Trial Outcomes & Findings for Pentostatin, Cyclophosphamide, and Rituximab With or Without Bevacizumab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (NCT NCT00816595)
NCT ID: NCT00816595
Last Updated: 2017-06-15
Results Overview
A Complete Response (CR) requires all of the following for 2 months: * Absence of lymphadenopathy by physical examination (PE) * No hepato- or splenomegaly by PE * Neutrophils \>1500/ul, Platelets \>100,000/ul. Hemoglobin \>11.0 gm/dl, Peripheral blood lymphocytes \<4000/uL Nodular Partial Response (nPR) is defined as a patient qualified for a CR, but regenerative nodules are histologically present on bone marrow samples. A Clinical Complete Response (CCR) is defined as a patient qualified for a CR, but bone marrow samples are not available. A Partial Response (PR) requires 50% reduction in 2 of the following: peripheral blood lymphocytes, or the sum of the products of the maximal perpendicular diameters, or the size of liver and/or spleen; and a 50% increase in neutrophils, platelets, or hemoglobin. Overall response rate is calculated as the number of patients receiving CR, CCR, nPR, or PR as their objective status divided by the total number of evaluable patients.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
68 participants
Primary outcome timeframe
Evaluated after 6 cycles (up to 196 days)
Results posted on
2017-06-15
Participant Flow
Participant milestones
| Measure |
Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin
Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m\^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m\^3 pentostatin IV over 30 minutes and 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV
|
Arm B: Pentostatin, Cyclophosphamide, and Rituximab
Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m\^2 on day 2 of course 1 and 375 mg/m\^2 on day 1 of courses 2-6. They receive 2 mg/m\^2 pentostatin IV over 30 minutes and 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
33
|
|
Overall Study
COMPLETED
|
33
|
33
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin
Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m\^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m\^3 pentostatin IV over 30 minutes and 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV
|
Arm B: Pentostatin, Cyclophosphamide, and Rituximab
Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m\^2 on day 2 of course 1 and 375 mg/m\^2 on day 1 of courses 2-6. They receive 2 mg/m\^2 pentostatin IV over 30 minutes and 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Pentostatin, Cyclophosphamide, and Rituximab With or Without Bevacizumab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Baseline characteristics by cohort
| Measure |
Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin
n=33 Participants
Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m\^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m\^3 pentostatin IV over 30 minutes and 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B: Pentostatin, Cyclophosphamide, and Rituximab
n=33 Participants
Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m\^2 on day 2 of course 1 and 375 mg/m\^2 on day 1 of courses 2-6. They receive 2 mg/m\^2 pentostatin IV over 30 minutes and 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
63 years
n=7 Participants
|
63.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
33 participants
n=7 Participants
|
66 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Evaluated after 6 cycles (up to 196 days)Population: One patient on Arm A was treated at an incorrect dose level and was not evaluable for this endpoint. On Arm B, one patient did not have correct eligibility reported, one patient did not complete an assessment, and one patient was incorrectly treated. The primary endpoint is based on 32 Arm A and 30 Arm B patients.
A Complete Response (CR) requires all of the following for 2 months: * Absence of lymphadenopathy by physical examination (PE) * No hepato- or splenomegaly by PE * Neutrophils \>1500/ul, Platelets \>100,000/ul. Hemoglobin \>11.0 gm/dl, Peripheral blood lymphocytes \<4000/uL Nodular Partial Response (nPR) is defined as a patient qualified for a CR, but regenerative nodules are histologically present on bone marrow samples. A Clinical Complete Response (CCR) is defined as a patient qualified for a CR, but bone marrow samples are not available. A Partial Response (PR) requires 50% reduction in 2 of the following: peripheral blood lymphocytes, or the sum of the products of the maximal perpendicular diameters, or the size of liver and/or spleen; and a 50% increase in neutrophils, platelets, or hemoglobin. Overall response rate is calculated as the number of patients receiving CR, CCR, nPR, or PR as their objective status divided by the total number of evaluable patients.
Outcome measures
| Measure |
Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin
n=32 Participants
Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m\^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m\^3 pentostatin IV over 30 minutes and 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B: Pentostatin, Cyclophosphamide, and Rituximab
n=30 Participants
Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m\^2 on day 2 of course 1 and 375 mg/m\^2 on day 1 of courses 2-6. They receive 2 mg/m\^2 pentostatin IV over 30 minutes and 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Complete and Overall Response Rate
Complete Response (CR) Rate
|
50.0 percentage of patients
|
33.3 percentage of patients
|
|
Complete and Overall Response Rate
Overall Response Rate
|
93.8 percentage of patients
|
96.7 percentage of patients
|
SECONDARY outcome
Timeframe: Assessed up to 5 years from registrationPopulation: One patient on Arm A was treated at an incorrect dose level and was not evaluable for this endpoint. On Arm B, one patient did not have correct eligibility reported, one patient did not complete an assessment, and one patient was incorrectly treated. The primary endpoint is based on 32 Arm A and 30 Arm B patients.
The Kaplan-Meier method will be used to estimate overall survival distributions Overall survival is measured as the time from registration to the time of death due to any cause.
Outcome measures
| Measure |
Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin
n=32 Participants
Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m\^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m\^3 pentostatin IV over 30 minutes and 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B: Pentostatin, Cyclophosphamide, and Rituximab
n=30 Participants
Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m\^2 on day 2 of course 1 and 375 mg/m\^2 on day 1 of courses 2-6. They receive 2 mg/m\^2 pentostatin IV over 30 minutes and 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Survival
|
NA months
Insufficient data has been collected to provide an estimate.
|
NA months
Interval 54.3 to
Insufficient data has been collected to provide an estimate.
|
SECONDARY outcome
Timeframe: Assessed up to 5 years from registrationPopulation: One patient on Arm A was treated at an incorrect dose level and was not evaluable for this endpoint. On Arm B, one patient did not have correct eligibility reported, one patient did not complete an assessment, and one patient was incorrectly treated. The primary endpoint is based on 32 Arm A and 30 Arm B patients.
The Kaplan-Meier method will be used to estimate progression-free survival distribution. Progression-free survival is defined as the time from registration to the time of progression or death, whichever occurs first.
Outcome measures
| Measure |
Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin
n=32 Participants
Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m\^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m\^3 pentostatin IV over 30 minutes and 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B: Pentostatin, Cyclophosphamide, and Rituximab
n=30 Participants
Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m\^2 on day 2 of course 1 and 375 mg/m\^2 on day 1 of courses 2-6. They receive 2 mg/m\^2 pentostatin IV over 30 minutes and 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Progression-free Survival
|
NA months
Interval 26.0 to
Insufficient data has been collected to provide an estimate.
|
34.1 months
Interval 23.0 to 52.1
|
Adverse Events
Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin
Serious events: 11 serious events
Other events: 32 other events
Deaths: 0 deaths
Arm B: Pentostatin, Cyclophosphamide, and Rituximab
Serious events: 5 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin
n=33 participants at risk
Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m\^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m\^3 pentostatin IV over 30 minutes and 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV
|
Arm B: Pentostatin, Cyclophosphamide, and Rituximab
n=33 participants at risk
Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m\^2 on day 2 of course 1 and 375 mg/m\^2 on day 1 of courses 2-6. They receive 2 mg/m\^2 pentostatin IV over 30 minutes and 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV
|
|---|---|---|
|
Cardiac disorders
Left ventricular dysfunction
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
|
Cardiac disorders
Left ventricular failure
|
6.1%
2/33 • Number of events 2
|
0.00%
0/33
|
|
Cardiac disorders
Myocardial ischemia
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
|
Cardiac disorders
Myocarditis
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
|
Gastrointestinal disorders
Nausea
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
|
General disorders
Chills
|
0.00%
0/33
|
3.0%
1/33 • Number of events 1
|
|
General disorders
Edema limbs
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
|
General disorders
Fatigue
|
0.00%
0/33
|
3.0%
1/33 • Number of events 1
|
|
General disorders
Fever
|
0.00%
0/33
|
3.0%
1/33 • Number of events 1
|
|
General disorders
Localized edema
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
|
Infections and infestations
Pneumonia
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
|
Infections and infestations
Sepsis
|
0.00%
0/33
|
3.0%
1/33 • Number of events 1
|
|
Investigations
Creatinine increased
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
|
Investigations
Neutrophil count decreased
|
12.1%
4/33 • Number of events 5
|
6.1%
2/33 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
|
Nervous system disorders
Neurological disorder NOS
|
0.00%
0/33
|
3.0%
1/33 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
0.00%
0/33
|
3.0%
1/33 • Number of events 1
|
|
Renal and urinary disorders
Bladder hemorrhage
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
|
Renal and urinary disorders
Bladder pain
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
|
Renal and urinary disorders
Cystitis
|
6.1%
2/33 • Number of events 2
|
0.00%
0/33
|
|
Renal and urinary disorders
Protein urine positive
|
6.1%
2/33 • Number of events 2
|
0.00%
0/33
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/33
|
3.0%
1/33 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.1%
2/33 • Number of events 2
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.1%
3/33 • Number of events 3
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
|
Vascular disorders
Hypertension
|
6.1%
2/33 • Number of events 2
|
0.00%
0/33
|
|
Vascular disorders
Vascular disorder
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
Other adverse events
| Measure |
Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin
n=33 participants at risk
Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m\^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m\^3 pentostatin IV over 30 minutes and 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV
|
Arm B: Pentostatin, Cyclophosphamide, and Rituximab
n=33 participants at risk
Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m\^2 on day 2 of course 1 and 375 mg/m\^2 on day 1 of courses 2-6. They receive 2 mg/m\^2 pentostatin IV over 30 minutes and 600 mg/m\^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood disorder
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
39.4%
13/33 • Number of events 52
|
48.5%
16/33 • Number of events 24
|
|
Cardiac disorders
Cardiac disorder
|
6.1%
2/33 • Number of events 4
|
0.00%
0/33
|
|
Cardiac disorders
Left ventricular failure
|
3.0%
1/33 • Number of events 2
|
0.00%
0/33
|
|
Cardiac disorders
Myocardial ischemia
|
3.0%
1/33 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/33
|
3.0%
1/33 • Number of events 2
|
|
Cardiac disorders
Torsade de pointes
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
|
Cardiac disorders
Ventricular tachycardia
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
|
Endocrine disorders
Hyperthyroidism
|
6.1%
2/33 • Number of events 2
|
0.00%
0/33
|
|
Endocrine disorders
Hypothyroidism
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
|
Gastrointestinal disorders
Abdominal pain
|
12.1%
4/33 • Number of events 7
|
18.2%
6/33 • Number of events 8
|
|
Gastrointestinal disorders
Ascites
|
6.1%
2/33 • Number of events 2
|
0.00%
0/33
|
|
Gastrointestinal disorders
Diarrhea
|
9.1%
3/33 • Number of events 3
|
3.0%
1/33 • Number of events 2
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/33
|
3.0%
1/33 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
27.3%
9/33 • Number of events 16
|
30.3%
10/33 • Number of events 17
|
|
Gastrointestinal disorders
Rectal pain
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
|
Gastrointestinal disorders
Vomiting
|
21.2%
7/33 • Number of events 12
|
18.2%
6/33 • Number of events 11
|
|
General disorders
Chest pain
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
|
General disorders
Death
|
0.00%
0/33
|
3.0%
1/33 • Number of events 1
|
|
General disorders
Edema limbs
|
3.0%
1/33 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
|
General disorders
Fatigue
|
93.9%
31/33 • Number of events 214
|
87.9%
29/33 • Number of events 152
|
|
General disorders
Fever
|
24.2%
8/33 • Number of events 10
|
39.4%
13/33 • Number of events 26
|
|
General disorders
Hypothermia
|
0.00%
0/33
|
3.0%
1/33 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
|
Immune system disorders
Cytokine release syndrome
|
3.0%
1/33 • Number of events 1
|
6.1%
2/33 • Number of events 4
|
|
Immune system disorders
Hypersensitivity
|
3.0%
1/33 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
|
Immune system disorders
Immune system disorder
|
3.0%
1/33 • Number of events 2
|
0.00%
0/33
|
|
Infections and infestations
Bronchitis
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
|
Infections and infestations
Gallbladder infection
|
0.00%
0/33
|
3.0%
1/33 • Number of events 1
|
|
Infections and infestations
Infection
|
0.00%
0/33
|
6.1%
2/33 • Number of events 2
|
|
Infections and infestations
Pharyngitis
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
|
Infections and infestations
Pneumonia
|
9.1%
3/33 • Number of events 5
|
9.1%
3/33 • Number of events 4
|
|
Infections and infestations
Sepsis
|
6.1%
2/33 • Number of events 3
|
9.1%
3/33 • Number of events 4
|
|
Infections and infestations
Sinusitis
|
6.1%
2/33 • Number of events 2
|
3.0%
1/33 • Number of events 2
|
|
Infections and infestations
Upper aerodigestive tract infection
|
0.00%
0/33
|
3.0%
1/33 • Number of events 1
|
|
Infections and infestations
Upper respiratory infection
|
9.1%
3/33 • Number of events 4
|
18.2%
6/33 • Number of events 9
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/33
|
3.0%
1/33 • Number of events 1
|
|
Infections and infestations
Wound infection
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
|
Investigations
Creatinine increased
|
30.3%
10/33 • Number of events 28
|
33.3%
11/33 • Number of events 40
|
|
Investigations
Neutrophil count decreased
|
54.5%
18/33 • Number of events 26
|
51.5%
17/33 • Number of events 36
|
|
Investigations
Platelet count decreased
|
63.6%
21/33 • Number of events 79
|
42.4%
14/33 • Number of events 60
|
|
Investigations
Weight loss
|
0.00%
0/33
|
3.0%
1/33 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
15.2%
5/33 • Number of events 9
|
3.0%
1/33 • Number of events 3
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
3.0%
1/33 • Number of events 1
|
15.2%
5/33 • Number of events 10
|
|
Metabolism and nutrition disorders
Dehydration
|
6.1%
2/33 • Number of events 2
|
3.0%
1/33 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
3.0%
1/33 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
3.0%
1/33 • Number of events 1
|
9.1%
3/33 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
0.00%
0/33
|
3.0%
1/33 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
3.0%
1/33 • Number of events 2
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.0%
1/33 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
3.0%
1/33 • Number of events 2
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/33
|
3.0%
1/33 • Number of events 2
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/33
|
3.0%
1/33 • Number of events 1
|
|
Nervous system disorders
Encephalopathy
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/33
|
3.0%
1/33 • Number of events 1
|
|
Nervous system disorders
Headache
|
57.6%
19/33 • Number of events 48
|
33.3%
11/33 • Number of events 23
|
|
Nervous system disorders
Neuralgia
|
3.0%
1/33 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.0%
1/33 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.0%
1/33 • Number of events 2
|
3.0%
1/33 • Number of events 1
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/33
|
3.0%
1/33 • Number of events 1
|
|
Nervous system disorders
Tremor
|
0.00%
0/33
|
3.0%
1/33 • Number of events 5
|
|
Psychiatric disorders
Agitation
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
|
Psychiatric disorders
Depression
|
0.00%
0/33
|
3.0%
1/33 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
3.0%
1/33 • Number of events 4
|
3.0%
1/33 • Number of events 4
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/33
|
3.0%
1/33 • Number of events 1
|
|
Renal and urinary disorders
Hemorrhage urinary tract
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
|
Renal and urinary disorders
Protein urine positive
|
36.4%
12/33 • Number of events 22
|
9.1%
3/33 • Number of events 3
|
|
Renal and urinary disorders
Renal failure
|
3.0%
1/33 • Number of events 2
|
0.00%
0/33
|
|
Renal and urinary disorders
Urinary frequency
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
|
Renal and urinary disorders
Urinary incontinence
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/33
|
3.0%
1/33 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.0%
1/33 • Number of events 1
|
6.1%
2/33 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.0%
1/33 • Number of events 1
|
9.1%
3/33 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.0%
1/33 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
9.1%
3/33 • Number of events 3
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.0%
1/33 • Number of events 2
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/33
|
3.0%
1/33 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/33
|
3.0%
1/33 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/33
|
3.0%
1/33 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
12.1%
4/33 • Number of events 6
|
6.1%
2/33 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/33
|
3.0%
1/33 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Sweating
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
|
Vascular disorders
Flushing
|
0.00%
0/33
|
3.0%
1/33 • Number of events 2
|
|
Vascular disorders
Hot flashes
|
3.0%
1/33 • Number of events 2
|
0.00%
0/33
|
|
Vascular disorders
Hypertension
|
51.5%
17/33 • Number of events 52
|
27.3%
9/33 • Number of events 19
|
|
Vascular disorders
Hypotension
|
0.00%
0/33
|
6.1%
2/33 • Number of events 2
|
|
Vascular disorders
Thrombosis
|
0.00%
0/33
|
3.0%
1/33 • Number of events 1
|
|
Vascular disorders
Vascular disorder
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place