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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Basiliximab | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Basiliximab | Drug | Basiliximab given 1 time on Day +7 or Day +9. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Grade 3-4 Acute GVHD Rate | The percent of patients where a patient experienced a Grade 3 or 4 acute GVHD | Transplant (Day 0) up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Neutrophil Engraftment | 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. |
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Inclusion Criteria:
Acute myelogenous leukemia:
Acute lymphocytic leukemia:
Chronic myelogenous leukemia:
Chronic lymphocytic leukemia:
Myelodysplasia:
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:
Patients with low-grade lymphoma must have experienced progressive disease after receiving three or more of the following regimens:
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.
Multiple Myeloma, ages 18-75
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:
Paroxysmal nocturnal hemoglobinuria; age greater than 18 years.
Donor Requirement:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Nelson, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Cancer Center | Indianapolis | Indiana | 46202 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Transplant (Day 0) up to 1 year |
| Time to Platelet Engraftment | 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. | Transplant (Day 0) up to 1 year |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Grade 3-4 Acute GVHD Rate | The percent of patients where a patient experienced a Grade 3 or 4 acute GVHD | All patients enrolled and received treatment | Posted | Number | 95% Confidence Interval | percentage of participants | Transplant (Day 0) up to 1 year |
|
|
| |||||||||||||||||||||||||
| Secondary | Time to Neutrophil Engraftment | 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. | All patients enrolled and received treatment, excluding the patient who entered after the stopping rule was met. | Posted | Median | 95% Confidence Interval | days | Transplant (Day 0) up to 1 year |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Platelet Engraftment | 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. | All patients enrolled and received treatment, excluding the patient who entered after the stopping rule was met. | Posted | Median | 95% Confidence Interval | days | Transplant (Day 0) up to 1 year |
|
|
From transplant until the end of the study, for up to 2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Overall | 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 | 7 | 17 | 17 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CARDIAC ARRHYTHMIA - OTHER | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| CONDUCTION ABNORMALITY/ATRIOVENTRICULAR HEART BLOCK - ASYSTOLE | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| DIARRHEA | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| GASTROINTESTINAL - OTHER | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| PAIN - ABDOMEN NOS | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| FATIGUE (ASTHENIA, LETHARGY, MALAISE) | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L) | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER) | Immune system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| INFECTION - OTHER | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| INFECTION WITH UNKNOWN ANC - BLOOD | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| INFECTION WITH UNKNOWN ANC - UPPER AIRWAY NOS | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| THROMBOSIS/EMBOLISM (VASCULAR ACCESS-RELATED) | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE) | Investigations | MedDRA (9.0) | Non-systematic Assessment |
| |
| AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE) | Investigations | MedDRA (9.0) | Non-systematic Assessment |
| |
| CREATININE | Investigations | MedDRA (9.0) | Non-systematic Assessment |
| |
| PLATELETS | Investigations | MedDRA (9.0) | Non-systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| PAIN - HEAD/HEADACHE | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| ADULT RESPIRATORY DISTRESS SYNDROME (ARDS) | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| PULMONARY/UPPER RESPIRATORY - OTHER (SPECIFY, __) | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| RASH/DESQUAMATION | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HEMOLYSIS (E.G., IMMUNE HEMOLYTIC ANEMIA, DRUG-RELATED HEMOLYSIS) | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| LYMPHATICS - OTHER | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| PALPITATIONS | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| PETECHIAE/PURPURA (HEMORRHAGE/BLEEDING INTO SKIN OR MUCOSA) | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| CARDIAC ARRHYTHMIA - OTHER | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| CARDIAC GENERAL - OTHER | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - ATRIAL FIBRILLATION | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - ATRIAL TACHYCARDIA/PAROXYSMAL ATRIAL TACHYCARDIA | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - SINUS BRADYCARDIA | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - SINUS TACHYCARDIA | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| VENTRICULAR ARRHYTHMIA - PVCS | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| AUDITORY/EAR - OTHER | Ear and labyrinth disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| ADRENAL INSUFFICIENCY | Endocrine disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| DRY EYE SYNDROME | Eye disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| OCULAR/VISUAL - OTHER | Eye disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| VISION-BLURRED VISION | Eye disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| VITREOUS HEMORRHAGE | Eye disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| DIARRHEA | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| DISTENSION/BLOATING, ABDOMINAL | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| DYSPHAGIA (DIFFICULTY SWALLOWING) | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| ESOPHAGITIS | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| FLATULENCE | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| GASTROINTESTINAL - OTHER | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| HEARTBURN/DYSPEPSIA | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| HEMORRHOIDS | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| ILEUS, GI (FUNCTIONAL OBSTRUCTION OF BOWEL, I.E., NEUROCONSTIPATION) | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| PAIN - ABDOMEN NOS | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| PAIN - DENTAL/TEETH/PERIDONTAL | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| ULCER, GI - ESOPHAGUS | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| FATIGUE (ASTHENIA, LETHARGY, MALAISE) | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L) | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| HOT FLASHES/FLUSHES | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| HYPOTHERMIA | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| PAIN - OTHER | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| RIGORS/CHILLS | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| SWEATING (DIAPHORESIS) | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| ASCITES (NON-MALIGNANT) | Hepatobiliary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| BILIRUBIN (HYPERBILIRUBINEMIA) | Hepatobiliary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER) | Immune system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP) | Immune system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| INFECTION - OTHER | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - BLOOD | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| INFECTION WITH UNKNOWN ANC - BLOOD | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| INFECTION WITH UNKNOWN ANC - COLON | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| INFECTION WITH UNKNOWN ANC - LUNG (PNEUMONIA) | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| INFECTION WITH UNKNOWN ANC - ORAL CAVITY-GUMS (GINGIVITIS) | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| INFECTION WITH UNKNOWN ANC - SINUS | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| INFECTION WITH UNKNOWN ANC - SKIN (CELLULITIS) | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| INFECTION WITH UNKNOWN ANC - UPPER AIRWAY NOS | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| INFECTION WITH UNKNOWN ANC - URINARY TRACT NOS | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| THROMBOSIS/EMBOLISM (VASCULAR ACCESS-RELATED) | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| ALKALINE PHOSPHATASE | Investigations | MedDRA (9.0) | Non-systematic Assessment |
| |
| ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE) | Investigations | MedDRA (9.0) | Non-systematic Assessment |
| |
| AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE) | Investigations | MedDRA (9.0) | Non-systematic Assessment |
| |
| CREATININE | Investigations | MedDRA (9.0) | Non-systematic Assessment |
| |
| IRON OVERLOAD | Investigations | MedDRA (9.0) | Non-systematic Assessment |
| |
| MUCOSITIS/STOMATITIS (CLINICAL EXAM) - ORAL CAVITY | Investigations | MedDRA (9.0) | Non-systematic Assessment |
| |
| ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA) | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| ANOREXIA | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| CALCIUM, SERUM-HIGH (HYPERCALCEMIA) | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| CALCIUM, SERUM-LOW (HYPOCALCEMIA) | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| EDEMA: HEAD AND NECK | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| EDEMA: LIMB | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| EDEMA: TRUNK/GENITAL | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA) | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| GLUCOSE, SERUM-LOW (HYPOGLYCEMIA) | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA) | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| PHOSPHATE, SERUM-LOW (HYPOPHOSPHATEMIA) | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| POTASSIUM, SERUM-HIGH (HYPERKALEMIA) | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| POTASSIUM, SERUM-LOW (HYPOKALEMIA) | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| SODIUM, SERUM-LOW (HYPONATREMIA) | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| ARTHRITIS (NON-SEPTIC) | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| JOINT-FUNCTION | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| MUSCULOSKELETAL/SOFT TISSUE - OTHER | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| OSTEOPOROSIS | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| PAIN - BACK | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| PAIN - BONE | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| PAIN - EXTREMITY-LIMB | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| PAIN - JOINT | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| PAIN - MUSCLE | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| PAIN - NECK | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| CONFUSION | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| CONSTIPATION | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| ENCEPHALOPATHY | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| INSOMNIA | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| NEUROLOGY - OTHER | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| NEUROPATHY: MOTOR | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| NEUROPATHY: SENSORY | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| PAIN - HEAD/HEADACHE | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| SEIZURE | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| TREMOR | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| MOOD ALTERATION - ANXIETY | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| MOOD ALTERATION - DEPRESSION | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| PSYCHOSIS (HALLUCINATIONS/DELUSIONS) | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| BLADDER SPASMS | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| PAIN - BLADDER | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| RENAL/GENITOURINARY - OTHER | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| URINE COLOR CHANGE | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| SEXUAL/REPRODUCTIVE FUNCTION - OTHER | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| VAGINAL DRYNESS | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| APNEA | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| BRONCHOSPASM, WHEEZING | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| DYSPNEA (SHORTNESS OF BREATH) | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| HICCOUGHS (HICCUPS, SINGULTUS) | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| PAIN - CHEST WALL | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| PAIN - CHEST/THORAX NOS | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| PAIN - THROAT/PHARYNX/LARYNX | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| PLEURAL EFFUSION (NON-MALIGNANT) | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| PULMONARY/UPPER RESPIRATORY - OTHER | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| DERMATOLOGY/SKIN - OTHER | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| HAIR LOSS/ALOPECIA (SCALP OR BODY) | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| PRURITUS/ITCHING | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| RASH/DESQUAMATION | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| RASH: ACNE/ACNEIFORM | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| SKIN BREAKDOWN/DECUBITUS ULCER | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| HEMORRHAGE, GI - LOWER GI NOS | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| HEMORRHAGE, GI - VARICES (RECTAL) | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| HEMORRHAGE, GU - BLADDER | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| HEMORRHAGE, GU - URINARY NOS | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - NOSE | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| HEMORRHAGE/BLEEDING - OTHER | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| THROMBOSIS/THROMBUS/EMBOLISM | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Nelson | IndianaU | 317-944-0920 | ronelson@iu.edu |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D000754 | Anemia, Refractory, with Excess of Blasts |
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| D009101 | Multiple Myeloma |
| D055728 | Primary Myelofibrosis |
| D000741 | Anemia, Aplastic |
| D006457 | Hemoglobinuria, Paroxysmal |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015448 | Leukemia, B-Cell |
| D000753 | Anemia, Refractory |
| D000740 | Anemia |
| D009190 | Myelodysplastic Syndromes |
| D008223 | Lymphoma |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D000080983 | Bone Marrow Failure Disorders |
| D000743 | Anemia, Hemolytic |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077552 | Basiliximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|