or subsequent remission; patient over 18 yrs of age.

• Relapsed after autologous HC transplant, over 18 years of age.

• First remission, Philadelphia chromosome + over age 18.

• Secondary AML, in first or subsequent remissions.

• Acute lymphocytic leukemia:

• Philadelphia chromosome + over the age of 50, first or subsequent remission.

• Relapse following Autologous HC transplantation, ages over 50.

• Second or subsequent remission over the age of 50

• Chronic myelogenous leukemia:

• First or second chronic phase over the age of 18.

• Accelerated phase over the age of 18.

• Must have failed or been intolerant to a standard tyrosine kinase inhibitor.

• Chronic lymphocytic leukemia:

• Failed nucleoside-based therapy, ages >18.

• Myelodysplasia:

• All-risk categories, age greater than 18.

• Non-Hodgkin's Lymphoma, less than 76 years of age

• Relapsed diffuse aggressive NHL (intermediate and high grade) that fails to achieve CR or PR to conventional salvage chemotherapy.

• Aggressive NHL includes diffuse large B cell lymphoma, diffuse mixed small and large cell lymphoma, follicular lymphoma for grade 3 (follicular large cell lymphoma), T or B cell lymphoblastic lymphoma, diffuse small noncleaved (Burkett's or Burkett-like ) lymphoma, mantle cell lymphoma, peripheral T cell lymphoma, anaplastic large cell lymphoma, and other diffuse aggressive lymphomas that are not otherwise classifiable

• Aggressive NHL that has relapsed following autologous HCT. Patients that respond to additional treatment for post-transplant relapse are eligible.

• Aggressive NHL that does not achieve CR or PR with primary chemotherapy (i.e., primary induction failure).

• Low-grade lymphoma refractory to standard therapy, including the following:

1. small cell lymphocytic lymphoma,

2. follicular lymphoma of grades 1 and 2 (follicular small cleaved and follicular mixed small and large cell lymphoma)

3. marginal cell lymphoma, splenic lymphoma),

4. lymphoplasmacytic lymphoma and

5. other lymphomas not otherwise classifiable.

• Patients with low-grade lymphoma must have experienced progressive disease after receiving three or more of the following regimens:

• alkylator-based therapy (cyclophosphamide/ vincristine/ prednisone) chlorambucil, monoclonal antibody based therapy (e.g., rituximab, Campath-1H, radiolabelled CD20+ antibodies);

• nucleoside analog-based therapy (e.g., fludarabine, cladribine).)

• Patients with marginal zone lymphoma or gastric MALT type associated with Helicobacter pylori infection must have progressed after receiving appropriate antibiotic therapy as well as three or more regimens as described above

• Mantle cell, ages 18-75.

• Hodgkin's Disease, ages 18-75.

• Relapsed or refractory disease after autologous transplant.

• Multiple Myeloma, ages 18-75

• Recurrent disease after two medical therapies

• Relapse following autologous transplant

• Myelofibrosis, age greater than 18 years

• Severe aplastic anemia (refractory to immunosuppressive therapy); age greater than 18 years

• Patients with aplastic anemia must have marrow cellularity ≤ 10% plus 2 of the following:

1. Absolute granulocyte count <500/mm3

2. Corrected reticulocyte count <1%

3. Untransfused platelet count <20,000/mm3 on at least 2 occasions

4. Hemoglobin <9 g/dL (adults) or < 8 g/dL (children) on at least 2 occasions

• Paroxysmal nocturnal hemoglobinuria; age greater than 18 years.

• Renal function: creatinine greater than 2.5

• Donor Requirement:

• Must have a fully HLA-matched (10 of 10 Antigen matched) related or unrelated donor, eighteen years of age or older, who is capable of undergoing GCSF mobilization and apheresis

Exclusion Criteria:

• Active CNS disease (the presence of leukemic blasts in the CSF)

• Pregnancy or breast-feeding.

• Inability to give informed consent.

• AST, ALT, total bilirubin >3x upper limit of normal.

• Creatinine > 2 or creatinine clearance < 50mL/hr. If patient has a creatinine of > 2 or creatinine clearance < 50mL/hr and it is due to the disease process then the patient will not be excluded based on this.

• Fractional shortening by echocardiogram not within normal limits per institution or LVEF of < 40 %.

• Pulmonary function: DLCO not within institutional normal limits or DLCO less than 45% of normal predicted, corrected for anemia

• Prior allogeneic transplant.

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Indiana University School of Medicine

Investigators

• Principal Investigator: Robert Nelson, MD, Indiana University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Indiana University School of Medicine
• ClinicalTrials.gov Identifier: NCT00975975
• Other Study ID Numbers: 0908-04; IUCRO-0256
• First Posted: Sep 14, 2009
• Last Update Posted: Feb 26, 2016
• Last Verified: Jan 1, 2016

• Keywords provided by Indiana University School of Medicine: Paroxysmal nocturnal hemoglobinuria; severe aplastic anemia; Mantle cell
• Additional relevant MeSH terms: Leukemia; Multiple Myeloma; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Acute; Hodgkin Disease; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Hemoglobinuria; Anemia, Aplastic; Hemoglobinuria, Paroxysmal; Basiliximab

Study Results

Participant Flow

Recruitment Details	This protocol has 17 patients. The study was stopped prior to 20 due to the meeting of a stopping rule of 5 or more deaths within the first 15 patients. An additional patient was enrolled after the stopping rule was met. This patient was followed for safety/AE but is not included in the analysis of the efficacy measures, as recommended by the IRB.

Arm/Group Title	Overall
Arm/Group Description	Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
Period Title: Overall Study
STARTED	17
COMPLETED	11
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
Overall Participants	17
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.1 (7.05)
Sex: Female, Male (Count of Participants)
Female	8 47.1%
Male	9 52.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	17 100%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Grade 3-4 Acute GVHD Rate
Description	The percent of patients where a patient experienced a Grade 3 or 4 acute GVHD
Time Frame	Transplant (Day 0) up to 1 year

Outcome Measure Data

Analysis Population Description

All patients enrolled and received treatment

Arm/Group Title	Overall
Arm/Group Description	Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
Measure Participants	17
Number (95% Confidence Interval) [percentage of participants]	29.4 172.9%

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.
Time Frame	Transplant (Day 0) up to 1 year

Outcome Measure Data

Analysis Population Description

All patients enrolled and received treatment, excluding the patient who entered after the stopping rule was met.

Arm/Group Title	Overall
Arm/Group Description	Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
Measure Participants	16
Median (95% Confidence Interval) [days]	13.5

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. Patients who did not have platelet engraftment before death will be censored at the date of death. 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, excluding the patient who entered after the stopping rule was met.

Arm/Group Title	Overall
Arm/Group Description	Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
Measure Participants	16
Median (95% Confidence Interval) [days]	12.0

Adverse Events

Time Frame	From transplant until the end of the study, for up to 2 years
Arm/Group Title	Overall
Arm/Group Description	Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
All Cause Mortality
	Overall
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Overall
	Affected / at Risk (%)	# Events
Total	7/17 (41.2%)
Cardiac disorders
CARDIAC ARRHYTHMIA - OTHER	1/17 (5.9%)
CONDUCTION ABNORMALITY/ATRIOVENTRICULAR HEART BLOCK - ASYSTOLE	1/17 (5.9%)
Gastrointestinal disorders
DIARRHEA	2/17 (11.8%)
GASTROINTESTINAL - OTHER	1/17 (5.9%)
PAIN - ABDOMEN NOS	2/17 (11.8%)
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)	1/17 (5.9%)
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)	2/17 (11.8%)
Immune system disorders
ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)	1/17 (5.9%)
Infections and infestations
INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E	1/17 (5.9%)
INFECTION - OTHER	4/17 (23.5%)
INFECTION WITH UNKNOWN ANC - BLOOD	2/17 (11.8%)
INFECTION WITH UNKNOWN ANC - UPPER AIRWAY NOS	1/17 (5.9%)
Injury, poisoning and procedural complications
THROMBOSIS/EMBOLISM (VASCULAR ACCESS-RELATED)	1/17 (5.9%)
Investigations
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)	1/17 (5.9%)
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)	1/17 (5.9%)
CREATININE	2/17 (11.8%)
PLATELETS	1/17 (5.9%)
Metabolism and nutrition disorders
DEHYDRATION	1/17 (5.9%)
Nervous system disorders
PAIN - HEAD/HEADACHE	1/17 (5.9%)
Respiratory, thoracic and mediastinal disorders
ADULT RESPIRATORY DISTRESS SYNDROME (ARDS)	1/17 (5.9%)
HYPOXIA	2/17 (11.8%)
PULMONARY/UPPER RESPIRATORY - OTHER (SPECIFY, __)	1/17 (5.9%)
Skin and subcutaneous tissue disorders
RASH/DESQUAMATION	1/17 (5.9%)
Other (Not Including Serious) Adverse Events
	Overall
	Affected / at Risk (%)	# Events
Total	17/17 (100%)
Blood and lymphatic system disorders
HEMOLYSIS (E.G., IMMUNE HEMOLYTIC ANEMIA, DRUG-RELATED HEMOLYSIS)	3/17 (17.6%)
LYMPHATICS - OTHER	1/17 (5.9%)
PALPITATIONS	1/17 (5.9%)
PETECHIAE/PURPURA (HEMORRHAGE/BLEEDING INTO SKIN OR MUCOSA)	1/17 (5.9%)
Cardiac disorders
CARDIAC ARRHYTHMIA - OTHER	3/17 (17.6%)
CARDIAC GENERAL - OTHER	1/17 (5.9%)
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - ATRIAL FIBRILLATION	2/17 (11.8%)
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - ATRIAL TACHYCARDIA/PAROXYSMAL ATRIAL TACHYCARDIA	1/17 (5.9%)
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - SINUS BRADYCARDIA	3/17 (17.6%)
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - SINUS TACHYCARDIA	5/17 (29.4%)
VENTRICULAR ARRHYTHMIA - PVCS	1/17 (5.9%)
Ear and labyrinth disorders
AUDITORY/EAR - OTHER	2/17 (11.8%)
Endocrine disorders
ADRENAL INSUFFICIENCY	1/17 (5.9%)
Eye disorders
DRY EYE SYNDROME	1/17 (5.9%)
OCULAR/VISUAL - OTHER	1/17 (5.9%)
VISION-BLURRED VISION	2/17 (11.8%)
VITREOUS HEMORRHAGE	1/17 (5.9%)
Gastrointestinal disorders
CONSTIPATION	4/17 (23.5%)
DIARRHEA	14/17 (82.4%)
DISTENSION/BLOATING, ABDOMINAL	3/17 (17.6%)
DYSPHAGIA (DIFFICULTY SWALLOWING)	3/17 (17.6%)
ESOPHAGITIS	1/17 (5.9%)
FLATULENCE	1/17 (5.9%)
GASTROINTESTINAL - OTHER	2/17 (11.8%)
HEARTBURN/DYSPEPSIA	2/17 (11.8%)
HEMORRHOIDS	3/17 (17.6%)
ILEUS, GI (FUNCTIONAL OBSTRUCTION OF BOWEL, I.E., NEUROCONSTIPATION)	2/17 (11.8%)
NAUSEA	11/17 (64.7%)
PAIN - ABDOMEN NOS	6/17 (35.3%)
PAIN - DENTAL/TEETH/PERIDONTAL	2/17 (11.8%)
ULCER, GI - ESOPHAGUS	1/17 (5.9%)
VOMITING	10/17 (58.8%)
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)	3/17 (17.6%)
FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE	8/17 (47.1%)
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)	14/17 (82.4%)
HOT FLASHES/FLUSHES	1/17 (5.9%)
HYPOTHERMIA	1/17 (5.9%)
PAIN - OTHER	8/17 (47.1%)
RIGORS/CHILLS	4/17 (23.5%)
SWEATING (DIAPHORESIS)	3/17 (17.6%)
Hepatobiliary disorders
ASCITES (NON-MALIGNANT)	2/17 (11.8%)
BILIRUBIN (HYPERBILIRUBINEMIA)	14/17 (82.4%)
Immune system disorders
ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)	2/17 (11.8%)
ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)	2/17 (11.8%)
Infections and infestations
INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E	1/17 (5.9%)
INFECTION - OTHER	14/17 (82.4%)
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - BLOOD	1/17 (5.9%)
INFECTION WITH UNKNOWN ANC - BLOOD	2/17 (11.8%)
INFECTION WITH UNKNOWN ANC - COLON	1/17 (5.9%)
INFECTION WITH UNKNOWN ANC - LUNG (PNEUMONIA)	2/17 (11.8%)
INFECTION WITH UNKNOWN ANC - ORAL CAVITY-GUMS (GINGIVITIS)	1/17 (5.9%)
INFECTION WITH UNKNOWN ANC - SINUS	2/17 (11.8%)
INFECTION WITH UNKNOWN ANC - SKIN (CELLULITIS)	1/17 (5.9%)
INFECTION WITH UNKNOWN ANC - UPPER AIRWAY NOS	6/17 (35.3%)
INFECTION WITH UNKNOWN ANC - URINARY TRACT NOS	5/17 (29.4%)
Injury, poisoning and procedural complications
THROMBOSIS/EMBOLISM (VASCULAR ACCESS-RELATED)	1/17 (5.9%)
Investigations
ALKALINE PHOSPHATASE	12/17 (70.6%)
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)	14/17 (82.4%)
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)	14/17 (82.4%)
CREATININE	14/17 (82.4%)
IRON OVERLOAD	1/17 (5.9%)
MUCOSITIS/STOMATITIS (CLINICAL EXAM) - ORAL CAVITY	5/17 (29.4%)
Metabolism and nutrition disorders
ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)	7/17 (41.2%)
ANOREXIA	2/17 (11.8%)
CALCIUM, SERUM-HIGH (HYPERCALCEMIA)	1/17 (5.9%)
CALCIUM, SERUM-LOW (HYPOCALCEMIA)	4/17 (23.5%)
DEHYDRATION	1/17 (5.9%)
EDEMA: HEAD AND NECK	2/17 (11.8%)
EDEMA: LIMB	14/17 (82.4%)
EDEMA: TRUNK/GENITAL	1/17 (5.9%)
GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)	9/17 (52.9%)
GLUCOSE, SERUM-LOW (HYPOGLYCEMIA)	1/17 (5.9%)
MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)	6/17 (35.3%)
PHOSPHATE, SERUM-LOW (HYPOPHOSPHATEMIA)	3/17 (17.6%)
POTASSIUM, SERUM-HIGH (HYPERKALEMIA)	1/17 (5.9%)
POTASSIUM, SERUM-LOW (HYPOKALEMIA)	4/17 (23.5%)
SODIUM, SERUM-LOW (HYPONATREMIA)	4/17 (23.5%)
Musculoskeletal and connective tissue disorders
ARTHRITIS (NON-SEPTIC)	1/17 (5.9%)
JOINT-FUNCTION	1/17 (5.9%)
MUSCULOSKELETAL/SOFT TISSUE - OTHER	3/17 (17.6%)
OSTEOPOROSIS	1/17 (5.9%)
PAIN - BACK	4/17 (23.5%)
PAIN - BONE	3/17 (17.6%)
PAIN - EXTREMITY-LIMB	6/17 (35.3%)
PAIN - JOINT	4/17 (23.5%)
PAIN - MUSCLE	2/17 (11.8%)
PAIN - NECK	2/17 (11.8%)
Nervous system disorders
CONFUSION	3/17 (17.6%)
CONSTIPATION	1/17 (5.9%)
DIZZINESS	4/17 (23.5%)
ENCEPHALOPATHY	1/17 (5.9%)
INSOMNIA	3/17 (17.6%)
NEUROLOGY - OTHER	3/17 (17.6%)
NEUROPATHY: MOTOR	1/17 (5.9%)
NEUROPATHY: SENSORY	2/17 (11.8%)
PAIN - HEAD/HEADACHE	7/17 (41.2%)
SEIZURE	1/17 (5.9%)
TREMOR	7/17 (41.2%)
Psychiatric disorders
MOOD ALTERATION - ANXIETY	1/17 (5.9%)
MOOD ALTERATION - DEPRESSION	4/17 (23.5%)
PSYCHOSIS (HALLUCINATIONS/DELUSIONS)	2/17 (11.8%)
Renal and urinary disorders
BLADDER SPASMS	1/17 (5.9%)
PAIN - BLADDER	2/17 (11.8%)
RENAL FAILURE	2/17 (11.8%)
RENAL/GENITOURINARY - OTHER	3/17 (17.6%)
URINE COLOR CHANGE	1/17 (5.9%)
Reproductive system and breast disorders
SEXUAL/REPRODUCTIVE FUNCTION - OTHER	1/17 (5.9%)
VAGINAL DRYNESS	1/17 (5.9%)
Respiratory, thoracic and mediastinal disorders
APNEA	1/17 (5.9%)
ASPIRATION	1/17 (5.9%)
BRONCHOSPASM, WHEEZING	2/17 (11.8%)
COUGH	9/17 (52.9%)
DYSPNEA (SHORTNESS OF BREATH)	12/17 (70.6%)
HICCOUGHS (HICCUPS, SINGULTUS)	3/17 (17.6%)
HYPOXIA	9/17 (52.9%)
PAIN - CHEST WALL	3/17 (17.6%)
PAIN - CHEST/THORAX NOS	1/17 (5.9%)
PAIN - THROAT/PHARYNX/LARYNX	3/17 (17.6%)
PLEURAL EFFUSION (NON-MALIGNANT)	5/17 (29.4%)
PULMONARY/UPPER RESPIRATORY - OTHER	3/17 (17.6%)
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN - OTHER	3/17 (17.6%)
HAIR LOSS/ALOPECIA (SCALP OR BODY)	2/17 (11.8%)
PRURITUS/ITCHING	5/17 (29.4%)
RASH/DESQUAMATION	11/17 (64.7%)
RASH: ACNE/ACNEIFORM	3/17 (17.6%)
SKIN BREAKDOWN/DECUBITUS ULCER	2/17 (11.8%)
Vascular disorders
HEMORRHAGE, GI - LOWER GI NOS	3/17 (17.6%)
HEMORRHAGE, GI - VARICES (RECTAL)	1/17 (5.9%)
HEMORRHAGE, GU - BLADDER	1/17 (5.9%)
HEMORRHAGE, GU - URINARY NOS	2/17 (11.8%)
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - NOSE	2/17 (11.8%)
HEMORRHAGE/BLEEDING - OTHER	3/17 (17.6%)
HYPERTENSION	5/17 (29.4%)
HYPOTENSION	5/17 (29.4%)
THROMBOSIS/THROMBUS/EMBOLISM	1/17 (5.9%)

Limitations/Caveats

[Not Specified]

More Information

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.