Trial Outcomes & Findings for Chemotherapy and HAART to Treat AIDS-related Primary Brain Lymphoma (NCT NCT00267865)
NCT ID: NCT00267865
Last Updated: 2020-06-01
Results Overview
Recurrent lymphoma as defined by the International Primary Central Nervous System (CNS) Lymphoma Collaborative Group for response assessment of aggressive Non-Hodgkin's Lymphoma (NHL) using fluorodeoxyglucose F 18 (18FDG-PET). Severe cognitive problems are defined as the inability to carry out normal activities with minimal difficulty and not requiring nursing care or hospitalization because of neurological impairment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
2 years
Results posted on
2020-06-01
Participant Flow
Participant milestones
| Measure |
Rituximab, High-Dose Methotrexate & Leucovorin Treatment
Induction treatment cycles with rituximab, high-dose methotrexate and leucovorin will be administered every 2 weeks for 6 cycles. Two additional consolidation cycles of high-dose methotrexate without rituximab will be administered at 4 weeks and 8 weeks following completion of the combined therapy.
Methotrexate: 6000 mg/m\^2 will be administered by intravenous infusion over 4 hours after confirming that the recipient patients urine pH is within the range greater than or equal to 7 to less than or equal to 8, and urine output is greater than or equal to 100 mL/hour.
Rituximab: 375 mg/m\^2 intravenous (IV) day 1 of each cycle prior to administration of high-dose methotrexate
Leucovorin: Leucovorin calcium doses will be administered orally or by short intravenous (IV) infusion over 15 minutes
|
|---|---|
|
Induction Treatment
STARTED
|
12
|
|
Induction Treatment
COMPLETED
|
9
|
|
Induction Treatment
NOT COMPLETED
|
3
|
|
Consolidation Treatment
STARTED
|
5
|
|
Consolidation Treatment
COMPLETED
|
5
|
|
Consolidation Treatment
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Rituximab, High-Dose Methotrexate & Leucovorin Treatment
Induction treatment cycles with rituximab, high-dose methotrexate and leucovorin will be administered every 2 weeks for 6 cycles. Two additional consolidation cycles of high-dose methotrexate without rituximab will be administered at 4 weeks and 8 weeks following completion of the combined therapy.
Methotrexate: 6000 mg/m\^2 will be administered by intravenous infusion over 4 hours after confirming that the recipient patients urine pH is within the range greater than or equal to 7 to less than or equal to 8, and urine output is greater than or equal to 100 mL/hour.
Rituximab: 375 mg/m\^2 intravenous (IV) day 1 of each cycle prior to administration of high-dose methotrexate
Leucovorin: Leucovorin calcium doses will be administered orally or by short intravenous (IV) infusion over 15 minutes
|
|---|---|
|
Induction Treatment
Died before completing.
|
2
|
|
Induction Treatment
Started induction w/MTX, RIX, & Temozol
|
1
|
Baseline Characteristics
Chemotherapy and HAART to Treat AIDS-related Primary Brain Lymphoma
Baseline characteristics by cohort
| Measure |
Rituximab, High-Dose Methotrexate & Leucovorin Treatment
n=12 Participants
Induction treatment cycles with rituximab, high-dose methotrexate and leucovorin will be administered every 2 weeks for 6 cycles. Two additional consolidation cycles of high-dose methotrexate without rituximab will be administered at 4 weeks and 8 weeks following completion of the combined therapy.
Methotrexate: 6000 mg/m\^2 will be administered by intravenous infusion over 4 hours after confirming that the recipient patients urine pH is within the range greater than or equal to 7 to less than or equal to 8, and urine output is greater than or equal to 100 mL/hour.
Rituximab: 375 mg/m\^2 intravenous (IV) day 1 of each cycle prior to administration of high-dose methotrexate
Leucovorin: Leucovorin calcium doses will be administered orally or by short intravenous (IV) infusion over 15 minutes
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
33.74 years
STANDARD_DEVIATION 10.01 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
|
Median Baseline Mini Mental State Exam (MMSE) Score
|
22 score on a scale
n=5 Participants
|
|
Median Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status
|
2 scores on a scale
n=5 Participants
|
|
Baseline Cluster of Differentiation (CD4) T Cell Count at PCNSL Diagnosis
|
16 cells/µL
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsRecurrent lymphoma as defined by the International Primary Central Nervous System (CNS) Lymphoma Collaborative Group for response assessment of aggressive Non-Hodgkin's Lymphoma (NHL) using fluorodeoxyglucose F 18 (18FDG-PET). Severe cognitive problems are defined as the inability to carry out normal activities with minimal difficulty and not requiring nursing care or hospitalization because of neurological impairment.
Outcome measures
| Measure |
Rituximab, High-Dose Methotrexate & Leucovorin Treatment
n=12 Participants
Induction treatment cycles with rituximab, high-dose methotrexate and leucovorin will be administered every 2 weeks for 6 cycles. Two additional consolidation cycles of high-dose methotrexate without rituximab will be administered at 4 weeks and 8 weeks following completion of the combined therapy.
Methotrexate: 6000 mg/m\^2 will be administered by intravenous infusion over 4 hours after confirming that the recipient patients urine pH is within the range greater than or equal to 7 to less than or equal to 8, and urine output is greater than or equal to 100 mL/hour.
Rituximab: 375 mg/m\^2 intravenous (IV) day 1 of each cycle prior to administration of high-dose methotrexate
Leucovorin: Leucovorin calcium doses will be administered orally or by short intravenous (IV) infusion over 15 minutes
|
|---|---|
|
Number of Patients Alive at 2 Years Without Recurrent Brain Lymphoma or Severe Neurocognitive Defects
|
8 Participants
|
SECONDARY outcome
Timeframe: Date treatment consent signed to date off study, approximately 142 months and 11 days.Here is the count of participants with serious and 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.
Outcome measures
| Measure |
Rituximab, High-Dose Methotrexate & Leucovorin Treatment
n=12 Participants
Induction treatment cycles with rituximab, high-dose methotrexate and leucovorin will be administered every 2 weeks for 6 cycles. Two additional consolidation cycles of high-dose methotrexate without rituximab will be administered at 4 weeks and 8 weeks following completion of the combined therapy.
Methotrexate: 6000 mg/m\^2 will be administered by intravenous infusion over 4 hours after confirming that the recipient patients urine pH is within the range greater than or equal to 7 to less than or equal to 8, and urine output is greater than or equal to 100 mL/hour.
Rituximab: 375 mg/m\^2 intravenous (IV) day 1 of each cycle prior to administration of high-dose methotrexate
Leucovorin: Leucovorin calcium doses will be administered orally or by short intravenous (IV) infusion over 15 minutes
|
|---|---|
|
Number of Participants With Serious and Non-serious Adverse Events
|
11 Participants
|
SECONDARY outcome
Timeframe: At the end of 6 cycles or 12 weeks of treatmentPopulation: Two participants were not evaluable. One participant received one cycle of therapy and one was not evaluable due to treatment failure.
Response was assessed by the International Workshop Criteria for Non-Hodgkin's Lymphoma. Complete Response is disappearance of all enhancing lesions on magnetic resonance imaging of the brain. Partial Response is a reduction of enhancing tumor volume by more than 50% for at least 4 weeks. Progressive Disease is an increase of tumor volume of more than 25% or occurrence of new lesions.
Outcome measures
| Measure |
Rituximab, High-Dose Methotrexate & Leucovorin Treatment
n=10 Participants
Induction treatment cycles with rituximab, high-dose methotrexate and leucovorin will be administered every 2 weeks for 6 cycles. Two additional consolidation cycles of high-dose methotrexate without rituximab will be administered at 4 weeks and 8 weeks following completion of the combined therapy.
Methotrexate: 6000 mg/m\^2 will be administered by intravenous infusion over 4 hours after confirming that the recipient patients urine pH is within the range greater than or equal to 7 to less than or equal to 8, and urine output is greater than or equal to 100 mL/hour.
Rituximab: 375 mg/m\^2 intravenous (IV) day 1 of each cycle prior to administration of high-dose methotrexate
Leucovorin: Leucovorin calcium doses will be administered orally or by short intravenous (IV) infusion over 15 minutes
|
|---|---|
|
Number of Participants With Response to Treatment After Rituximab, High-Dose Methotrexate (R-HD-MTX) Induction
Complete Response
|
5 Participants
|
|
Number of Participants With Response to Treatment After Rituximab, High-Dose Methotrexate (R-HD-MTX) Induction
Partial Response
|
4 Participants
|
|
Number of Participants With Response to Treatment After Rituximab, High-Dose Methotrexate (R-HD-MTX) Induction
Progressive Disease
|
1 Participants
|
SECONDARY outcome
Timeframe: Time from treatment start date until date of death or date last known alive, approximately 60 monthsParticipants that are estimated to be alive or last known to be alive after Rituximab, High-Dose Methotrexate and Leucovorin treatment.
Outcome measures
| Measure |
Rituximab, High-Dose Methotrexate & Leucovorin Treatment
n=12 Participants
Induction treatment cycles with rituximab, high-dose methotrexate and leucovorin will be administered every 2 weeks for 6 cycles. Two additional consolidation cycles of high-dose methotrexate without rituximab will be administered at 4 weeks and 8 weeks following completion of the combined therapy.
Methotrexate: 6000 mg/m\^2 will be administered by intravenous infusion over 4 hours after confirming that the recipient patients urine pH is within the range greater than or equal to 7 to less than or equal to 8, and urine output is greater than or equal to 100 mL/hour.
Rituximab: 375 mg/m\^2 intravenous (IV) day 1 of each cycle prior to administration of high-dose methotrexate
Leucovorin: Leucovorin calcium doses will be administered orally or by short intravenous (IV) infusion over 15 minutes
|
|---|---|
|
Estimated Percentage of Participants Overall Survival
|
66 percentage of participants
Interval 32.0 to 86.0
|
SECONDARY outcome
Timeframe: up to 2.5 yearsPopulation: Two participants were not evaluable. One participant received one cycle of therapy and one was not evaluable due to treatment failure.
The MMSE is scored out of a maximum of 30 points. A score of \>25 is considered normal, with scores \<25 indicating different levels of cognitive impairment: mild (21-24) moderate (10-20), and severe (0-10).
Outcome measures
| Measure |
Rituximab, High-Dose Methotrexate & Leucovorin Treatment
n=10 Participants
Induction treatment cycles with rituximab, high-dose methotrexate and leucovorin will be administered every 2 weeks for 6 cycles. Two additional consolidation cycles of high-dose methotrexate without rituximab will be administered at 4 weeks and 8 weeks following completion of the combined therapy.
Methotrexate: 6000 mg/m\^2 will be administered by intravenous infusion over 4 hours after confirming that the recipient patients urine pH is within the range greater than or equal to 7 to less than or equal to 8, and urine output is greater than or equal to 100 mL/hour.
Rituximab: 375 mg/m\^2 intravenous (IV) day 1 of each cycle prior to administration of high-dose methotrexate
Leucovorin: Leucovorin calcium doses will be administered orally or by short intravenous (IV) infusion over 15 minutes
|
|---|---|
|
Median Mini Mental Status Exam (MMSE) Score in Surviving Participants After Rituximab, High-Dose Methotrexate & Leucovorin ( R-HD-MTX) Treatment
|
28 Scores on a scale
Interval 27.0 to 30.0
|
SECONDARY outcome
Timeframe: Baseline and up to 2.5 yearsPopulation: Two participants were not evaluable. One participant received one cycle of therapy and one was not evaluable due to treatment failure.
An increase in CD4 cells is determined by the number of CD4+ T lymphocytes /µL of peripheral blood.
Outcome measures
| Measure |
Rituximab, High-Dose Methotrexate & Leucovorin Treatment
n=10 Participants
Induction treatment cycles with rituximab, high-dose methotrexate and leucovorin will be administered every 2 weeks for 6 cycles. Two additional consolidation cycles of high-dose methotrexate without rituximab will be administered at 4 weeks and 8 weeks following completion of the combined therapy.
Methotrexate: 6000 mg/m\^2 will be administered by intravenous infusion over 4 hours after confirming that the recipient patients urine pH is within the range greater than or equal to 7 to less than or equal to 8, and urine output is greater than or equal to 100 mL/hour.
Rituximab: 375 mg/m\^2 intravenous (IV) day 1 of each cycle prior to administration of high-dose methotrexate
Leucovorin: Leucovorin calcium doses will be administered orally or by short intravenous (IV) infusion over 15 minutes
|
|---|---|
|
Change From Baseline in Cluster of Differentiation 4 (CD4) T Cell Count at up to 2.5 Years
|
35 cells/µL
Interval -54.0 to 369.0
|
Adverse Events
Rituximab, High-Dose Methotrexate & Leucovorin Treatment
Serious events: 3 serious events
Other events: 11 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Rituximab, High-Dose Methotrexate & Leucovorin Treatment
n=12 participants at risk
Induction treatment cycles with rituximab, high-dose methotrexate and leucovorin will be administered every 2 weeks for 6 cycles. Two additional consolidation cycles of high-dose methotrexate without rituximab will be administered at 4 weeks and 8 weeks following completion of the combined therapy.
Methotrexate: 6000 mg/m\^2 will be administered by intravenous infusion over 4 hours after confirming that the recipient patients urine pH is within the range greater than or equal to 7 to less than or equal to 8, and urine output is greater than or equal to 100 mL/hour.
Rituximab: 375 mg/m\^2 intravenous (IV) day 1 of each cycle prior to administration of high-dose methotrexate
Leucovorin: Leucovorin calcium doses will be administered orally or by short intravenous (IV) infusion over 15 minutes
|
|---|---|
|
General disorders
Death not associated with CTCAE term::Death NOS
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
General disorders
Death not associated with CTCAE term::Disease progression NOS
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Gastrointestinal disorders
Hemorrhage, GI::Upper GI NOS
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, Patient intubated)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, Pulmonary embolism)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
Other adverse events
| Measure |
Rituximab, High-Dose Methotrexate & Leucovorin Treatment
n=12 participants at risk
Induction treatment cycles with rituximab, high-dose methotrexate and leucovorin will be administered every 2 weeks for 6 cycles. Two additional consolidation cycles of high-dose methotrexate without rituximab will be administered at 4 weeks and 8 weeks following completion of the combined therapy.
Methotrexate: 6000 mg/m\^2 will be administered by intravenous infusion over 4 hours after confirming that the recipient patients urine pH is within the range greater than or equal to 7 to less than or equal to 8, and urine output is greater than or equal to 100 mL/hour.
Rituximab: 375 mg/m\^2 intravenous (IV) day 1 of each cycle prior to administration of high-dose methotrexate
Leucovorin: Leucovorin calcium doses will be administered orally or by short intravenous (IV) infusion over 15 minutes
|
|---|---|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
75.0%
9/12 • Number of events 58 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
91.7%
11/12 • Number of events 64 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Endocrine disorders
Adrenal insufficiency
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
83.3%
10/12 • Number of events 72 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
50.0%
6/12 • Number of events 39 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Metabolism and nutrition disorders
Alkalosis (metabolic or respiratory)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Gastrointestinal disorders
Anorexia
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Nervous system disorders
Ataxia (incoordination)
|
16.7%
2/12 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
16.7%
2/12 • Number of events 12 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Eye disorders
Blurred vision
|
8.3%
1/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Blood and lymphatic system disorders
CD4 count
|
41.7%
5/12 • Number of events 19 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Metabolism and nutrition disorders
CPK (creatine phosphokinase)
|
16.7%
2/12 • Number of events 4 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
33.3%
4/12 • Number of events 8 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
33.3%
4/12 • Number of events 5 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Nervous system disorders
Cognitive disturbance
|
25.0%
3/12 • Number of events 6 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Nervous system disorders
Confusion
|
25.0%
3/12 • Number of events 5 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Nervous system disorders
Constitutional Symptoms - Other (Specify, Concentration)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
2/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Metabolism and nutrition disorders
Creatinine
|
33.3%
4/12 • Number of events 7 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Musculoskeletal and connective tissue disorders
Decreased gait
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Gastrointestinal disorders
Dental: teeth
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Gastrointestinal disorders
Diarrhea
|
41.7%
5/12 • Number of events 7 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Nervous system disorders
Dizziness
|
16.7%
2/12 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
16.7%
2/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
33.3%
4/12 • Number of events 10 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Blood and lymphatic system disorders
Fibrinogen
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Metabolism and nutrition disorders
GGT (gamma-Glutamyl transpeptidase)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, (+) stool crytosporidium)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
83.3%
10/12 • Number of events 46 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
16.7%
2/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
83.3%
10/12 • Number of events 79 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Metabolism and nutrition disorders
Hemoglobinuria
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Gastrointestinal disorders
Hemorrhage, GI::Lower GI NOS
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Cardiac disorders
Hypertension
|
16.7%
2/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Cardiac disorders
Hypotension
|
16.7%
2/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Infections and infestations
Infection
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Infections and infestations
Infection - Other (Specify, HSV)
|
41.7%
5/12 • Number of events 9 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Infections and infestations
Infection - Other (Specify, Pneumonia)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Infections and infestations
Infection - Other (Specify, Pruritic warts)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Infections and infestations
Infection - Other (Specify, Staph infection)
|
8.3%
1/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Infections and infestations
Infection - Other (Specify, Stool Novovirus positive)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Infections and infestations
Infection - Other (Specify, Stool rotavirus)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Infections and infestations
Infection - Other (Specify, Urine culture positive)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Infections and infestations
Infection - Other (Specify, )
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Sinus
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS
|
16.7%
2/12 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Infections and infestations
Infection with unknown ANC::Urinary tract NOS
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
91.7%
11/12 • Number of events 108 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
66.7%
8/12 • Number of events 69 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
16.7%
2/12 • Number of events 4 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
75.0%
9/12 • Number of events 40 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Nervous system disorders
Memory impairment
|
33.3%
4/12 • Number of events 7 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Nervous system disorders
Mood alteration::Agitation
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Nervous system disorders
Mood alteration::Anxiety
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Nervous system disorders
Mood alteration::Depression
|
8.3%
1/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)::Extremity-lower
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Specify, Intermittent myoclonic)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
2/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Nervous system disorders
Neuropathy: motor
|
8.3%
1/12 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Nervous system disorders
Neuropathy: sensory
|
16.7%
2/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
83.3%
10/12 • Number of events 89 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis (avascular necrosis)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Infections and infestations
PCP Infection
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Blood and lymphatic system disorders
PTT (Partial Thromboplastin Time)
|
16.7%
2/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Musculoskeletal and connective tissue disorders
Pain - Other (Specify, BLE pain)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Ear and labyrinth disorders
Pain - Other (Specify, Ear pain)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Eye disorders
Pain - Other (Specify, Left eye discomfort)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Musculoskeletal and connective tissue disorders
Pain - Other (Specify, Thigh pain)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Reproductive system and breast disorders
Pain - Other (Specify, Testicular pain)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Gastrointestinal disorders
Pain::Abdomen NOS
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Gastrointestinal disorders
Pain::Dental/teeth/peridontal
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Nervous system disorders
Pain::Head/headache
|
16.7%
2/12 • Number of events 4 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Musculoskeletal and connective tissue disorders
Pain::Joint
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Musculoskeletal and connective tissue disorders
Pain::Muscle
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Gastrointestinal disorders
Pain::Oral-gums
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
General disorders
Pain::Pain NOS
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Gastrointestinal disorders
Pain::Rectum
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
50.0%
6/12 • Number of events 15 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Blood and lymphatic system disorders
Platelets
|
75.0%
9/12 • Number of events 29 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
25.0%
3/12 • Number of events 3 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
58.3%
7/12 • Number of events 14 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Metabolism and nutrition disorders
Proteinuria
|
25.0%
3/12 • Number of events 10 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Nervous system disorders
Seizure
|
8.3%
1/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Nervous system disorders
Sleepy Somnolence
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
41.7%
5/12 • Number of events 15 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
33.3%
4/12 • Number of events 12 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Nervous system disorders
Speech impairment (e.g., dysphasia or aphasia)
|
16.7%
2/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Atrial tachycardia/Paroxysmal Atrial Tachycardia
|
8.3%
1/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Sinus tachycardia
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Nervous system disorders
Syncope (fainting)
|
16.7%
2/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Nervous system disorders
Tremor
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Cardiac disorders
Ventricular arrhythmia::Ventricular tachycardia
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Eye disorders
Vision-blurred vision
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Eye disorders
Vision-photophobia
|
8.3%
1/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
2/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
|
General disorders
Weight gain
|
25.0%
3/12 • Number of events 4 • Date treatment consent signed to date off study, approximately 142 months and 11 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place