Trial Outcomes & Findings for CAR T Cell Receptor Immunotherapy for Patients With B-cell Lymphoma (NCT NCT00924326)
NCT ID: NCT00924326
Last Updated: 2022-01-12
Results Overview
Participants were assessed by the Response Criteria for Malignant Lymphoma. Complete Remission (CR) is complete disappearance of all detectable evidence of disease and disease-related symptoms if present before therapy. Partial Remission (PR) requires ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses; no increase in size of nodes, liver or spleen and no new sites of disease. Progressive disease (PD) is defined by ≥50% increase from nadir in the sum of the products of at least two lymph nodes, or if a single node is involved at least a 50% increase in the product of the diameters of this one node; and appearance of a new lesion greater than 1.5 cm in any axis even if other lesions are decreasing in size. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
43 participants
Primary outcome timeframe
Scans performed at 6 weeks, 12 weeks and every 3-6 months for approximately 2 years
Results posted on
2022-01-12
Participant Flow
Three patients treated in arm 1 (1x10e9-1x10e10 cells/kg + high dose IL2) had disease progression and were then retreated in Period 2 (1x10e9-1x10e10 cells/kg + high dose IL2).
Participant milestones
| Measure |
1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2
Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
Aldesleukin (Day 0): 720,000 IU/kg intravenously (IV) every 8 hours for a maximum of 15 doses.
|
0.5x10^7 Cells/kg
Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
2.5x10^6 Cells/kg
Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
1.0x10^6 Cells/kg
Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
1.0x10^6 Cells/kg (Reduced Chemo)
Cyclophosphamide (Days -5 to -3): 300mg/m\^2 intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
2.0x10^6 Cells/kg (Reduced Chemo)
Cyclophosphamide (Days -5 to -3): 300mg/m\^2 intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
6.0x10^6 Cells/kg (Reduced Chemo)
Cyclophosphamide (Days -5 to -3): 300mg/m\^2 intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
2.0x10^6 Cells/kg (Moderate Chemo)
Cyclophosphamide (Days -5 to -3): 300mg/m\^2 intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
2.0x10^6 Cells/kg (9-12 Days Culture)
Cyclophosphamide (Days -5 to -3): 300mg/m\^2 intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
|---|---|---|---|---|---|---|---|---|---|
|
Dose Administration
STARTED
|
8
|
2
|
5
|
6
|
7
|
10
|
1
|
2
|
2
|
|
Dose Administration
COMPLETED
|
8
|
2
|
5
|
6
|
7
|
10
|
1
|
2
|
2
|
|
Dose Administration
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
1x10^9-1x10^10 + High Dose Retreat
STARTED
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
1x10^9-1x10^10 + High Dose Retreat
COMPLETED
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
1x10^9-1x10^10 + High Dose Retreat
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CAR T Cell Receptor Immunotherapy for Patients With B-cell Lymphoma
Baseline characteristics by cohort
| Measure |
1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2
n=8 Participants
Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
Aldesleukin (Day 0): 720,000 IU/kg intravenously (IV) every 8 hours for a maximum of 15 doses.
|
0.5x10^7 Cells/kg
n=2 Participants
Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
Aldesleukin (Day 0): 720,000 IU/kg intravenously (IV) every 8 hours for a maximum of 15 doses.
|
2.5x10^6 Cells/kg
n=5 Participants
Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
1.0x10^6 Cells/kg
n=6 Participants
Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
1.0x10^6 Cells/kg (Reduced Chemo)
n=7 Participants
Cyclophosphamide (Days -5 to -3): 300mg/m\^2 intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
2.0x10^6 Cells/kg (Reduced Chemo)
n=10 Participants
Cyclophosphamide (Days -5 to -3): 300mg/m\^2 intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
6.0x10^6 Cells/kg (Reduced Chemo)
n=1 Participants
Cyclophosphamide (Days -5 to -3): 300mg/m\^2 intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
2.0x10^6 Cells/kg (Moderate Chemo)
n=2 Participants
Cyclophosphamide (Days -5 to -3): 300mg/m\^2 intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
2.0x10^6 Cells/kg (9-12 Days Culture)
n=2 Participants
Cyclophosphamide (Days -5 to -3): 300mg/m\^2 intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
37 Participants
n=64 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
6 Participants
n=64 Participants
|
|
Age, Continuous
|
55.5 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
52.0 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
40.4 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
58.0 years
STANDARD_DEVIATION 8.6 • n=4 Participants
|
55.0 years
STANDARD_DEVIATION 13.7 • n=21 Participants
|
52.1 years
STANDARD_DEVIATION 15.2 • n=10 Participants
|
40.0 years
n=115 Participants
|
51.5 years
STANDARD_DEVIATION 2.1 • n=6 Participants
|
58.5 years
STANDARD_DEVIATION 10.6 • n=6 Participants
|
52.7 years
STANDARD_DEVIATION 11.5 • n=64 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
10 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
33 Participants
n=64 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=64 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
41 Participants
n=64 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=64 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
40 Participants
n=64 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=64 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
43 Participants
n=64 Participants
|
PRIMARY outcome
Timeframe: Scans performed at 6 weeks, 12 weeks and every 3-6 months for approximately 2 yearsPopulation: 1x10\^9-1x10\^10 Cells/kg + High-dose Interleukin-2 Retreat Arm/Group: "3 participants in group 1 (1x10e9-1x10e10 cells/kg + high-dose IL2)) initially responded but were then retreated in group 2 after progression."
Participants were assessed by the Response Criteria for Malignant Lymphoma. Complete Remission (CR) is complete disappearance of all detectable evidence of disease and disease-related symptoms if present before therapy. Partial Remission (PR) requires ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses; no increase in size of nodes, liver or spleen and no new sites of disease. Progressive disease (PD) is defined by ≥50% increase from nadir in the sum of the products of at least two lymph nodes, or if a single node is involved at least a 50% increase in the product of the diameters of this one node; and appearance of a new lesion greater than 1.5 cm in any axis even if other lesions are decreasing in size. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Outcome measures
| Measure |
1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2
n=8 Participants
Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
Aldesleukin (Day 0): 720,000 IU/kg intravenously (IV) every 8 hours for a maximum of 15 doses.
|
1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2 Retreat
n=3 Participants
Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
Aldesleukin (Day 0): 720,000 IU/kg intravenously (IV) every 8 hours for a maximum of 15 doses.
|
0.5x10^7 Cells/kg
n=2 Participants
Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
2.5x10^6 Cells/kg
n=5 Participants
Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
1.0x10^6 Cells/kg
n=6 Participants
Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
1.0x10^6 Cells/kg (Reduced Chemo)
n=7 Participants
Cyclophosphamide (Days -5 to -3): 300mg/m\^2 intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
2.0x10^6 Cells/kg (Reduced Chemo)
n=10 Participants
Cyclophosphamide (Days -5 to -3): 300mg/m\^2 intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
6.0x10^6 Cells/kg (Reduced Chemo)
n=1 Participants
Cyclophosphamide (Days -5 to -3): 300mg/m\^2 intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
2.0x10^6 Cells/kg (Moderate Chemo)
n=2 Participants
Cyclophosphamide (Days -5 to -3): 300mg/m\^2 intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
2.0x10^6 Cells/kg (9-12 Days Culture)
n=2 Participants
Cyclophosphamide (Days -5 to -3): 300mg/m\^2 intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With a Response Assessed by the Response Criteria for Malignant Lymphoma
Complete Remission
|
2 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
6 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With a Response Assessed by the Response Criteria for Malignant Lymphoma
Partial Remission
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Response Assessed by the Response Criteria for Malignant Lymphoma
Stable Disease
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Response Assessed by the Response Criteria for Malignant Lymphoma
Progressive Disease
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Response Assessed by the Response Criteria for Malignant Lymphoma
Not Evaluable
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Date treatment consent signed to date off study, approximately 101 months and 17 days.Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2
n=8 Participants
Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
Aldesleukin (Day 0): 720,000 IU/kg intravenously (IV) every 8 hours for a maximum of 15 doses.
|
1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2 Retreat
n=3 Participants
Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
Aldesleukin (Day 0): 720,000 IU/kg intravenously (IV) every 8 hours for a maximum of 15 doses.
|
0.5x10^7 Cells/kg
n=2 Participants
Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
2.5x10^6 Cells/kg
n=5 Participants
Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
1.0x10^6 Cells/kg
n=6 Participants
Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
1.0x10^6 Cells/kg (Reduced Chemo)
n=7 Participants
Cyclophosphamide (Days -5 to -3): 300mg/m\^2 intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
2.0x10^6 Cells/kg (Reduced Chemo)
n=10 Participants
Cyclophosphamide (Days -5 to -3): 300mg/m\^2 intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
6.0x10^6 Cells/kg (Reduced Chemo)
n=1 Participants
Cyclophosphamide (Days -5 to -3): 300mg/m\^2 intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
2.0x10^6 Cells/kg (Moderate Chemo)
n=2 Participants
Cyclophosphamide (Days -5 to -3): 300mg/m\^2 intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
2.0x10^6 Cells/kg (9-12 Days Culture)
n=2 Participants
Cyclophosphamide (Days -5 to -3): 300mg/m\^2 intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0).
|
8 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
6 Participants
|
7 Participants
|
10 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
Adverse Events
1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2
Serious events: 7 serious events
Other events: 8 other events
Deaths: 1 deaths
1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2 Retreat
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
0.5x10^7 Cells/kg
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
2.5x10^6 Cells/kg
Serious events: 3 serious events
Other events: 5 other events
Deaths: 1 deaths
1.0x10^6 Cells/kg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
1.0x10^6 Cells/kg (Reduced Chemo)
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
2.0x10^6 Cells/kg (Reduced Chemo)
Serious events: 7 serious events
Other events: 10 other events
Deaths: 0 deaths
6.0x10^6 Cells/kg (Reduced Chemo)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
2.0x10^6 Cells/kg (Moderate Chemo)
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
2.0x10^6 Cells/kg (9-12 Days Culture)
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2
n=8 participants at risk
Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
Aldesleukin (Day 0): 720,000 IU/kg intravenously (IV) every 8 hours for a maximum of 15 doses.
|
1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2 Retreat
n=3 participants at risk
Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
Aldesleukin (Day 0): 720,000 IU/kg intravenously (IV) every 8 hours for a maximum of 15 doses.
|
0.5x10^7 Cells/kg
n=2 participants at risk
Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
2.5x10^6 Cells/kg
n=5 participants at risk
Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
1.0x10^6 Cells/kg
n=6 participants at risk
Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
1.0x10^6 Cells/kg (Reduced Chemo)
n=7 participants at risk
Cyclophosphamide (Days -5 to -3): 300mg/m\^2 intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
2.0x10^6 Cells/kg (Reduced Chemo)
n=10 participants at risk
Cyclophosphamide (Days -5 to -3): 300mg/m\^2 intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
6.0x10^6 Cells/kg (Reduced Chemo)
n=1 participants at risk
Cyclophosphamide (Days -5 to -3): 300mg/m\^2 intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
2.0x10^6 Cells/kg (Moderate Chemo)
n=2 participants at risk
Cyclophosphamide (Days -5 to -3): 300mg/m\^2 intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
2.0x10^6 Cells/kg (9-12 Days Culture)
n=2 participants at risk
Cyclophosphamide (Days -5 to -3): 300mg/m\^2 intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Supraventricular tachycardia
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Nervous system disorders
Tremor
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Sinus tachycardia
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Nervous system disorders
Psychosis (hallucinations/delusions)
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Metabolism and nutrition disorders
Creatinine
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Nervous system disorders
Encephalopathy
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Infections and infestations
Febrile neutropenia
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
40.0%
4/10 • Number of events 4 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
2/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Infections and infestations
Infection (documented clinically or microbiologically)
|
12.5%
1/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Infections and infestations
Opportunistic infection associated with >=Grade 2 Lymphopenia
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Renal and urinary disorders
Renal failure
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Nervous system disorders
Seizure
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
25.0%
2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
40.0%
4/10 • Number of events 4 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
2/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Atrial fibrillation
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Cardiac disorders
Valvular heart disease
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Nervous system disorders
Confusion
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
2/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
30.0%
3/10 • Number of events 3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
2/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
2/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Cardiac disorders
Hypotension
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
20.0%
2/10 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Nervous system disorders
Neuropathy: cranial::CN VII Motor-face; Sensory-taste
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
General disorders
Death not associated with CTCAE term
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Nervous system disorders
Pyramidal tract dysfunction
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Nervous system disorders
Speech impairment (e.g., dysphasia or aphasia)
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
60.0%
6/10 • Number of events 6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
2/2 • Number of events 3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
2/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
General disorders
Syndromes - Other (Myelodysplastic syndrome)
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Nervous system disorders
Myelitis
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Nervous system disorders
Ataxia (incoordination)
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
20.0%
2/10 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Renal and urinary disorders
Incontinence, urinary
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Infections and infestations
Infection
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Nervous system disorders
Mood alteration::Agitation
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)::Extremity-lower
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Nervous system disorders
Neuropathy: motor
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
20.0%
2/10 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
50.0%
1/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
Other adverse events
| Measure |
1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2
n=8 participants at risk
Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
Aldesleukin (Day 0): 720,000 IU/kg intravenously (IV) every 8 hours for a maximum of 15 doses.
|
1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2 Retreat
n=3 participants at risk
Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
Aldesleukin (Day 0): 720,000 IU/kg intravenously (IV) every 8 hours for a maximum of 15 doses.
|
0.5x10^7 Cells/kg
n=2 participants at risk
Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
2.5x10^6 Cells/kg
n=5 participants at risk
Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
1.0x10^6 Cells/kg
n=6 participants at risk
Cyclophosphamide (Days -5 to -4): 60mg/kg intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -1 after administration of cyclophosphamide): 25 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0 two to four days after the last dose of fludarabine); Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
1.0x10^6 Cells/kg (Reduced Chemo)
n=7 participants at risk
Cyclophosphamide (Days -5 to -3): 300mg/m\^2 intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
2.0x10^6 Cells/kg (Reduced Chemo)
n=10 participants at risk
Cyclophosphamide (Days -5 to -3): 300mg/m\^2 intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
6.0x10^6 Cells/kg (Reduced Chemo)
n=1 participants at risk
Cyclophosphamide (Days -5 to -3): 300mg/m\^2 intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
2.0x10^6 Cells/kg (Moderate Chemo)
n=2 participants at risk
Cyclophosphamide (Days -5 to -3): 300mg/m\^2 intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
2.0x10^6 Cells/kg (9-12 Days Culture)
n=2 participants at risk
Cyclophosphamide (Days -5 to -3): 300mg/m\^2 intravenous (IV) over 60 minutes
Fludarabine (Days -5 to -3: after administration of cyclophosphamide): 30 mg/m\^2 intravenous (IV) over 30 minutes
Anti-CD19 CAR PBL (Day 0, two to four days after the last dose of fludarabine): Cells will be infused via intravenous (IV) on the Patient Care Unit over 20-30 minutes.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Tremor
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
60.0%
6/10 • Number of events 6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
25.0%
2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Vascular disorders
Acute vascular leak syndrome
|
50.0%
4/8 • Number of events 4 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
25.0%
2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Gastrointestinal disorders
Anorexia
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
25.0%
2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other (Hypogammaglobulinemia (IG A))
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other (Hypogammaglobulinemia (IGG))
|
12.5%
1/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other (Hypogammaglobulinemia (IG M))
|
12.5%
1/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
62.5%
5/8 • Number of events 5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Nervous system disorders
Confusion
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Metabolism and nutrition disorders
Creatinine
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
50.0%
4/8 • Number of events 4 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
66.7%
2/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Infections and infestations
Febrile neutropenia
|
37.5%
3/8 • Number of events 3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
2/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
5/5 • Number of events 5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
66.7%
4/6 • Number of events 4 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
57.1%
4/7 • Number of events 4 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
42.9%
3/7 • Number of events 3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
60.0%
6/10 • Number of events 6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Ear and labyrinth disorders
Hearing: patients without baseline audiogram and not enrolled in a monitoring program
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
75.0%
6/8 • Number of events 6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
80.0%
4/5 • Number of events 4 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
50.0%
3/6 • Number of events 3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
42.9%
3/7 • Number of events 3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
80.0%
8/10 • Number of events 8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
2/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory::Nose
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Eye disorders
Hemorrhage/Bleeding - Other (Subconjunctival hemorrhages)
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Congenital, familial and genetic disorders
Hypotension
|
62.5%
5/8 • Number of events 5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
33.3%
2/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Infections and infestations
Infection (documented clinically or microbiologically)
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
33.3%
2/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Blood
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
33.3%
2/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Infections and infestations
Infection
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::External ear (otitis externa)
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Middle ear (otitis media)
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Nerve-peripheral
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Paranasal
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
50.0%
3/6 • Number of events 3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Infections and infestations
Infection with normal ANC or Grade 3 or 4 neutrophils::Blood
|
50.0%
4/8 • Number of events 4 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Infections and infestations
Infection with unknown ANC::Urinary tract NOS
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Nervous system disorders
Laryngeal nerve dysfunction
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
100.0%
8/8 • Number of events 9 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
2/2 • Number of events 3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
5/5 • Number of events 5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
6/6 • Number of events 6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
71.4%
5/7 • Number of events 5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
100.0%
8/8 • Number of events 8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
3/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
2/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
5/5 • Number of events 5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
6/6 • Number of events 6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
7/7 • Number of events 7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
10/10 • Number of events 10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
2/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Nervous system disorders
Mood alteration::Agitation
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Nervous system disorders
Mood alteration::Anxiety
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Nervous system disorders
Mood alteration::Depression
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)::Whole body/generalized
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Nervous system disorders
Neuropathy: cranial: CN III Pupil, upper eyelid, extra ocular movements
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Nervous system disorders
Neuropathy: motor
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
30.0%
3/10 • Number of events 3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Nervous system disorders
Neuropathy: sensory
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
100.0%
8/8 • Number of events 9 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
2/2 • Number of events 3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
5/5 • Number of events 5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
83.3%
5/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
7/7 • Number of events 7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
90.0%
9/10 • Number of events 9 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
2/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Blood and lymphatic system disorders
PTT (Partial Thromboplastin Time)
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Gastrointestinal disorders
Pain::Abdomen NOS
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Nervous system disorders
Pain::Head/headache
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
2/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
25.0%
2/8 • Number of events 3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
60.0%
3/5 • Number of events 3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Blood and lymphatic system disorders
Platelets
|
100.0%
8/8 • Number of events 8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
2/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
100.0%
5/5 • Number of events 5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
66.7%
4/6 • Number of events 4 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Nervous system disorders
Psychosis (hallucinations/delusions)
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
20.0%
2/10 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Cardiac disorders
Pulmonary hypertension
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (low urine output)
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Oliguria)
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
28.6%
2/7 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Nervous system disorders
Speech impairment (e.g., dysphasia or aphasia)
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
30.0%
3/10 • Number of events 3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Sinus tachycardia
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Nervous system disorders
Syncope (fainting)
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
25.0%
2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
|
General disorders
Weight loss
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 101 months and 17 days.
|
Additional Information
Steven Rosenberg, M.D., Ph.D.
National Cancer Institute
Phone: 240-858.3080
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place