Trial Outcomes & Findings for Yttrium-90 Ibritumomab Tiuxetan Plus High-Dose BEAM Followed By ASCT For Relapsed B-Cell Non-Hodgkin Lymphoma (NCT NCT00695409)
NCT ID: NCT00695409
Last Updated: 2018-07-06
Results Overview
Progression-free survival (PFS) was defined as time from peripheral stem cell infusion to recurrence, progression or death. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works. Progression-free survival was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula \[Breslow NE, Day NE. Statistical methods in cancer research: volume II, the design and analysis of cohort studies. IARC Sci Publ 1987;82:1-406.\]
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
122 participants
Primary outcome timeframe
From peripheral stem cell infusion (Day0 ASCT) to first observation of progressive disease or death due to any cause, whichever comes first, assessed up to 5 years
Results posted on
2018-07-06
Participant Flow
Participant milestones
| Measure |
Treatment (RIT, ZBEAM, ASCT)
RADIOIMMUNOTHERAPY: Patients receive yttrium Y 90 ibritumomab tiuxetan IV following rituximab IV on day -14. HIGH-DOSE COMBINATION CHEMOTHERAPY: Patients receive carmustine IV on days -7 and -6; etoposide IV over 1 hour twice daily and cytarabine IV over 2 hours twice daily on days -5 to -2; and melphalan IV on day -1. STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplant on day 0. Patients also receive rituximab on day 8\*. NOTE: \* Some patients may also receive rituximab on day -1. Treatment continues in the absence of disease progression or unacceptable toxicity.
rituximab: Given IV
carmustine: Given IV
cytarabine: Given IV
etoposide: Given IV
melphalan: Given IV
ASCT: Undergo autologous peripheral blood stem cell transplant
yttrium Y 90 ibritumomab tiuxetan: Given IV
|
|---|---|
|
Overall Study
STARTED
|
122
|
|
Overall Study
COMPLETED
|
122
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Yttrium-90 Ibritumomab Tiuxetan Plus High-Dose BEAM Followed By ASCT For Relapsed B-Cell Non-Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Treatment (RIT, ZBEAM, ASCT)
n=122 Participants
RADIOIMMUNOTHERAPY: Patients receive yttrium Y 90 ibritumomab tiuxetan IV following rituximab IV on day -14. HIGH-DOSE COMBINATION CHEMOTHERAPY: Patients receive carmustine IV on days -7 and -6; etoposide IV over 1 hour twice daily and cytarabine IV over 2 hours twice daily on days -5 to -2; and melphalan IV on day -1. STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplant on day 0. Patients also receive rituximab on day 8\*. NOTE: \* Some patients may also receive rituximab on day -1. Treatment continues in the absence of disease progression or unacceptable toxicity.
rituximab: Given IV
carmustine: Given IV
cytarabine: Given IV
etoposide: Given IV
melphalan: Given IV
ASCT: Undergo autologous peripheral blood stem cell transplant
yttrium Y 90 ibritumomab tiuxetan: Given IV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
103 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
92 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
10 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
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
104 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
122 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From peripheral stem cell infusion (Day0 ASCT) to first observation of progressive disease or death due to any cause, whichever comes first, assessed up to 5 yearsPopulation: 6 patients did not receive full treatment so are excluded from the result analysis.
Progression-free survival (PFS) was defined as time from peripheral stem cell infusion to recurrence, progression or death. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works. Progression-free survival was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula \[Breslow NE, Day NE. Statistical methods in cancer research: volume II, the design and analysis of cohort studies. IARC Sci Publ 1987;82:1-406.\]
Outcome measures
| Measure |
Treatment (RIT, ZBEAM, ASCT)
n=116 Participants
RADIOIMMUNOTHERAPY: Patients receive yttrium Y 90 ibritumomab tiuxetan IV following rituximab IV on day -14. HIGH-DOSE COMBINATION CHEMOTHERAPY: Patients receive carmustine IV on days -7 and -6; etoposide IV over 1 hour twice daily and cytarabine IV over 2 hours twice daily on days -5 to -2; and melphalan IV on day -1. STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplant on day 0. Patients also receive rituximab on day 8\*. NOTE: \* Some patients may also receive rituximab on day -1. Treatment continues in the absence of disease progression or unacceptable toxicity.
rituximab: Given IV
carmustine: Given IV
cytarabine: Given IV
etoposide: Given IV
melphalan: Given IV
ASCT: Undergo autologous peripheral blood stem cell transplant
yttrium Y 90 ibritumomab tiuxetan: Given IV
|
|---|---|
|
2-Year Progression-Free Survival
|
71 Percentage of Participants (%)
Interval 61.0 to 78.0
|
SECONDARY outcome
Timeframe: From peripheral stem cell infusion (Day0 ASCT) to death due to any cause, assessed up to 5 yearsPopulation: 6 patients did not receive full treatment so are excluded from the result analysis.
Overall survival (OS) was measured from peripheral stem cell infusion to death from any cause. It was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula. \[Breslow NE, Day NE. Statistical methods in cancer research: volume II, the design and analysis of cohort studies. IARC Sci Publ 1987;82:1-406.\]
Outcome measures
| Measure |
Treatment (RIT, ZBEAM, ASCT)
n=116 Participants
RADIOIMMUNOTHERAPY: Patients receive yttrium Y 90 ibritumomab tiuxetan IV following rituximab IV on day -14. HIGH-DOSE COMBINATION CHEMOTHERAPY: Patients receive carmustine IV on days -7 and -6; etoposide IV over 1 hour twice daily and cytarabine IV over 2 hours twice daily on days -5 to -2; and melphalan IV on day -1. STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplant on day 0. Patients also receive rituximab on day 8\*. NOTE: \* Some patients may also receive rituximab on day -1. Treatment continues in the absence of disease progression or unacceptable toxicity.
rituximab: Given IV
carmustine: Given IV
cytarabine: Given IV
etoposide: Given IV
melphalan: Given IV
ASCT: Undergo autologous peripheral blood stem cell transplant
yttrium Y 90 ibritumomab tiuxetan: Given IV
|
|---|---|
|
2-Year Overall Survival
|
89 Percentage of Participants (%)
Interval 82.0 to 94.0
|
SECONDARY outcome
Timeframe: From peripheral stem cell infusion (Day0 ASCT) to date of first observation of progressive disease or relapsed disease, assessed up to 5 yearsPopulation: 6 patients did not receive full treatment so are excluded from the result analysis
The cumulative incidence was estimated after taking into account the competing risk of early death.
Outcome measures
| Measure |
Treatment (RIT, ZBEAM, ASCT)
n=116 Participants
RADIOIMMUNOTHERAPY: Patients receive yttrium Y 90 ibritumomab tiuxetan IV following rituximab IV on day -14. HIGH-DOSE COMBINATION CHEMOTHERAPY: Patients receive carmustine IV on days -7 and -6; etoposide IV over 1 hour twice daily and cytarabine IV over 2 hours twice daily on days -5 to -2; and melphalan IV on day -1. STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplant on day 0. Patients also receive rituximab on day 8\*. NOTE: \* Some patients may also receive rituximab on day -1. Treatment continues in the absence of disease progression or unacceptable toxicity.
rituximab: Given IV
carmustine: Given IV
cytarabine: Given IV
etoposide: Given IV
melphalan: Given IV
ASCT: Undergo autologous peripheral blood stem cell transplant
yttrium Y 90 ibritumomab tiuxetan: Given IV
|
|---|---|
|
2-Year Cumulative Incidence of Progression
|
28 Percentage of Participants (%)
Interval 20.0 to 37.0
|
SECONDARY outcome
Timeframe: Up to Day 100 post-ASCTResponses are assessed using the Revised Criteria for Malignant Lymphoma Response Definitions for Clinical Trials (Cheson et al. 2007). Complete Response (CR) defined as disappearance of all evidence of disease. Partial Response (PR) defined as regression of measurable disease and no new sites.
Outcome measures
| Measure |
Treatment (RIT, ZBEAM, ASCT)
n=64 Participants
RADIOIMMUNOTHERAPY: Patients receive yttrium Y 90 ibritumomab tiuxetan IV following rituximab IV on day -14. HIGH-DOSE COMBINATION CHEMOTHERAPY: Patients receive carmustine IV on days -7 and -6; etoposide IV over 1 hour twice daily and cytarabine IV over 2 hours twice daily on days -5 to -2; and melphalan IV on day -1. STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplant on day 0. Patients also receive rituximab on day 8\*. NOTE: \* Some patients may also receive rituximab on day -1. Treatment continues in the absence of disease progression or unacceptable toxicity.
rituximab: Given IV
carmustine: Given IV
cytarabine: Given IV
etoposide: Given IV
melphalan: Given IV
ASCT: Undergo autologous peripheral blood stem cell transplant
yttrium Y 90 ibritumomab tiuxetan: Given IV
|
|---|---|
|
Number of Patients With Active Disease at ASCT Achieving CR/PR by Day 100 After ASCT
|
53 Participants
|
SECONDARY outcome
Timeframe: From initial of study treatment to Day 100 post-ASCTToxicities were recorded using the modified Bearman Scale for non-hematologic adverse events.
Outcome measures
| Measure |
Treatment (RIT, ZBEAM, ASCT)
n=122 Participants
RADIOIMMUNOTHERAPY: Patients receive yttrium Y 90 ibritumomab tiuxetan IV following rituximab IV on day -14. HIGH-DOSE COMBINATION CHEMOTHERAPY: Patients receive carmustine IV on days -7 and -6; etoposide IV over 1 hour twice daily and cytarabine IV over 2 hours twice daily on days -5 to -2; and melphalan IV on day -1. STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplant on day 0. Patients also receive rituximab on day 8\*. NOTE: \* Some patients may also receive rituximab on day -1. Treatment continues in the absence of disease progression or unacceptable toxicity.
rituximab: Given IV
carmustine: Given IV
cytarabine: Given IV
etoposide: Given IV
melphalan: Given IV
ASCT: Undergo autologous peripheral blood stem cell transplant
yttrium Y 90 ibritumomab tiuxetan: Given IV
|
|---|---|
|
Number of Patients With Grade 3-4 Bearman Toxicities.
Gastrointestinal Toxicity
|
1 Participants
|
|
Number of Patients With Grade 3-4 Bearman Toxicities.
Pulmonary Toxicity
|
1 Participants
|
|
Number of Patients With Grade 3-4 Bearman Toxicities.
No Grade 3-4 Toxicity
|
120 Participants
|
SECONDARY outcome
Timeframe: From peripheral stem cell infusion (Day0 ASCT) to death due to any couse, assessed up to 5 yearsPopulation: 6 patients did not receive full treatment so are excluded from the result analysis.
The cumulative incidence was estimated after taking into account the competing risk of relapse post-ASCT.
Outcome measures
| Measure |
Treatment (RIT, ZBEAM, ASCT)
n=116 Participants
RADIOIMMUNOTHERAPY: Patients receive yttrium Y 90 ibritumomab tiuxetan IV following rituximab IV on day -14. HIGH-DOSE COMBINATION CHEMOTHERAPY: Patients receive carmustine IV on days -7 and -6; etoposide IV over 1 hour twice daily and cytarabine IV over 2 hours twice daily on days -5 to -2; and melphalan IV on day -1. STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplant on day 0. Patients also receive rituximab on day 8\*. NOTE: \* Some patients may also receive rituximab on day -1. Treatment continues in the absence of disease progression or unacceptable toxicity.
rituximab: Given IV
carmustine: Given IV
cytarabine: Given IV
etoposide: Given IV
melphalan: Given IV
ASCT: Undergo autologous peripheral blood stem cell transplant
yttrium Y 90 ibritumomab tiuxetan: Given IV
|
|---|---|
|
100-Day Treatment-Related Mortality
|
0.9 Percentage of Participants (%)
Interval 0.1 to 6.1
|
SECONDARY outcome
Timeframe: From peripheral stem cell infusion (Day0 ASCT) till the first of 3 consecutive days of an absolute neutrophil count ≥ 500/µL.)Population: 6 patients did not receive full treatment so are excluded from the result analysis.
Neutrophil recovery was defined as the first of 3 consecutive days of an absolute neutrophil count ≥ 500/µL.
Outcome measures
| Measure |
Treatment (RIT, ZBEAM, ASCT)
n=116 Participants
RADIOIMMUNOTHERAPY: Patients receive yttrium Y 90 ibritumomab tiuxetan IV following rituximab IV on day -14. HIGH-DOSE COMBINATION CHEMOTHERAPY: Patients receive carmustine IV on days -7 and -6; etoposide IV over 1 hour twice daily and cytarabine IV over 2 hours twice daily on days -5 to -2; and melphalan IV on day -1. STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplant on day 0. Patients also receive rituximab on day 8\*. NOTE: \* Some patients may also receive rituximab on day -1. Treatment continues in the absence of disease progression or unacceptable toxicity.
rituximab: Given IV
carmustine: Given IV
cytarabine: Given IV
etoposide: Given IV
melphalan: Given IV
ASCT: Undergo autologous peripheral blood stem cell transplant
yttrium Y 90 ibritumomab tiuxetan: Given IV
|
|---|---|
|
Time to Neutrophil Recovery
|
10 Days
Interval 9.0 to 13.0
|
SECONDARY outcome
Timeframe: From peripheral stem cell infusion (Day0 ASCT) till the first of 7 consecutive days with a platelet count ≥ 20,000/µL with no transfusionsPopulation: 6 patients did not receive full treatment so are excluded from the result analysis.
Platelet recovery was defined as the first of 7 consecutive days with a platelet count ≥ 20,000/µL with no transfusions.
Outcome measures
| Measure |
Treatment (RIT, ZBEAM, ASCT)
n=116 Participants
RADIOIMMUNOTHERAPY: Patients receive yttrium Y 90 ibritumomab tiuxetan IV following rituximab IV on day -14. HIGH-DOSE COMBINATION CHEMOTHERAPY: Patients receive carmustine IV on days -7 and -6; etoposide IV over 1 hour twice daily and cytarabine IV over 2 hours twice daily on days -5 to -2; and melphalan IV on day -1. STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplant on day 0. Patients also receive rituximab on day 8\*. NOTE: \* Some patients may also receive rituximab on day -1. Treatment continues in the absence of disease progression or unacceptable toxicity.
rituximab: Given IV
carmustine: Given IV
cytarabine: Given IV
etoposide: Given IV
melphalan: Given IV
ASCT: Undergo autologous peripheral blood stem cell transplant
yttrium Y 90 ibritumomab tiuxetan: Given IV
|
|---|---|
|
Time to Platelet Recovery
|
12 Days
Interval 8.0 to 86.0
|
SECONDARY outcome
Timeframe: From peripheral stem cell infusion (Day0 ASCT) to onset of therapy induced MDS/AML, assessed up to 5 yearsPopulation: 6 patients did not receive full treatment so are excluded from the result analysis.
Patient receiving the full treatment of RIT/ZBEAM developed therapy induced MDS or AML.
Outcome measures
| Measure |
Treatment (RIT, ZBEAM, ASCT)
n=116 Participants
RADIOIMMUNOTHERAPY: Patients receive yttrium Y 90 ibritumomab tiuxetan IV following rituximab IV on day -14. HIGH-DOSE COMBINATION CHEMOTHERAPY: Patients receive carmustine IV on days -7 and -6; etoposide IV over 1 hour twice daily and cytarabine IV over 2 hours twice daily on days -5 to -2; and melphalan IV on day -1. STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplant on day 0. Patients also receive rituximab on day 8\*. NOTE: \* Some patients may also receive rituximab on day -1. Treatment continues in the absence of disease progression or unacceptable toxicity.
rituximab: Given IV
carmustine: Given IV
cytarabine: Given IV
etoposide: Given IV
melphalan: Given IV
ASCT: Undergo autologous peripheral blood stem cell transplant
yttrium Y 90 ibritumomab tiuxetan: Given IV
|
|---|---|
|
Number of Patients With RIT/ZBEAM Developing Therapy Induced MDS and AML
|
0 Participants
|
Adverse Events
Treatment (RIT, ZBEAM, ASCT)
Serious events: 2 serious events
Other events: 121 other events
Deaths: 25 deaths
Serious adverse events
| Measure |
Treatment (RIT, ZBEAM, ASCT)
n=122 participants at risk
RADIOIMMUNOTHERAPY: Patients receive yttrium Y 90 ibritumomab tiuxetan IV following rituximab IV on day -14. HIGH-DOSE COMBINATION CHEMOTHERAPY: Patients receive carmustine IV on days -7 and -6; etoposide IV over 1 hour twice daily and cytarabine IV over 2 hours twice daily on days -5 to -2; and melphalan IV on day -1. STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplant on day 0. Patients also receive rituximab on day 8\*. NOTE: \* Some patients may also receive rituximab on day -1. Treatment continues in the absence of disease progression or unacceptable toxicity.
rituximab: Given IV
carmustine: Given IV
cytarabine: Given IV
etoposide: Given IV
melphalan: Given IV
ASCT: Undergo autologous peripheral blood stem cell transplant
yttrium Y 90 ibritumomab tiuxetan: Given IV
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
0.82%
1/122 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Secondary Malignancy
|
0.82%
1/122 • Number of events 1 • Up to 5 years
|
Other adverse events
| Measure |
Treatment (RIT, ZBEAM, ASCT)
n=122 participants at risk
RADIOIMMUNOTHERAPY: Patients receive yttrium Y 90 ibritumomab tiuxetan IV following rituximab IV on day -14. HIGH-DOSE COMBINATION CHEMOTHERAPY: Patients receive carmustine IV on days -7 and -6; etoposide IV over 1 hour twice daily and cytarabine IV over 2 hours twice daily on days -5 to -2; and melphalan IV on day -1. STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplant on day 0. Patients also receive rituximab on day 8\*. NOTE: \* Some patients may also receive rituximab on day -1. Treatment continues in the absence of disease progression or unacceptable toxicity.
rituximab: Given IV
carmustine: Given IV
cytarabine: Given IV
etoposide: Given IV
melphalan: Given IV
ASCT: Undergo autologous peripheral blood stem cell transplant
yttrium Y 90 ibritumomab tiuxetan: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other (Specify, __)
|
1.7%
2/121 • Number of events 2 • Up to 5 years
|
|
Blood and lymphatic system disorders
Bone marrow cellularity
|
9.1%
11/121 • Number of events 11 • Up to 5 years
|
|
Blood and lymphatic system disorders
Hemoglobin
|
98.3%
119/121 • Number of events 119 • Up to 5 years
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
96.7%
117/121 • Number of events 130 • Up to 5 years
|
|
Blood and lymphatic system disorders
Lymphopenia
|
97.5%
118/121 • Number of events 129 • Up to 5 years
|
|
Blood and lymphatic system disorders
Myelodysplasia
|
0.83%
1/121 • Number of events 1 • Up to 5 years
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
95.0%
115/121 • Number of events 154 • Up to 5 years
|
|
Blood and lymphatic system disorders
Phlebitis (including superficial thrombosis)
|
0.83%
1/121 • Number of events 1 • Up to 5 years
|
|
Blood and lymphatic system disorders
Platelets
|
95.0%
115/121 • Number of events 121 • Up to 5 years
|
|
Blood and lymphatic system disorders
Thrombosis/embolism (vascular access-related)
|
0.83%
1/121 • Number of events 1 • Up to 5 years
|
|
Blood and lymphatic system disorders
Thrombosis/thrombus/embolism
|
1.7%
2/121 • Number of events 4 • Up to 5 years
|
|
Blood and lymphatic system disorders
INR (International Normalized Ratio of prothrombin time)
|
1.7%
2/121 • Number of events 2 • Up to 5 years
|
|
Blood and lymphatic system disorders
PTT (Partial Thromboplastin Time)
|
3.3%
4/121 • Number of events 4 • Up to 5 years
|
|
Cardiac disorders
Cardiac Arrhythmia - Other (Specify, __)
|
2.5%
3/121 • Number of events 3 • Up to 5 years
|
|
Cardiac disorders
Cardiac General - Other (Specify, __)
|
10.7%
13/121 • Number of events 17 • Up to 5 years
|
|
Cardiac disorders
Conduction abnormality/atrioventricular heart block
|
1.7%
2/121 • Number of events 2 • Up to 5 years
|
|
Cardiac disorders
Hypertension
|
29.8%
36/121 • Number of events 43 • Up to 5 years
|
|
Cardiac disorders
Hypotension
|
38.8%
47/121 • Number of events 47 • Up to 5 years
|
|
Cardiac disorders
Left ventricular diastolic dysfunction
|
0.83%
1/121 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
14.9%
18/121 • Number of events 18 • Up to 5 years
|
|
Cardiac disorders
Palpitations
|
2.5%
3/121 • Number of events 3 • Up to 5 years
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
4.1%
5/121 • Number of events 5 • Up to 5 years
|
|
Cardiac disorders
Prolonged QTc interval
|
15.7%
19/121 • Number of events 19 • Up to 5 years
|
|
Cardiac disorders
Pulmonary hypertension
|
0.83%
1/121 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Right ventricular dysfunction (cor pulmonale)
|
0.83%
1/121 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia
|
36.4%
44/121 • Number of events 56 • Up to 5 years
|
|
Cardiac disorders
Valvular heart disease
|
3.3%
4/121 • Number of events 4 • Up to 5 years
|
|
Cardiac disorders
Ventricular arrhythmia
|
1.7%
2/121 • Number of events 2 • Up to 5 years
|
|
Ear and labyrinth disorders
Auditory/Ear - Other (Specify, __)
|
3.3%
4/121 • Number of events 4 • Up to 5 years
|
|
Ear and labyrinth disorders
Hearing: patients without baseline audiogram and not enrolled in a monitoring program
|
5.8%
7/121 • Number of events 10 • Up to 5 years
|
|
Ear and labyrinth disorders
Tinnitus
|
6.6%
8/121 • Number of events 8 • Up to 5 years
|
|
Endocrine disorders
Endocrine - Other (Specify, __)
|
0.83%
1/121 • Number of events 1 • Up to 5 years
|
|
Endocrine disorders
Hot flashes/flushes
|
1.7%
2/121 • Number of events 2 • Up to 5 years
|
|
Eye disorders
Dry eye syndrome
|
4.1%
5/121 • Number of events 5 • Up to 5 years
|
|
Eye disorders
Glaucoma
|
1.7%
2/121 • Number of events 2 • Up to 5 years
|
|
Eye disorders
Nystagmus
|
2.5%
3/121 • Number of events 3 • Up to 5 years
|
|
Eye disorders
Ocular surface disease
|
2.5%
3/121 • Number of events 3 • Up to 5 years
|
|
Eye disorders
Ocular/Visual - Other (Specify, __)
|
5.0%
6/121 • Number of events 8 • Up to 5 years
|
|
Eye disorders
Retinal detachment
|
0.83%
1/121 • Number of events 1 • Up to 5 years
|
|
Eye disorders
Vision-blurred vision
|
5.8%
7/121 • Number of events 7 • Up to 5 years
|
|
Eye disorders
Vision-flashing lights/floaters
|
1.7%
2/121 • Number of events 2 • Up to 5 years
|
|
Eye disorders
Watery eye (epiphora, tearing)
|
2.5%
3/121 • Number of events 3 • Up to 5 years
|
|
Gastrointestinal disorders
Anorexia
|
82.6%
100/121 • Number of events 100 • Up to 5 years
|
|
Gastrointestinal disorders
Colitis
|
6.6%
8/121 • Number of events 8 • Up to 5 years
|
|
Gastrointestinal disorders
Constipation
|
56.2%
68/121 • Number of events 69 • Up to 5 years
|
|
Gastrointestinal disorders
Dehydration
|
6.6%
8/121 • Number of events 8 • Up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
91.7%
111/121 • Number of events 112 • Up to 5 years
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
25.6%
31/121 • Number of events 31 • Up to 5 years
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
39.7%
48/121 • Number of events 48 • Up to 5 years
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
13.2%
16/121 • Number of events 16 • Up to 5 years
|
|
Gastrointestinal disorders
Esophagitis
|
5.8%
7/121 • Number of events 7 • Up to 5 years
|
|
Gastrointestinal disorders
Fistula, GI
|
0.83%
1/121 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Flatulence
|
5.0%
6/121 • Number of events 6 • Up to 5 years
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
0.83%
1/121 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, __)
|
6.6%
8/121 • Number of events 9 • Up to 5 years
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
30.6%
37/121 • Number of events 37 • Up to 5 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
14.9%
18/121 • Number of events 18 • Up to 5 years
|
|
Gastrointestinal disorders
Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
|
1.7%
2/121 • Number of events 2 • Up to 5 years
|
|
Gastrointestinal disorders
Incontinence, anal
|
0.83%
1/121 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)
|
83.5%
101/121 • Number of events 152 • Up to 5 years
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)
|
81.0%
98/121 • Number of events 151 • Up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
93.4%
113/121 • Number of events 114 • Up to 5 years
|
|
Gastrointestinal disorders
Obstruction, GI
|
0.83%
1/121 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Proctitis
|
0.83%
1/121 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Salivary gland changes/saliva
|
9.1%
11/121 • Number of events 11 • Up to 5 years
|
|
Gastrointestinal disorders
Stricture/stenosis (including anastomotic), GI
|
0.83%
1/121 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
30.6%
37/121 • Number of events 37 • Up to 5 years
|
|
Gastrointestinal disorders
Vomiting
|
77.7%
94/121 • Number of events 96 • Up to 5 years
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
97.5%
118/121 • Number of events 120 • Up to 5 years
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
26.4%
32/121 • Number of events 32 • Up to 5 years
|
|
General disorders
Insomnia
|
59.5%
72/121 • Number of events 72 • Up to 5 years
|
|
General disorders
Pain
|
95.9%
116/121 • Number of events 646 • Up to 5 years
|
|
General disorders
Pain - Other (Specify, __)
|
28.1%
34/121 • Number of events 42 • Up to 5 years
|
|
General disorders
Rigors/chills
|
40.5%
49/121 • Number of events 49 • Up to 5 years
|
|
General disorders
Sweating (diaphoresis)
|
16.5%
20/121 • Number of events 20 • Up to 5 years
|
|
General disorders
Weight gain
|
28.1%
34/121 • Number of events 34 • Up to 5 years
|
|
General disorders
Weight loss
|
50.4%
61/121 • Number of events 61 • Up to 5 years
|
|
Blood and lymphatic system disorders
Hematoma
|
2.5%
3/121 • Number of events 3 • Up to 5 years
|
|
Blood and lymphatic system disorders
Hemorrhage, GI
|
27.3%
33/121 • Number of events 35 • Up to 5 years
|
|
Blood and lymphatic system disorders
Hemorrhage, GU
|
19.8%
24/121 • Number of events 26 • Up to 5 years
|
|
Blood and lymphatic system disorders
Hemorrhage, pulmonary/upper respiratory
|
19.0%
23/121 • Number of events 24 • Up to 5 years
|
|
Blood and lymphatic system disorders
Hemorrhage/Bleeding - Other (Specify, __)
|
1.7%
2/121 • Number of events 2 • Up to 5 years
|
|
Blood and lymphatic system disorders
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
|
29.8%
36/121 • Number of events 36 • Up to 5 years
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
3.3%
4/121 • Number of events 4 • Up to 5 years
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
5.0%
6/121 • Number of events 6 • Up to 5 years
|
|
Immune system disorders
Allergy/Immunology - Other (Specify, __)
|
0.83%
1/121 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
6.6%
8/121 • Number of events 8 • Up to 5 years
|
|
Infections and infestations
Febrile neutropenia
|
32.2%
39/121 • Number of events 40 • Up to 5 years
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils
|
23.1%
28/121 • Number of events 32 • Up to 5 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
38.8%
47/121 • Number of events 60 • Up to 5 years
|
|
Infections and infestations
Infection with unknown ANC
|
10.7%
13/121 • Number of events 15 • Up to 5 years
|
|
General disorders
Edema:head and neck
|
10.7%
13/121 • Number of events 13 • Up to 5 years
|
|
General disorders
Edema:limb
|
43.0%
52/121 • Number of events 52 • Up to 5 years
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
49.6%
60/121 • Number of events 60 • Up to 5 years
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
58.7%
71/121 • Number of events 71 • Up to 5 years
|
|
Metabolism and nutrition disorders
Acidosis (metabolic or respiratory)
|
1.7%
2/121 • Number of events 2 • Up to 5 years
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
87.6%
106/121 • Number of events 106 • Up to 5 years
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
33.9%
41/121 • Number of events 41 • Up to 5 years
|
|
Metabolism and nutrition disorders
Alkalosis (metabolic or respiratory)
|
0.83%
1/121 • Number of events 1 • Up to 5 years
|
|
Metabolism and nutrition disorders
Amylase
|
0.83%
1/121 • Number of events 1 • Up to 5 years
|
|
Metabolism and nutrition disorders
Bicarbonate, serum-low
|
19.0%
23/121 • Number of events 23 • Up to 5 years
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
9.9%
12/121 • Number of events 13 • Up to 5 years
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
4.1%
5/121 • Number of events 5 • Up to 5 years
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
76.0%
92/121 • Number of events 92 • Up to 5 years
|
|
Metabolism and nutrition disorders
Cholesterol, serum-high (hypercholesteremia)
|
35.5%
43/121 • Number of events 43 • Up to 5 years
|
|
Metabolism and nutrition disorders
Creatinine
|
11.6%
14/121 • Number of events 14 • Up to 5 years
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
57.9%
70/121 • Number of events 78 • Up to 5 years
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
39.7%
48/121 • Number of events 48 • Up to 5 years
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
6.6%
8/121 • Number of events 8 • Up to 5 years
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
29.8%
36/121 • Number of events 36 • Up to 5 years
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other (Specify, __)
|
0.83%
1/121 • Number of events 1 • Up to 5 years
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
38.8%
47/121 • Number of events 49 • Up to 5 years
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
4.1%
5/121 • Number of events 5 • Up to 5 years
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
67.8%
82/121 • Number of events 84 • Up to 5 years
|
|
Metabolism and nutrition disorders
Proteinuria
|
1.7%
2/121 • Number of events 2 • Up to 5 years
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
4.1%
5/121 • Number of events 5 • Up to 5 years
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
85.1%
103/121 • Number of events 103 • Up to 5 years
|
|
Metabolism and nutrition disorders
Triglyceride, serum-high (hypertriglyceridemia)
|
28.1%
34/121 • Number of events 34 • Up to 5 years
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
5.8%
7/121 • Number of events 8 • Up to 5 years
|
|
Metabolism and nutrition disorders
Obesity
|
62.8%
76/121 • Number of events 190 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis (non-septic)
|
2.5%
3/121 • Number of events 3 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Extremity-lower (gait/walking)
|
1.7%
2/121 • Number of events 2 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Extremity-upper (function)
|
1.7%
2/121 • Number of events 2 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Joint-effusion
|
0.83%
1/121 • Number of events 1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Joint-function
|
0.83%
1/121 • Number of events 1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)
|
69.4%
84/121 • Number of events 123 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Specify, __)
|
2.5%
3/121 • Number of events 3 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis (avascular necrosis)
|
0.83%
1/121 • Number of events 2 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
1.7%
2/121 • Number of events 2 • Up to 5 years
|
|
Nervous system disorders
Arachnoiditis/meningismus/radiculitis
|
0.83%
1/121 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Ataxia (incoordination)
|
1.7%
2/121 • Number of events 2 • Up to 5 years
|
|
Nervous system disorders
Cognitive disturbance
|
0.83%
1/121 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Confusion
|
14.9%
18/121 • Number of events 18 • Up to 5 years
|
|
Nervous system disorders
Dizziness
|
54.5%
66/121 • Number of events 66 • Up to 5 years
|
|
Nervous system disorders
Encephalopathy
|
1.7%
2/121 • Number of events 2 • Up to 5 years
|
|
Nervous system disorders
Extrapyramidal/involuntary movement/restlessness
|
14.0%
17/121 • Number of events 17 • Up to 5 years
|
|
Nervous system disorders
Memory impairment
|
5.8%
7/121 • Number of events 7 • Up to 5 years
|
|
Nervous system disorders
Mood alteration
|
72.7%
88/121 • Number of events 137 • Up to 5 years
|
|
Nervous system disorders
Neurology - Other (Specify, __)
|
8.3%
10/121 • Number of events 10 • Up to 5 years
|
|
Nervous system disorders
Neuropathy: cranial
|
0.83%
1/121 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Neuropathy: motor
|
5.8%
7/121 • Number of events 8 • Up to 5 years
|
|
Nervous system disorders
Neuropathy: sensory
|
34.7%
42/121 • Number of events 43 • Up to 5 years
|
|
Nervous system disorders
Psychosis (hallucinations/delusions)
|
9.9%
12/121 • Number of events 12 • Up to 5 years
|
|
Nervous system disorders
Seizure
|
1.7%
2/121 • Number of events 2 • Up to 5 years
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
5.8%
7/121 • Number of events 8 • Up to 5 years
|
|
Nervous system disorders
Syncope (fainting)
|
2.5%
3/121 • Number of events 4 • Up to 5 years
|
|
Nervous system disorders
Tremor
|
5.0%
6/121 • Number of events 6 • Up to 5 years
|
|
Renal and urinary disorders
Cystitis
|
0.83%
1/121 • Number of events 1 • Up to 5 years
|
|
Renal and urinary disorders
Incontinence, urinary
|
2.5%
3/121 • Number of events 3 • Up to 5 years
|
|
Renal and urinary disorders
Renal failure
|
1.7%
2/121 • Number of events 2 • Up to 5 years
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Specify, __)
|
2.5%
3/121 • Number of events 3 • Up to 5 years
|
|
Renal and urinary disorders
Stricture/stenosis (including anastomotic), GU
|
0.83%
1/121 • Number of events 1 • Up to 5 years
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
9.1%
11/121 • Number of events 11 • Up to 5 years
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
0.83%
1/121 • Number of events 1 • Up to 5 years
|
|
Renal and urinary disorders
Urine color change
|
6.6%
8/121 • Number of events 8 • Up to 5 years
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
2.5%
3/121 • Number of events 3 • Up to 5 years
|
|
Reproductive system and breast disorders
Irregular menses (change from baseline)
|
1.7%
2/121 • Number of events 2 • Up to 5 years
|
|
Reproductive system and breast disorders
Libido
|
1.7%
2/121 • Number of events 2 • Up to 5 years
|
|
Reproductive system and breast disorders
Sexual/Reproductive Function - Other (Specify, __)
|
0.83%
1/121 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome (ARDS)
|
0.83%
1/121 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
14.0%
17/121 • Number of events 17 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
7.4%
9/121 • Number of events 9 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Carbon monoxide diffusion capacity (DL(co))
|
48.8%
59/121 • Number of events 61 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
59.5%
72/121 • Number of events 73 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
28.9%
35/121 • Number of events 35 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
FEV(1)
|
20.7%
25/121 • Number of events 25 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
7.4%
9/121 • Number of events 9 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
16.5%
20/121 • Number of events 20 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reactions
|
0.83%
1/121 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Obstruction/stenosis of airway
|
0.83%
1/121 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
9.1%
11/121 • Number of events 11 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
17.4%
21/121 • Number of events 23 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis (radiographic changes)
|
0.83%
1/121 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, __)
|
44.6%
54/121 • Number of events 74 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Vital capacity
|
22.3%
27/121 • Number of events 27 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
9.1%
11/121 • Number of events 11 • Up to 5 years
|
|
Investigations
Secondary Malignancy - possibly related to cancer treatment (Specify, __)
|
5.0%
6/121 • Number of events 6 • Up to 5 years
|
|
Investigations
Syndromes - Other (Specify, __)
|
7.4%
9/121 • Number of events 9 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
11.6%
14/121 • Number of events 14 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Burn
|
0.83%
1/121 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __)
|
19.8%
24/121 • Number of events 27 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
24.0%
29/121 • Number of events 30 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Flushing
|
28.9%
35/121 • Number of events 35 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
41.3%
50/121 • Number of events 50 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
17.4%
21/121 • Number of events 21 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Induration/fibrosis (skin and subcutaneous tissue)
|
0.83%
1/121 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Injection site reaction/extravasation changes
|
0.83%
1/121 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
0.83%
1/121 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
38.0%
46/121 • Number of events 46 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
69.4%
84/121 • Number of events 84 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
6.6%
8/121 • Number of events 8 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash: dermatitis associated with radiation
|
2.5%
3/121 • Number of events 3 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
0.83%
1/121 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
0.83%
1/121 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Urticaria (hives, welts, wheals)
|
5.0%
6/121 • Number of events 6 • Up to 5 years
|
Additional Information
Dr. Amrita Krishnan
City of Hope National Medical Center
Phone: 626-256-4673
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place