Trial Outcomes & Findings for Vorinostat and Combination Chemotherapy With Rituximab in Treating Patients With HIV-Related Diffuse Large B-Cell Non-Hodgkin Lymphoma or Other Aggressive B-Cell Lymphomas (NCT NCT01193842)
NCT ID: NCT01193842
Last Updated: 2023-11-21
Results Overview
Percentage of participants with complete response as assessed by Response Evaluation Criteria in Solid Tumors (Phase II) according to treatment arm. Participants are planned to be treated for a total of 6 cycles (21 day cycle length). Participants with CR after Cycle 4 will receive two additional cycles of chemotherapy and complete 6 cycles of chemotherapy. Participants who achieve a partial response (PR) only after Cycle 4 may continue on protocol therapy or they may be removed from the study at the AMC discretion of the physician (local Principal Investigator). Participants with stable disease after 4 cycles (i.e., who did not achieve at least a PR) or progressive disease at any time will be removed from study. In phase II, there are two arms: Vorinostat RPTD+rituximab-DA-EPOCH arm (VR-DA-EPOCH) and Rituximab-DA-EPOCH arm (DA-R-EPOCH).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
107 participants
Primary outcome timeframe
Up to 6 months
Results posted on
2023-11-21
Participant Flow
Participant milestones
| Measure |
Phase I: VR-DA-EPOCH, Dose Level 1
Arm A (VR-DA-EPOCH) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1)
|
Phase I: VR-DA-EPOCH, Dose Level 2
Arm A (VR-DA-EPOCH) with Vorinostat at 400 mg once a day on days 1-5 of a cycle (Phase I Dose Level 2)
|
Phase I: VR-CHOP, Dose Level 1
Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
|
Phase II: VR-DA-EPOCH
Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)
|
Phase II: DA-R-EPOCH
Arm B (DA-R-EPOCH), which is the same treatment as Arm A, but without Vorinostat
|
|---|---|---|---|---|---|
|
Phase I: VR-DA-EPOCH, Dose Level (DL) 1
STARTED
|
3
|
0
|
0
|
0
|
0
|
|
Phase I: VR-DA-EPOCH, Dose Level (DL) 1
COMPLETED
|
3
|
0
|
0
|
0
|
0
|
|
Phase I: VR-DA-EPOCH, Dose Level (DL) 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Phase I: VR-DA-EPOCH, DL 2
STARTED
|
0
|
7
|
0
|
0
|
0
|
|
Phase I: VR-DA-EPOCH, DL 2
COMPLETED
|
0
|
6
|
0
|
0
|
0
|
|
Phase I: VR-DA-EPOCH, DL 2
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
|
Phase I: VR-DA-EPOCH, DL 1 (De-escalate)
STARTED
|
4
|
0
|
0
|
0
|
0
|
|
Phase I: VR-DA-EPOCH, DL 1 (De-escalate)
COMPLETED
|
3
|
0
|
0
|
0
|
0
|
|
Phase I: VR-DA-EPOCH, DL 1 (De-escalate)
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
|
Phase I: VR-CHOP, DL 1
STARTED
|
0
|
0
|
2
|
0
|
0
|
|
Phase I: VR-CHOP, DL 1
COMPLETED
|
0
|
0
|
1
|
0
|
0
|
|
Phase I: VR-CHOP, DL 1
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
|
Phase II: Randomized Groups
STARTED
|
0
|
0
|
0
|
45
|
46
|
|
Phase II: Randomized Groups
COMPLETED
|
0
|
0
|
0
|
33
|
36
|
|
Phase II: Randomized Groups
NOT COMPLETED
|
0
|
0
|
0
|
12
|
10
|
Reasons for withdrawal
| Measure |
Phase I: VR-DA-EPOCH, Dose Level 1
Arm A (VR-DA-EPOCH) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1)
|
Phase I: VR-DA-EPOCH, Dose Level 2
Arm A (VR-DA-EPOCH) with Vorinostat at 400 mg once a day on days 1-5 of a cycle (Phase I Dose Level 2)
|
Phase I: VR-CHOP, Dose Level 1
Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
|
Phase II: VR-DA-EPOCH
Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)
|
Phase II: DA-R-EPOCH
Arm B (DA-R-EPOCH), which is the same treatment as Arm A, but without Vorinostat
|
|---|---|---|---|---|---|
|
Phase I: VR-DA-EPOCH, DL 2
Ineligible
|
0
|
1
|
0
|
0
|
0
|
|
Phase I: VR-DA-EPOCH, DL 1 (De-escalate)
Ineligible
|
1
|
0
|
0
|
0
|
0
|
|
Phase I: VR-CHOP, DL 1
Noncompliant (Cycle 1 not complete)
|
0
|
0
|
1
|
0
|
0
|
|
Phase II: Randomized Groups
Death
|
0
|
0
|
0
|
1
|
1
|
|
Phase II: Randomized Groups
Adverse Event
|
0
|
0
|
0
|
5
|
3
|
|
Phase II: Randomized Groups
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
2
|
|
Phase II: Randomized Groups
Ineligible
|
0
|
0
|
0
|
0
|
1
|
|
Phase II: Randomized Groups
Disease progression/relapse on treatment
|
0
|
0
|
0
|
5
|
3
|
Baseline Characteristics
Vorinostat and Combination Chemotherapy With Rituximab in Treating Patients With HIV-Related Diffuse Large B-Cell Non-Hodgkin Lymphoma or Other Aggressive B-Cell Lymphomas
Baseline characteristics by cohort
| Measure |
Phase I: VR-DA-EPOCH, Dose Level 1
n=6 Participants
Arm A (VR-DA-EPOCH) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1)
|
Phase I: VR-DA-EPOCH, Dose Level 2
n=6 Participants
Arm A (VR-DA-EPOCH) with Vorinostat at 400 mg once a day on days 1-5 of a cycle (Phase I Dose Level 2)
|
Phase I: VR-CHOP, Dose Level 1
n=1 Participants
Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
|
Phase II, V+DA-EPOCH
n=45 Participants
Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)
|
Phase II, DA-R-EPOCH
n=45 Participants
Arm B (DA-R-EPOCH), which is the same treatment as Arm A, but without Vorinostat
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
45.7 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
50.4 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
59.5 years
STANDARD_DEVIATION 0 • n=5 Participants
|
49.2 years
STANDARD_DEVIATION 10.1 • n=4 Participants
|
45 years
STANDARD_DEVIATION 9.2 • n=21 Participants
|
47.2 years
STANDARD_DEVIATION 9.8 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
96 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
29 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
70 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 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=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
65 Participants
n=8 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=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
103 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Up to 6 monthsPopulation: Reviewed responses from participants who completed at least one cycle of treatment. In phase II, there are two arms: Vorinostat RPTD+rituximab-DA-EPOCH arm (VR-DA-EPOCH) and Rituximab-DA-EPOCH arm (DA-R-EPOCH). In phase I, patients in DA-R-EPOCH were not included in the analysis.
Percentage of participants with complete response as assessed by Response Evaluation Criteria in Solid Tumors (Phase II) according to treatment arm. Participants are planned to be treated for a total of 6 cycles (21 day cycle length). Participants with CR after Cycle 4 will receive two additional cycles of chemotherapy and complete 6 cycles of chemotherapy. Participants who achieve a partial response (PR) only after Cycle 4 may continue on protocol therapy or they may be removed from the study at the AMC discretion of the physician (local Principal Investigator). Participants with stable disease after 4 cycles (i.e., who did not achieve at least a PR) or progressive disease at any time will be removed from study. In phase II, there are two arms: Vorinostat RPTD+rituximab-DA-EPOCH arm (VR-DA-EPOCH) and Rituximab-DA-EPOCH arm (DA-R-EPOCH).
Outcome measures
| Measure |
Phase II: VR-DA-EPOCH
n=40 Participants
Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)
|
Phase II: DA-R-EPOCH
n=42 Participants
Arm B (DA-R-EPOCH), which is the same treatment as Arm A, but without Vorinostat
|
Phase I: VR-CHOP, Dose Level 1
Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
|
Phase I: VR-DA-EPOCH, Dose Level 2
Arm A (VR-DA-EPOCH) with Vorinostat at 400mg once a day on days 1-5 of a cycle (Phase I dose Level 1)
|
Phase I: VR-CHOP, Dose Level 1
Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Complete Response (CR) as Assessed by Response Evaluation Criteria in Solid Tumors (Phase II)
|
67.5 percentage of participants
Interval 50.9 to 81.4
|
76.2 percentage of participants
Interval 60.6 to 88.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: Eligible randomized participants
The percentage of participants with AEs and their worst severity will be tabulated for each treatment arm. If a participant has more than one AE, the most severe AE is analyzed. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any serious AE (SAE) that the investigator considers related to protocol therapy.
Outcome measures
| Measure |
Phase II: VR-DA-EPOCH
n=45 Participants
Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)
|
Phase II: DA-R-EPOCH
n=45 Participants
Arm B (DA-R-EPOCH), which is the same treatment as Arm A, but without Vorinostat
|
Phase I: VR-CHOP, Dose Level 1
Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
|
Phase I: VR-DA-EPOCH, Dose Level 2
Arm A (VR-DA-EPOCH) with Vorinostat at 400mg once a day on days 1-5 of a cycle (Phase I dose Level 1)
|
Phase I: VR-CHOP, Dose Level 1
Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
|
|---|---|---|---|---|---|
|
Percentage of Participant Experiencing Adverse Events (AEs) for Each Treatment Arm as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase II)
Death
|
28.9 percentage of participants
|
20.0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participant Experiencing Adverse Events (AEs) for Each Treatment Arm as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase II)
Life-threatening
|
37.8 percentage of participants
|
28.9 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participant Experiencing Adverse Events (AEs) for Each Treatment Arm as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase II)
Severe
|
20.0 percentage of participants
|
31.1 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participant Experiencing Adverse Events (AEs) for Each Treatment Arm as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase II)
Moderate
|
8.9 percentage of participants
|
17.8 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participant Experiencing Adverse Events (AEs) for Each Treatment Arm as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase II)
Mild
|
2.2 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 21 daysPopulation: Eligible Phase I Arm A (VR-DA-EPOCH) participants who completed at least 1 cycle of treatment. This arm includes participants treated at 300 mg once a day (n=6) or 400 mg once a day (n=6) of Vorinostat for days 1-5.
Recommended phase II dose of vorinostat is defined as the dose level at which 0/6 or 1/6 subjects experience dose limiting toxicity (DLT) with the next higher dose having at least 2/3 or 2/6 subjects encountering DLT (Phase I). Toxicities will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Using a 3+3 design, the recommended phase II dose is defined as the level at which 0/6 or 1/6 patients experiences at dose-limiting toxicity in the first cycle.
Outcome measures
| Measure |
Phase II: VR-DA-EPOCH
n=12 Participants
Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)
|
Phase II: DA-R-EPOCH
Arm B (DA-R-EPOCH), which is the same treatment as Arm A, but without Vorinostat
|
Phase I: VR-CHOP, Dose Level 1
Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
|
Phase I: VR-DA-EPOCH, Dose Level 2
Arm A (VR-DA-EPOCH) with Vorinostat at 400mg once a day on days 1-5 of a cycle (Phase I dose Level 1)
|
Phase I: VR-CHOP, Dose Level 1
Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
|
|---|---|---|---|---|---|
|
Recommended Phase II Dose of Vorinostat Determined According to Dose-limiting Toxicities Graded Using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase I)
|
300 Mg per day of Vorinostat
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 12 monthsPopulation: Eligible participants who returned for follow-up with evaluable data.
Differences from baseline (specified follow-up assessment minus baseline) in absolute CD8 counts.
Outcome measures
| Measure |
Phase II: VR-DA-EPOCH
n=4 Participants
Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)
|
Phase II: DA-R-EPOCH
n=5 Participants
Arm B (DA-R-EPOCH), which is the same treatment as Arm A, but without Vorinostat
|
Phase I: VR-CHOP, Dose Level 1
n=1 Participants
Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
|
Phase I: VR-DA-EPOCH, Dose Level 2
Arm A (VR-DA-EPOCH) with Vorinostat at 400mg once a day on days 1-5 of a cycle (Phase I dose Level 1)
|
Phase I: VR-CHOP, Dose Level 1
Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
|
|---|---|---|---|---|---|
|
Change in CD8 Cell Counts (Phase I)
End of cycle 2
|
35.5 cells/mm^3
Interval -348.5 to 356.5
|
-115 cells/mm^3
Interval -162.0 to 75.0
|
-172 cells/mm^3
Interval -172.0 to -172.0
|
—
|
—
|
|
Change in CD8 Cell Counts (Phase I)
Treatment discontinuation
|
-164.5 cells/mm^3
Interval -962.5 to 198.5
|
211 cells/mm^3
Interval 18.0 to 359.0
|
-81 cells/mm^3
Interval -81.0 to -81.0
|
—
|
—
|
|
Change in CD8 Cell Counts (Phase I)
6-month follow-up
|
-56 cells/mm^3
Interval -177.0 to 443.0
|
275 cells/mm^3
Interval -152.0 to 728.0
|
-16 cells/mm^3
Interval -16.0 to -16.0
|
—
|
—
|
|
Change in CD8 Cell Counts (Phase I)
12-month follow-up
|
604 cells/mm^3
Interval 604.0 to 604.0
|
154 cells/mm^3
Interval -97.0 to 692.0
|
128 cells/mm^3
Interval 128.0 to 128.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 12 monthsPopulation: Eligible participants who completed at least 1 cycle of treatment with evaluable data.
Differences from baseline (specified follow-up assessment minus baseline) in absolute CD4 counts.
Outcome measures
| Measure |
Phase II: VR-DA-EPOCH
n=6 Participants
Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)
|
Phase II: DA-R-EPOCH
n=6 Participants
Arm B (DA-R-EPOCH), which is the same treatment as Arm A, but without Vorinostat
|
Phase I: VR-CHOP, Dose Level 1
n=1 Participants
Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
|
Phase I: VR-DA-EPOCH, Dose Level 2
Arm A (VR-DA-EPOCH) with Vorinostat at 400mg once a day on days 1-5 of a cycle (Phase I dose Level 1)
|
Phase I: VR-CHOP, Dose Level 1
Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
|
|---|---|---|---|---|---|
|
Changes in Absolute CD4 Cell Counts (Phase I)
End of cycle 2
|
92 cell/mm^3
Interval 9.0 to 143.0
|
-9 cell/mm^3
Interval -41.0 to 49.0
|
-218 cell/mm^3
Interval -218.0 to -218.0
|
—
|
—
|
|
Changes in Absolute CD4 Cell Counts (Phase I)
Treatment discontinuation
|
-39 cell/mm^3
Interval -53.0 to 56.0
|
-29 cell/mm^3
Interval -32.0 to 41.0
|
-190 cell/mm^3
Interval -190.0 to -190.0
|
—
|
—
|
|
Changes in Absolute CD4 Cell Counts (Phase I)
6-month follow-up
|
76 cell/mm^3
Interval 75.0 to 181.0
|
31 cell/mm^3
Interval -9.0 to 45.0
|
-175 cell/mm^3
Interval -175.0 to -175.0
|
—
|
—
|
|
Changes in Absolute CD4 Cell Counts (Phase I)
12-month follow-up
|
169 cell/mm^3
Interval 169.0 to 169.0
|
31 cell/mm^3
Interval -16.0 to 104.0
|
-84 cell/mm^3
Interval -84.0 to -84.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 12 monthsPopulation: Median Change from the baseline and IQR were calculated. The measurement unit is IU/mL.
Differences from baseline (specified follow-up assessment minus baseline) in EBV viral load.
Outcome measures
| Measure |
Phase II: VR-DA-EPOCH
n=16 Participants
Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)
|
Phase II: DA-R-EPOCH
n=19 Participants
Arm B (DA-R-EPOCH), which is the same treatment as Arm A, but without Vorinostat
|
Phase I: VR-CHOP, Dose Level 1
n=1 Participants
Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
|
Phase I: VR-DA-EPOCH, Dose Level 2
n=1 Participants
Arm A (VR-DA-EPOCH) with Vorinostat at 400mg once a day on days 1-5 of a cycle (Phase I dose Level 1)
|
Phase I: VR-CHOP, Dose Level 1
Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
|
|---|---|---|---|---|---|
|
Changes in Epstein-Barr Virus (EBV) Viral Load
End of Cycle 2
|
-0.61 IU/mL
Interval -104.1 to 0.0
|
0 IU/mL
Interval -0.61 to 0.0
|
0 IU/mL
Interval 0.0 to 0.0
|
-2436.1 IU/mL
Interval -2436.1 to -2436.1
|
—
|
|
Changes in Epstein-Barr Virus (EBV) Viral Load
At treatment discontinuation
|
-2.9 IU/mL
Interval -449.6 to -0.14
|
-0.28 IU/mL
Interval -1.9 to 0.0
|
0 IU/mL
Interval 0.0 to 0.0
|
-1.92 IU/mL
Interval -1.92 to -1.92
|
—
|
|
Changes in Epstein-Barr Virus (EBV) Viral Load
6-month follow-up
|
-1.55 IU/mL
Interval -2.98 to 0.0
|
0 IU/mL
Interval -4.87 to 4.07
|
0 IU/mL
Interval 0.0 to 0.0
|
-1.92 IU/mL
Interval -1.92 to -1.92
|
—
|
|
Changes in Epstein-Barr Virus (EBV) Viral Load
12-month follow-up
|
-0.56 IU/mL
Interval -228.2 to -0.07
|
-2.7 IU/mL
Interval -4.75 to 0.0
|
0 IU/mL
Interval 0.0 to 0.0
|
-1.15 IU/mL
Interval -1.15 to -1.15
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 12 monthsPopulation: Outcome measure is the difference between the baseline and specific time points (End of Cycle 2, Treatment discontinuation, 6-month, and 12-month follow-ups. Only a few differences can be calculated.
Differences from baseline (specified follow-up assessment minus baseline) in (HHV)-8 viral load.
Outcome measures
| Measure |
Phase II: VR-DA-EPOCH
n=1 Participants
Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)
|
Phase II: DA-R-EPOCH
n=2 Participants
Arm B (DA-R-EPOCH), which is the same treatment as Arm A, but without Vorinostat
|
Phase I: VR-CHOP, Dose Level 1
Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
|
Phase I: VR-DA-EPOCH, Dose Level 2
Arm A (VR-DA-EPOCH) with Vorinostat at 400mg once a day on days 1-5 of a cycle (Phase I dose Level 1)
|
Phase I: VR-CHOP, Dose Level 1
Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
|
|---|---|---|---|---|---|
|
Changes in Human Herpes Virus (HHV)-8 Viral Load
At treatment discontinuation
|
—
|
0 copies per 100uL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Changes in Human Herpes Virus (HHV)-8 Viral Load
6-month follow-up
|
—
|
0 copies per 100uL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Changes in Human Herpes Virus (HHV)-8 Viral Load
12-month follow-up
|
0 copies per 100uL
Interval 0.0 to 0.0
|
0 copies per 100uL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 12 monthsPopulation: Phase II participants who returned for follow-up with evaluable data.
Differences from baseline (specified follow-up assessment minus baseline) in HIV viral load. Undetectable viral load results were treated as 0 values.
Outcome measures
| Measure |
Phase II: VR-DA-EPOCH
n=42 Participants
Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)
|
Phase II: DA-R-EPOCH
n=41 Participants
Arm B (DA-R-EPOCH), which is the same treatment as Arm A, but without Vorinostat
|
Phase I: VR-CHOP, Dose Level 1
Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
|
Phase I: VR-DA-EPOCH, Dose Level 2
Arm A (VR-DA-EPOCH) with Vorinostat at 400mg once a day on days 1-5 of a cycle (Phase I dose Level 1)
|
Phase I: VR-CHOP, Dose Level 1
Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
|
|---|---|---|---|---|---|
|
Changes in Human Immunodeficiency Virus (HIV) Viral Load
End of Cycle 2
|
-20 median change in copies per mL
Interval -22607.0 to 0.0
|
-25 median change in copies per mL
Interval -3308.0 to 0.0
|
—
|
—
|
—
|
|
Changes in Human Immunodeficiency Virus (HIV) Viral Load
At treatment discontinuation
|
-87 median change in copies per mL
Interval -28176.0 to 0.0
|
-22.5 median change in copies per mL
Interval -1962.0 to 4.5
|
—
|
—
|
—
|
|
Changes in Human Immunodeficiency Virus (HIV) Viral Load
6-month follow-up
|
-20 median change in copies per mL
Interval -24703.0 to 0.0
|
-18 median change in copies per mL
Interval -3258.0 to 0.0
|
—
|
—
|
—
|
|
Changes in Human Immunodeficiency Virus (HIV) Viral Load
12-month follow-up
|
0 median change in copies per mL
Interval -22656.0 to 20.0
|
-20 median change in copies per mL
Interval -3361.0 to 0.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Eligible randomized participants.
The percentage of participants surviving without events (relapse or death) one year after starting treatment.
Outcome measures
| Measure |
Phase II: VR-DA-EPOCH
n=45 Participants
Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)
|
Phase II: DA-R-EPOCH
n=45 Participants
Arm B (DA-R-EPOCH), which is the same treatment as Arm A, but without Vorinostat
|
Phase I: VR-CHOP, Dose Level 1
Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
|
Phase I: VR-DA-EPOCH, Dose Level 2
Arm A (VR-DA-EPOCH) with Vorinostat at 400mg once a day on days 1-5 of a cycle (Phase I dose Level 1)
|
Phase I: VR-CHOP, Dose Level 1
Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
|
|---|---|---|---|---|---|
|
Event-free Survival (EFS) (Phase II)
|
75.6 percentage of participants
Interval 63.0 to 88.1
|
82.2 percentage of participants
Interval 71.1 to 93.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Eligible randomized participants.
The percentage of participants surviving one year after starting treatment.
Outcome measures
| Measure |
Phase II: VR-DA-EPOCH
n=45 Participants
Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)
|
Phase II: DA-R-EPOCH
n=45 Participants
Arm B (DA-R-EPOCH), which is the same treatment as Arm A, but without Vorinostat
|
Phase I: VR-CHOP, Dose Level 1
Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
|
Phase I: VR-DA-EPOCH, Dose Level 2
Arm A (VR-DA-EPOCH) with Vorinostat at 400mg once a day on days 1-5 of a cycle (Phase I dose Level 1)
|
Phase I: VR-CHOP, Dose Level 1
Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
|
|---|---|---|---|---|---|
|
Overall Survival (OS) (Phase II)
|
77.6 percentage of participants
Interval 65.3 to 89.8
|
86.7 percentage of participants
Interval 76.7 to 96.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 12 monthsPopulation: Eligible participants who returned for follow-up with evaluable data.
Differences from baseline (specified follow-up assessment minus baseline) in HIV viral load. Undetectable viral load results were treated as 0 values.
Outcome measures
| Measure |
Phase II: VR-DA-EPOCH
n=6 Participants
Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)
|
Phase II: DA-R-EPOCH
n=6 Participants
Arm B (DA-R-EPOCH), which is the same treatment as Arm A, but without Vorinostat
|
Phase I: VR-CHOP, Dose Level 1
n=1 Participants
Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
|
Phase I: VR-DA-EPOCH, Dose Level 2
Arm A (VR-DA-EPOCH) with Vorinostat at 400mg once a day on days 1-5 of a cycle (Phase I dose Level 1)
|
Phase I: VR-CHOP, Dose Level 1
Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
|
|---|---|---|---|---|---|
|
Change in Plasma Associated Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) (Phase I)
End of cycle 2
|
-14518 copies per milliliter
Interval -54352.0 to 0.0
|
-12.5 copies per milliliter
Interval -66.0 to 0.0
|
28 copies per milliliter
Interval 28.0 to 28.0
|
—
|
—
|
|
Change in Plasma Associated Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) (Phase I)
Treatment discontinuation
|
-4517 copies per milliliter
Interval -55116.0 to 0.0
|
0 copies per milliliter
Interval -88.0 to 49.0
|
0 copies per milliliter
Interval 0.0 to 0.0
|
—
|
—
|
|
Change in Plasma Associated Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) (Phase I)
6-month follow-up
|
-55116 copies per milliliter
Interval -282977.0 to 0.0
|
0 copies per milliliter
Interval -88.0 to 0.0
|
0 copies per milliliter
Interval 0.0 to 0.0
|
—
|
—
|
|
Change in Plasma Associated Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) (Phase I)
12-month follow-up
|
0 copies per milliliter
Interval 0.0 to 0.0
|
0 copies per milliliter
Interval -88.0 to 0.0
|
0 copies per milliliter
Interval 0.0 to 0.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 24-48, 48-72, and 72-96 hours after the start of the first chemotherapy infusionPopulation: Phase I participants with evaluable pharmacokinetic data
Serial plasma samples for pharmacokinetic analysis were collected at 24-48, 48-72, and 72-96 hours after the start of the first chemotherapy infusion. Doxorubicin, etoposide, and vincristine concentrations were determined using a validated liquid chromatography-tandem mass spectrometry method. The clearance was determined by dividing the drug-infusion rate by the steady-state concentrations, which was the average of the three time points.
Outcome measures
| Measure |
Phase II: VR-DA-EPOCH
n=6 Participants
Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)
|
Phase II: DA-R-EPOCH
n=5 Participants
Arm B (DA-R-EPOCH), which is the same treatment as Arm A, but without Vorinostat
|
Phase I: VR-CHOP, Dose Level 1
Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
|
Phase I: VR-DA-EPOCH, Dose Level 2
Arm A (VR-DA-EPOCH) with Vorinostat at 400mg once a day on days 1-5 of a cycle (Phase I dose Level 1)
|
Phase I: VR-CHOP, Dose Level 1
Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
|
|---|---|---|---|---|---|
|
Pharmacokinetic Clearance (Phase I)
Doxorubicin
|
78.6 Liter/hour
Standard Deviation 48.0
|
76.0 Liter/hour
Standard Deviation 47.9
|
—
|
—
|
—
|
|
Pharmacokinetic Clearance (Phase I)
Etoposide
|
3.0 Liter/hour
Standard Deviation 1.6
|
2.4 Liter/hour
Standard Deviation 0.7
|
—
|
—
|
—
|
|
Pharmacokinetic Clearance (Phase I)
Vincristine
|
22.4 Liter/hour
Standard Deviation 10.2
|
16.8 Liter/hour
Standard Deviation 8.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2 years post treatmentPopulation: Eligible participants who completed at least 1 cycle of treatment.
The percentage of participants whose best tumor response is complete response (CR) or partial response (PR). Based on clinical, radiologic (CT), and pathologic criteria, CR requires 1) complete disappearance of all detectable disease and disease-related symptoms if present before therapy, 2) bone marrow aspirate and biopsy to confirm a CR if initially positive or if clinically indicated by new abnormalities in the peripheral blood counts or blood smear, 3) negative PET results, depending on typically, variably, or unknown pre-treatment FDG status, and 4) spleen and/or liver, if considered to be enlarged before therapy on physical examination or CT scan, not being palpable on physical examination and considered normal size by imaging studies, and nodules related to lymphoma disappeared. PR includes 1) ≥50% decrease in sum of product of diameters (SPD), 2) no increase in size of nodes, liver, or spleen, 3) splenic/hepatic nodules regressed by ≥ 50% SPD, 4) no new sites of disease
Outcome measures
| Measure |
Phase II: VR-DA-EPOCH
n=6 Participants
Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)
|
Phase II: DA-R-EPOCH
n=6 Participants
Arm B (DA-R-EPOCH), which is the same treatment as Arm A, but without Vorinostat
|
Phase I: VR-CHOP, Dose Level 1
n=1 Participants
Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
|
Phase I: VR-DA-EPOCH, Dose Level 2
Arm A (VR-DA-EPOCH) with Vorinostat at 400mg once a day on days 1-5 of a cycle (Phase I dose Level 1)
|
Phase I: VR-CHOP, Dose Level 1
Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
|
|---|---|---|---|---|---|
|
Tumor Response (Phase I)
Complete response
|
83.3 percentage of participants
Interval 35.9 to 99.6
|
83.3 percentage of participants
Interval 35.9 to 99.6
|
100 percentage of participants
Interval 2.5 to 100.0
|
—
|
—
|
|
Tumor Response (Phase I)
Partial Response
|
16.7 percentage of participants
Interval 0.4 to 64.1
|
16.7 percentage of participants
Interval 0.4 to 64.1
|
0 percentage of participants
Interval 0.0 to 97.5
|
—
|
—
|
Adverse Events
Phase I: VR-DA-EPOCH, Dose Level 1
Serious events: 5 serious events
Other events: 7 other events
Deaths: 2 deaths
Phase I: VR-DA-EPOCH, Dose Level 2
Serious events: 3 serious events
Other events: 6 other events
Deaths: 1 deaths
Phase I: VR-CHOP, Dose Level 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase II: VR-DA-EPOCH
Serious events: 25 serious events
Other events: 43 other events
Deaths: 13 deaths
Phase II: DA-R-EPOCH
Serious events: 21 serious events
Other events: 43 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Phase I: VR-DA-EPOCH, Dose Level 1
n=7 participants at risk
Arm A (VR-DA-EPOCH) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1)
|
Phase I: VR-DA-EPOCH, Dose Level 2
n=7 participants at risk
Arm A (VR-DA-EPOCH) with Vorinostat at 400 mg once a day on days 1-5 of a cycle (Phase I Dose Level 2)
|
Phase I: VR-CHOP, Dose Level 1
n=2 participants at risk
Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
|
Phase II: VR-DA-EPOCH
n=45 participants at risk
Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)
|
Phase II: DA-R-EPOCH
n=46 participants at risk
Arm B (DA-R-EPOCH), which is the same treatment as Arm A but without Vorinostat
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
22.2%
10/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
17.4%
8/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
4.3%
2/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
6.7%
3/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
4.3%
2/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Cardiac disorders
Cardiac Disorders - Other, Specify
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Cardiac disorders
Pericardial Effusion
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Gastrointestinal disorders
Abdominal Pain
|
28.6%
2/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
4.4%
2/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Gastrointestinal disorders
Colitis
|
28.6%
2/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Gastrointestinal disorders
Diarrhea
|
28.6%
2/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Gastrointestinal disorders
Esophageal Ulcer
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Gastrointestinal disorders
Esophagitis
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Gastrointestinal disorders
Gastric Hemorrhage
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Gastrointestinal disorders
Intra-Abdominal Hemorrhage
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Gastrointestinal disorders
Mucositis Oral
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Gastrointestinal disorders
Rectal Pain
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
6.5%
3/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
General disorders
Death Nos
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
General disorders
Fatigue
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
General disorders
Multi-Organ Failure
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Infections and infestations
Enterocolitis Infectious
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Infections and infestations
Infections And Infestations - Other, Specify
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Infections and infestations
Kidney Infection
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Infections and infestations
Lung Infection
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
4.3%
2/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Infections and infestations
Sepsis
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
6.7%
3/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
6.5%
3/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Infections and infestations
Soft Tissue Infection
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Infections and infestations
Tooth Infection
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Investigations
Lymphocyte Count Decreased
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
4.4%
2/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Investigations
Neutrophil Count Decreased
|
71.4%
5/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
28.6%
2/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
26.7%
12/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
4.3%
2/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
42.9%
3/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
24.4%
11/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Investigations
White Blood Cell Decreased
|
71.4%
5/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
11.1%
5/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps) - Other, Specify
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
15.6%
7/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
8.7%
4/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
4.4%
2/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Nervous system disorders
Nervous System Disorders - Other, Specify
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Renal and urinary disorders
Renal And Urinary Disorders - Other, Specify
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Renal and urinary disorders
Renal Colic
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
4.4%
2/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Surgical and medical procedures
Surgical And Medical Procedures - Other, Specify
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Vascular disorders
Thromboembolic Event
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
Other adverse events
| Measure |
Phase I: VR-DA-EPOCH, Dose Level 1
n=7 participants at risk
Arm A (VR-DA-EPOCH) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1)
|
Phase I: VR-DA-EPOCH, Dose Level 2
n=7 participants at risk
Arm A (VR-DA-EPOCH) with Vorinostat at 400 mg once a day on days 1-5 of a cycle (Phase I Dose Level 2)
|
Phase I: VR-CHOP, Dose Level 1
n=2 participants at risk
Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
|
Phase II: VR-DA-EPOCH
n=45 participants at risk
Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)
|
Phase II: DA-R-EPOCH
n=46 participants at risk
Arm B (DA-R-EPOCH), which is the same treatment as Arm A but without Vorinostat
|
|---|---|---|---|---|---|
|
Investigations
Lymphocyte Count Increased
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
4.3%
2/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Blood and lymphatic system disorders
Anemia
|
28.6%
2/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
57.1%
4/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
50.0%
1/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
60.0%
27/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
50.0%
23/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
6.7%
3/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
6.7%
3/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Cardiac disorders
Pericarditis
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
8.9%
4/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
4.3%
2/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Eye disorders
Watering Eyes
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Gastrointestinal disorders
Abdominal Pain
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
17.8%
8/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
8.7%
4/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Gastrointestinal disorders
Anal Mucositis
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
6.5%
3/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Gastrointestinal disorders
Constipation
|
42.9%
3/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
28.6%
2/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
44.4%
20/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
39.1%
18/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Gastrointestinal disorders
Diarrhea
|
42.9%
3/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
37.8%
17/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
21.7%
10/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
4.4%
2/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
4.3%
2/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
4.4%
2/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
6.5%
3/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other, Specify
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
6.5%
3/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Gastrointestinal disorders
Mucositis Oral
|
28.6%
2/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
28.6%
2/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
20.0%
9/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
19.6%
9/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Gastrointestinal disorders
Nausea
|
85.7%
6/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
42.9%
3/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
50.0%
1/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
44.4%
20/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
47.8%
22/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
2/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
50.0%
1/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
22.2%
10/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
19.6%
9/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
General disorders
Chills
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
11.1%
5/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
General disorders
Edema Limbs
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
22.2%
10/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
8.7%
4/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
General disorders
Fatigue
|
28.6%
2/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
28.6%
2/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
100.0%
2/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
40.0%
18/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
28.3%
13/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
General disorders
Fever
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
28.6%
2/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
17.8%
8/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
4.3%
2/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
General disorders
Flu Like Symptoms
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
General disorders
General Disorders And Administration Site Conditions - Other, Specify
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
4.4%
2/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
6.5%
3/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
General disorders
Infusion Related Reaction
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
4.3%
2/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
General disorders
Non-Cardiac Chest Pain
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
General disorders
Pain
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
4.4%
2/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
6.5%
3/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Infections and infestations
Abdominal Infection
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Infections and infestations
Esophageal Infection
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Infections and infestations
Infections And Infestations - Other, Specify
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
11.1%
5/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Infections and infestations
Mucosal Infection
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
8.7%
4/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Infections and infestations
Nail Infection
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Infections and infestations
Rhinitis Infective
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Infections and infestations
Upper Respiratory Infection
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
4.4%
2/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
4.3%
2/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Injury, poisoning and procedural complications
Seroma
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
40.0%
18/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
19.6%
9/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Investigations
Alkaline Phosphatase Increased
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
24.4%
11/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
19.6%
9/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Investigations
Aspartate Aminotransferase Increased
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
33.3%
15/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
21.7%
10/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Investigations
Blood Bilirubin Increased
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
8.9%
4/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
4.3%
2/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Investigations
Creatinine Increased
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
8.9%
4/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
8.7%
4/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Investigations
Ggt Increased
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
4.4%
2/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
6.5%
3/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Investigations
Lymphocyte Count Decreased
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
42.9%
3/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
50.0%
1/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
44.4%
20/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
41.3%
19/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Investigations
Neutrophil Count Decreased
|
57.1%
4/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
28.6%
2/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
53.3%
24/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
41.3%
19/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Investigations
Platelet Count Decreased
|
57.1%
4/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
42.9%
3/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
50.0%
1/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
60.0%
27/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
41.3%
19/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Investigations
Weight Loss
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
6.7%
3/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Investigations
White Blood Cell Decreased
|
42.9%
3/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
28.6%
2/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
55.6%
25/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
45.7%
21/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
6.7%
3/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
8.7%
4/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
28.6%
2/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
51.1%
23/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
34.8%
16/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
6.7%
3/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
8.7%
4/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
8.9%
4/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
4.3%
2/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
4.3%
2/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
8.7%
4/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
31.1%
14/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
32.6%
15/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
24.4%
11/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
34.8%
16/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
4.4%
2/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
10.9%
5/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
28.6%
2/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
51.1%
23/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
32.6%
15/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
13.3%
6/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
15.2%
7/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
31.1%
14/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
21.7%
10/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
15.6%
7/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
17.4%
8/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
8.9%
4/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
50.0%
1/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
4.4%
2/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
8.7%
4/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Pain
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
8.7%
4/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
28.6%
2/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
6.7%
3/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
6.5%
3/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Nervous system disorders
Cognitive Disturbance
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
13.3%
6/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
10.9%
5/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Nervous system disorders
Dysesthesia
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Nervous system disorders
Headache
|
28.6%
2/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
20.0%
9/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
37.0%
17/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
50.0%
1/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
6.7%
3/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
6.5%
3/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
8.9%
4/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
4.3%
2/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
28.6%
2/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
26.7%
12/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
43.5%
20/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
11.1%
5/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
6.5%
3/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Psychiatric disorders
Depression
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
8.9%
4/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
4.3%
2/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Psychiatric disorders
Insomnia
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
11.1%
5/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
15.2%
7/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Renal and urinary disorders
Urinary Frequency
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
4.4%
2/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
8.7%
4/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Renal and urinary disorders
Urinary Tract Pain
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
6.5%
3/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Reproductive system and breast disorders
Oligospermia
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
50.0%
1/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
8.7%
4/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
8.9%
4/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
21.7%
10/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
50.0%
1/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
8.9%
4/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
6.5%
3/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
4.3%
2/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
6.5%
3/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
50.0%
1/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
8.9%
4/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
13.0%
6/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Skin and subcutaneous tissue disorders
Bullous Dermatitis
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
8.9%
4/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperhidrosis
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Skin and subcutaneous tissue disorders
Nail Discoloration
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
4.3%
2/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
28.6%
2/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
4.4%
2/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
4.3%
2/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Vascular disorders
Flushing
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Vascular disorders
Hypertension
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
8.9%
4/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
6.5%
3/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Vascular disorders
Hypotension
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
8.7%
4/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Vascular disorders
Lymphedema
|
14.3%
1/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/7 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
0.00%
0/2 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
11.1%
5/45 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
2.2%
1/46 • Up to 5 years. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any SAE that the investigator considers related to protocol therapy.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60