Metastatic Melanoma, Skin Cancer
Conditions
Keywords
Young TIL, Metastatic Melanoma, Immunotherapy, Adoptive Cell Therapy, Skin Cancer
Brief summary
Background: \- An experimental treatment for metastatic melanoma involves cell therapy, in which researchers take white blood cells (lymphocytes) from the tumor tissue, grow them in the laboratory in large numbers, and then use the cells to attack the tumor tissue. Before receiving the cells, chemotherapy is needed to temporarily suppress the immune system to improve the chances that the tumor-fighting cells will be able to survive in the body. In some studies of cell therapy, individuals who have received total body irradiation (TBI) in addition to the chemotherapy (in order to increase the length of time that they do not produce white blood cells) seem to have a slightly better response to the treatment, but it is not known if adding radiation to the cell therapy will cause a better response for all individuals. Researchers are interested in comparing cell therapy given with the usual chemotherapy to cell therapy given with the usual chemotherapy and TBI. Objectives: \- To compare the effectiveness of cell therapy given with chemotherapy to cell therapy given with chemotherapy and total body irradiation in individuals with metastatic melanoma. Eligibility: \- Individuals at least 18 years of age who have been diagnosed with metastatic melanoma. Design: * Participants will be screened with a physical examination, medical history, blood tests, and tumor imaging studies. * Participants will be divided into two groups: cell therapy with chemotherapy alone (group 1) or cell therapy with chemotherapy plus TBI (group 2). * All participants will provide a tumor sample from either surgery or a tumor biopsy for white blood cell collection. * Participants will have leukapheresis to collect additional white blood cells for cell growth and future testing, and TBI group participants will also provide stem cells to help them recover after radiation. (TBI participants who cannot provide enough stem cells will be moved to the non-radiation treatment group.) * Participants will have chemotherapy with cyclophosphamide (two treatments over 2 days) and fludarabine (five treatments over 5 days) starting 7 days before the cell therapy. Participants in the TBI group will also have TBI for the 3 days immediately before the cell therapy. * All participants will receive the white blood cells, followed by high dose aldesleukin every 8 hours for up to 5 days after the cell infusion to help keep the therapy cells alive and active. Participants will also have injections of filgrastim to stimulate blood cell production, and participants in the TBI group will also receive their stem cells. * Participants will take an antibiotic for at least 6 months after treatment to prevent pneumonia and will be asked to return for regular monitoring and follow-up visits for at least 5 years to evaluate the tumors response to treatment.
Detailed description
Background: * Adoptive cell therapy (ACT) using autologous tumor infiltrating lymphocytes can mediate the regression of bulky metastatic melanoma when administered along with high-dose aldesleukin (IL-2) following a non-myeloablative lymphodepleting chemotherapy preparative regimen consisting of cyclophosphamide and fludarabine. * In a series of consecutive trials using this chemotherapy preparative regimen alone or with 2 Gray (Gy) or 12 Gy total body irradiation (TBI) objective response rates using Response Evaluation Criteria in Solid Tumors (RECIST) criteria were 49%, 52%, and 72%, respectively. Complete regression rates in these three consecutive trials were 12%, 20%, and 40%, respectively strongly suggesting that the addition of TBI could improve the complete regression rate. Of the 20 complete regressions seen in this trial, 19 are on-going at 37 to 82 months. * Because of the complexity of developing selected TIL for use in adoptive transfer, we have recently developed a simplified method for producing TIL that is more applicable to use in outside institutions. Utilizing young TIL cells (sometimes with cluster of differentiation 8 (CD8) purification) in 105 patients, the objective response rate was 34% with a 6.6 % incidence of complete regressions. All patients in this trial received the cyclophosphamide fludarabine regimen alone. * Because of the strong suggestion that the addition of TBI to the chemotherapy regimen could increase durable, complete regression rates in patients with metastatic melanoma, we are now attempting to definitively determine whether the addition of TBI to the chemotherapy preparative regimen can improve complete response rates, and overall survival in patients receiving young TIL. Objectives: -To determine, in a prospective randomized trial, the complete response rate and survival of patients with metastatic melanoma receiving adoptive cell transfer (ACT) using young TIL plus aldesleukin treatment following either a chemotherapy preparative regimen alone, or the same chemotherapy preparative regimen plus TBI. Eligibility: -Patients who are 18 years or older must have: * Evaluable metastatic melanoma; * Metastatic melanoma lesion suitable for surgical resection for the preparation of TIL; * No contraindications to high dose aldesleukin administration or total body irradiation; * No concurrent major medical illnesses or any form of immunodeficiency Design: -Patients with metastatic melanoma will have lesions resected and after TIL growth is established patients with will be prospectively randomized to receive ACT with young TIL plus aldesleukin following either a non-myeloablative chemotherapy preparative regimen or this same regimen plus TBI.
Interventions
DRUGAldesleukin
Arm 1 and Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
DRUGCyclophosphamide
Arm 1 and Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
DRUGFludarabine
Arm 1 and Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
BIOLOGICALYoung TIL
Arm 1 and Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
RADIATIONTotal Body Irradiation (TBI)
Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology.
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 66 Years
Healthy volunteers
No
Inclusion criteria
* INCLUSION CRITERIA: 1. Measurable metastatic melanoma with at least one lesion that is resectable for tumor infiltrating lymphocytes (TIL) generation. The lesion must be of at least 1cm in diameter that can be surgically removed with minimal morbidity (defined as any operation for which expected hospitalization less than or equal to 7 days). 2. Patients with 3 or less brain metastases are eligible. Note: If lesions are symptomatic or greater than or equal to 1 cm each, these lesions must have been treated and stable for 3 months for the patient to be eligible. 3. Greater than or equal to 18 years of age and less than or equal to 66 years of age. 4. Willing to practice birth control during treatment and for four months after receiving all protocol related therapy. 5. Life expectancy of greater than three months 6. Willing to sign a durable power of attorney. 7. Able to understand and sign the Informed Consent Document 8. Clinical performance status of eastern Cooperative Oncology Group (ECOG) 0 or 1. 9. Hematology: * Absolute neutrophil count greater than 1000/mm(3) * Hemoglobin greater than 8.0 g/dl * Platelet count greater than 100,000/mm(3) j. Serology: * Seronegative for human immunodeficiency virus (HIV) antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities.) * Seronegative for hepatitis B antigen, or hepatitis C antibody or antigen. k. Chemistry: * Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less than three times the upper limit of normal. * Calculated creatinine clearance (eGFR) \> 50 ml/min. * Total bilirubin less than or equal to 2 mg/dl, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3 mg/dl. l. More than four weeks must have elapsed since any prior systemic therapy at the time of randomization, and patient's toxicities must have recovered to a grade 1 or less (except for alopecia or vitiligo). Patients must have stable or progressing disease after prior treatment. Note: Patients may have undergone minor surgical procedures within the past 3 weeks, as long as all toxicities have recovered to grade 1 or less or as specified in the inclusion criteria. m. Six weeks must have elapsed since any prior anti-cytotoxic T-lymphocyte associated protein 4 (CTLA4) antibody therapy to allow antibody levels to decline. Note: Patients who have previously received ipilimumab or tremelimumab, anti-programmed cell death protein 1 (PD1) or anti-programmed cell death ligand 1 (PD-L1) antibodies and have documented gastrointestinal (GI) toxicity must have a normal colonoscopy with normal colonic biopsies.
Exclusion criteria
1. Prior cell transfer therapy which included a non-myeloablative or myeloablative chemotherapy regimen. 2. Women of child-bearing potential who are pregnant or breastfeeding because 10 of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. 3. Systemic steroid therapy requirement. 4. Active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease. 5. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and acquired immunodeficiency syndrome (AIDS). 6. Opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities.) 7. History of severe immediate hypersensitivity reaction to any of the agents used in this study. 8. History of coronary revascularization or ischemic symptoms. 9. Any patient known to have a left ventricular ejection fraction (LVEF) less than or equal to 45%. 10. In patients \> 60 years old, documented LVEF of less than or equal to 45%. 11. Documented forced expiratory volume in one second (FEV1) less than or equal to 60% predicted tested in patients with: * A prolonged history of cigarette smoking (20 pk/year of smoking within the past 2 years) * Symptoms of respiratory dysfunction 12. Prior radiation therapy that, in the judgment of the radiation oncologist, precludes the administration of total body irradiation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression) | Participants were followed from treatment to progression of disease or until principal investigator (PI) discretion (average 91.8 months). | Percentage of participants who have a clinical response to treatment (objective tumor regression) was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete Response (CR) is disappearance of all target lesions. Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as refence the baseline sum LD. Progressive Disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD. The appearance of one or more new lesions is also considered progressions. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD. |
| Overall Survival (OS) | Participants were followed from treatment until death (median 14 months) or until principal investigator (PI) discretion (median 99.0 months) for participants alive at study closure. | OS is defined as the time to death following the start of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) | Participants were followed from treatment until death or until principal investigator (PI) discretion. A median of 91.8 months. | PFS is defined as time to disease progression following the start of treatment. Disease progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v3.0. Progressive Disease is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD. The appearance of one or more new lesions is also considered progression. |
| Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Time of registration through 6 years after the last treatment. | Here is the number of Grades 2, 3, 4, and/or 5 serious adverse events possibly and/or probably related to treatment. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event. |
| Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | 30 days after end of treatment, up to 6 years | Here is the number of Grades 1, 2, 3, 4, and/or 5 non-serious adverse events possibly and/or probably related to treatment. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0) | Participants will be followed for adverse events from registration through 30 days after the last treatment, up to 6 years | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin
Aldesleukin: Arm 1 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 1 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 1 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 1 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes. | 51 |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young tumor infiltrating lymphocytes (TIL) + high dose aldesleukin + total body irradiation (TBI)
Aldesleukin: Arm 2 - Days 1 to 4: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) for up to 5 days (maximum 15 doses).
Cyclophosphamide: Arm 2 - Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 mL dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Fludarabine: Arm 2 - Days -7 to -3: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 15-30 minutes for 5 days.
Young TIL: Arm 2 - Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Total Body Irradiation (TBI): Arm 2 - Days -3 to -1: Ondansetron 0.15 mg/kg intravenous (IV) x 1 dose pre-total body irradiation (TBI). Patients will then receive 2 Gray (Gy) TBI twice a day for 3 days (total dose 12 Gy using a linear accelerator in Radiation Oncology. | 50 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Not treated: Rapid disease progression prior to start | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 50 Participants | 100 Participants |
| Age, Continuous | 47.1 years | 46.0 years | 47.0 years |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Ethnicity Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 49 Participants | 50 Participants | 99 Participants |
| Race/Ethnicity, Customized Race Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 46 Participants | 50 Participants | 96 Participants |
| Region of Enrollment United States | 50 participants | 51 participants | 101 participants |
| Sex: Female, Male Female | 20 Participants | 17 Participants | 37 Participants |
| Sex: Female, Male Male | 30 Participants | 34 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 23 / 51 | 23 / 50 |
| other Total, other adverse events | 51 / 51 | 48 / 48 |
| serious Total, serious adverse events | 2 / 51 | 17 / 48 |
Outcome results
Primary
Overall Survival (OS)
OS is defined as the time to death following the start of treatment.
Time frame: Participants were followed from treatment until death (median 14 months) or until principal investigator (PI) discretion (median 99.0 months) for participants alive at study closure.
Population: 99/102 participants were analyzed. Two participants were enrolled and not treated due to rapid disease progression prior to start of treatment (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Overall Survival (OS) | 36.2 Months |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Overall Survival (OS) | 37.3 Months |
Primary
Percentage of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression)
Percentage of participants who have a clinical response to treatment (objective tumor regression) was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete Response (CR) is disappearance of all target lesions. Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as refence the baseline sum LD. Progressive Disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD. The appearance of one or more new lesions is also considered progressions. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD.
Time frame: Participants were followed from treatment to progression of disease or until principal investigator (PI) discretion (average 91.8 months).
Population: 99/102 participants were analyzed. Two participants were not treated due to rapidly progressive disease after enrollment but before treatment. One participant on Arm 1X is not reported for privacy concerns (n=1).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Percentage of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression) | Partial Response | 19.6 Percentage of participants |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Percentage of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression) | Complete Response | 27.5 Percentage of participants |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Percentage of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression) | Progressive Disease | 52.9 Percentage of participants |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Percentage of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression) | Stable Disease | 0 Percentage of participants |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Percentage of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression) | Progressive Disease | 35.4 Percentage of participants |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Percentage of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression) | Complete Response | 27.1 Percentage of participants |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Percentage of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression) | Stable Disease | 0 Percentage of participants |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Percentage of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression) | Partial Response | 37.5 Percentage of participants |
Secondary
Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment
Here is the number of Grades 1, 2, 3, 4, and/or 5 non-serious adverse events possibly and/or probably related to treatment. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.
Time frame: 30 days after end of treatment, up to 6 years
Population: 99/102 participants were analyzed. Two participants were enrolled and not treated due to disease progression prior to start of treatment (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Febrile neutropenia | 1 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - PTT (Partial Thromboplastin Time) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Hemoglobin | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Rash/desquamation | 1 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Anorexia | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Mucositis/stomatitis (clinical exam)::Oral cavity | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Ocular/Visual - Other, Specify (Corneal Edema, OU) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Chest/thorax NOS | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Fatigue (asthenia, lethargy, malaise) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - AST, SGOT(serum glutamic oxaloacetic transaminase) | 1 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Albumin, serum-low (hypoalbuminemia) | 1 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Psychosis (hallucinations/delusions) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Confusion | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Edema: head and neck | 1 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Fatigue (asthenia, lethargy, malaise) | 2 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Rash/desquamation | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Acute vascular leak syndrome | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Rigors/chills | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Hemorrhage, GI::Ileum | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Leukocytes (total WBC) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Dyspnea (shortness of breath) | 1 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Rash/desquamation | 2 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Dyspnea (shortness of breath) | 9 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Lymphopenia | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Acute vascular leak syndrome | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 - possibly related - hypopigmentation | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Hemoglobin | 12 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Leukocytes (total WBC) | 1 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 Pain::Chest wall | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Dry mouth/salivary gland (xerostomia) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Supraventricular and nodal arrhythmia::Atrial fibrillation | 1 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Infection (documented clinically or microbiologically)..Blood | 1 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Renal failure | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Syncope (fainting) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Neutrophils/granulocytes (ANC/AGC) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Head/headache | 3 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Mental status | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Dry mouth/salivary gland (xerostomia) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Renal/Genitourinary - Other (Specify, Oliguria) | 1 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Mood alteration::Agitation | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Thrombotic microangiopathy | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Renal failure | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Diarrhea | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - AST, SGOT(serum glutamic oxaloacetic transaminase) | 1 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Hemorrhage, GU:: Bladder | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Fever | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Muscle | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Supraventricular and nodal arrhythmia::Atrial fibrillation | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Potassium, serum-low (hypokalemia) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Mucositis/stomatitis (clinical exam)::Oral cavity | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Bilirubin (hyperbilirubinemia) | 1 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Retinopathy | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Creatinine | 1 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Fever | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Pain NOS | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Colitis, infectious (e.g., Clostridium difficile) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Rigors/chills | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Neutrophils/granulocytes (ANC/AGC) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Supraventricular and nodal arrhythmia::Atrial fibrillation | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Rigors/chills | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils Urinary tract NOS | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Acute vascular leak syndrome | 1 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Calcium, serum low (hypocalcemia) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Sodium, serum-low (hyponatremia) | 1 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Confusion | 4 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Cardiac troponin I (cTnl) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Abdomen NOS | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Neutrophils/granulocytes (ANC/AGC) | 1 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Renal/Genitourinary - Other (Specify, Lower urine output) | 1 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 Fatigue (asthenia, lethargy, malaise) | 1 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | 1 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Calcium, serum low (hypocalcemia) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Hypopigmentation | 1 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Syncope (fainting) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Hypoxia | 10 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Pain::Abdomen NOS | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Trachea | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Phosphate, serum-low (hypophosphatemia) | 4 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Creatinine | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Phosphate, serum-low (hypophosphatemia) | 1 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably relatedRenal/Genitourinary-Other (Low urine output(nonoliguric renal insufficiency) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Nausea | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Supraventricular and nodal arrhythmia::Sinus tachycardia | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Lymphopenia | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Platelets | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Albumin, serum-low (hypoalbuminemia) | 1 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Creatinine | 1 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 possibly related - Hypopigmentation | 2 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Hypoxia | 1 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Vomiting | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pleural effusion | 1 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Lymphopenia | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Trachea | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pneumonitis/pulmonary infiltrates | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Nausea | 1 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Diarrhea | 1 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Acidosis (metabolic or respiratory) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Vomiting | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Platelets | 1 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Hypotension | 2 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Renal/Genitourinary - Other (Specify, Lower urine output) | 2 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Dry mouth/salivary gland (xerostomia) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related- Infection (documented clinically or microbiologically)...Urinary tract NOS | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Neuropathy:sensory | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Pneumonitis/pulmonary infiltrates | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Alkaline phosphatase | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Lymphopenia | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Hypotension | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Potassium, serum-low (hypokalemia) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Dyspnea (shortness of breath) | 1 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Mood alteration::Agitation | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 possibly related - Diarrhea | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Somnolence/depressed level of consciousness | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Febrile neutropenia | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Potassium, serum-low (hypokalemia) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Joint | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Dyspnea (shortness of breath) | 13 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Infection (documented clinically or microbiologically)...Blood | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - ALT, SGPT (serum glutamic pyruvic transaminase) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Leukocytes (total WBC) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Calcium, serum-low (hypocalcemia) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Hemorrhage, GI::Ileum | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Uveitis | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Calcium, serum-low (hypocalcemia) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Fatigue | 1 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Mental status | 1 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Psychosis | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - ALT, SGPT (serum glutamic pyruvic transaminase) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Platelets | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Leukocytes (total WBC) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Bilirubin (hyperbilirubinemia) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Supraventricular and nodal arrhythmia::Sinus bradycardia | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 - probably related - hypopigmentation | 4 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Pain::Bladder | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Hypotension | 7 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Neutrophils/granulocytes (ANC/AGC) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - PTT (Partial Thromboplastin Time) | 1 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Vision-blurred vision | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Phosphate, serum-low (hypophosphatemia) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Febrile neutropenia | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Hypoxia | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Somnolence/depressed level of consciousness | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 possibly related - Hypopigmentation | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Mucositis/stomatitis (clinical exam)::Oral cavity | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Acute vascular leak syndrome | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Mucositis/stomatitis (clinical exam)::Oral cavity | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related- Infection (documented clinically or microbiologically)...Urinary tract NOS | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Mental status | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Supraventricular and nodal arrhythmia::Atrial fibrillation | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Confusion | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Lymphopenia | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Acidosis (metabolic or respiratory) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Lymphopenia | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Leukocytes (total WBC) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Vision-blurred vision | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Leukocytes (total WBC) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Uveitis | 1 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Leukocytes (total WBC) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Platelets | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Syncope (fainting) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Syncope (fainting) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Confusion | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably relatedRenal/Genitourinary-Other (Low urine output(nonoliguric renal insufficiency) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Trachea | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Creatinine | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Supraventricular and nodal arrhythmia::Sinus tachycardia | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Supraventricular and nodal arrhythmia::Sinus bradycardia | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Creatinine | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Platelets | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Trachea | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Diarrhea | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Dry mouth/salivary gland (xerostomia) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Hypotension | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Dyspnea (shortness of breath) | 1 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Febrile neutropenia | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Calcium, serum-low (hypocalcemia) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 possibly related - Diarrhea | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Calcium, serum-low (hypocalcemia) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Fatigue | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Bilirubin (hyperbilirubinemia) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 - probably related - hypopigmentation | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Hypotension | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Phosphate, serum-low (hypophosphatemia) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Fatigue (asthenia, lethargy, malaise) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Fatigue (asthenia, lethargy, malaise) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Ocular/Visual - Other, Specify (Corneal Edema, OU) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Edema: head and neck | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Psychosis (hallucinations/delusions) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Febrile neutropenia | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Hemorrhage, GI::Ileum | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Neutrophils/granulocytes (ANC/AGC) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Dry mouth/salivary gland (xerostomia) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Renal failure | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Supraventricular and nodal arrhythmia::Atrial fibrillation | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Thrombotic microangiopathy | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Dry mouth/salivary gland (xerostomia) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Diarrhea | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils Urinary tract NOS | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Mood alteration::Agitation | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Creatinine | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Potassium, serum-low (hypokalemia) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Colitis, infectious (e.g., Clostridium difficile) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Supraventricular and nodal arrhythmia::Atrial fibrillation | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Febrile neutropenia | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Cardiac troponin I (cTnl) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Neutrophils/granulocytes (ANC/AGC) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Sodium, serum-low (hyponatremia) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Calcium, serum low (hypocalcemia) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Hypopigmentation | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 Pain::Chest wall | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Renal/Genitourinary - Other (Specify, Lower urine output) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Calcium, serum low (hypocalcemia) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Acute vascular leak syndrome | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Rigors/chills | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Rigors/chills | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Retinopathy | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Fever | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Bilirubin (hyperbilirubinemia) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Fever | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Lymphopenia | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - AST, SGOT(serum glutamic oxaloacetic transaminase) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Hemorrhage, GU:: Bladder | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Renal/Genitourinary - Other (Specify, Oliguria) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Renal failure | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 - possibly related - hypopigmentation | 1 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Hemoglobin | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Rash/desquamation | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - AST, SGOT(serum glutamic oxaloacetic transaminase) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Anorexia | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Rash/desquamation | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Hemoglobin | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - PTT (Partial Thromboplastin Time) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Hypoxia | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - PTT (Partial Thromboplastin Time) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - ALT, SGPT (serum glutamic pyruvic transaminase) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Psychosis | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Hemorrhage, GI::Ileum | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Mental status | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Potassium, serum-low (hypokalemia) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - ALT, SGPT (serum glutamic pyruvic transaminase) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Mood alteration::Agitation | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Potassium, serum-low (hypokalemia) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Vomiting | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Alkaline phosphatase | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Pneumonitis/pulmonary infiltrates | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pneumonitis/pulmonary infiltrates | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Neuropathy:sensory | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Hypotension | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pleural effusion | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Hypoxia | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Lymphopenia | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Platelets | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Phosphate, serum-low (hypophosphatemia) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Phosphate, serum-low (hypophosphatemia) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Hypoxia | 1 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Pain NOS | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 Fatigue (asthenia, lethargy, malaise) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Muscle | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Joint | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Head/headache | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Infection (documented clinically or microbiologically)..Blood | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Albumin, serum-low (hypoalbuminemia) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Rash/desquamation | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Chest/thorax NOS | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Pain::Bladder | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Infection (documented clinically or microbiologically)...Blood | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Renal/Genitourinary - Other (Specify, Lower urine output) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Vomiting | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Pain::Abdomen NOS | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Albumin, serum-low (hypoalbuminemia) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Abdomen NOS | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Leukocytes (total WBC) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Neutrophils/granulocytes (ANC/AGC) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Neutrophils/granulocytes (ANC/AGC) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Rigors/chills | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Nausea | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Acute vascular leak syndrome | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Nausea | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Mental status | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Fatigue (asthenia, lethargy, malaise) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - ALT, SGPT (serum glutamic pyruvic transaminase) | 1 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - PTT (Partial Thromboplastin Time) | 1 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Febrile neutropenia | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis) | 1 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Hypoxia | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Pain::Bladder | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Hypotension | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 possibly related - Hypopigmentation | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Bilirubin (hyperbilirubinemia) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Psychosis | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Vision-blurred vision | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 possibly related - Diarrhea | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Fatigue | 10 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Potassium, serum-low (hypokalemia) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Calcium, serum-low (hypocalcemia) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Albumin, serum-low (hypoalbuminemia) | 2 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Leukocytes (total WBC) | 1 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Hemorrhage, GI::Ileum | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Mental status | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably relatedRenal/Genitourinary-Other (Low urine output(nonoliguric renal insufficiency) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Vomiting | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | 1 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - ALT, SGPT (serum glutamic pyruvic transaminase) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Infection (documented clinically or microbiologically)...Blood | 1 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Calcium, serum-low (hypocalcemia) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Potassium, serum-low (hypokalemia) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Dyspnea (shortness of breath) | 1 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS | 1 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Mood alteration::Agitation | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Lymphopenia | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Lymphopenia | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Febrile neutropenia | 2 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Hemorrhage, GI::Ileum | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Rigors/chills | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Alkaline phosphatase | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Renal/Genitourinary - Other (Specify, Lower urine output) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Hypotension | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Pneumonitis/pulmonary infiltrates | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Leukocytes (total WBC) | 50 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Phosphate, serum-low (hypophosphatemia) | 1 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pneumonitis/pulmonary infiltrates | 1 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Acute vascular leak syndrome | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Dry mouth/salivary gland (xerostomia) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Pain::Abdomen NOS | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related- Infection (documented clinically or microbiologically)...Urinary tract NOS | 1 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Hypotension | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Diarrhea | 1 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pleural effusion | 1 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Mucositis/stomatitis (clinical exam)::Oral cavity | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Trachea | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Platelets | 4 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Creatinine | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS | 1 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Hypoxia | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Lymphopenia | 2 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Acidosis (metabolic or respiratory) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Supraventricular and nodal arrhythmia::Sinus bradycardia | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Phosphate, serum-low (hypophosphatemia) | 3 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Nausea | 2 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Creatinine | 1 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Phosphate, serum-low (hypophosphatemia) | 10 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Supraventricular and nodal arrhythmia::Sinus tachycardia | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Trachea | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Abdomen NOS | 2 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Hypoxia | 1 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Confusion | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Pain NOS | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Somnolence/depressed level of consciousness | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Syncope (fainting) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Muscle | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Ocular/Visual - Other, Specify (Corneal Edema, OU) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 Pain::Chest wall | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Sodium, serum-low (hyponatremia) | 1 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Hypopigmentation | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Renal/Genitourinary - Other (Specify, Lower urine output) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Calcium, serum low (hypocalcemia) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Cardiac troponin I (cTnl) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Calcium, serum low (hypocalcemia) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Neutrophils/granulocytes (ANC/AGC) | 1 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Platelets | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Rigors/chills | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Febrile neutropenia | 23 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Syncope (fainting) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Acute vascular leak syndrome | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Psychosis (hallucinations/delusions) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Supraventricular and nodal arrhythmia::Atrial fibrillation | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Rigors/chills | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 Fatigue (asthenia, lethargy, malaise) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Supraventricular and nodal arrhythmia::Atrial fibrillation | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Retinopathy | 1 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Joint | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Colitis, infectious (e.g., Clostridium difficile) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Mucositis/stomatitis (clinical exam)::Oral cavity | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Fever | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Lymphopenia | 51 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Mood alteration::Agitation | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Bilirubin (hyperbilirubinemia) | 2 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Head/headache | 7 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Potassium, serum-low (hypokalemia) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Renal failure | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Platelets | 39 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Acute vascular leak syndrome | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Fever | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - AST, SGOT(serum glutamic oxaloacetic transaminase) | 2 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Confusion | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Creatinine | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Albumin, serum-low (hypoalbuminemia) | 2 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Hemorrhage, GU:: Bladder | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Neutrophils/granulocytes (ANC/AGC) | 1 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils Urinary tract NOS | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Supraventricular and nodal arrhythmia::Atrial fibrillation | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Diarrhea | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Renal failure | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Leukocytes (total WBC) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Dry mouth/salivary gland (xerostomia) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Renal/Genitourinary - Other (Specify, Oliguria) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Dry mouth/salivary gland (xerostomia) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Infection (documented clinically or microbiologically)..Blood | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 - possibly related - hypopigmentation | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Uveitis | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Rash/desquamation | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Neutrophils/granulocytes (ANC/AGC) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 - probably related - hypopigmentation | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Leukocytes (total WBC) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Hemoglobin | 9 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Nausea | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Dyspnea (shortness of breath) | 1 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - AST, SGOT(serum glutamic oxaloacetic transaminase) | 1 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Thrombotic microangiopathy | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Edema: head and neck | 1 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Rash/desquamation | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Anorexia | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Rash/desquamation | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Fatigue (asthenia, lethargy, malaise) | 2 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Vomiting | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Neutrophils/granulocytes (ANC/AGC) | 50 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Neuropathy:sensory | 1 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Chest/thorax NOS | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Hemoglobin | 13 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - PTT (Partial Thromboplastin Time) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Supraventricular and nodal arrhythmia::Atrial fibrillation | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Confusion | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 possibly related - Diarrhea | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Mood alteration::Agitation | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 Fatigue (asthenia, lethargy, malaise) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Hypopigmentation | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 Pain::Chest wall | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Acute vascular leak syndrome | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Confusion | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Creatinine | 1 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Creatinine | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Diarrhea | 1 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Dry mouth/salivary gland (xerostomia) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Dyspnea (shortness of breath) | 1 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Fatigue | 10 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Hemorrhage, GU:: Bladder | 1 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Hypotension | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Hypoxia | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Neuropathy:sensory | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Leukocytes (total WBC) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Syncope (fainting) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Platelets | 39 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Potassium, serum-low (hypokalemia) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Febrile neutropenia | 23 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 possibly related - Hypopigmentation | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Renal/Genitourinary - Other (Specify, Lower urine output) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Fever | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Fever | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 - possibly related - hypopigmentation | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 - probably related - hypopigmentation | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Hemoglobin | 9 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Hemoglobin | 13 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Hemorrhage, GI::Ileum | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Mental status | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Mood alteration::Agitation | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Hemorrhage, GI::Ileum | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Hypotension | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Hypoxia | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Hypoxia | 1 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Ocular/Visual - Other, Specify (Corneal Edema, OU) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Psychosis (hallucinations/delusions) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Infection (documented clinically or microbiologically)..Blood | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Rash/desquamation | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Renal/Genitourinary - Other (Specify, Lower urine output) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Infection (documented clinically or microbiologically)...Blood | 1 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Rigors/chills | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | 1 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Somnolence/depressed level of consciousness | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related- Infection (documented clinically or microbiologically)...Urinary tract NOS | 1 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Supraventricular and nodal arrhythmia::Atrial fibrillation | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS | 1 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS | 1 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis) | 1 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Uveitis | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Vision-blurred vision | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Leukocytes (total WBC) | 1 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Lymphopenia | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Lymphopenia | 2 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Acidosis (metabolic or respiratory) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Mental status | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Mucositis/stomatitis (clinical exam)::Oral cavity | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Acute vascular leak syndrome | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Mucositis/stomatitis (clinical exam)::Oral cavity | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Nausea | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Nausea | 2 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Acute vascular leak syndrome | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Neutrophils/granulocytes (ANC/AGC) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Neutrophils/granulocytes (ANC/AGC) | 1 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Abdomen NOS | 2 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Pain::Abdomen NOS | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Albumin, serum-low (hypoalbuminemia) | 2 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Pain::Bladder | 1 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Chest/thorax NOS | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Albumin, serum-low (hypoalbuminemia) | 2 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Head/headache | 7 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Joint | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Muscle | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Pain NOS | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Phosphate, serum-low (hypophosphatemia) | 10 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Phosphate, serum-low (hypophosphatemia) | 3 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Platelets | 4 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pleural effusion | 1 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pneumonitis/pulmonary infiltrates | 1 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Alkaline phosphatase | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Pneumonitis/pulmonary infiltrates | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Potassium, serum-low (hypokalemia) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - ALT, SGPT (serum glutamic pyruvic transaminase) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Potassium, serum-low (hypokalemia) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Psychosis | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - ALT, SGPT (serum glutamic pyruvic transaminase) | 1 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - PTT (Partial Thromboplastin Time) | 1 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - PTT (Partial Thromboplastin Time) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Anorexia | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Rash/desquamation | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - AST, SGOT(serum glutamic oxaloacetic transaminase) | 1 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Rash/desquamation | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Renal failure | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Renal/Genitourinary - Other (Specify, Oliguria) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - AST, SGOT(serum glutamic oxaloacetic transaminase) | 2 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Renal failure | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Bilirubin (hyperbilirubinemia) | 2 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Retinopathy | 1 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Rigors/chills | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Rigors/chills | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Calcium, serum low (hypocalcemia) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Calcium, serum low (hypocalcemia) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Cardiac troponin I (cTnl) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Sodium, serum-low (hyponatremia) | 1 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Supraventricular and nodal arrhythmia::Atrial fibrillation | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Colitis, infectious (e.g., Clostridium difficile) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Creatinine | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Diarrhea | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Dry mouth/salivary gland (xerostomia) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Dry mouth/salivary gland (xerostomia) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Dyspnea (shortness of breath) | 1 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Edema: head and neck | 1 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Fatigue (asthenia, lethargy, malaise) | 2 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Fatigue (asthenia, lethargy, malaise) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Febrile neutropenia | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Bilirubin (hyperbilirubinemia) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Calcium, serum-low (hypocalcemia) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Calcium, serum-low (hypocalcemia) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Febrile neutropenia | 2 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Hypotension | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Trachea | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Supraventricular and nodal arrhythmia::Sinus bradycardia | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Supraventricular and nodal arrhythmia::Sinus tachycardia | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Trachea | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Syncope (fainting) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils Urinary tract NOS | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Thrombotic microangiopathy | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Leukocytes (total WBC) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Leukocytes (total WBC) | 50 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Vomiting | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Lymphopenia | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Vomiting | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Lymphopenia | 51 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Neutrophils/granulocytes (ANC/AGC) | 1 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Neutrophils/granulocytes (ANC/AGC) | 50 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Phosphate, serum-low (hypophosphatemia) | 1 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably relatedRenal/Genitourinary-Other (Low urine output(nonoliguric renal insufficiency) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Platelets | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - AST, SGOT(serum glutamic oxaloacetic transaminase) | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 Fatigue (asthenia, lethargy, malaise) | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Vomiting | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Creatinine | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Pain::Bladder | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Hypoxia | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Hemorrhage, GU:: Bladder | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Neutrophils/granulocytes (ANC/AGC) | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Platelets | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Supraventricular and nodal arrhythmia::Atrial fibrillation | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Potassium, serum-low (hypokalemia) | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Leukocytes (total WBC) | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Supraventricular and nodal arrhythmia::Sinus bradycardia | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Trachea | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Neutrophils/granulocytes (ANC/AGC) | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Rash/desquamation | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pleural effusion | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Rigors/chills | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Creatinine | 3 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Vision-blurred vision | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Hypotension | 3 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Uveitis | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Diarrhea | 2 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Thrombotic microangiopathy | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Cardiac troponin I (cTnl) | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Renal failure | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Chest/thorax NOS | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Infection (documented clinically or microbiologically)..Blood | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Hypotension | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Dry mouth/salivary gland (xerostomia) | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Pneumonitis/pulmonary infiltrates | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis) | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Creatinine | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Nausea | 3 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Acidosis (metabolic or respiratory) | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Febrile neutropenia | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Neutrophils/granulocytes (ANC/AGC) | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Leukocytes (total WBC) | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Rigors/chills | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Hemorrhage, GI::Ileum | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Alkaline phosphatase | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Leukocytes (total WBC) | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Neutrophils/granulocytes (ANC/AGC) | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Calcium, serum-low (hypocalcemia) | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Albumin, serum-low (hypoalbuminemia) | 2 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Mood alteration::Agitation | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Dyspnea (shortness of breath) | 12 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Lymphopenia | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Potassium, serum-low (hypokalemia) | 2 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Infection (documented clinically or microbiologically)...Blood | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Renal/Genitourinary - Other (Specify, Oliguria) | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Sodium, serum-low (hyponatremia) | 2 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Calcium, serum-low (hypocalcemia) | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Head/headache | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Febrile neutropenia | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Hemorrhage, GI::Ileum | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Somnolence/depressed level of consciousness | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Mental status | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Bilirubin (hyperbilirubinemia) | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 Pain::Chest wall | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Mucositis/stomatitis (clinical exam)::Oral cavity | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Potassium, serum-low (hypokalemia) | 2 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - ALT, SGPT (serum glutamic pyruvic transaminase) | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Colitis, infectious (e.g., Clostridium difficile) | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Lymphopenia | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Phosphate, serum-low (hypophosphatemia) | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Fatigue | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 - possibly related - hypopigmentation | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Psychosis (hallucinations/delusions) | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Platelets | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Supraventricular and nodal arrhythmia::Atrial fibrillation | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Acute vascular leak syndrome | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Joint | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Vomiting | 2 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Psychosis | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Hypoxia | 4 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably relatedRenal/Genitourinary-Other (Low urine output(nonoliguric renal insufficiency) | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Hypopigmentation | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Rigors/chills | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Renal/Genitourinary - Other (Specify, Lower urine output) | 3 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Syncope (fainting) | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Febrile neutropenia | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Pain::Abdomen NOS | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Hemoglobin | 2 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Ocular/Visual - Other, Specify (Corneal Edema, OU) | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils Urinary tract NOS | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Fatigue (asthenia, lethargy, malaise) | 4 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related- Infection (documented clinically or microbiologically)...Urinary tract NOS | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - ALT, SGPT (serum glutamic pyruvic transaminase) | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - PTT (Partial Thromboplastin Time) | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Muscle | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Calcium, serum low (hypocalcemia) | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 possibly related - Hypopigmentation | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Abdomen NOS | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Fatigue (asthenia, lethargy, malaise) | 2 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 possibly related - Diarrhea | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Acute vascular leak syndrome | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Supraventricular and nodal arrhythmia::Atrial fibrillation | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Hypotension | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Neuropathy:sensory | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Acute vascular leak syndrome | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Mood alteration::Agitation | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Hypoxia | 10 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Edema: head and neck | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Syncope (fainting) | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Pain NOS | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Dyspnea (shortness of breath) | 5 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Renal/Genitourinary - Other (Specify, Lower urine output) | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Mucositis/stomatitis (clinical exam)::Oral cavity | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Hemoglobin | 13 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Nausea | 3 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Anorexia | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Fever | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Leukocytes (total WBC) | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Confusion | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Rash/desquamation | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Albumin, serum-low (hypoalbuminemia) | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Bilirubin (hyperbilirubinemia) | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Calcium, serum low (hypocalcemia) | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Trachea | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pneumonitis/pulmonary infiltrates | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Phosphate, serum-low (hypophosphatemia) | 11 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Diarrhea | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 - probably related - hypopigmentation | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Lymphopenia | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - AST, SGOT(serum glutamic oxaloacetic transaminase) | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Confusion | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Dry mouth/salivary gland (xerostomia) | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - PTT (Partial Thromboplastin Time) | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Fever | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Rash/desquamation | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Platelets | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Lymphopenia | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Retinopathy | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Dry mouth/salivary gland (xerostomia) | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Mental status | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Supraventricular and nodal arrhythmia::Sinus tachycardia | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Phosphate, serum-low (hypophosphatemia) | 2 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Renal failure | 1 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Nausea | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Renal failure | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Infection (documented clinically or microbiologically)...Blood | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Diarrhea | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Hemorrhage, GU:: Bladder | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Renal/Genitourinary - Other (Specify, Oliguria) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Supraventricular and nodal arrhythmia::Atrial fibrillation | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Creatinine | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Platelets | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Fever | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - AST, SGOT(serum glutamic oxaloacetic transaminase) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Mood alteration::Agitation | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Renal failure | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Colitis, infectious (e.g., Clostridium difficile) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Potassium, serum-low (hypokalemia) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Fever | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably relatedRenal/Genitourinary-Other (Low urine output(nonoliguric renal insufficiency) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Supraventricular and nodal arrhythmia::Atrial fibrillation | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Fatigue | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Retinopathy | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Pain::Abdomen NOS | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Bilirubin (hyperbilirubinemia) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Cardiac troponin I (cTnl) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Dyspnea (shortness of breath) | 1 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Sodium, serum-low (hyponatremia) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Rigors/chills | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Leukocytes (total WBC) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Diarrhea | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Febrile neutropenia | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Calcium, serum low (hypocalcemia) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Neutrophils/granulocytes (ANC/AGC) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Rigors/chills | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Mucositis/stomatitis (clinical exam)::Oral cavity | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 possibly related - Hypopigmentation | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Renal/Genitourinary - Other (Specify, Lower urine output) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Calcium, serum low (hypocalcemia) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Albumin, serum-low (hypoalbuminemia) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Thrombotic microangiopathy | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Somnolence/depressed level of consciousness | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Rash/desquamation | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Pain::Bladder | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Rigors/chills | 1 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Leukocytes (total WBC) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Uveitis | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 Fatigue (asthenia, lethargy, malaise) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Vomiting | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Infection (documented clinically or microbiologically)..Blood | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Chest/thorax NOS | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Leukocytes (total WBC) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Hypopigmentation | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Nausea | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Head/headache | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 Pain::Chest wall | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Psychosis (hallucinations/delusions) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils Urinary tract NOS | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Joint | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Syncope (fainting) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Ocular/Visual - Other, Specify (Corneal Edema, OU) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Muscle | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Platelets | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Syncope (fainting) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Hypoxia | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Pain NOS | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Mental status | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Acute vascular leak syndrome | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Trachea | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related- Infection (documented clinically or microbiologically)...Urinary tract NOS | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Neuropathy:sensory | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Phosphate, serum-low (hypophosphatemia) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Confusion | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Trachea | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Supraventricular and nodal arrhythmia::Sinus tachycardia | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Phosphate, serum-low (hypophosphatemia) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Confusion | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Hypoxia | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Creatinine | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Platelets | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Neutrophils/granulocytes (ANC/AGC) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Supraventricular and nodal arrhythmia::Sinus bradycardia | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Hypotension | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Acidosis (metabolic or respiratory) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Creatinine | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pneumonitis/pulmonary infiltrates | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Lymphopenia | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Hypotension | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Pneumonitis/pulmonary infiltrates | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Albumin, serum-low (hypoalbuminemia) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Dry mouth/salivary gland (xerostomia) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Calcium, serum-low (hypocalcemia) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Hemorrhage, GI::Ileum | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Alkaline phosphatase | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Mood alteration::Agitation | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Potassium, serum-low (hypokalemia) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Neutrophils/granulocytes (ANC/AGC) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Calcium, serum-low (hypocalcemia) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Phosphate, serum-low (hypophosphatemia) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Dyspnea (shortness of breath) | 1 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Hemorrhage, GI::Ileum | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Mental status | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Lymphopenia | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Acute vascular leak syndrome | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Potassium, serum-low (hypokalemia) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - ALT, SGPT (serum glutamic pyruvic transaminase) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 - possibly related - hypopigmentation | 1 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Vomiting | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Bilirubin (hyperbilirubinemia) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Psychosis | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Renal/Genitourinary - Other (Specify, Lower urine output) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Febrile neutropenia | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Hemoglobin | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Hypoxia | 1 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Fatigue (asthenia, lethargy, malaise) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Fatigue (asthenia, lethargy, malaise) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - PTT (Partial Thromboplastin Time) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Leukocytes (total WBC) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - ALT, SGPT (serum glutamic pyruvic transaminase) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Abdomen NOS | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Hypotension | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - PTT (Partial Thromboplastin Time) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Mucositis/stomatitis (clinical exam)::Oral cavity | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Edema: head and neck | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 possibly related - Diarrhea | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Acute vascular leak syndrome | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Hemoglobin | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Anorexia | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Supraventricular and nodal arrhythmia::Atrial fibrillation | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Dyspnea (shortness of breath) | 1 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Rash/desquamation | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pleural effusion | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Lymphopenia | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 - probably related - hypopigmentation | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Dry mouth/salivary gland (xerostomia) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - AST, SGOT(serum glutamic oxaloacetic transaminase) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Lymphopenia | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Rash/desquamation | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Dry mouth/salivary gland (xerostomia) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Neutrophils/granulocytes (ANC/AGC) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Febrile neutropenia | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Vision-blurred vision | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Mucositis/stomatitis (clinical exam)::Oral cavity | 1 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 Fatigue (asthenia, lethargy, malaise) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Nausea | 3 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Rigors/chills | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Nausea | 4 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Neutrophils/granulocytes (ANC/AGC) | 1 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Neutrophils/granulocytes (ANC/AGC) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Renal/Genitourinary - Other (Specify, Lower urine output) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Abdomen NOS | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Acute vascular leak syndrome | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Infection (documented clinically or microbiologically)...Blood | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Leukocytes (total WBC) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Pain::Abdomen NOS | 1 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Platelets | 15 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Rash/desquamation | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Pain::Bladder | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Infection (documented clinically or microbiologically)..Blood | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Albumin, serum-low (hypoalbuminemia) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Chest/thorax NOS | 1 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Psychosis (hallucinations/delusions) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Head/headache | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Joint | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Vomiting | 1 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Muscle | 1 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Hypoxia | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Pain NOS | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Neuropathy:sensory | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Phosphate, serum-low (hypophosphatemia) | 2 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Hypoxia | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Phosphate, serum-low (hypophosphatemia) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Platelets | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Hypotension | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pleural effusion | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pneumonitis/pulmonary infiltrates | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Mood alteration::Agitation | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Albumin, serum-low (hypoalbuminemia) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Pneumonitis/pulmonary infiltrates | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Hemorrhage, GI::Ileum | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Alkaline phosphatase | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Potassium, serum-low (hypokalemia) | 2 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Lymphopenia | 1 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Potassium, serum-low (hypokalemia) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - ALT, SGPT (serum glutamic pyruvic transaminase) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Hypoxia | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Hemoglobin | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Psychosis | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - PTT (Partial Thromboplastin Time) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - ALT, SGPT (serum glutamic pyruvic transaminase) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Hypotension | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - PTT (Partial Thromboplastin Time) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Hemoglobin | 12 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Mood alteration::Agitation | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Fatigue | 6 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Anorexia | 1 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Rash/desquamation | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 - probably related - hypopigmentation | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Rash/desquamation | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Hemorrhage, GU:: Bladder | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Lymphopenia | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Renal failure | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Renal failure | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - AST, SGOT(serum glutamic oxaloacetic transaminase) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Fever | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Retinopathy | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Bilirubin (hyperbilirubinemia) | 1 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Rigors/chills | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Rigors/chills | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Renal/Genitourinary - Other (Specify, Lower urine output) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Neutrophils/granulocytes (ANC/AGC) | 11 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Calcium, serum low (hypocalcemia) | 1 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 possibly related - Hypopigmentation | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Calcium, serum low (hypocalcemia) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Febrile neutropenia | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Sodium, serum-low (hyponatremia) | 1 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Cardiac troponin I (cTnl) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Supraventricular and nodal arrhythmia::Atrial fibrillation | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably relatedRenal/Genitourinary-Other (Low urine output(nonoliguric renal insufficiency) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Fever | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Potassium, serum-low (hypokalemia) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 possibly related - Diarrhea | 1 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Colitis, infectious (e.g., Clostridium difficile) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Creatinine | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Diarrhea | 3 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Febrile neutropenia | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Dry mouth/salivary gland (xerostomia) | 1 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Renal/Genitourinary - Other (Specify, Oliguria) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Neutrophils/granulocytes (ANC/AGC) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Dry mouth/salivary gland (xerostomia) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Hemorrhage, GI::Ileum | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - AST, SGOT(serum glutamic oxaloacetic transaminase) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Edema: head and neck | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Ocular/Visual - Other, Specify (Corneal Edema, OU) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Fatigue (asthenia, lethargy, malaise) | 5 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Fatigue (asthenia, lethargy, malaise) | 1 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Mental status | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Platelets | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Febrile neutropenia | 4 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Supraventricular and nodal arrhythmia::Atrial fibrillation | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 - possibly related - hypopigmentation | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Vomiting | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Bilirubin (hyperbilirubinemia) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Calcium, serum-low (hypocalcemia) | 1 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Phosphate, serum-low (hypophosphatemia) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Calcium, serum-low (hypocalcemia) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Dry mouth/salivary gland (xerostomia) | 1 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Hypotension | 1 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Diarrhea | 1 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Creatinine | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Confusion | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Creatinine | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Supraventricular and nodal arrhythmia::Sinus bradycardia | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Trachea | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Confusion | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Trachea | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Supraventricular and nodal arrhythmia::Sinus tachycardia | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Acute vascular leak syndrome | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Syncope (fainting) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Syncope (fainting) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils Urinary tract NOS | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 Pain::Chest wall | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Hypopigmentation | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Leukocytes (total WBC) | 13 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Uveitis | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Leukocytes (total WBC) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Thrombotic microangiopathy | 5 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Leukocytes (total WBC) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Vision-blurred vision | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Lymphopenia | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Supraventricular and nodal arrhythmia::Atrial fibrillation | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Lymphopenia | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Acidosis (metabolic or respiratory) | 1 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related- Infection (documented clinically or microbiologically)...Urinary tract NOS | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Mental status | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Somnolence/depressed level of consciousness | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Mucositis/stomatitis (clinical exam)::Oral cavity | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Acute vascular leak syndrome | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Calcium, serum low (hypocalcemia) | 2 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 - possibly related - hypopigmentation | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Rigors/chills | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Vision-blurred vision | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Dry mouth/salivary gland (xerostomia) | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - PTT (Partial Thromboplastin Time) | 2 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Rash/desquamation | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 - probably related - hypopigmentation | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Neutrophils/granulocytes (ANC/AGC) | 46 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Anorexia | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Mucositis/stomatitis (clinical exam)::Oral cavity | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Thrombotic microangiopathy | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Hemoglobin | 16 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Ocular/Visual - Other, Specify (Corneal Edema, OU) | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - PTT (Partial Thromboplastin Time) | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Supraventricular and nodal arrhythmia::Atrial fibrillation | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Edema: head and neck | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Mood alteration::Agitation | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - ALT, SGPT (serum glutamic pyruvic transaminase) | 2 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Fatigue (asthenia, lethargy, malaise) | 2 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Mental status | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Hypotension | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Fatigue (asthenia, lethargy, malaise) | 4 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Lymphopenia | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Psychosis | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Febrile neutropenia | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Hemoglobin | 18 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Acute vascular leak syndrome | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Supraventricular and nodal arrhythmia::Atrial fibrillation | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Abdomen NOS | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Lymphopenia | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - ALT, SGPT (serum glutamic pyruvic transaminase) | 2 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Vomiting | 2 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Hypoxia | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Potassium, serum-low (hypokalemia) | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Leukocytes (total WBC) | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Bilirubin (hyperbilirubinemia) | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Neutrophils/granulocytes (ANC/AGC) | 4 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Hemorrhage, GI::Ileum | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Potassium, serum-low (hypokalemia) | 2 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Calcium, serum-low (hypocalcemia) | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Renal/Genitourinary - Other (Specify, Lower urine output) | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Alkaline phosphatase | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Calcium, serum-low (hypocalcemia) | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | 2 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Dry mouth/salivary gland (xerostomia) | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Phosphate, serum-low (hypophosphatemia) | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Pneumonitis/pulmonary infiltrates | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Febrile neutropenia | 3 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Lymphopenia | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Albumin, serum-low (hypoalbuminemia) | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Hemorrhage, GI::Ileum | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Hypotension | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Diarrhea | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Neutrophils/granulocytes (ANC/AGC) | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Confusion | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pneumonitis/pulmonary infiltrates | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Platelets | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Creatinine | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Mood alteration::Agitation | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pleural effusion | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related- Infection (documented clinically or microbiologically)...Urinary tract NOS | 2 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Hypotension | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Creatinine | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Platelets | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Acidosis (metabolic or respiratory) | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Supraventricular and nodal arrhythmia::Sinus bradycardia | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Phosphate, serum-low (hypophosphatemia) | 2 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Hypoxia | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Trachea | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Confusion | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Phosphate, serum-low (hypophosphatemia) | 12 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Neuropathy:sensory | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Trachea | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Pain NOS | 3 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Vomiting | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Mucositis/stomatitis (clinical exam)::Oral cavity | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Syncope (fainting) | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Muscle | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Platelets | 39 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Hypoxia | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Joint | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Mental status | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Syncope (fainting) | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 Pain::Chest wall | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Nausea | 9 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Head/headache | 2 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Hypopigmentation | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Psychosis (hallucinations/delusions) | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Fatigue | 6 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Chest/thorax NOS | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis) | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Somnolence/depressed level of consciousness | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Leukocytes (total WBC) | 48 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Albumin, serum-low (hypoalbuminemia) | 2 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Infection (documented clinically or microbiologically)..Blood | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Uveitis | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Pain::Bladder | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 Fatigue (asthenia, lethargy, malaise) | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Rigors/chills | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Dry mouth/salivary gland (xerostomia) | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 possibly related - Hypopigmentation | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Leukocytes (total WBC) | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Renal/Genitourinary - Other (Specify, Lower urine output) | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Neutrophils/granulocytes (ANC/AGC) | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Bilirubin (hyperbilirubinemia) | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Calcium, serum low (hypocalcemia) | 2 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS | 2 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Acute vascular leak syndrome | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Rigors/chills | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Sodium, serum-low (hyponatremia) | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably relatedRenal/Genitourinary-Other (Low urine output(nonoliguric renal insufficiency) | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 possibly related - Diarrhea | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Retinopathy | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Cardiac troponin I (cTnl) | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Febrile neutropenia | 35 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Supraventricular and nodal arrhythmia::Atrial fibrillation | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Pain::Abdomen NOS | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Fever | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Potassium, serum-low (hypokalemia) | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Nausea | 2 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Rash/desquamation | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - AST, SGOT(serum glutamic oxaloacetic transaminase) | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Renal failure | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Acute vascular leak syndrome | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Colitis, infectious (e.g., Clostridium difficile) | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Fever | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Renal/Genitourinary - Other (Specify, Oliguria) | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Leukocytes (total WBC) | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - AST, SGOT(serum glutamic oxaloacetic transaminase) | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Creatinine | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils Urinary tract NOS | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Lymphopenia | 48 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Renal failure | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Infection (documented clinically or microbiologically)...Blood | 2 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Diarrhea | 3 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Hemorrhage, GU:: Bladder | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Supraventricular and nodal arrhythmia::Sinus tachycardia | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Rash/desquamation | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Calcium, serum low (hypocalcemia) | 2 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Dry mouth/salivary gland (xerostomia) | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Renal failure | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Hypoxia | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Acidosis (metabolic or respiratory) | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 possibly related - Hypopigmentation | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 - possibly related - hypopigmentation | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Rash/desquamation | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Trachea | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Febrile neutropenia | 35 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Dry mouth/salivary gland (xerostomia) | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Leukocytes (total WBC) | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Phosphate, serum-low (hypophosphatemia) | 12 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Renal failure | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Vomiting | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Anorexia | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Supraventricular and nodal arrhythmia::Atrial fibrillation | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Renal/Genitourinary - Other (Specify, Lower urine output) | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Bilirubin (hyperbilirubinemia) | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 - probably related - hypopigmentation | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Rash/desquamation | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Fatigue (asthenia, lethargy, malaise) | 4 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Neutrophils/granulocytes (ANC/AGC) | 46 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - ALT, SGPT (serum glutamic pyruvic transaminase) | 2 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Supraventricular and nodal arrhythmia::Sinus tachycardia | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Vision-blurred vision | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Pain NOS | 3 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Infection (documented clinically or microbiologically)...Blood | 2 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Ocular/Visual - Other, Specify (Corneal Edema, OU) | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Trachea | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Hemoglobin | 16 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - PTT (Partial Thromboplastin Time) | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Acute vascular leak syndrome | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Nausea | 9 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Edema: head and neck | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Abdomen NOS | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Neuropathy:sensory | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Fatigue | 6 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - PTT (Partial Thromboplastin Time) | 2 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Renal/Genitourinary - Other (Specify, Lower urine output) | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Mood alteration::Agitation | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Rigors/chills | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Muscle | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Fatigue (asthenia, lethargy, malaise) | 2 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Mental status | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Leukocytes (total WBC) | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Confusion | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Lymphopenia | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - AST, SGOT(serum glutamic oxaloacetic transaminase) | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Acute vascular leak syndrome | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Syncope (fainting) | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Calcium, serum low (hypocalcemia) | 2 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Hypotension | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Lymphopenia | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Psychosis | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 Pain::Chest wall | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Mucositis/stomatitis (clinical exam)::Oral cavity | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Hemorrhage, GU:: Bladder | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Febrile neutropenia | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Creatinine | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - ALT, SGPT (serum glutamic pyruvic transaminase) | 2 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Joint | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Rigors/chills | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Supraventricular and nodal arrhythmia::Atrial fibrillation | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Neutrophils/granulocytes (ANC/AGC) | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 possibly related - Diarrhea | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Syncope (fainting) | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Neutrophils/granulocytes (ANC/AGC) | 4 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Diarrhea | 3 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Vomiting | 2 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Hypoxia | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Potassium, serum-low (hypokalemia) | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Mental status | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Hemoglobin | 18 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils Urinary tract NOS | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Dry mouth/salivary gland (xerostomia) | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Bilirubin (hyperbilirubinemia) | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Head/headache | 2 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Alkaline phosphatase | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Rash/desquamation | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Potassium, serum-low (hypokalemia) | 2 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably relatedRenal/Genitourinary-Other (Low urine output(nonoliguric renal insufficiency) | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Thrombotic microangiopathy | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Leukocytes (total WBC) | 48 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Calcium, serum-low (hypocalcemia) | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Hemorrhage, GI::Ileum | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Hypoxia | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | 2 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Retinopathy | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Albumin, serum-low (hypoalbuminemia) | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Neutrophils/granulocytes (ANC/AGC) | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Calcium, serum-low (hypocalcemia) | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 probably related - Hypopigmentation | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Pneumonitis/pulmonary infiltrates | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 1 Fatigue (asthenia, lethargy, malaise) | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Somnolence/depressed level of consciousness | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Febrile neutropenia | 3 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Sodium, serum-low (hyponatremia) | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Platelets | 39 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pain::Chest/thorax NOS | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Platelets | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Phosphate, serum-low (hypophosphatemia) | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Infection (documented clinically or microbiologically)..Blood | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Hemorrhage, GI::Ileum | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Lymphopenia | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Hypotension | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Diarrhea | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis) | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Colitis, infectious (e.g., Clostridium difficile) | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Fever | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pneumonitis/pulmonary infiltrates | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Lymphopenia | 48 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Psychosis (hallucinations/delusions) | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Albumin, serum-low (hypoalbuminemia) | 2 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Creatinine | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Leukocytes (total WBC) | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Cardiac troponin I (cTnl) | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Mood alteration::Agitation | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Acute vascular leak syndrome | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Nausea | 2 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related- Infection (documented clinically or microbiologically)...Urinary tract NOS | 2 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pleural effusion | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - AST, SGOT(serum glutamic oxaloacetic transaminase) | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Uveitis | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Pain::Bladder | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 possibly related - Creatinine | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS | 2 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Potassium, serum-low (hypokalemia) | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Platelets | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Mucositis/stomatitis (clinical exam)::Oral cavity | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Pain::Abdomen NOS | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Rigors/chills | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Fever | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Supraventricular and nodal arrhythmia::Sinus bradycardia | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Hypotension | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Phosphate, serum-low (hypophosphatemia) | 3 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Confusion | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Supraventricular and nodal arrhythmia::Atrial fibrillation | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Non-serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Renal/Genitourinary - Other (Specify, Oliguria) | 0 adverse events |
Secondary
Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment
Here is the number of Grades 2, 3, 4, and/or 5 serious adverse events possibly and/or probably related to treatment. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.
Time frame: Time of registration through 6 years after the last treatment.
Population: 99/102 participants were analyzed. Two participants were enrolled and not treated due to disease progression prior to start of treatment (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Hemoglobin | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade (Gr) 2 possibly related - Somnolence/depressed level of consciousness | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Any Grade 1 possibly and/or probably related | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Anorexia | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Creatinine | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Creatinine | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Any Grade 5 possibly and/or probably related | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Renal failure | 1 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pleural effusion (non-malignant) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Dyspnea (shortness of breath) | 1 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Cardiopulmonary arrest, cause unknown (non-fatal) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura...) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Supraventricular and nodal arrhythmia::Sinus tachycardia | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Renal failure | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - left ventricular diastolic dysfunction | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura...) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Neurology - Other Specify, hydrocephalus | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Infection (documented clinically or microbiologically) w/Grade 3 or 4 ANC | 1 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Secondary Malignancy - possibly related to cancer treatment (Specify, __) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Anorexia | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Calcium, serum low (hypocalcemia) | 0 adverse events |
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Infection (documented clinically or microbiologically) w/Grade 3 or 4 ANC | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Infection (documented clinically or microbiologically) w/Grade 3 or 4 ANC | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Hemoglobin | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - left ventricular diastolic dysfunction | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Infection (documented clinically or microbiologically) w/Grade 3 or 4 ANC | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura...) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Anorexia | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Secondary Malignancy - possibly related to cancer treatment (Specify, __) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Calcium, serum low (hypocalcemia) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Renal failure | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Creatinine | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Anorexia | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pleural effusion (non-malignant) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Creatinine | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Renal failure | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade (Gr) 2 possibly related - Somnolence/depressed level of consciousness | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Supraventricular and nodal arrhythmia::Sinus tachycardia | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Any Grade 1 possibly and/or probably related | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Any Grade 5 possibly and/or probably related | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Neurology - Other Specify, hydrocephalus | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Cardiopulmonary arrest, cause unknown (non-fatal) | 0 adverse events |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura...) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Anorexia | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Secondary Malignancy - possibly related to cancer treatment (Specify, __) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Supraventricular and nodal arrhythmia::Sinus tachycardia | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Renal failure | 1 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Any Grade 1 possibly and/or probably related | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Cardiopulmonary arrest, cause unknown (non-fatal) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Infection (documented clinically or microbiologically) w/Grade 3 or 4 ANC | 1 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Neurology - Other Specify, hydrocephalus | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade (Gr) 2 possibly related - Somnolence/depressed level of consciousness | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Calcium, serum low (hypocalcemia) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Any Grade 5 possibly and/or probably related | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Infection (documented clinically or microbiologically) w/Grade 3 or 4 ANC | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Creatinine | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Creatinine | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura...) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pleural effusion (non-malignant) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Hemoglobin | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Anorexia | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - left ventricular diastolic dysfunction | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura...) | 0 adverse events |
| Arm 1: Related to Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Renal failure | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Renal failure | 1 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Neurology - Other Specify, hydrocephalus | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - left ventricular diastolic dysfunction | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Any Grade 1 possibly and/or probably related | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pleural effusion (non-malignant) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Renal failure | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura...) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Cardiopulmonary arrest, cause unknown (non-fatal) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Infection (documented clinically or microbiologically) w/Grade 3 or 4 ANC | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura...) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Infection (documented clinically or microbiologically) w/Grade 3 or 4 ANC | 1 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Hemoglobin | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Any Grade 5 possibly and/or probably related | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Secondary Malignancy - possibly related to cancer treatment (Specify, __) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Anorexia | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade (Gr) 2 possibly related - Somnolence/depressed level of consciousness | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Supraventricular and nodal arrhythmia::Sinus tachycardia | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Anorexia | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Calcium, serum low (hypocalcemia) | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Creatinine | 0 adverse events |
| Arm 1: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Creatinine | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Hemoglobin | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis) | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Neurology - Other Specify, hydrocephalus | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Anorexia | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura...) | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade (Gr) 2 possibly related - Somnolence/depressed level of consciousness | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Creatinine | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Any Grade 1 possibly and/or probably related | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Any Grade 5 possibly and/or probably related | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Calcium, serum low (hypocalcemia) | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Anorexia | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Creatinine | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Supraventricular and nodal arrhythmia::Sinus tachycardia | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Infection (documented clinically or microbiologically) w/Grade 3 or 4 ANC | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Secondary Malignancy - possibly related to cancer treatment (Specify, __) | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Renal failure | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Infection (documented clinically or microbiologically) w/Grade 3 or 4 ANC | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura...) | 0 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - left ventricular diastolic dysfunction | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Renal failure | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pleural effusion (non-malignant) | 1 adverse events |
| Arm 2: Related to Interleukin-2 (IL-2) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Cardiopulmonary arrest, cause unknown (non-fatal) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Cardiopulmonary arrest, cause unknown (non-fatal) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pleural effusion (non-malignant) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Any Grade 5 possibly and/or probably related | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura...) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Renal failure | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Any Grade 1 possibly and/or probably related | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade (Gr) 2 possibly related - Somnolence/depressed level of consciousness | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Hemoglobin | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Renal failure | 1 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Supraventricular and nodal arrhythmia::Sinus tachycardia | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Neurology - Other Specify, hydrocephalus | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Anorexia | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Creatinine | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Anorexia | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Creatinine | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Calcium, serum low (hypocalcemia) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - left ventricular diastolic dysfunction | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Infection (documented clinically or microbiologically) w/Grade 3 or 4 ANC | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Infection (documented clinically or microbiologically) w/Grade 3 or 4 ANC | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura...) | 0 adverse events |
| Arm 2: Related to Tumor Infiltrating Lymphocytes | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Secondary Malignancy - possibly related to cancer treatment (Specify, __) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Creatinine | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade (Gr) 2 possibly related - Somnolence/depressed level of consciousness | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Anorexia | 1 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Neurology - Other Specify, hydrocephalus | 1 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Renal failure | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Renal failure | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura...) | 12 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Cardiopulmonary arrest, cause unknown (non-fatal) | 1 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Infection (documented clinically or microbiologically) w/Grade 3 or 4 ANC | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Infection (documented clinically or microbiologically) w/Grade 3 or 4 ANC | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Any Grade 1 possibly and/or probably related | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Supraventricular and nodal arrhythmia::Sinus tachycardia | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Anorexia | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Calcium, serum low (hypocalcemia) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Creatinine | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - left ventricular diastolic dysfunction | 1 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pleural effusion (non-malignant) | 1 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura...) | 1 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Hemoglobin | 2 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis) | 1 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Secondary Malignancy - possibly related to cancer treatment (Specify, __) | 1 adverse events |
| Arm 2: Related to Total Body Irradiation (TBI) | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Any Grade 5 possibly and/or probably related | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura...) | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Calcium, serum low (hypocalcemia) | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Renal failure | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Secondary Malignancy - possibly related to cancer treatment (Specify, __) | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Hemoglobin | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Supraventricular and nodal arrhythmia::Sinus tachycardia | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Renal failure | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura...) | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Any Grade 1 possibly and/or probably related | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Neurology - Other Specify, hydrocephalus | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Infection (documented clinically or microbiologically) w/Grade 3 or 4 ANC | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Creatinine | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade (Gr) 2 possibly related - Somnolence/depressed level of consciousness | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis) | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pleural effusion (non-malignant) | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Infection (documented clinically or microbiologically) w/Grade 3 or 4 ANC | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Anorexia | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Anorexia | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - left ventricular diastolic dysfunction | 1 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Cardiopulmonary arrest, cause unknown (non-fatal) | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Any Grade 5 possibly and/or probably related | 0 adverse events |
| Arm 2: Fludarabine | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Creatinine | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Hemoglobin | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 2 probably related - Supraventricular and nodal arrhythmia::Sinus tachycardia | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Renal failure | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Anorexia | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Any Grade 1 possibly and/or probably related | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Any Grade 5 possibly and/or probably related | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Renal failure | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Secondary Malignancy - possibly related to cancer treatment (Specify, __) | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Infection (documented clinically or microbiologically) w/Grade 3 or 4 ANC | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Infection (documented clinically or microbiologically) w/Grade 3 or 4 ANC | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 probably related - Cardiopulmonary arrest, cause unknown (non-fatal) | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura...) | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura...) | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade (Gr) 2 possibly related - Somnolence/depressed level of consciousness | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Calcium, serum low (hypocalcemia) | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Pleural effusion (non-malignant) | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Neurology - Other Specify, hydrocephalus | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Creatinine | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 4 possibly related - Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis) | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - Anorexia | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 possibly related - left ventricular diastolic dysfunction | 1 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Dyspnea (shortness of breath) | 0 adverse events |
| Arm 2: Related to Cyclophosphamide | Number of Grades 1, 2, 3, 4, and/or 5 Serious Adverse Events Possibly and/or Probably Related to Treatment | Grade 3 probably related - Creatinine | 0 adverse events |
Secondary
Progression-free Survival (PFS)
PFS is defined as time to disease progression following the start of treatment. Disease progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v3.0. Progressive Disease is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD. The appearance of one or more new lesions is also considered progression.
Time frame: Participants were followed from treatment until death or until principal investigator (PI) discretion. A median of 91.8 months.
Population: 99/102 participants were analyzed. Two participants were enrolled and not treated due to rapid disease progression prior to start of treatment (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Progression-free Survival (PFS) | 6.8 Months |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Progression-free Survival (PFS) | 9.3 Months |
Other Pre-specified
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0)
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time frame: Participants will be followed for adverse events from registration through 30 days after the last treatment, up to 6 years
Population: 99/102 participants were analyzed. Two participants were enrolled and not treated due to disease progression prior to start of treatment (Arm 2). One participant on Arm 1X is not reported for privacy concerns (n=1). \*Grade 1 and 2 adverse events were only captured when attributed to Young TIL or concurrently with other Grade ≥3 serious adverse events.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: Tumor Infiltrating Lymphocytes (TIL) + High Dose (HD) Interleukin-2 (IL-2) | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0) | 51 Participants |
| Arm 2: Tumor Infiltrating Lymphocytes + High Dose Interleukin-2 + 1200 Total Body Irradiation (TBI) | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0) | 48 Participants |