Trial Outcomes & Findings for Therapy for Patients With Untreated Age-Adjusted International Prognostic Index Low-Intermediate Risk, High-Intermediate Risk, or High Risk Diffuse Large B Cell Lymphoma (NCT NCT00712582)
NCT ID: NCT00712582
Last Updated: 2022-06-21
Results Overview
2-year PFS from the start of induction therapy conditional on attaining either a negative FDG-PET or a negative biopsy at the interim evaluation.
COMPLETED
PHASE2
96 participants
2 years
2022-06-21
Participant Flow
Participant milestones
| Measure |
Consolidation A
Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow.
Patients whose disease is FDG-PET negative or patients whose FDG-PET scan is positive but repeat biopsy is negative and whose initial Ki-67 expression is \< 80% will receive 3 cycles of standard dose ICE Chemotherapy.
Etoposide, carboplatin, ifosfamide: Patients in consolidation A will receive three drugs in a regimen called ICE. You will have 3 cycles. Each new cycle begins 2 to 3 weeks after the last one.
|
Consolidation B
Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow.
Patients whose disease is FDG-PET negative or patients whose FDG-PET scan is positive but repeat biopsy is negative and whose initial Ki-67 expression is ≥80% will receive 2 cycles of augmented RICE Chemotherapy (as per MSKCC protocol 03-075).
Rituximab, Ifosfamide, Etoposide, Carboplatin: It consists of four drugs in a regimen called augmented RICE (augRICE). It is given every 3 weeks for 2 cycles.
|
Consolidation C
Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow.
Consolidation C: Patients with biopsy proven disease after induction therapy. Patients whose bone marrow remain positive at interim restaging will have the option of getting an allogeneic\[m3\] stem cell transplant, in lieu of an ASCT, if they have an acceptable HLA match donor. The allogeneic\[m4\] stem cell transplant regimen will be decided by the MSK Bone Marrow Transplant Service.
Rituximab, Ifosfamide, Etoposide, Carboplatin, Stem Cell Collection, Mitoxantrone, Cyclophosphamide and etoposide, Carmustine: It consists of four drugs in a regimen called augRICE. It is given every 3 weeks for 2 cycles. After the rituximab on day 3, you will then be admitted to the hospital for 2 to 3 nights.
Part 2: Stem Cell Collection, Part 3: High dose chemoradiotherapy and stem cell transplant. Your doctor may want you to get radiation therapy. If so, it will start 2 weeks before the highdose chemotherapy. This regimen is called CBV-N chemotherapy. It is given by vein in the hospital.
|
|---|---|---|---|
|
Overall Study
STARTED
|
60
|
32
|
4
|
|
Overall Study
COMPLETED
|
60
|
32
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Therapy for Patients With Untreated Age-Adjusted International Prognostic Index Low-Intermediate Risk, High-Intermediate Risk, or High Risk Diffuse Large B Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Consolidation A
n=60 Participants
Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow.
Patients whose disease is FDG-PET negative or patients whose FDG-PET scan is positive but repeat biopsy is negative and whose initial Ki-67 expression is \< 80% will receive 3 cycles of standard dose ICE Chemotherapy.
Etoposide, carboplatin, ifosfamide: Patients in consolidation A will receive three drugs in a regimen called ICE. You will have 3 cycles. Each new cycle begins 2 to 3 weeks after the last one.
|
Consolidation B
n=32 Participants
Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow.
Patients whose disease is FDG-PET negative or patients whose FDG-PET scan is positive but repeat biopsy is negative and whose initial Ki-67 expression is ≥80% will receive 2 cycles of augmented RICE Chemotherapy (as per MSKCC protocol 03-075).
Rituximab, Ifosfamide, Etoposide, Carboplatin: It consists of four drugs in a regimen called augmented RICE (augRICE). It is given every 3 weeks for 2 cycles.
|
Consolidation C
n=4 Participants
Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow.
Consolidation C: Patients with biopsy proven disease after induction therapy. Patients whose bone marrow remain positive at interim restaging will have the option of getting an allogeneic\[m3\] stem cell transplant, in lieu of an ASCT, if they have an acceptable HLA match donor. The allogeneic\[m4\] stem cell transplant regimen will be decided by the MSK Bone Marrow Transplant Service.
Rituximab, Ifosfamide, Etoposide, Carboplatin, Stem Cell Collection, Mitoxantrone, Cyclophosphamide and etoposide, Carmustine: It consists of four drugs in a regimen called augRICE. It is given every 3 weeks for 2 cycles. After the rituximab on day 3, you will then be admitted to the hospital for 2 to 3 nights.
Part 2: Stem Cell Collection, Part 3: High dose chemoradiotherapy and stem cell transplant. Your doctor may want you to get radiation therapy. If so, it will start 2 weeks before the highdose chemotherapy. This regimen is called CBV-N chemotherapy. It is given by vein in the hospital.
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52 years
n=99 Participants
|
49.5 years
n=107 Participants
|
59 years
n=206 Participants
|
51.45 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
49 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
47 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
60 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
96 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
60 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
96 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
60 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
96 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 2 years2-year PFS from the start of induction therapy conditional on attaining either a negative FDG-PET or a negative biopsy at the interim evaluation.
Outcome measures
| Measure |
Consolidation A
n=60 Participants
Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow.
Patients whose disease is FDG-PET negative or patients whose FDG-PET scan is positive but repeat biopsy is negative and whose initial Ki-67 expression is \< 80% will receive 3 cycles of standard dose ICE Chemotherapy.
Etoposide, carboplatin, ifosfamide: Patients in consolidation A will receive three drugs in a regimen called ICE. You will have 3 cycles. Each new cycle begins 2 to 3 weeks after the last one.
|
Consolidation B
n=32 Participants
Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow.
Patients whose disease is FDG-PET negative or patients whose FDG-PET scan is positive but repeat biopsy is negative and whose initial Ki-67 expression is ≥80% will receive 2 cycles of augmented RICE Chemotherapy (as per MSKCC protocol 03-075).
Rituximab, Ifosfamide, Etoposide, Carboplatin: It consists of four drugs in a regimen called augmented RICE (augRICE). It is given every 3 weeks for 2 cycles.
|
Consolidation C
n=4 Participants
Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow.
Consolidation C: Patients with biopsy proven disease after induction therapy. Patients whose bone marrow remain positive at interim restaging will have the option of getting an allogeneic\[m3\] stem cell transplant, in lieu of an ASCT, if they have an acceptable HLA match donor. The allogeneic\[m4\] stem cell transplant regimen will be decided by the MSK Bone Marrow Transplant Service.
Rituximab, Ifosfamide, Etoposide, Carboplatin, Stem Cell Collection, Mitoxantrone, Cyclophosphamide and etoposide, Carmustine: It consists of four drugs in a regimen called augRICE. It is given every 3 weeks for 2 cycles. After the rituximab on day 3, you will then be admitted to the hospital for 2 to 3 nights.
Part 2: Stem Cell Collection, Part 3: High dose chemoradiotherapy and stem cell transplant. Your doctor may want you to get radiation therapy. If so, it will start 2 weeks before the highdose chemotherapy. This regimen is called CBV-N chemotherapy. It is given by vein in the hospital.
|
|---|---|---|---|
|
2-year PFS From the Start of Induction Therapy Conditional
|
86.6 percentage of patients
Interval 78.4 to 95.7
|
90.6 percentage of patients
Interval 81.1 to 100.0
|
0.4 percentage of patients
Interval 0.2 to 0.5
|
SECONDARY outcome
Timeframe: 1 yearOverall survival from the start of induction therapy conditional on attaining either a negative FDG-PET or a negative biopsy at the interim evaluation.
Outcome measures
| Measure |
Consolidation A
n=60 Participants
Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow.
Patients whose disease is FDG-PET negative or patients whose FDG-PET scan is positive but repeat biopsy is negative and whose initial Ki-67 expression is \< 80% will receive 3 cycles of standard dose ICE Chemotherapy.
Etoposide, carboplatin, ifosfamide: Patients in consolidation A will receive three drugs in a regimen called ICE. You will have 3 cycles. Each new cycle begins 2 to 3 weeks after the last one.
|
Consolidation B
n=32 Participants
Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow.
Patients whose disease is FDG-PET negative or patients whose FDG-PET scan is positive but repeat biopsy is negative and whose initial Ki-67 expression is ≥80% will receive 2 cycles of augmented RICE Chemotherapy (as per MSKCC protocol 03-075).
Rituximab, Ifosfamide, Etoposide, Carboplatin: It consists of four drugs in a regimen called augmented RICE (augRICE). It is given every 3 weeks for 2 cycles.
|
Consolidation C
n=4 Participants
Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow.
Consolidation C: Patients with biopsy proven disease after induction therapy. Patients whose bone marrow remain positive at interim restaging will have the option of getting an allogeneic\[m3\] stem cell transplant, in lieu of an ASCT, if they have an acceptable HLA match donor. The allogeneic\[m4\] stem cell transplant regimen will be decided by the MSK Bone Marrow Transplant Service.
Rituximab, Ifosfamide, Etoposide, Carboplatin, Stem Cell Collection, Mitoxantrone, Cyclophosphamide and etoposide, Carmustine: It consists of four drugs in a regimen called augRICE. It is given every 3 weeks for 2 cycles. After the rituximab on day 3, you will then be admitted to the hospital for 2 to 3 nights.
Part 2: Stem Cell Collection, Part 3: High dose chemoradiotherapy and stem cell transplant. Your doctor may want you to get radiation therapy. If so, it will start 2 weeks before the highdose chemotherapy. This regimen is called CBV-N chemotherapy. It is given by vein in the hospital.
|
|---|---|---|---|
|
Overall Survival at 1 Year
|
98.3 Percent of patients
Interval 95.1 to 100.0
|
96.9 Percent of patients
Interval 91.0 to 100.0
|
50.0 Percent of patients
Interval 18.8 to 100.0
|
SECONDARY outcome
Timeframe: Through study completion, up to 10 yearsPopulation: N/A - data were not collected
Obtain preliminary data on potential clinical usefulness of the proliferation marker \[18F\] fluorothymidine (FLT) in pts with diffuse large cell lymphoma, using combined (FDG-PET/CT). 18F-FLT uptake by visual analysis (stratified as grades 1-3 vs grades 4-5)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through the completion of study, up to 10 yearsPopulation: N/A - data were not collected
Obtain preliminary data on potential clinical usefulness of the proliferation marker \[18F\] fluorothymidine (FLT) in pts with diffuse large cell lymphoma, using combined (FDG-PET/CT). 18F-FLT uptake by visual analysis (stratified as grades 1-3 vs grades 4-5)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: conclusion of studyPopulation: N/A - Data were not collected
Outcome measures
Outcome data not reported
Adverse Events
Consolidation A
Consolidation B
Consolidation C
Serious adverse events
| Measure |
Consolidation A
n=60 participants at risk
Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow.
Patients whose disease is FDG-PET negative or patients whose FDG-PET scan is positive but repeat biopsy is negative and whose initial Ki-67 expression is \< 80% will receive 3 cycles of standard dose ICE Chemotherapy.
Etoposide, carboplatin, ifosfamide: Patients in consolidation A will receive three drugs in a regimen called ICE. You will have 3 cycles. Each new cycle begins 2 to 3 weeks after the last one.
|
Consolidation B
n=32 participants at risk
Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow.
Patients whose disease is FDG-PET negative or patients whose FDG-PET scan is positive but repeat biopsy is negative and whose initial Ki-67 expression is ≥80% will receive 2 cycles of augmented RICE Chemotherapy (as per MSKCC protocol 03-075).
Rituximab, Ifosfamide, Etoposide, Carboplatin: It consists of four drugs in a regimen called augmented RICE (augRICE). It is given every 3 weeks for 2 cycles.
|
Consolidation C
n=4 participants at risk
Induction: RR-CHOP-14 Chemotherapy for Three Cycles Each cycle lasts approximately 14 days. A total of 3 cycles of RR-CHOP-14 will be given. One cycle of CHOP will follow.
Consolidation C: Patients with biopsy proven disease after induction therapy. Patients whose bone marrow remain positive at interim restaging will have the option of getting an allogeneic\[m3\] stem cell transplant, in lieu of an ASCT, if they have an acceptable HLA match donor. The allogeneic\[m4\] stem cell transplant regimen will be decided by the MSK Bone Marrow Transplant Service.
Rituximab, Ifosfamide, Etoposide, Carboplatin, Stem Cell Collection, Mitoxantrone, Cyclophosphamide and etoposide, Carmustine: It consists of four drugs in a regimen called augRICE. It is given every 3 weeks for 2 cycles. After the rituximab on day 3, you will then be admitted to the hospital for 2 to 3 nights.
Part 2: Stem Cell Collection, Part 3: High dose chemoradiotherapy and stem cell transplant. Your doctor may want you to get radiation therapy. If so, it will start 2 weeks before the highdose chemotherapy. This regimen is called CBV-N chemotherapy. It is given by vein in the hospital.
|
|---|---|---|---|
|
Immune system disorders
Allerg react/hypersens (incl drug fever)
|
1.7%
1/60 • Up to 2 years
|
0.00%
0/32 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/60 • Up to 2 years
|
3.1%
1/32 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow, other
|
0.00%
0/60 • Up to 2 years
|
3.1%
1/32 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/60 • Up to 2 years
|
3.1%
1/32 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/60 • Up to 2 years
|
3.1%
1/32 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
3.3%
2/60 • Up to 2 years
|
9.4%
3/32 • Up to 2 years
|
25.0%
1/4 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/60 • Up to 2 years
|
3.1%
1/32 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Investigations
Creatinine
|
1.7%
1/60 • Up to 2 years
|
0.00%
0/32 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
3.3%
2/60 • Up to 2 years
|
3.1%
1/32 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/60 • Up to 2 years
|
0.00%
0/32 • Up to 2 years
|
25.0%
1/4 • Up to 2 years
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/60 • Up to 2 years
|
3.1%
1/32 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/60 • Up to 2 years
|
3.1%
1/32 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
General disorders
Fatigue
|
1.7%
1/60 • Up to 2 years
|
3.1%
1/32 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
10.0%
6/60 • Up to 2 years
|
25.0%
8/32 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
General disorders
Fever (in the absence of neutropenia)
|
3.3%
2/60 • Up to 2 years
|
3.1%
1/32 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/60 • Up to 2 years
|
3.1%
1/32 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Blood and lymphatic system disorders
Hemoglobin
|
5.0%
3/60 • Up to 2 years
|
3.1%
1/32 • Up to 2 years
|
25.0%
1/4 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/60 • Up to 2 years
|
3.1%
1/32 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Investigations
Leukocytes
|
5.0%
3/60 • Up to 2 years
|
0.00%
0/32 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/60 • Up to 2 years
|
6.2%
2/32 • Up to 2 years
|
25.0%
1/4 • Up to 2 years
|
|
Investigations
Neutrophils/granulocytes
|
0.00%
0/60 • Up to 2 years
|
3.1%
1/32 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Gastrointestinal disorders
Pain - Anus
|
0.00%
0/60 • Up to 2 years
|
3.1%
1/32 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
0.00%
0/60 • Up to 2 years
|
3.1%
1/32 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
General disorders
Pain - Chest/thorax NOS
|
0.00%
0/60 • Up to 2 years
|
0.00%
0/32 • Up to 2 years
|
50.0%
2/4 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Neck
|
1.7%
1/60 • Up to 2 years
|
0.00%
0/32 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Gastrointestinal disorders
Pain - Rectum
|
1.7%
1/60 • Up to 2 years
|
0.00%
0/32 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Vascular disorders
Phlebitis (incl superficial thrombosis)
|
1.7%
1/60 • Up to 2 years
|
3.1%
1/32 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Investigations
Platelets
|
5.0%
3/60 • Up to 2 years
|
3.1%
1/32 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Infections and infestations
Pneumonia (lung)
|
1.7%
1/60 • Up to 2 years
|
0.00%
0/32 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Metabolism and nutrition disorders
Potassium, low (hypokalemia)
|
1.7%
1/60 • Up to 2 years
|
0.00%
0/32 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Renal and urinary disorders
Renal/Genitourinary-Other Specify
|
1.7%
1/60 • Up to 2 years
|
0.00%
0/32 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary malig-poss related to ca txt
|
1.7%
1/60 • Up to 2 years
|
0.00%
0/32 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
|
0.00%
0/60 • Up to 2 years
|
3.1%
1/32 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Nervous system disorders
Syncope (fainting)
|
1.7%
1/60 • Up to 2 years
|
0.00%
0/32 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
1.7%
1/60 • Up to 2 years
|
3.1%
1/32 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/60 • Up to 2 years
|
3.1%
1/32 • Up to 2 years
|
0.00%
0/4 • Up to 2 years
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Andrew Zelenetz, MD, PhD
Memorial Sloan Kettering Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place