Trial Outcomes & Findings for Filgrastim, Cladribine, Cytarabine, and Mitoxantrone With Sorafenib in Treating Patients With Newly-Diagnosed, Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome (NCT NCT02728050)
NCT ID: NCT02728050
Last Updated: 2023-07-05
Results Overview
MTD/RP2D will be defined as the highest dose studied in which the incidence of dose-limiting toxicity (DLT) is \< 33% assuming at least 6 patients have been treated at this dose. DLTs were defined as: 1) grade ≥3 non-hematologic toxicity lasting \>48 hours leading to \>7-day delay of the next cycle; 2) grade ≥4 non-hematologic toxicity if no recovery to grade ≤2 in 14 days (both excluding febrile neutropenia/ infection); 3) Absolute neutrophil count \<500/ µL or platelet count \<50,000/µL for \>49 days after CLAGM+S without marrow evidence of AML. Doses were escalated up to dose level six if \<2/6 patients out of each cohort of 6 had a DLT (some cohorts were expanded to 12 patients while awaiting completion of DLT monitoring period). The dose level at which dose escalation was stopped was the recommended phase 2 dose (RP2D).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
84 participants
Primary outcome timeframe
First 28 days of treatment
Results posted on
2023-07-05
Participant Flow
Participant milestones
| Measure |
Phase 1, Dose Level 1
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 10mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\^2 days 1-5 Cytarabine IV 2g/m\^2 days 1-5
|
Phase 1, Dose Level 2
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 12mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\^2 days 1-5 Cytarabine IV 2g/m\^2 days 1-5
|
Phase 1, Dose Level 3
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 15mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\^2 days 1-5 Cytarabine IV 2g/m\^2 days 1-5
|
Phase 1, Dose Level 4
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\^2 days 1-5 Cytarabine IV 2g/m\^2 days 1-5
|
Phase 1, Dose Level 5
Sorafenib 400mg AM, 200mg PM PO days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\^2 days 1-5 Cytarabine IV 2g/m\^2 days 1-5
|
Phase 1, Dose Level 6
Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\^2 days 1-5 Cytarabine IV 2g/m\^2 days 1-5
|
Phase 2, Dose Level 6
Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\^2 days 1-5 Cytarabine IV 2g/m\^2 days 1-5
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
11
|
8
|
9
|
7
|
37
|
|
Overall Study
COMPLETED
|
6
|
6
|
11
|
8
|
9
|
7
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Filgrastim, Cladribine, Cytarabine, and Mitoxantrone With Sorafenib in Treating Patients With Newly-Diagnosed, Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
Baseline characteristics by cohort
| Measure |
Phase 1, Dose Level 1
n=6 Participants
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 10mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\^2 days 1-5 Cytarabine IV 2g/m\^2 days 1-5
|
Phase 1, Dose Level 2
n=6 Participants
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 12mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\^2 days 1-5 Cytarabine IV 2g/m\^2 days 1-5
|
Phase 1, Dose Level 3
n=11 Participants
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 15mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\^2 days 1-5 Cytarabine IV 2g/m\^2 days 1-5
|
Phase 1, Dose Level 4
n=8 Participants
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\^2 days 1-5 Cytarabine IV 2g/m\^2 days 1-5
|
Phase 1, Dose Level 5
n=9 Participants
Sorafenib 400mg AM, 200mg PM PO days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\^2 days 1-5 Cytarabine IV 2g/m\^2 days 1-5
|
Phase 1, Dose Level 6
n=7 Participants
Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\^2 days 1-5 Cytarabine IV 2g/m\^2 days 1-5
|
Phase 2, Dose Level 6
n=37 Participants
Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\^2 days 1-5 Cytarabine IV 2g/m\^2 days 1-5
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Customized
|
40.5 years
n=99 Participants
|
49.5 years
n=107 Participants
|
41 years
n=206 Participants
|
49 years
n=7 Participants
|
56 years
n=31 Participants
|
48 years
n=30 Participants
|
49 years
n=3 Participants
|
48 years
n=6 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
11 Participants
n=3 Participants
|
38 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
26 Participants
n=3 Participants
|
46 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
11 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
35 Participants
n=3 Participants
|
73 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
8 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
30 Participants
n=3 Participants
|
65 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Disease classification
AML
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
29 Participants
n=3 Participants
|
69 Participants
n=6 Participants
|
|
Disease classification
MDS
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
12 Participants
n=6 Participants
|
|
Disease classification
CMML-2
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
|
MRC Risk Category
Favorable
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
|
MRC Risk Category
Intermediate
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
24 Participants
n=3 Participants
|
60 Participants
n=6 Participants
|
|
MRC Risk Category
Adverse
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
10 Participants
n=3 Participants
|
19 Participants
n=6 Participants
|
|
ELN 2017 Risk Group
Favorable
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
10 Participants
n=3 Participants
|
25 Participants
n=6 Participants
|
|
ELN 2017 Risk Group
Intermediate
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
13 Participants
n=3 Participants
|
26 Participants
n=6 Participants
|
|
ELN 2017 Risk Group
Adverse
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
14 Participants
n=3 Participants
|
32 Participants
n=6 Participants
|
|
ELN 2017 Risk Group
Unable to assess
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Secondary Disease
Secondary disease
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
7 Participants
n=3 Participants
|
13 Participants
n=6 Participants
|
|
Secondary Disease
No secondary disease
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
30 Participants
n=3 Participants
|
71 Participants
n=6 Participants
|
|
ECOG Performance Status
0
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
10 Participants
n=6 Participants
|
|
ECOG Performance Status
1
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
32 Participants
n=3 Participants
|
68 Participants
n=6 Participants
|
|
ECOG Performance Status
2
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
|
ECOG Performance Status
3
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Treatment Related Mortality (TRM) Score
|
1.15 units on a scale
n=99 Participants
|
2.00 units on a scale
n=107 Participants
|
2.72 units on a scale
n=206 Participants
|
2.19 units on a scale
n=7 Participants
|
1.57 units on a scale
n=31 Participants
|
1.28 units on a scale
n=30 Participants
|
2.21 units on a scale
n=3 Participants
|
1.96 units on a scale
n=6 Participants
|
|
FLT3 Mutations
FLT3-ITD mutation
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
10 Participants
n=3 Participants
|
21 Participants
n=6 Participants
|
|
FLT3 Mutations
FLT3-TKD mutation
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
|
FLT3 Mutations
No FLT3 mutations
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
24 Participants
n=3 Participants
|
52 Participants
n=6 Participants
|
|
FLT3 Mutations
FLT3 mutation status unknown
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: First 28 days of treatmentMTD/RP2D will be defined as the highest dose studied in which the incidence of dose-limiting toxicity (DLT) is \< 33% assuming at least 6 patients have been treated at this dose. DLTs were defined as: 1) grade ≥3 non-hematologic toxicity lasting \>48 hours leading to \>7-day delay of the next cycle; 2) grade ≥4 non-hematologic toxicity if no recovery to grade ≤2 in 14 days (both excluding febrile neutropenia/ infection); 3) Absolute neutrophil count \<500/ µL or platelet count \<50,000/µL for \>49 days after CLAGM+S without marrow evidence of AML. Doses were escalated up to dose level six if \<2/6 patients out of each cohort of 6 had a DLT (some cohorts were expanded to 12 patients while awaiting completion of DLT monitoring period). The dose level at which dose escalation was stopped was the recommended phase 2 dose (RP2D).
Outcome measures
| Measure |
CLAGM+Sorafenib Phase 1
n=47 Participants
Participants enrolled during Phase 1 were assigned to one of six escalating dose levels. Six to 12 participants were enrolled in each dose level. Doses were escalated up to dose level 6 if \<2 out of 6 participants out of each cohort had a dose limiting toxicity (DLT). The dose level at which dose escalation was stopped was the recommended phase 2 dose (RP2D).
|
Phase 1, Dose Level 2
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 12mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 1, Dose Level 3
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 15mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 1, Dose Level 4
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 1, Dose Level 5
Sorafenib 400mg AM, 200mg PM PO days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 1, Dose Level 6
Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 2, Dose Level 6
Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
|---|---|---|---|---|---|---|---|
|
Phase 1: Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of Mitoxantrone
|
18 mg/m^2
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: First 28 days of treatmentMTD/RP2D will be defined as the highest dose studied in which the incidence of dose-limiting toxicity (DLT) is \< 33% assuming at least 6 patients have been treated at this dose. DLTs were defined as: 1) grade ≥3 non-hematologic toxicity lasting \>48 hours leading to \>7-day delay of the next cycle; 2) grade ≥4 non-hematologic toxicity if no recovery to grade ≤2 in 14 days (both excluding febrile neutropenia/ infection); 3) Absolute neutrophil count \<500/ µL or platelet count \<50,000/µL for \>49 days after CLAGM+S without marrow evidence of AML. Doses were escalated up to dose level six if \<2/6 patients out of each cohort of 6 had a DLT (some cohorts were expanded to 12 patients while awaiting completion of DLT monitoring period). The dose level at which dose escalation was stopped was the recommended phase 2 dose (RP2D).
Outcome measures
| Measure |
CLAGM+Sorafenib Phase 1
n=47 Participants
Participants enrolled during Phase 1 were assigned to one of six escalating dose levels. Six to 12 participants were enrolled in each dose level. Doses were escalated up to dose level 6 if \<2 out of 6 participants out of each cohort had a dose limiting toxicity (DLT). The dose level at which dose escalation was stopped was the recommended phase 2 dose (RP2D).
|
Phase 1, Dose Level 2
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 12mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 1, Dose Level 3
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 15mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 1, Dose Level 4
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 1, Dose Level 5
Sorafenib 400mg AM, 200mg PM PO days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 1, Dose Level 6
Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 2, Dose Level 6
Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
|---|---|---|---|---|---|---|---|
|
Phase 1: Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of Sorafenib
|
400 mg BID
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 56 days (2 cycles of induction chemotherapy)We will determine if the addition of sorafenib to CLAG-M improves the rate of MRDneg CR compared to our institution's historical control of CLAG-M alone in adults with newly-diagnosed AML/high-risk MDS.
Outcome measures
| Measure |
CLAGM+Sorafenib Phase 1
n=6 Participants
Participants enrolled during Phase 1 were assigned to one of six escalating dose levels. Six to 12 participants were enrolled in each dose level. Doses were escalated up to dose level 6 if \<2 out of 6 participants out of each cohort had a dose limiting toxicity (DLT). The dose level at which dose escalation was stopped was the recommended phase 2 dose (RP2D).
|
Phase 1, Dose Level 2
n=6 Participants
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 12mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 1, Dose Level 3
n=11 Participants
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 15mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 1, Dose Level 4
n=8 Participants
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 1, Dose Level 5
n=9 Participants
Sorafenib 400mg AM, 200mg PM PO days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 1, Dose Level 6
n=7 Participants
Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 2, Dose Level 6
n=37 Participants
Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
|---|---|---|---|---|---|---|---|
|
Phase I and II: Rate of Minimal Residual Disease Negative (MRDneg) Complete Response (CR)
|
3 Participants
|
6 Participants
|
8 Participants
|
4 Participants
|
9 Participants
|
7 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsComplete remission (CR) is defined as bone marrow blasts \<5%; absence of circulating blasts; absence of extramedullary disease; ANC ≥1.0 x 10\^9/L; platelet count ≥100 x 10\^9/L. CR with incomplete hematologic recovery (CRi) is CR with ANC \<1.0 x10\^9/L or platelet count \<100 x 10\^9/L. Measurable residual disease (MRD) is assessed by multiparameter flow cytometry and PCR. Morphologic leukemia free state (MLFS) is bone marrow blasts \<5%; absence of circulating blasts; absence of extramedullary disease; no hematologic recovery. Resistant disease is defined as not not meeting the criteria for CR, CRi, MLFS.
Outcome measures
| Measure |
CLAGM+Sorafenib Phase 1
n=6 Participants
Participants enrolled during Phase 1 were assigned to one of six escalating dose levels. Six to 12 participants were enrolled in each dose level. Doses were escalated up to dose level 6 if \<2 out of 6 participants out of each cohort had a dose limiting toxicity (DLT). The dose level at which dose escalation was stopped was the recommended phase 2 dose (RP2D).
|
Phase 1, Dose Level 2
n=6 Participants
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 12mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 1, Dose Level 3
n=11 Participants
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 15mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 1, Dose Level 4
n=8 Participants
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 1, Dose Level 5
n=9 Participants
Sorafenib 400mg AM, 200mg PM PO days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 1, Dose Level 6
n=7 Participants
Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 2, Dose Level 6
n=37 Participants
Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
|---|---|---|---|---|---|---|---|
|
Complete Remission (CR)
MLFS
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Complete Remission (CR)
CR: MRD-negative
|
3 Participants
|
6 Participants
|
8 Participants
|
4 Participants
|
9 Participants
|
7 Participants
|
31 Participants
|
|
Complete Remission (CR)
CR: MRD-positive
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Complete Remission (CR)
CRi: MRD-negative
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Complete Remission (CR)
CRi: MRD-positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Complete Remission (CR)
Resistant disease
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Complete Remission (CR)
Indeterminate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsORR, defined as CR+CRi, rates of patients treated with CLAG-M with sorafenib.
Outcome measures
| Measure |
CLAGM+Sorafenib Phase 1
n=6 Participants
Participants enrolled during Phase 1 were assigned to one of six escalating dose levels. Six to 12 participants were enrolled in each dose level. Doses were escalated up to dose level 6 if \<2 out of 6 participants out of each cohort had a dose limiting toxicity (DLT). The dose level at which dose escalation was stopped was the recommended phase 2 dose (RP2D).
|
Phase 1, Dose Level 2
n=6 Participants
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 12mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 1, Dose Level 3
n=11 Participants
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 15mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 1, Dose Level 4
n=8 Participants
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 1, Dose Level 5
n=9 Participants
Sorafenib 400mg AM, 200mg PM PO days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 1, Dose Level 6
n=7 Participants
Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 2, Dose Level 6
n=37 Participants
Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
|---|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR)
|
6 Participants
|
6 Participants
|
8 Participants
|
5 Participants
|
9 Participants
|
7 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: 12 months12-month overall survival
Outcome measures
| Measure |
CLAGM+Sorafenib Phase 1
n=44 Participants
Participants enrolled during Phase 1 were assigned to one of six escalating dose levels. Six to 12 participants were enrolled in each dose level. Doses were escalated up to dose level 6 if \<2 out of 6 participants out of each cohort had a dose limiting toxicity (DLT). The dose level at which dose escalation was stopped was the recommended phase 2 dose (RP2D).
|
Phase 1, Dose Level 2
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 12mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 1, Dose Level 3
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 15mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 1, Dose Level 4
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 1, Dose Level 5
Sorafenib 400mg AM, 200mg PM PO days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 1, Dose Level 6
Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 2, Dose Level 6
Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
86 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 months12-month event free survival
Outcome measures
| Measure |
CLAGM+Sorafenib Phase 1
n=44 Participants
Participants enrolled during Phase 1 were assigned to one of six escalating dose levels. Six to 12 participants were enrolled in each dose level. Doses were escalated up to dose level 6 if \<2 out of 6 participants out of each cohort had a dose limiting toxicity (DLT). The dose level at which dose escalation was stopped was the recommended phase 2 dose (RP2D).
|
Phase 1, Dose Level 2
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 12mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 1, Dose Level 3
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 15mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 1, Dose Level 4
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 1, Dose Level 5
Sorafenib 400mg AM, 200mg PM PO days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 1, Dose Level 6
Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 2, Dose Level 6
Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
|---|---|---|---|---|---|---|---|
|
Event-free Survival (EFS)
|
81 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 months12-month relapse free survival (RFS)
Outcome measures
| Measure |
CLAGM+Sorafenib Phase 1
n=44 Participants
Participants enrolled during Phase 1 were assigned to one of six escalating dose levels. Six to 12 participants were enrolled in each dose level. Doses were escalated up to dose level 6 if \<2 out of 6 participants out of each cohort had a dose limiting toxicity (DLT). The dose level at which dose escalation was stopped was the recommended phase 2 dose (RP2D).
|
Phase 1, Dose Level 2
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 12mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 1, Dose Level 3
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 15mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 1, Dose Level 4
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 1, Dose Level 5
Sorafenib 400mg AM, 200mg PM PO days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 1, Dose Level 6
Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 2, Dose Level 6
Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
|---|---|---|---|---|---|---|---|
|
Relapse-free Survival (RFS)
|
82 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsWill be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Outcome measures
| Measure |
CLAGM+Sorafenib Phase 1
n=6 Participants
Participants enrolled during Phase 1 were assigned to one of six escalating dose levels. Six to 12 participants were enrolled in each dose level. Doses were escalated up to dose level 6 if \<2 out of 6 participants out of each cohort had a dose limiting toxicity (DLT). The dose level at which dose escalation was stopped was the recommended phase 2 dose (RP2D).
|
Phase 1, Dose Level 2
n=6 Participants
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 12mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 1, Dose Level 3
n=11 Participants
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 15mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 1, Dose Level 4
n=8 Participants
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 1, Dose Level 5
n=9 Participants
Sorafenib 400mg AM, 200mg PM PO days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 1, Dose Level 6
n=7 Participants
Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
Phase 2, Dose Level 6
n=37 Participants
Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
|
6 Participants
|
6 Participants
|
11 Participants
|
8 Participants
|
9 Participants
|
7 Participants
|
32 Participants
|
Adverse Events
Phase 1, Dose Level 1
Serious events: 2 serious events
Other events: 6 other events
Deaths: 2 deaths
Phase 1, Dose Level 2
Serious events: 2 serious events
Other events: 6 other events
Deaths: 2 deaths
Phase 1, Dose Level 3
Serious events: 4 serious events
Other events: 10 other events
Deaths: 2 deaths
Phase 1, Dose Level 4
Serious events: 4 serious events
Other events: 8 other events
Deaths: 4 deaths
Phase 1, Dose Level 5
Serious events: 4 serious events
Other events: 8 other events
Deaths: 3 deaths
Phase 1, Dose Level 6
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 2, Dose Level 6
Serious events: 22 serious events
Other events: 27 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Phase 1, Dose Level 1
n=6 participants at risk
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 10mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\^2 days 1-5 Cytarabine IV 2g/m\^2 days 1-5
|
Phase 1, Dose Level 2
n=6 participants at risk
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 12mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\^2 days 1-5 Cytarabine IV 2g/m\^2 days 1-5
|
Phase 1, Dose Level 3
n=11 participants at risk
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 15mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\^2 days 1-5 Cytarabine IV 2g/m\^2 days 1-5
|
Phase 1, Dose Level 4
n=8 participants at risk
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\^2 days 1-5 Cytarabine IV 2g/m\^2 days 1-5
|
Phase 1, Dose Level 5
n=9 participants at risk
Sorafenib 400mg AM, 200mg PM PO days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\^2 days 1-5 Cytarabine IV 2g/m\^2 days 1-5
|
Phase 1, Dose Level 6
n=7 participants at risk
Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\^2 days 1-5 Cytarabine IV 2g/m\^2 days 1-5
|
Phase 2, Dose Level 6
n=37 participants at risk
Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\^2 days 1-5 Cytarabine IV 2g/m\^2 days 1-5
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
2.7%
1/37 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Ear and labyrinth disorders
Sweet's Syndrome
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
12.5%
1/8 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/37 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
16.7%
1/6 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
27.3%
3/11 • Number of events 5 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
25.0%
2/8 • Number of events 6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
33.3%
3/9 • Number of events 5 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
71.4%
5/7 • Number of events 5 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
43.2%
16/37 • Number of events 27 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Gastrointestinal disorders
GI malignancy
|
16.7%
1/6 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
11.1%
1/9 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/37 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Gastrointestinal disorders
Perianal abscess
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
5.4%
2/37 • Number of events 2 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
16.7%
1/6 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
9.1%
1/11 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
2.7%
1/37 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
2.7%
1/37 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
2.7%
1/37 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
12.5%
1/8 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/37 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
12.5%
1/8 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/37 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
2.7%
1/37 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Cardiac disorders
Heart failure
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
2.7%
1/37 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
2.7%
1/37 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
14.3%
1/7 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/37 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Infections and infestations
Lung infection
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
5.4%
2/37 • Number of events 2 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
2.7%
1/37 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
9.1%
1/11 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
2.7%
1/37 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
5.4%
2/37 • Number of events 2 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Gastrointestinal disorders
Rectal fistula
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
11.1%
1/9 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/37 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
11.1%
1/9 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/37 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
9.1%
1/11 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
12.5%
1/8 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
2.7%
1/37 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
5.4%
2/37 • Number of events 2 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
5.4%
2/37 • Number of events 2 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Vascular disorders
Line associated DVT
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
12.5%
1/8 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/37 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Reproductive system and breast disorders
Depressed
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
12.5%
1/8 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/37 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
2.7%
1/37 • Number of events 10 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Blood and lymphatic system disorders
Sepsis
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
25.0%
2/8 • Number of events 2 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/37 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
2.7%
1/37 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Investigations
Infusion related reaction
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
2.7%
1/37 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Gastrointestinal disorders
Mucositis oral
|
16.7%
1/6 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/37 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Nervous system disorders
Seizire
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
2.7%
1/37 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
12.5%
1/8 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/37 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
11.1%
1/9 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
2.7%
1/37 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
Other adverse events
| Measure |
Phase 1, Dose Level 1
n=6 participants at risk
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 10mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\^2 days 1-5 Cytarabine IV 2g/m\^2 days 1-5
|
Phase 1, Dose Level 2
n=6 participants at risk
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 12mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\^2 days 1-5 Cytarabine IV 2g/m\^2 days 1-5
|
Phase 1, Dose Level 3
n=11 participants at risk
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 15mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\^2 days 1-5 Cytarabine IV 2g/m\^2 days 1-5
|
Phase 1, Dose Level 4
n=8 participants at risk
Sorafenib 200mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\^2 days 1-5 Cytarabine IV 2g/m\^2 days 1-5
|
Phase 1, Dose Level 5
n=9 participants at risk
Sorafenib 400mg AM, 200mg PM PO days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\^2 days 1-5 Cytarabine IV 2g/m\^2 days 1-5
|
Phase 1, Dose Level 6
n=7 participants at risk
Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\^2 days 1-5 Cytarabine IV 2g/m\^2 days 1-5
|
Phase 2, Dose Level 6
n=37 participants at risk
Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\^2 days 1-5 Cytarabine IV 2g/m\^2 days 1-5
|
|---|---|---|---|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
2.7%
1/37 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
25.0%
2/8 • Number of events 2 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/37 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
11.1%
1/9 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
2.7%
1/37 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
16.7%
1/6 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
16.7%
1/6 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
12.5%
1/8 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
11.1%
1/9 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/37 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
12.5%
1/8 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/37 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Eye disorders
Blurred vision
|
16.7%
1/6 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/37 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Cardiac disorders
Cardiac troponin I increased
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
12.5%
1/8 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/37 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
9.1%
1/11 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
12.5%
1/8 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
11.1%
1/9 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
14.3%
1/7 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
2.7%
1/37 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
9.1%
1/11 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
11.1%
1/9 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
2.7%
1/37 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
9.1%
1/11 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
14.3%
1/7 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/37 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
2.7%
1/37 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
83.3%
5/6 • Number of events 9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
100.0%
6/6 • Number of events 13 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
81.8%
9/11 • Number of events 14 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
87.5%
7/8 • Number of events 13 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
66.7%
6/9 • Number of events 8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
28.6%
2/7 • Number of events 2 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
32.4%
12/37 • Number of events 45 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Blood and lymphatic system disorders
Bacteremia
|
50.0%
3/6 • Number of events 4 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
9.1%
1/11 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
12.5%
1/8 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
14.3%
1/7 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
2.7%
1/37 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Blood and lymphatic system disorders
Cellulitis
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
33.3%
2/6 • Number of events 2 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
5.4%
2/37 • Number of events 2 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Blood and lymphatic system disorders
Fever
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
11.1%
1/9 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/37 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Blood and lymphatic system disorders
Epistaxis
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
16.7%
1/6 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/37 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
12.5%
1/8 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
22.2%
2/9 • Number of events 2 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
8.1%
3/37 • Number of events 3 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
2/6 • Number of events 2 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
16.7%
1/6 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
36.4%
4/11 • Number of events 4 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
12.5%
1/8 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
66.7%
6/9 • Number of events 7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
57.1%
4/7 • Number of events 4 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
18.9%
7/37 • Number of events 8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Gastrointestinal disorders
Dental caries
|
16.7%
1/6 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
2.7%
1/37 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
16.7%
1/6 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
5.4%
2/37 • Number of events 2 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
General disorders
Edema face
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
14.3%
1/7 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/37 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
2.7%
1/37 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Blood and lymphatic system disorders
Activated partial thromboplastin time prolonged
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
11.1%
1/9 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/37 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
9.1%
1/11 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/37 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Investigations
Fibrinogen decreased
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
2.7%
1/37 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
12.5%
1/8 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/37 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
8.1%
3/37 • Number of events 3 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
11.1%
1/9 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/37 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Infections and infestations
Toe infection
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
9.1%
1/11 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/37 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
2.7%
1/37 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
2.7%
1/37 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
2.7%
1/37 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
2.7%
1/37 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
11.1%
1/9 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/37 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
2.7%
1/37 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Gastrointestinal disorders
Rectal fissure
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
11.1%
1/9 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/37 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
2.7%
1/37 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Vascular disorders
Pulmonary embolism
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
16.7%
1/6 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
12.5%
1/8 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/37 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
12.5%
1/8 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
14.3%
1/7 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/37 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Gastrointestinal disorders
Typhlitis
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
2.7%
1/37 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
12.5%
1/8 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
11.1%
1/9 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
14.3%
1/7 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
5.4%
2/37 • Number of events 2 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Infections and infestations
Tongue infection
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
12.5%
1/8 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/37 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Infections and infestations
C.difficile infection
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
11.1%
1/9 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/37 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Blood and lymphatic system disorders
Injury to jugular vein
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
9.1%
1/11 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/37 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
16.7%
1/6 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/37 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
33.3%
2/6 • Number of events 2 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
16.7%
1/6 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/37 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
2.7%
1/37 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Nervous system disorders
Syncope
|
16.7%
1/6 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/37 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
|
Gastrointestinal disorders
Toothache
|
16.7%
1/6 • Number of events 1 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/6 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/11 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/8 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/9 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/7 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
0.00%
0/37 • From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place