Trial Outcomes & Findings for Venetoclax and Vincristine in Treating Patients With Relapsed or Refractory T-cell or B-cell Acute Lymphoblastic Leukemia (NCT NCT03504644)
NCT ID: NCT03504644
Last Updated: 2026-05-13
Results Overview
A dose limiting toxicity (DLT) was defined by the occurrence of any protocol-listed toxicities (CTCAE version 5.0 criteria) possibly, probably, or definitely related to study medication or combination within the first cycle (i.e., ≤ 42 days of first dose of study drug). The phase I portion of this study will use a standard 3+3 design. Escalation would continue until \> 33% of a particular dose arm experiences a DLT. The next lower dose arm would be considered the MTD. If \< two (2) patients experience a DLT in Arm C, then the Arm C dose would be considered the MTD.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
40 participants
Primary outcome timeframe
From start of treatment up to 42 days
Results posted on
2026-05-13
Participant Flow
Phase I Arm A (Dose Level 1) enrollment: 3 Phase I Arm B (Dose Level 2) enrollment: 12 Phase I Arm C (Dose Level 3) enrollment: 3 Phase II enrollment: 22
Phase I treatment employed a standard 3 + 3 dose escalation design, starting at dose level 1. The phase II portion of this trial was a single arm, open-label study.
Participant milestones
| Measure |
Phase Ib Arm A (Dose Level 1)
Dose Level 1: venetoclax 20, 50, 100, 200 mg on Days 1, 2, 3, 4 and 400 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial.
|
Phase Ib Arm B (Dose Level 2)
Dose Level 2: venetoclax 50, 100, 200, 400 mg on Days 1, 2, 3, 4 and 600 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial.
|
Phase Ib Arm C (Dose Level 3)
Dose Level 3: - Venetolcax 100, 200, 400, 600 mg on Days 1, 2, 3, 4 and 800 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial.
|
Phase II (Venetoclax, Vincristine Liposomal/Sulfate) - Phenotype B-cell ALL/LL
Patients receive combination of venetoclax (600mg, orally once daily, Days 1-28) and liposomal vincristine (2.25mg/m2 IV weekly x 4, starting on Day 1) or vincristine sulfate (1.4mg/m2 IV weekly x 4 \[capped at 2mg\], starting on Day 1). Due to liposomal vincristine was removed in the US market as of April 2022, no new patients started with liposomal vincristine on this trial and patients receiving liposomal vincristine at that time were switched to vincristine sulfate at the beginning of their next cycle or as the drug supply required, whichever came first. Once a patient switched, patient must have continued with conventional vincristine sulfate for the duration of the trial.
|
Phase II (Venetoclax, Vincristine Liposomal/Sulfate) - Phenotype T-cell ALL/LL
Patients receive combination of venetoclax (600mg, orally once daily, Days 1-28) and liposomal vincristine (2.25mg/m2 IV weekly x 4, starting on Day 1) or vincristine sulfate (1.4mg/m2 IV weekly x 4 \[capped at 2mg\], starting on Day 1). Due to liposomal vincristine was removed in the US market as of April 2022, no new patients started with liposomal vincristine on this trial and patients receiving liposomal vincristine at that time were switched to vincristine sulfate at the beginning of their next cycle or as the drug supply required, whichever came first. Once a patient switched, patient must have continued with conventional vincristine sulfate for the duration of the trial.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
12
|
3
|
13
|
9
|
|
Overall Study
Never Started Assigned Therapy
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
12
|
3
|
13
|
9
|
Reasons for withdrawal
| Measure |
Phase Ib Arm A (Dose Level 1)
Dose Level 1: venetoclax 20, 50, 100, 200 mg on Days 1, 2, 3, 4 and 400 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial.
|
Phase Ib Arm B (Dose Level 2)
Dose Level 2: venetoclax 50, 100, 200, 400 mg on Days 1, 2, 3, 4 and 600 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial.
|
Phase Ib Arm C (Dose Level 3)
Dose Level 3: - Venetolcax 100, 200, 400, 600 mg on Days 1, 2, 3, 4 and 800 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial.
|
Phase II (Venetoclax, Vincristine Liposomal/Sulfate) - Phenotype B-cell ALL/LL
Patients receive combination of venetoclax (600mg, orally once daily, Days 1-28) and liposomal vincristine (2.25mg/m2 IV weekly x 4, starting on Day 1) or vincristine sulfate (1.4mg/m2 IV weekly x 4 \[capped at 2mg\], starting on Day 1). Due to liposomal vincristine was removed in the US market as of April 2022, no new patients started with liposomal vincristine on this trial and patients receiving liposomal vincristine at that time were switched to vincristine sulfate at the beginning of their next cycle or as the drug supply required, whichever came first. Once a patient switched, patient must have continued with conventional vincristine sulfate for the duration of the trial.
|
Phase II (Venetoclax, Vincristine Liposomal/Sulfate) - Phenotype T-cell ALL/LL
Patients receive combination of venetoclax (600mg, orally once daily, Days 1-28) and liposomal vincristine (2.25mg/m2 IV weekly x 4, starting on Day 1) or vincristine sulfate (1.4mg/m2 IV weekly x 4 \[capped at 2mg\], starting on Day 1). Due to liposomal vincristine was removed in the US market as of April 2022, no new patients started with liposomal vincristine on this trial and patients receiving liposomal vincristine at that time were switched to vincristine sulfate at the beginning of their next cycle or as the drug supply required, whichever came first. Once a patient switched, patient must have continued with conventional vincristine sulfate for the duration of the trial.
|
|---|---|---|---|---|---|
|
Overall Study
Never started therapy
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
3
|
1
|
0
|
1
|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Disease progression- relapse during active treatment
|
2
|
4
|
1
|
5
|
5
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
1
|
1
|
|
Overall Study
Alternative therapy
|
0
|
2
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
3
|
1
|
|
Overall Study
Difficulty swallowing venetoclax
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Patient moved
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
No detailed information
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Still on therapy
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Venetoclax and Vincristine in Treating Patients With Relapsed or Refractory T-cell or B-cell Acute Lymphoblastic Leukemia
Baseline characteristics by cohort
| Measure |
Phase Ib Arm A (Dose Level 1)
n=3 Participants
Dose Level 1: venetoclax 20, 50, 100, 200 mg on Days 1, 2, 3, 4 and 400 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial.
|
Phase Ib Arm B (Dose Level 2)
n=12 Participants
Dose Level 2: venetoclax 50, 100, 200, 400 mg on Days 1, 2, 3, 4 and 600 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial.
|
Phase Ib Arm C (Dose Level 3)
n=3 Participants
Dose Level 3: - Venetolcax 100, 200, 400, 600 mg on Days 1, 2, 3, 4 and 800 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial.
|
Phase II (Venetoclax, Vincristine Liposomal/Sulfate) - Phenotype B-cell ALL/LL
n=12 Participants
Patients receive combination of venetoclax (600mg, orally once daily, Days 1-28) and liposomal vincristine (2.25mg/m2 IV weekly x 4, starting on Day 1) or vincristine sulfate (1.4mg/m2 IV weekly x 4 \[capped at 2mg\], starting on Day 1). Due to liposomal vincristine was removed in the US market as of April 2022, no new patients started with liposomal vincristine on this trial and patients receiving liposomal vincristine at that time were switched to vincristine sulfate at the beginning of their next cycle or as the drug supply required, whichever came first. Once a patient switched, patient must have continued with conventional vincristine sulfate for the duration of the trial.
|
Phase II (Venetoclax, Vincristine Liposomal/Sulfate) - Phenotype T-cell ALL/LL
n=9 Participants
Patients receive combination of venetoclax (600mg, orally once daily, Days 1-28) and liposomal vincristine (2.25mg/m2 IV weekly x 4, starting on Day 1) or vincristine sulfate (1.4mg/m2 IV weekly x 4 \[capped at 2mg\], starting on Day 1). Due to liposomal vincristine was removed in the US market as of April 2022, no new patients started with liposomal vincristine on this trial and patients receiving liposomal vincristine at that time were switched to vincristine sulfate at the beginning of their next cycle or as the drug supply required, whichever came first. Once a patient switched, patient must have continued with conventional vincristine sulfate for the duration of the trial.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
73 years
n=1512 Participants
|
33 years
n=504 Participants
|
32 years
n=2016 Participants
|
55 years
n=99 Participants
|
45 years
n=97 Participants
|
49 years
n=488 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=1512 Participants
|
4 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
3 Participants
n=99 Participants
|
2 Participants
n=97 Participants
|
13 Participants
n=488 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=1512 Participants
|
8 Participants
n=504 Participants
|
2 Participants
n=2016 Participants
|
9 Participants
n=99 Participants
|
7 Participants
n=97 Participants
|
26 Participants
n=488 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=1512 Participants
|
3 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
4 Participants
n=99 Participants
|
0 Participants
n=97 Participants
|
8 Participants
n=488 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=1512 Participants
|
9 Participants
n=504 Participants
|
2 Participants
n=2016 Participants
|
8 Participants
n=99 Participants
|
9 Participants
n=97 Participants
|
31 Participants
n=488 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
2 Participants
n=99 Participants
|
0 Participants
n=97 Participants
|
2 Participants
n=488 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=1512 Participants
|
2 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
2 Participants
n=99 Participants
|
1 Participants
n=97 Participants
|
6 Participants
n=488 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=1512 Participants
|
8 Participants
n=504 Participants
|
2 Participants
n=2016 Participants
|
7 Participants
n=99 Participants
|
8 Participants
n=97 Participants
|
27 Participants
n=488 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
2 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
1 Participants
n=99 Participants
|
0 Participants
n=97 Participants
|
4 Participants
n=488 Participants
|
PRIMARY outcome
Timeframe: From start of treatment up to 42 daysPopulation: If a patient never starts the study drug, withdraws prior to Day 42 of cycle 1 for non-DLT reasons, is lost to follow up prior to Day 42, or dose not receive 75% of study medications, this slot would be made available for replacement. In total 6 patients were replaced, all were assigned to Arm B.
A dose limiting toxicity (DLT) was defined by the occurrence of any protocol-listed toxicities (CTCAE version 5.0 criteria) possibly, probably, or definitely related to study medication or combination within the first cycle (i.e., ≤ 42 days of first dose of study drug). The phase I portion of this study will use a standard 3+3 design. Escalation would continue until \> 33% of a particular dose arm experiences a DLT. The next lower dose arm would be considered the MTD. If \< two (2) patients experience a DLT in Arm C, then the Arm C dose would be considered the MTD.
Outcome measures
| Measure |
Phase Ib Arm A (Dose Level 1)
n=3 Participants
Dose Level 1: venetoclax 20, 50, 100, 200 mg on Days 1, 2, 3, 4 and 400 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial.
|
Phase Ib Arm B (Dose Level 2)
n=6 Participants
Dose Level 2: venetoclax 50, 100, 200, 400 mg on Days 1, 2, 3, 4 and 600 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial.
|
Phase Ib Arm C (Dose Level 3)
n=3 Participants
Dose Level 3: - Venetolcax 100, 200, 400, 600 mg on Days 1, 2, 3, 4 and 800 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial.
|
|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicity (Phase I)
|
0 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 6 years and 11 monthsPopulation: All treated patients
Toxicities will be assessed and graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Outcome measures
| Measure |
Phase Ib Arm A (Dose Level 1)
n=3 Participants
Dose Level 1: venetoclax 20, 50, 100, 200 mg on Days 1, 2, 3, 4 and 400 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial.
|
Phase Ib Arm B (Dose Level 2)
n=12 Participants
Dose Level 2: venetoclax 50, 100, 200, 400 mg on Days 1, 2, 3, 4 and 600 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial.
|
Phase Ib Arm C (Dose Level 3)
n=3 Participants
Dose Level 3: - Venetolcax 100, 200, 400, 600 mg on Days 1, 2, 3, 4 and 800 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial.
|
|---|---|---|---|
|
Number of Participants With Treatment-Related Toxicities (Phase I)
Patients with worst degree of grade 3 treatment-related toxicities
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Related Toxicities (Phase I)
Patients with worst degree of grade 4 treatment-related toxicities
|
3 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants With Treatment-Related Toxicities (Phase I)
Patients with worst degree of grade 5 treatment-related toxicities
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Assessed at baseline, then every cycle, up to the end of cycle 3 (1 cycle = 28 days)Population: Eligible and treated patients with results reported by phenotype
CR+CRi rate (for the best overall response) by the end of cycle 3. A 90% confidence interval will be computed. Tumor response was determined by patient's bone marrow samples that were locally analyzed according to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Acute Lymphoblastic Leukemia; 2019 \[updated May 15 2019\]. Available from: https://www.nccn.org/professionals/physician\_gls/pdf/all.pdf.
Outcome measures
| Measure |
Phase Ib Arm A (Dose Level 1)
n=12 Participants
Dose Level 1: venetoclax 20, 50, 100, 200 mg on Days 1, 2, 3, 4 and 400 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial.
|
Phase Ib Arm B (Dose Level 2)
n=9 Participants
Dose Level 2: venetoclax 50, 100, 200, 400 mg on Days 1, 2, 3, 4 and 600 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial.
|
Phase Ib Arm C (Dose Level 3)
Dose Level 3: - Venetolcax 100, 200, 400, 600 mg on Days 1, 2, 3, 4 and 800 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial.
|
|---|---|---|---|
|
Complete Remission (CR) + Complete Remission Incomplete (CRi) Rate (Phase II)
|
0 percentage of participants
Interval 0.0 to 0.22
|
0.11 percentage of participants
Interval 0.01 to 0.43
|
—
|
SECONDARY outcome
Timeframe: While on treatment and every 6 months during follow-up if discontinued for reasons other than PD, up to 5 years from study registrationPopulation: Eligible and treated patients with results reported by phenotype
From study registration to documented disease progression or death from any cause, whichever occurs first. PFS will be estimated using the Kaplan-Meier method, and the median PFS along with its corresponding 95% confidence interval will be reported. Progressive disease is defined as a 50% increase in blasts in the marrow. Tumor response was determined by patient's bone marrow samples that were locally analyzed according to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Acute Lymphoblastic Leukemia; 2019 \[updated May 15 2019\]. Available from: https://www.nccn.org/professionals/physician\_gls/pdf/all.pdf.
Outcome measures
| Measure |
Phase Ib Arm A (Dose Level 1)
n=12 Participants
Dose Level 1: venetoclax 20, 50, 100, 200 mg on Days 1, 2, 3, 4 and 400 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial.
|
Phase Ib Arm B (Dose Level 2)
n=9 Participants
Dose Level 2: venetoclax 50, 100, 200, 400 mg on Days 1, 2, 3, 4 and 600 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial.
|
Phase Ib Arm C (Dose Level 3)
Dose Level 3: - Venetolcax 100, 200, 400, 600 mg on Days 1, 2, 3, 4 and 800 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial.
|
|---|---|---|---|
|
Progression Free Survival (PFS) (Phase II)
|
2.9 months
Interval 1.7 to 3.7
|
1.2 months
Interval 0.7 to 4.6
|
—
|
SECONDARY outcome
Timeframe: While on treatment and every 6 months during follow-up, up to 5 years from study registrationPopulation: Eligible and treated patients with results reported by phenotype
From study registration to death from any cause. OS will be estimated using the Kaplan-Meier method, and the median OS along with its corresponding 95% confidence interval will be reported.
Outcome measures
| Measure |
Phase Ib Arm A (Dose Level 1)
n=12 Participants
Dose Level 1: venetoclax 20, 50, 100, 200 mg on Days 1, 2, 3, 4 and 400 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial.
|
Phase Ib Arm B (Dose Level 2)
n=9 Participants
Dose Level 2: venetoclax 50, 100, 200, 400 mg on Days 1, 2, 3, 4 and 600 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial.
|
Phase Ib Arm C (Dose Level 3)
Dose Level 3: - Venetolcax 100, 200, 400, 600 mg on Days 1, 2, 3, 4 and 800 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial.
|
|---|---|---|---|
|
Overall Survival (OS) (Phase II)
|
4.3 months
Interval 1.5 to 22.0
|
10.2 months
Interval 2.0 to 16.4
|
—
|
SECONDARY outcome
Timeframe: Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 yearsPopulation: All treated patients
Toxicity incidences will be assessed and graded according to the CTCAE and will be tabulated by patient cohort.
Outcome measures
| Measure |
Phase Ib Arm A (Dose Level 1)
n=12 Participants
Dose Level 1: venetoclax 20, 50, 100, 200 mg on Days 1, 2, 3, 4 and 400 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial.
|
Phase Ib Arm B (Dose Level 2)
n=9 Participants
Dose Level 2: venetoclax 50, 100, 200, 400 mg on Days 1, 2, 3, 4 and 600 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial.
|
Phase Ib Arm C (Dose Level 3)
Dose Level 3: - Venetolcax 100, 200, 400, 600 mg on Days 1, 2, 3, 4 and 800 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial.
|
|---|---|---|---|
|
Incidence of Toxicities (Phase II)
Patients with worst degree of grade 3 treatment-related toxicities
|
2 Participants
|
2 Participants
|
—
|
|
Incidence of Toxicities (Phase II)
Patients with worst degree of grade 4 treatment-related toxicities
|
7 Participants
|
2 Participants
|
—
|
|
Incidence of Toxicities (Phase II)
Patients with worst degree of grade 5 treatment-related toxicities
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Assessed at baseline, then every cycle, up to the end of cycle 3 (1 cycle = 28 days)Population: Eligible and treated patients who had MRD assessment performed at the follow-up visits.
The MRD response reported here was based on the local assessment (i.e., by site) and met the criteria per protocol: "An MRD negative response must meet the criteria for CR or CRi and have any residual disease \<0.01% based on original testing technique."
Outcome measures
| Measure |
Phase Ib Arm A (Dose Level 1)
n=6 Participants
Dose Level 1: venetoclax 20, 50, 100, 200 mg on Days 1, 2, 3, 4 and 400 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial.
|
Phase Ib Arm B (Dose Level 2)
n=4 Participants
Dose Level 2: venetoclax 50, 100, 200, 400 mg on Days 1, 2, 3, 4 and 600 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial.
|
Phase Ib Arm C (Dose Level 3)
Dose Level 3: - Venetolcax 100, 200, 400, 600 mg on Days 1, 2, 3, 4 and 800 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial.
|
|---|---|---|---|
|
Minimal Residual Disease (MRD) Negativity Rate (Phase II)
|
0 percentage of participants
|
0 percentage of participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 5 yearsWill be assessed by flow cytometry and dichotomized into two groups by the median (low versus \[vs\] high). Univariate Cox proportional hazards (PH) models will be used to evaluate the association of the BCL-2 expression at baseline and immunophenotype (B-cell and T-cell acute lymphoblastic leukemia) with OS and PFS, separately. Logistic regression models will be used to investigate the association of the BCL-2 expression at baseline and immunophenotype with response (CR/CRi/partial remission \[PR\] vs others by 70 days). Multivariable Cox PH modelling and logistic regression modelling will also be used to adjust for the effect of covariates that are possibly associated with these efficacy outcomes.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsLogistic regression models will be used to investigate the association of the BCL-2 expression at baseline and immunophenotype with response (CR/CRi/PR vs. others by 70 days). Multivariable Cox PH modelling and logistic regression modelling will also be used to adjust for the effect of covariates that are possibly associated with these efficacy outcomes.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsWill be assessed by next generation sequencing.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsWill determine if the BH3 profile is associated with response to combination.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsWill determine if relative expression of BCL-2 measure by flow cytometry is associated with response to combination.
Outcome measures
Outcome data not reported
Adverse Events
Phase Ib Arm A (Dose Level 1)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase Ib Arm B (Dose Level 2)
Serious events: 9 serious events
Other events: 12 other events
Deaths: 2 deaths
Phase Ib Arm C (Dose Level 3)
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase II (Venetoclax, Vincristine Liposomal/Sulfate)
Serious events: 12 serious events
Other events: 21 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
Phase Ib Arm A (Dose Level 1)
n=3 participants at risk
Dose Level 1: venetoclax 20, 50, 100, 200 mg on Days 1, 2, 3, 4 and 400 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial.
|
Phase Ib Arm B (Dose Level 2)
n=12 participants at risk
Dose Level 2: venetoclax 50, 100, 200, 400 mg on Days 1, 2, 3, 4 and 600 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial.
|
Phase Ib Arm C (Dose Level 3)
n=3 participants at risk
Dose Level 3: - Venetolcax 100, 200, 400, 600 mg on Days 1, 2, 3, 4 and 800 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial.
|
Phase II (Venetoclax, Vincristine Liposomal/Sulfate)
n=21 participants at risk
Patients receive combination of venetoclax (600mg, orally once daily, Days 1-28) and liposomal vincristine (2.25mg/m2 IV weekly x 4, starting on Day 1) or vincristine sulfate (1.4mg/m2 IV weekly x 4 \[capped at 2mg\], starting on Day 1). Due to liposomal vincristine was removed in the US market as of April 2022, no new patients started with liposomal vincristine on this trial and patients receiving liposomal vincristine at that time were switched to vincristine sulfate at the beginning of their next cycle or as the drug supply required, whichever came first. Once a patient switched, patient must have continued with conventional vincristine sulfate for the duration of the trial.
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
16.7%
2/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
100.0%
3/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
19.0%
4/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
General disorders and administration site conditions
Death NOS
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
General disorders and administration site conditions
Edema face
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
General disorders and administration site conditions
Fever
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
General disorders and administration site conditions
Non-cardiac chest pain
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
General disorders and administration site conditions
Disease progression
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
16.7%
2/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
9.5%
2/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
16.7%
2/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
16.7%
2/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
9.5%
2/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
16.7%
2/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
9.5%
2/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Infections and infestations
Bacteremia
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Infections and infestations
Herpes simplex reactivation
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Infections and infestations
Fungemia
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
9.5%
2/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
16.7%
2/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
9.5%
2/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Investigations
White blood cell decreased
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
66.7%
2/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Nervous system disorders
Stroke
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
9.5%
2/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
Other adverse events
| Measure |
Phase Ib Arm A (Dose Level 1)
n=3 participants at risk
Dose Level 1: venetoclax 20, 50, 100, 200 mg on Days 1, 2, 3, 4 and 400 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial.
|
Phase Ib Arm B (Dose Level 2)
n=12 participants at risk
Dose Level 2: venetoclax 50, 100, 200, 400 mg on Days 1, 2, 3, 4 and 600 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial.
|
Phase Ib Arm C (Dose Level 3)
n=3 participants at risk
Dose Level 3: - Venetolcax 100, 200, 400, 600 mg on Days 1, 2, 3, 4 and 800 mg on Days 5 - 70 together with a fixed, standard dose of intravenous liposomal vincristine (i.e., 2.25mg/m2 IV weekly x 4) starting Day 15 (Cycle 1 = 42 days). All patients would continue onto a second 28-day cycle of the combination therapy (Cycle 2 = 28 days). A bone marrow biopsy would be performed at day 70 +/- 2 days. Patients with progressive disease would be off treatment. Patients who achieve at least a stable disease response could remain on a 28-day cycle of combination therapy until disease progression, or withdrawal from trial.
|
Phase II (Venetoclax, Vincristine Liposomal/Sulfate)
n=21 participants at risk
Patients receive combination of venetoclax (600mg, orally once daily, Days 1-28) and liposomal vincristine (2.25mg/m2 IV weekly x 4, starting on Day 1) or vincristine sulfate (1.4mg/m2 IV weekly x 4 \[capped at 2mg\], starting on Day 1). Due to liposomal vincristine was removed in the US market as of April 2022, no new patients started with liposomal vincristine on this trial and patients receiving liposomal vincristine at that time were switched to vincristine sulfate at the beginning of their next cycle or as the drug supply required, whichever came first. Once a patient switched, patient must have continued with conventional vincristine sulfate for the duration of the trial.
|
|---|---|---|---|---|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Cardiac disorders
Heart failure
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
3/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
66.7%
8/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
100.0%
3/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
66.7%
14/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
4/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
66.7%
2/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
16.7%
2/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
General disorders and administration site conditions
Chills
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
25.0%
3/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
General disorders and administration site conditions
Edema limbs
|
66.7%
2/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
25.0%
3/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
19.0%
4/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
General disorders and administration site conditions
Fatigue
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
58.3%
7/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
100.0%
3/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
38.1%
8/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
General disorders and administration site conditions
Fever
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
41.7%
5/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
23.8%
5/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
General disorders and administration site conditions
Non-cardiac chest pain
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
9.5%
2/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
General disorders and administration site conditions
Pain
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
25.0%
3/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
66.7%
2/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
9.5%
2/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
General disorders and administration site conditions
Generalized edema
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
General disorders and administration site conditions
General disorders and administration site conditions - Other, specify
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
25.0%
3/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
9.5%
2/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
4/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
14.3%
3/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
4/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
66.7%
2/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
23.8%
5/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Gastrointestinal disorders
Bloating
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
4/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
100.0%
3/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
7/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
4/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
100.0%
3/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
23.8%
5/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
66.7%
8/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
100.0%
3/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
52.4%
11/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
3/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
4/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
66.7%
2/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
7/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
16.7%
2/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
66.7%
2/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Immune system disorders
Immune system disorders - Other, specify
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
66.7%
2/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
9.5%
2/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Infections and infestations
Bacteremia
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
16.7%
2/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Infections and infestations
Thrush
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
14.3%
3/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
14.3%
3/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
50.0%
6/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
100.0%
3/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
19.0%
4/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Investigations
Alkaline phosphatase increased
|
66.7%
2/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
16.7%
2/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
66.7%
2/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
19.0%
4/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
66.7%
8/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
100.0%
3/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
57.1%
12/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Investigations
Blood bilirubin increased
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
16.7%
2/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
14.3%
3/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Investigations
Creatinine increased
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
14.3%
3/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Investigations
Fibrinogen decreased
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Investigations
INR increased
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
16.7%
2/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
66.7%
2/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Investigations
Lymphocyte count decreased
|
66.7%
2/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
16.7%
2/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
66.7%
2/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
7/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Investigations
Neutrophil count decreased
|
100.0%
3/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
50.0%
6/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
100.0%
3/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
71.4%
15/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Investigations
Platelet count decreased
|
100.0%
3/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
58.3%
7/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
100.0%
3/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
61.9%
13/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Investigations
Weight loss
|
66.7%
2/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Investigations
White blood cell decreased
|
100.0%
3/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
41.7%
5/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
100.0%
3/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
61.9%
13/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Investigations
Thyroid stimulating hormone increased
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
25.0%
3/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
9.5%
2/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
4/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
66.7%
2/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
7/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
66.7%
2/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
16.7%
2/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
66.7%
2/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
19.0%
4/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
23.8%
5/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
28.6%
6/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
25.0%
3/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
19.0%
4/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
16.7%
2/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
66.7%
2/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
14.3%
3/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
66.7%
2/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
25.0%
3/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
66.7%
2/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
23.8%
5/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
23.8%
5/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
66.7%
2/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
66.7%
2/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
16.7%
2/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
14.3%
3/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
19.0%
4/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
66.7%
2/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
25.0%
3/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
66.7%
2/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
9.5%
2/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
25.0%
3/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
9.5%
2/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
66.7%
2/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
9.5%
2/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
9.5%
2/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
23.8%
5/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
16.7%
2/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
25.0%
3/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
16.7%
2/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Nervous system disorders
Ataxia
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
14.3%
3/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
16.7%
2/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
16.7%
2/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
14.3%
3/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
16.7%
2/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Nervous system disorders
Leukoencephalopathy
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Nervous system disorders
Memory impairment
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
19.0%
4/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
100.0%
3/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
66.7%
8/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
66.7%
2/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
52.4%
11/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
16.7%
2/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Nervous system disorders
Tremor
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Eye disorders
Blurred vision
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
16.7%
2/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
19.0%
4/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Psychiatric disorders
Confusion
|
66.7%
2/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
16.7%
2/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
16.7%
2/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
16.7%
2/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
66.7%
2/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
9.5%
2/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
25.0%
3/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
4/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
19.0%
4/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
16.7%
2/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
66.7%
2/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
16.7%
2/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
9.5%
2/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
16.7%
2/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Renal and urinary disorders
Hematuria
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Renal and urinary disorders
Urinary retention
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Vascular disorders
Hematoma
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
16.7%
2/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
14.3%
3/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
33.3%
1/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
4.8%
1/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
8.3%
1/12 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/3 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
0.00%
0/21 • Assessed every treatment cycle while on treatment and for 30 days after the end of treatment, up to 7 years
All patients enrolled were included in the all-cause mortality analysis. Patients who received protocol treatment were included in the toxicity analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60